Medicolegal Issues in Obstetrics and Gynaecology: Swati Jha Emma Ferriman

Medicolegal Issues
in Obstetrics
and Gynaecology
Swati Jha
Emma Ferriman
Editors
123
Medicolegal Issues in Obstetrics
and Gynaecology
Swati Jha • Emma Ferriman
Editors
Medicolegal Issues
in Obstetrics and
Gynaecology
Section Editors
Robert Burrell
Danny Bryden
Janesh Gupta
Raj Mathur
John Murdoch
Editors
Swati Jha Emma Ferriman
Department of Obstetrics and Department of Obstetrics and
Gynaecology, Jessop Wing Gynaecology, Jessop Wing
Sheffield Teaching Hospitals NHS Trust Sheffield Teaching Hospitals NHS Trust
Sheffield, UK Sheffield, UK
ISBN 978-3-319-78682-7 ISBN 978-3-319-78683-4 (eBook)

https://doi.org/10.1007/978-3-319-78683-4
Library of Congress Control Number: 2018940256
© Springer International Publishing AG, part of Springer Nature 2018

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This book is dedicated to my Father who introduced me to
Pandora’s box and made me the Doctor I am today and my
Mother who gave me the values by which I live my life.
Swati Jha
Preface
The UK is experiencing a dramatic increase in medico-legal claims. The four

main reasons for litigation are accountability, the need for an explanation,
concern with standards of care and compensation. However the decision to
take legal action is determined not only by the original injury but also by a
failure to provide information, an explanation and an apology. Insensitive
handling of an injury and poor communication after the original incident
increases the risk of litigation and erodes the patient-doctor relationship.
Doctors almost never deliberately cause harm to patients; however increas-
ingly claims are being prosecuted successfully.
Medicine has always been an imperfect science and as humans we will
make mistakes. Whereas the principle of “Six Sigma” can be applied to cer-
tain areas of medical practice, surgery involves so many variables that it
would be impossible to apply those principles. It is also true that a single
failure rarely leads to harm but in complex systems, which is what surgery
involves, it is usually the Swiss cheese model of accident causation that
results in suffering for the patient. Unfortunately this is also what often results
in successful litigation.
Obstetrics and gynaecology in particular has always had a reputation for
being a highly litigious specialty. However for all those in the practice of
obstetrics and gynaecology, we are in the specialty because we enjoy it and
have chosen it in spite of it being a litigious specialty and have obviously not
been deterred by this fact. Awareness of issues related to litigation however
makes us more aware of how best to avoid injury and harm to our patients and
at the same time protects us from accusations of clinical negligence.
The aim of this book is to highlight minimum standards relating to the
management of different conditions in the practice of obstetrics and gynaeco-
logy. We also highlight clinical governance issues and common causes of liti-
gation. A section on how to avoid litigation is provided in each chapter
followed by a case study. This should be of use to clinicians and lawyers alike
and raise awareness of how to avoid facing clinical negligence claims in our
day-to-day practice.
Sheffield, UK Swati Jha
vii
Contents
Part I General
Swati Jha and Robert Burrell
1 Ethics in Medicine�� 3

Kate F. Walker and James G. Thornton
2 Why Doctors Get Sued�� 9
Eloise Powers
3 Consent After Montgomery: Clinical Considerations�� 15
Helen Bolton
4 Consent After Montgomery: Legal Considerations�� 19
Elizabeth Thomas and Bertie Leigh
5 Duty of Candour�� 23
Helen Bolton
6 Leading Cases�� 27
Fiona Paterson
7 The Claim Journey�� 31
Karen Ellison and Emma Ferriman
8 GMC Referral�� 37
Katherine Sheldrick and Angela Pilling
9 Report Writing �� 45
Eloise Powers and Sallie Booth
10 Being an Expert Witness �� 51
John Reynard
11 The Obstetrician/Gynaecologist in Coroner’s Court�� 55
A. R. W. Forrest
12 Intimate Examinations and Chaperones �� 61
Janesh K. Gupta
ix
x Contents
Part II Anaesthesia in Obstetrics and Gynaecology

Swati Jha and Danny Bryden
13 Pain Relief�� 67

Jeremy P. Campbell and Felicity Plaat
14 Regional Anaesthesia �� 73
Sujata Handa and David Bogod
15 General Anaesthesia�� 77
Samuel Hird and Rehana Iqbal
Part III Obstetrics

Emma Ferriman and Swati Jha
16 Prenatal Screening and Diagnosis�� 85

Emma Ferriman and Dilly Anumba
17 The 20-Week Anomaly Scan �� 89
18 Induction of Labour�� 93
Myles J. O. Taylor
19 Diabetes in Pregnancy �� 99
Alexander M. Pirie
20 Cardiac Disease in Pregnancy�� 105
Philip J. Steer
21 Pre-eclampsia and Hypertension�� 109
Alexander M. Pirie
22 Umbilical Cord Prolapse �� 115
Susana Pereira and Edwin Chandraharan
23 Fetal Growth Restriction (FGR)�� 121
William L. Martin
24 Placenta Praevia, Placenta Accreta and Vasa Praevia�� 127
Jeremy Brockelsby
25 CTG Interpretation�� 133
Vikram Talaulikar and Sabaratnam Arulkumaran
26 Operative Vaginal Birth�� 139
Stephen O’Brien, Mohamed ElHodaiby, and Tim Draycott
27 Caesarean Section�� 147
James Johnston Walker
28 Shoulder Dystocia�� 153
Tim Draycott and Jo Crofts
Contents xi
29 Vaginal Birth After Caesarean Section, Uterine Rupture�� 163

Kara Dent
30 Sepsis in Pregnancy�� 169
Derek J. Tuffnell
31 Twins �� 173
Mark D. Kilby and Peter J. Thomson
32 Vaginal Breech Delivery�� 179
Simon Grant and Emma Ferriman
33 Maternal Collapse in Pregnancy�� 185
Peter Brunskill and Emma Ferriman
34 Postpartum Haemorrhage and Retained
Products of Conception Postnatal�� 191
Stephen O. Porter
35 Perineal Trauma and Episiotomy �� 199
Dharmesh S. Kapoor and Abdul H. Sultan
Part IV General Gynaecology

Swati Jha and Janesh Gupta
36 Abdominal Hysterectomy�� 207

Thomas Keith Cunningham and Kevin Phillips
37 Diagnostic and Operative Laparoscopy�� 213
Andrew Baxter
38 Diagnostic and Operative Hysteroscopy�� 217
Ertan Saridogan
39 Endometriosis�� 221
Alfred Cutner
40 Ectopic Pregnancy and Miscarriage�� 225
Andrew Farkas
41 Ovarian Surgery�� 229
Swati Jha and Ian Currie
42 Laparotomy�� 235
James Campbell
43 Urological Injuries �� 243
Christopher R. Chapple
44 Bowel Injury �� 249
Janesh K. Gupta and Tariq Ismail
45 Vascular Injury�� 253
Jonathan D. Beard
xii Contents
Part V Urogynaecology
Swati Jha
46 Vaginal Repair and Concurrent Prolapse

and Continence Surgery�� 261
Philip Toozs-Hobson
47 Midurethral Synthetic Slings�� 265
Swati Jha
48 Colposuspension and Autologous Fascial Sling�� 269
Andrew Farkas
49 Vaginal Mesh Surgery�� 273
Mark Slack
50 Vaginal Hysterectomy�� 277
Swati Jha and Linda Cardozo
51 Laparoscopic Prolapse Surgery�� 281
Simon Jackson
52 Acute Urinary Retention �� 287
Mark Slack
53 Obstetric Anal Sphincter Injury [OASI] �� 291
Swati Jha and Abdul Sultan
Part VI Infertility, Subfertility and the Menopause

Swati Jha and Raj Mathur
54 Fertility Testing and Treatment Decisions �� 297

Ying Cheong and Rachel Broadley
55 Assisted Conception �� 301
Raj Mathur
56 Gamete Donation and Surrogacy �� 307
Sharon Pettle and Hannah Markham
57 Termination of Pregnancy (Abortion)�� 313
Swati Jha and Lesley Regan
58 Hormone Replacement Therapy (HRT)�� 317
Nick Nicholas
59 Long-Acting Reversible Contraception �� 325
Raj Mathur and Swati Jha
60 Sterilisation�� 329
Janesh K. Gupta
Contents xiii
Part VII Oncology

Swati Jha and John Murdoch
61 Fast Track Referrals and GP Perspectives�� 335

Rahul Kacker
62 Running a Safe Rapid Access Clinic�� 339
Vivek Nama
63 Cervical Screening, Cytology and Histology
Laboratory Issues�� 345
Karin Denton
64 MDT Function and the Law�� 351
Alan Farthing
65 Colposcopy and Surgical Management
of Early Stage Cervical Cancer�� 357
John Murdoch
66 Vulval Disorders and Neoplasia�� 363
Helen Bolton and Peter Baldwin
67 Uterine Cancer �� 367
Amit Patel
68 Ovarian and Tubal Cancer�� 373
Richard Clayton
69 Gestational Trophoblastic Disease�� 379
John Tidy
70 Chemotherapy and Radiotherapy
in Gynaecological Cancer�� 383
Paul Symonds
Index�� 389
Part I
General
Swati Jha and Robert Burrell
Ethics in Medicine
1
Kate F. Walker and James G. Thornton
1.1 he Difference Between

T 1.2 Ethical Principles
the Law and Ethics
Medical practice should respect the following
Good law should follow ethical principles, and in principles:
day to day life we usually act ethically if we fol- Beneficence
low the law. But in complex dilemmas the ethi- A doctor should act in the best interests of the
cally correct action cannot automatically be patient
determined by reference to current law. This is Non-maleficence
obvious when we consider past laws; in many First, do no harm
countries and for many periods slavery was legal, Autonomy
but it was never ethical. Similarly termination is The patient has a right to choose or refuse
legal in some jurisdictions and illegal in others, their own treatment
so its moral status cannot be judged simply by Justice
appeal to local laws; it must be judged by appeal Resource allocations between competing indi-
to more fundamental principles. viduals should be made justly.
However, philosophical thinking is hard, there Problems typically arise in two ways. Firstly,
is often insufficient time to do it properly, and if one principle conflicts with another. For exam-
individuals easily fall prey to self-interest and ple, termination of pregnancy puts respecting the
self-deception. For everyday decisions the law, autonomy of the mother with acting non-
and paralegal bodies such as the GMC, provide maleficently to the fetus. In UK law, the rights of
simple guidance that any doctor should be able to the fetus cannot supersede the autonomy of the
follow. mother. However, the fetus does have some
The rest of this book describes the law and the ‘rights’ or else there would be no need to regulate
above day to day rules. In this chapter we con- termination of pregnancy. Secondly, around the
sider the philosophical principles that underpin issue of justice. People arguing for a just alloca-
them. tion of resources often appeal to two different
conceptions of justice. On the one hand, justice
as entitlement, e.g., a kidney should be allocated
K. F. Walker (*) · J. G. Thornton
Division of Child Health, Obstetrics in accordance with the wishes of the person to
and Gynaecology, The University of Nottingham, whom it rightfully belongs, for example, the
Nottingham, UK donor. On the other hand, justice as fairness, it
e-mail: katefwalker@doctors.org.uk; should be allocated by a fair process for example
Jim.Thornton@nottingham.ac.uk
© Springer International Publishing AG, part of Springer Nature 2018 3

S. Jha, E. Ferriman (eds.), Medicolegal Issues in Obstetrics and Gynaecology,
https://doi.org/10.1007/978-3-319-78683-4_1
4 K. F. Walker and J. G. Thornton
equal shares for all, or by lottery, or to the person by disputing the status of the fetus as a person,
who will benefit most. or by arguing that respecting bodily autonomy
Many philosophers and religious leaders takes precedence over not killing.
have attempted to resolve such dilemmas by
appeal to a universal moral law, the Golden
Rule. Immanuel Kant expressed it as his cate- 1.3.2 Personhood
gorical imperative “act only in accord with
those rules which you can, will that it become One of the central issues to the debate is the sta-
universal moral laws” [1]. Richard Hare, con- tus of the human fetus. At what point in its devel-
sidering the termination decision, added “and opment from a zygote to an autonomous, mature
as we are glad was done to us when we were in person does a human acquire a “right to life”.
the same situation” [2]. First we need to define person. Let’s be circu-
lar, and define it as a “being who may not be
unjustly killed”. The obvious answer is humans,
1.3 Case Scenario members of the species Homo sapiens. On that
definition the fetus is a person and, on the face of
A young woman requests termination of preg- it, termination is wrong. However, although it
nancy. She reports that her last menstrual period makes intuitive sense, the Homo sapiens claim
was 8 weeks ago. On scan she was found to be does not bear close examination. It is “specie-
25 weeks gestation. The doctor explained that in sist”, in the same sense as it would be racist to
the UK it is illegal for a doctor to perform a ter- claim that only whites are persons. They are both
mination beyond 24 weeks unless there is a sub- distinctions based on morally irrelevant criteria,
stantial risk to the mother’s life, or fetal namely skin colour, or species membership. The
abnormalities. The patient found a clinic abroad reason we don’t immediately perceive the specie-
that would offer late termination and booked sist claim as such, is that on this planet the only
flights to go. undisputed contenders for personhood are mem-
bers of the species, Homo sapiens.
We need a thought experiment to clarify
1.3.1 Termination Ethics things. Imagine a spacecraft landed outside your
house one day. How would you decide in what
The ethics around termination of pregnancy sense to have the occupants to dinner? Would you
remain as controversial today as they did in eat them, or sit down together and share a meal?
1967 when the Abortion Act was enacted in Remember they are making the same decision
English Law. The central argument against ter- about you. The answer is obvious. You would not
mination is that following the principle of non- decide on the basis of their species. You would
maleficence, killing innocent people is wrong. assess their mental state. Are they conscious,
The fetus is a person. Therefore termination is self-aware, do they want to live, would they be
wrong. The central argument for termination is deprived of anything by painlessly dying? If the
that if we respect autonomy, people should be answer is yes, you should not kill them, and if
allowed to do what they like with their own they’ve made the same judgment about you, they
bodies, and the mother should be allowed to also should let you live.
empty her uterus/have a termination. The self- So now we have a better definition—con-
described “pro-lifer” resolves the conflict this sciousness, self-awareness, wanting to live, are
way: when one person’s desire to do what they what makes people, people. For now we need not
like with their own body conflicts with another go into the precise definition any further. If we
person’s desire not to be killed, not killing takes take this argument, the fetus does not make the
precedence. The self-described “pro-choicer” cut. Or if it does we are already being unfair to
usually finds fault with this in two ways, either many other animals.
1 Ethics in Medicine 5
On this definition personhood/non-personhood Several religions take the stance that the human
is a continuum. Some higher animals, primates, fetus is special because it has a soul, given by
dolphins and whales probably also fulfill some God from the moment of conception. Termination
criteria for personhood. Maybe they are con- is therefore prohibited. However no adult should
scious, aware of themselves and grieve when impose their religious belief on another. So a
their family members are killed. This is a strength belief that the fetus is special is an excellent rea-
of our definition; we should be careful how we son for a believer to forego termination. But it’s a
treat such higher animals. bad reason to prohibit an unbeliever, or a believer
But however we look at it, on the basis of this in a different tradition, from choosing one.
argument, the 12-week fetus say, is not even a However not all those who are anti-
borderline person on this definition, so termina- termination argue from a religious standpoint.
tion is permitted. Tom Huffman argues that a fetus has rights wor-
One problem is that this argument appears to thy of protection: “It is proper to consider a
commit us to permit infanticide. Newborn babies woman’s right to employ a physician in self-
are not self-aware, and don’t, as far as we can tell, defence against an unwanted fetus, then it is
care about their future life. Can we also kill them equally proper to consider an interested third-
if they are inconvenient? party exercising the fetus’ right of self-defence
Some philosophers would argue yes, if no on its behalf against a women who intends to
other person is prepared to make the effort to abort. The fetus is … a moral patient who has a
look after them (e.g. Singer). The value of new- right to life but must rely upon others to protect
born babies lies in the importance other people it against those who would threaten its interests”
give them. They are precious in the way an inani- [3]. In other words because the human fetus can-
mate, but otherwise important painting like the not themselves exercise rights whereas the
Mona Lisa is precious. It is not a person, but mother can and does exercise her rights, should
destroying it would be wrong. Killing a newborn make us sensitive to the protection of whatever
baby is not the same as killing an adult, but so rights the fetus may have.
long as its mother, or the nurses looking after it, If a fetus only has rights when it is born then
want it to live then it is still wrong. the following difficulty emerges: if a doctor may
But imagine if no-one cared enough to expend be sued on behalf of a child who suffered harm
effort looking after a particular newborn baby. due to negligence on the part of that doctor while
Perhaps its mother had other concerns, or it was the child was a fetus in utero then did those rights
so premature that the only nurses who could look exist at the time of the negligence? Can the
after it, also had other concerns. Perhaps they child’s rights only be exercised retrospectively
needed time with their own families. This might after the birth?
happen as technology for saving the lives of pre- If we reject the notion that a newborn baby is
mature babies grows more complex. At that point not a person with no rights to protect, then at
we would surely allow the last neonatal intensive what stage of pregnancy is termination permissi-
care nurse to switch off the ventilator with a clear ble. A former US Surgeon General Koop said “I
conscience. do not know anyone among my medical con-
Other societies, such as the Spartans, have freres, no matter how pro-abortion he might be,
permitted infanticide in the past, and some, India who would kill a newborn baby the minute after
and China, tolerate it even today. Such societies he was born….My question is this: would you
are different but not immoral. kill this infant a minute before that, or a minute
Many people will argue that this is the wrong before that, or a minute before that?....At what
way to think about the fetus. They would argue minute can one consider life to be worthless and
that any argument which leads to a conclusion the next minute consider that same life to be pre-
that newborn babies are not people and do not cious”. A fetus may not function in the same way
have a right to life should be rejected as absurd. as an adult “consciousness, self-awareness,
anting to live” but that fact alone may not

w ple to not travel home alone. And imagine that
remove the fetus from the status of a person. you decided to cross the local park to take the
pleasure of exercise, or of viewing the sunset, and
the Music Lovers jumped out of the bushes,
1.3.3 B
odily Autonomy Versus Not abducted and connected you. Would it make any
Killing sense for the clinic director to say, “I would have
disconnected you, but I can’t because you brought
Some people have argued that termination is per- this on yourself by your reckless behaviour”?
mitted even if the fetus is as much a person as you Surely not. By analogy taking sexual pleasure
and me. After all we don’t force women to give a does not commit you to bearing the pregnancies
kidney, or even a pint of blood to save an adult that occasionally result, whatever the personhood
life. Why should we force them to carry a preg- of the fetus.
nancy? But perhaps that’s not a fair analogy. The There are many critics of Thomson’s analogy.
philosopher, Judith Jarvis Thomson, came up Some argue that we do not have the same obliga-
with a better one [4]. Her thought experiment is tion to sustain a stranger who is plugged into us
an analogy with termination for rape, but not lim- as the obligation to sustain our own offspring.
ited to that. Koukl argues that were a woman to be surgically
A famous violinist, i.e. not just a person who plugged into our own child, it’s unlikely she
valued his own life but someone whose life was would be willing to cut off the life-support so
also valued by many others, develops a fatal kid- easily. He criticises Thomson’s assumption that a
ney disease, which can only be treated by con- mother has no more duty to her own offspring
nection to the circulation of another person for than a stranger. Others have argued that the com-
9 months. He has a rare blood group and it is dif- parison between disconnecting support or with-
ficult to find someone with the right group who is holding support is not a fair comparison with
also willing to be connected. A Society of Music termination of pregnancy as the former is a case
Lovers hear about the problem, search for a suit- of letting die and the latter is a case of killing.
able person and find you. Rather than asking if Some have argued that the burden of being bed-
you would agree to be connected, they kidnap ridden and connected to a stranger for 9 months
you and connect you to the violinist’s circulation. is not a fair comparison with 9 months of a
The next day you wake up and the clinic director mobile, healthy pregnancy.
explains what has happened. You demand to be
disconnected, but the director says his hands are
tied. He can’t disconnect you without killing the 1.3.4 Taking Potentiality Seriously
violinist, an undisputed person with his own right
not to be unjustly killed. Should you stay con- Many people find the above arguments uncon-
nected? Obviously it would be kind of you to do vincing. Their intuition is different from
so. But must you? Thomson’s, or they object to the personhood
Thomson says that if after due consideration arguments on the grounds that the fetus, unlike
you decided that you couldn’t cope with 9 months animals, has the potential to become a person. If
connection, you should be allowed to disconnect. we do nothing it will likely become a paradigm
If so we should also permit termination for rape person. The philosopher Richard Hare took such
victims, whatever our belief about the person- potentiality claims seriously, arguing from the
hood of the fetus. Golden Rule; “Treat others as you were glad that
It’s only a small step to extend this line of you were treated when you were in the same
argument to termination for a woman whose con- situation” [2]. Since most mothers would not
traception has failed? Imagine it was well known have wanted to be aborted when they were
that the Music Lovers were on the hunt for a suit- fetuses, termination is, on the face of it, wrong;
able victim in your town. The police warned peo- even for a fetus with spina bifida who is likely to
1 Ethics in Medicine 7
be h andicapped, because if we were that fetus aborted or be a replacement fetus after another
we would choose life in a wheelchair rather than termination. We would know the chance of being
no life at all. a boy or girl, being handicapped, being unwanted,
But, Hare says, imagine that the mother plans born to a single parent, living in an underpopu-
a family of just one child. If she carries this preg- lated or over crowded world. Hare thinks we
nancy she will bear a child with spina bifida. If think we might be fairly liberal.
she aborts she can have a normal child who would Or perhaps it is too complicated to judge.
not otherwise exist. That “replacement child” Thinking about future people and replacement
would wish the termination to happen. The fetuses is tricky. But the complications are simi-
mother cannot act as both the spina bifida and the lar to those faced by people deciding whether to
replacement child would wish. Hare asks what reproduce at all. We solve them by leaving the
you would choose if you had to live through the decision to parents. They, especially the mother,
lives of both children? Reject termination and get are probably best placed to act in their future
one life in a wheelchair and one non-life. Abort, children’s best interest.
and get one non-life and one replacement life in
full health. You’d obviously choose the latter, so
the mother should abort. At least for a predictably 1.3.5 Deprivation of Futures
handicapped fetus where the mother is fertile and
likely to have a replacement pregnancy, termina- An American Philosopher Don Marquis set out
tion is in the interests of the replacement child. his arguments against termination (except in rare
Hare then asks us to consider how this type circumstances) [5]. He sets out that termination is
of argument plays out with the more usual types wrong because it deprives an individual of their
of termination; those considered by young future: “what primarily makes killing wrong is
women not ready for a baby. They probably will neither its effect on the murderer nor its effect on
have another child later. How much better will the victim’s friends and relatives, but its effect on
that later child’s life be? Will it be better or the victim. The loss of one’s life is one of the
worse if the mother has the first termination? greatest losses one can suffer…. [It] deprives one
There are more people to consider than just this of all the experiences, activities, projects and
child now and possible replacement/future chil- enjoyments that would otherwise have consti-
dren. All children affect other people’s lives. tuted one’s future”. He argues that just as killing
Not just in big ways, by marrying them, or tak- an adult is wrong due to the loss of their future
ing the job they wanted, but in all the minor experiences, termination too is wrong because it
ways in which each of us improves or harms the is presumed that the fetus has a future of value.
welfare of others. Fortunately, few other common ethical dilem-
Consider how all these other people would mas are as tricky to resolve as the pregnancy ter-
view the termination, the decision becomes rather mination dilemma. Most others, are solvable
like deciding whether to reproduce at all. The with clear thinking. The following is one such.
high likelihood that the present fetus will exist
without termination creates a presumption that
termination is usually wrong, but it’s hardly a 1.4 Case Scenario
knock down argument. In an overpopulated
world, if the mother would struggle to look after A 49 year old woman presented with a history of
the baby, or if the present fetus will be handi- right iliac fossa pain, dyspareunia and dysmen-
capped, termination might be the right choice. orrhoea. An ultrasound revealed a 5 cm complex
Imagine what terminations we would choose right ovarian cyst. Her Ca-125 was elevated and
if we were as yet unconceived, i.e. from behind a her risk of malignancy index was 300. She was
veil of ignorance. If we did not know whether we booked to undergo a total abdominal hysterec-
would be conceived and live, conceived and tomy and bilateral salpingo-oophorectomies.
The patient was a Jehovah’s Witness. She was weighed saving her life. For a well-informed
fully counselled about the risks of surgery in par- competent adult, respecting autonomy trumps
ticular bleeding and an advanced directive stat- doing good.
ing her refusal of all blood products was
completed. At the operation the patient was Conclusion
found to have extensive endometriosis. The For the vast majority of decisions clear ethical
operation was difficult and there was significant thinking gives a clear answer. In the case of a
venous bleeding. Five hours later, despite the fully informed, competent Jehovah’s Witness
assistance of a vascular surgeon, it became clear experiencing life threatening bleeding, the
that the woman had lost 5 L of blood and was decision not to give blood while difficult for
going to die. The patient was kept ventilated and all involved is the right decision. The ethics of
died surrounded by her family. The husband, termination are deeply contentious but we
who was not a Witness was grateful to the gynae- hope this article has set out some of the impor-
cologist that he had respected the patient’s tant philosophical arguments for and against.
wishes and acknowledged that it must be a very When it comes to ethical considerations:
difficult situation for him. The woman’s parents think long and carefully; talk to colleagues;
were furious with the JW community. record your thought process and justify your
The striking ethical principle in this case is decision making.
autonomy. The patient had a clear wish to avoid
all blood products. She was fully aware that the
operation she was going to have had a risk of
bleeding and that without blood products that References
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Why Doctors Get Sued
2
Eloise Powers
2.1 Introduction Most clinical negligence claims in England and

Wales are brought against Trusts or other organisa-
In this chapter, an overview of the main categories of tions rather than against individual doctors. The vast
clinical negligence claims which are typically majority of claims do not proceed to trial: in 2015–
brought against medical professionals in England 16, the NHS Litigation Authority (now part of NHS
and Wales will be provided, namely: consent, errors Resolution) stated that “fewer than 1% of the claims
of treatment (including surgical errors) and errors of we resolved went to trial” [2]. It seems empirically
diagnosis. This is not intended to be an exhaustive likely that the cases which do proceed to trial are
categorisation of cases, but it covers the majority of closer to the borderline (in terms of merits) than the
clinical negligence cases which doctors are likely to cases which settle or are discontinued by claimants.
encounter in practice. Other types of cases include Under these circumstances, it is important to con-
secondary victim claims and systemic/procedural sider typical examples of cases which settle.
failings. In each category, key legal principles are set Obstetric claims deserve special consideration:
out, a case example is given and advice is provided 33% of NHS Resolution’s annual expenditure
on how doctors can avoid litigation. The guidance (10% of claims received) comes from obstetrics
set out in the chapter can only be regarded as generic [3]. Claims involving birth injuries, such as cere-
in nature and does not constitute legal advice. bral palsy claims, are often of very high value
The advantages of avoiding litigation are self- involving lifelong care claims. Obstetric claims
evident. For doctors, the litigation process is time- can often span two or three of the categories con-
consuming, difficult and distressing. For patients, sidered in this chapter: for example, in a shoulder
the consequences of clinical negligence are often dystocia case, a claimant may allege a failure to
devastating. For the NHS, the costs of litigation obtain properly informed consent followed by the
are burdensome: NHS Resolution’s stated strate- use of excessive traction in effecting the delivery.
gic objective is “a move to an organisation which
is more focused than before on prevention, learn-
ing and early intervention to address the rising 2.2 Consent
costs of harm in the NHS” [1]. For all concerned,
it is clear that prevention is better than cure. 2.2.1 Key Legal Principles
Following the 2015 case of Montgomery [4], a doc-

E. Powers
Serjeants’ Inn, London, UK tor is under a duty to obtain a patient’s informed
e-mail: EPower@serjeantsinn.com consent to treatment in the following manner:

https://doi.org/10.1007/978-3-319-78683-4_2
10 E. Powers
• Take reasonable care to ensure that the patient choices.” The implication is that the Montgomery
is aware of any material risks involved in any approach may (in the long run) serve to reduce
recommended treatment. litigation once it has been fully assimilated into
• Take reasonable care to inform the patient of medical practice.
any reasonable alternative or variant treat-
ment, and of the material risks of the reason-
able alternative or variant treatment. Case Study: Ms. A
Ms. A presented with a complaint of sig-
The concept of “material” risk is defined as nificant post-menopausal bleeding. Her
follows: “whether, in the circumstances of the medical history included two caesarean
particular case, a reasonable person in the section deliveries, Crohn’s disease and a
patient’s position would be likely to attach sig- right hemicolectomy, cholecystectomy and
nificance to the risk, or the doctor is or should hepaticojejunostomy and post-surgical pel-
reasonably be aware that the particular patient vic adhesions. She underwent an endome-
would be likely to attach significance to it.” trial biopsy, which revealed no evidence of
Importantly, it will not be a defence to estab- residual hyperplasia of the endometrium.
lish that the failure to warn of the material risk She was offered a hysterectomy to resolve
would be accepted as proper by a responsible the bleeding.
body of medical opinion. When a patient makes Ms. A was appropriately advised of the
a choice about medical treatment, it inevitably routine risks associated with a hysterec-
involves making value judgments. The Supreme tomy, but she was not advised of the sig-
Court held that these value judgments should be nificant risk to her bowel and biliary
made by the patient, not the doctor. Under the reconstruction due to her complex medical
circumstances, the Bolam approach becomes history. Further, she was not advised about
inappropriate in consent cases. alternative treatment options including hor-
In circumstances where a doctor reasonably monal treatment with progestogen, contin-
considers that disclosure of information would be uous HRT or a Mirena IUS. She was not
“seriously detrimental to the patient’s health,” or advised that the bleeding would be likely to
in circumstances of “necessity”, doctors will not stop within around a year even if she did
be required to obtain informed consent. not undergo treatment.
The effect of the Montgomery judgment is to Unfortunately, Ms. A sustained a small
move away from a paternalistic model of the bowel injury during her hysterectomy. She
relationship between doctor and patient. As the thereafter suffered a chain of complications
Court of Appeal observed in Webster [5]. “What including fistula and sepsis. Her condition
they point to is an approach to the law which, deteriorated, she went into multi-organ
instead of treating patients as placing them- failure and died at the age of 57.
selves in the hands of their doctors (and then This case illustrates the dangers of tak-
being prone to sue their doctors in the event of a ing a “standardised” approach to the con-
disappointing outcome) treats them so far as senting process. Ms. A needed to know that
possible as adults who are capable of under- she was at significantly increased risk of
standing that medical treatment is uncertain of serious complications if she underwent a
success and may involve risks, accepting respon- hysterectomy, and needed to know that
sibility for the taking of risks affecting their own there were far safer options available to
lives, and living with the consequences of their treat her vaginal bleeding.
2 Why Doctors Get Sued 11
respected professional opinion.” A doctor who

Avoiding Litigation acts in accordance with a standard of practice
• The consenting process does not start recognised as proper by a responsible body of
and finish with the consent form. Be medical opinion will not be held to be negli-
aware that a Court will review the whole gent merely because another body takes a con-
consenting process, including the trary view.
records of your pre-treatment discus- In the 1997 case of Bolitho [7], the House of
sions with the patient and Lords held that in applying the Bolam test, the
correspondence. court has to be satisfied “that the exponents of the
• As Baroness Hale observed in body of opinion relied on can demonstrate that
Montgomery, “it is not possible to con- such opinion has a logical basis.” Experts
sider a medical procedure in isolation should direct their minds to the question of com-
from its alternatives.” Make sure that parative risks and benefits and reach a defensible
you have discussed alternative proce- conclusion on the matter.
dures, and the risks and benefits of these
procedures, with your patient, and make
a record of these discussions.
Case Study: Ms. B
• Where appropriate, advise your patient
Ms. B suffered a perineal tear classed as 3b
that having no treatment/conservative
following the protracted and difficult deliv-
treatment is available as an option.
ery of her first child. The tear was repaired
• The consenting process is patient-
shortly after delivery. Two months later,
specific and should take account of the
Ms. B re-presented with symptoms of an
risks, benefits and alternative treatments
ano-perineal fistula, which was confirmed
applicable to each individual patient.
upon MRI and upon ano-rectal physiology.
• Where your patient has a history which
The doctors who performed the ano-rectal
puts her at additional risk if she under-
physiology strongly recommended that
goes the proposed treatment, you should
Ms. B should be referred to a colorectal
discuss the additional risk with the
surgeon to perform the repair.
patient, quantify the additional risk
The repair procedure nevertheless pro-
where possible and make a record of the
ceeded under the supervision of an urogyn-
discussion.
aecologist. The procedure was performed
• When managing labour/delivery, pres-
incorrectly, resulting in far more extensive
ent the pros and cons of different modes
damage than was necessary: the vaginal
of delivery in an objective manner
wall was opened, the perineum was opened
(regardless of your personal beliefs or
till the fistula, the anus was opened and the
preferences).
fistula track was excised. The correct pro-
cedure would have been to treat the fistula
with a seton (loose or cutting).
Ms. B suffered permanent and disabling
2.3 Errors of Treatment incontinence and requires ongoing treat-
or Surgery ment by way of inserts.
This case demonstrates the importance
2.3.1 Key Legal Principles of following correct procedures, and of
ensuring that patients are referred to the
The 1957 case of Bolam [6] established the fol- most appropriate specialist for their
lowing touchstone: whether the doctor is act- condition.
ing in accordance with a practice of “competent
12 E. Powers
in the higher courts, the legal principles relating to

Avoiding Litigation errors of diagnosis are the same as the legal prin-
• Familiarise yourself with up-to-date ciples relating to errors of treatment.
guidelines and literature. The National
Institute of Clinical Excellence (NICE)
and the Royal College of Obstetricians Case Study: Ms. C
and Gynaecologists (RCOG) guidance During a period lasting over a year, Ms. C
documents are routinely scrutinised in attended various appointments with her GP
the course of treatment/ surgical claims. and at the colposcopy clinic. She had a
• In situations where you are deviating sore, macerated area on her right labium
from best practice guidance, ensure that majorum, and experienced vulval pain to
you have fully thought through and docu- the extent that she was unable to tolerate
mented your rationale for doing this, and the colposcopy speculum. Despite this, she
that you have obtained clear and compre- was not referred to a gynaecologist for over
hensive consent from your patient. a year. When she was eventually referred to
• Where a particular procedure falls out- a gynaecologist, she was diagnosed with
side your specialism or is usually under- vulval cancer.
taken by a different specialism, consider Due to the delay in diagnosis, Ms. C was
referring your patient to a relevant advised to undergo a radical vulvectomy
specialist. rather than a simple removal of the lesion.
• In obstetrics, midwives should be aware She suffered disabling lymphoedema and
of the circumstances in which an obste- has lost all sexual function at a young age.
trician’s opinion is needed. This case demonstrates the importance
• In gynaecological surgery, consider of being alert to incidental findings, and
involving a colorectal specialist in cases the importance of taking action within a
where there is an increased risk of bowel reasonable time-frame where a patient has
injury. potentially worrying symptoms.
• Discuss difficult cases with colleagues/
at a multi-disciplinary team meeting,
and record your discussions.
Avoiding Litigation
• Be alert to the patient who repeatedly
presents with symptoms which are diffi-
2.4 Errors of Diagnosis/Delayed cult to explain. Discuss such patients at
Diagnosis MDT meetings, and make referrals
where appropriate.
2.4.1 Key Legal Principles • Take action quickly (investigations,
referral to other specialists, treatment)
In the 2017 first instance case of Muller [8], Mr. where a patient makes a poor recovery
Justice Kerr considered whether the Bolam prin- after surgery.
ciple applied to cases involving errors of diagno- • Have a high index of suspicion for the
sis or failure to make a diagnosis (as distinct from investigation and treatment of cancer. A
cases involving the exercise of professional judge- large number of clinical negligence cases
ment about treatment or surgery). He concluded— arise out of delayed diagnosis of cancer.
in his words, “with some regret”—that the • Be alert to sepsis and take rapid action
principles in Bolam and Bolitho do indeed apply where appropriate [9]. Failure to diag-
to cases involving errors of diagnosis. At the time nose and treat sepsis generates a
of writing, and pending any further developments
2 Why Doctors Get Sued 13
References
significant number of clinical negli-
gence cases, often with tragic 1. “Delivering fair resolution and learning from harm”:
Our strategy to 2022. NHS Resolution, p4.
consequences.
2. NHS Litigation Authority Annual report and accounts
• Encourage junior staff to escalate 2015/16, p16.
patients with troubling symptoms as 3. “Delivering fair resolution and learning from harm”:
soon as possible. Our strategy to 2022. NHS Resolution, p12. Note that
these statistics do not seem to include gynaecological
claims other than obstetrics.
4. Montgomery v Lanarkshire Health Board [2015]
UKSC 11. The facts of the Montgomery judgment
Key Points: Why Doctors Get Sued are considered in more detail in [chapter dealing with
• Plan the patient’s treatment in conjunc- case law].
tion with the patient. 5. Webster v Burton Hospitals NHS Foundation Trust
[2017] EWCA Civ 62, para 81.
• Advise the patient of alternative treat- 6. Bolam v Friern Hospital Management Committee
ment options/no treatment. [1957] 1 WLR 583, p587.
• Take a patient-specific approach when 7. Bolitho v City and Hackney Health Authority [1998]
advising about risks. AC 232, p1158.
8. Muller v King’s College Hospital NHS Foundation
• Be objective when advising about the Trust [2017] EWHC 128.
pros and cons of different birth options. 9. Sepsis: recognition, diagnosis and early management,
• Familiarise yourself with best practice https://www.nice.org.uk/guidance/ng51.
documents.
• Clearly consider and document your
rationale for any departure from best
practice in a particular case.
• Discuss complex or puzzling cases at an
MDT or with professional colleagues,
and record your discussions.
• Work within your competence and refer
patients to the most appropriate
specialist.
• Investigate or refer patients with ongo-
ing unexplained symptoms.
• Take action quickly where a patient fails
to recover as expected after surgery.
• Be alert to sepsis.
• Investigate potential cancer cases
rapidly.
• Follow up upon any concerns about
your patients.
• Encourage junior staff to escalate
patients with concerning symptoms.
Consent After Montgomery:
Clinical Considerations 3
Helen Bolton
3.1 Background Mrs. Montgomery claimed that had she been

advised of the risks of shoulder dystocia and
In March 2015 the UK Supreme Court ruled on a offered caesarean section, then she would have
landmark case that confirmed patients’ right to chosen that option, thus avoiding vaginal birth
autonomy [1]. During her first pregnancy Nadine and her son would have been healthy. The case
Montgomery, a petite, diabetic woman, expressed was won on appeal at the Supreme Court. She
anxieties on several occasions about her forthcom- received around £9 m in damages.
ing delivery, as scans had identified a large baby. Prior to Montgomery, consent cases were
She did not specifically request caesarean section. tested by traditional tests of negligence, i.e.,
The delivery was complicated by shoulder dystocia doctors only failed in their duty in consent
and consequently her son developed cerebral palsy. cases if it could be proven that their practice
Mrs. Montgomery had not been advised of the was not in line with how a body of responsible
potential risks of vaginal delivery or shoulder dys- practitioners would act (the Bolam [2] princi-
tocia. Nor had the option of a planned caesarean ple). Doctors were only obliged to inform
section been discussed. Defending her practice, patients of risks if these were perceived by the
the obstetrician claimed that although the risk of doctor to be significant (Sidaway [3]). The
shoulder dystocia was significant, the absolute Montgomery ruling now enshrines in case law
risk of grave injury resulting from it was minimal, that it is no longer up to the doctor to decide the
and therefore she was not obliged to discuss it. extent of disclosure about risk. Rather, it up to
Moreover, she claimed such discussions are not the patient to decide.
standard practice, and that if all diabetic women
were told of these risks then they would inevitably
choose caesarean delivery, which would not be in 3.2 Requirements for Consent
their best interests. As Mrs. Montgomery had not
asked about caesarean, she had been under no Doctors have an ethical and legal duty to obtain
obligation to discuss it with her. a competent patient’s consent before embark-
ing on treatment, unless there are exceptional
circumstances [4]. Competent patients have an
absolute right to accept or refuse treatment,
H. Bolton
without any need to justify their decision. A
Addenbrooke’s Hospital, Cambridge University
Hospitals NHS Foundation Trust, Cambridge, UK patient is free to withdraw her consent at any
e-mail: helenbolton@me.com time.

https://doi.org/10.1007/978-3-319-78683-4_3
16 H. Bolton
The Montgomery ruling has not altered the that the particular patient would be likely to
fundamentals of consent. It remains the case that attach significance to it.
for consent to be valid the patient must [5]:
What constitutes a ‘material risk’ cannot be
1. Have capacity to give their consent to make defined simply by percentages. The judges
that particular decision, gave clear guidance that the significance of
2. Be provided with sufficient information (clar- each risk for the individual patient is likely to
ified in Montgomery) reflect a range of factors other than just its
3. Be free from coercion, and able to give their magnitude. The significance of the risk should
decision voluntarily. be assessed by:
The Mental Capacity Act 2005 provides clear 1 . The nature of the risk
guidance on capacity and clinicians must be 2. The effect that it would have on the life of the
familiar with this [6]. It is good practice for con- patient
sent to be documented in writing, especially for 3. The importance of the potential benefits of the
interventions such as surgery, although this is not treatment to that particular patient
usually a legal requirement. 4. The alternatives available (including no

treatment)
5. The risks involved in those treatments
3.3 onsent After Montgomery:
C
What Constitutes Sufficient Therefore, the assessment of material risk
Information? requires both facts about the risk itself, in addi-
tion to knowledge about the characteristics and
The judgment in Montgomery clarifies that it is wishes of the patient. This requires clear dialogue
the patient, not the doctor, who determines how with the patient, and doctors must take time to
much information is required for sufficient con- have a discussion with the patient about risks and
sent. This is a clear departure from previous to establish (within reason) which risks will mat-
case law, where the doctor was required only to ter for that particular patient. Substituting dia-
impart the information that a reasonable body logue with written information, or overwhelming
of medical opinion thought appropriate. the patient with technical information is not
Although the Montgomery ruling has been per- acceptable. To avoid future litigation, it is essen-
ceived to have changed the landscape of medi- tial to document what was discussed in as much
cal consent, the same overriding principles detail as possible, and how the patient responded
have been enshrined in GMC guidance for to the information.
many years [5]. Although Montgomery requires doctors to dis-
Since Montgomery, the new test for sufficient cuss alternative options with the patient, it does
information is now as follows [1]: not require the doctor to provide that treatment. It
remains the doctor’s responsibility to advise
1. The doctor is under a duty to take reasonable patients on which treatment may be medically
care to ensure that the patient is aware of any preferable, but ultimately it is up to the patient to
material risk involved in the treatment, and be decide.
informed of any reasonable alternative treat-
ments, including no treatment.
2. The materiality test is whether, in the circum- 3.3.1 E
xceptions to Provision
stances of that particular case, a reasonable of Information
person, in that patient’s position would be
likely to attach any significance to that risk, or There are three situations where it may not be
the doctor is, or should reasonably be aware, necessary to discuss material risks:
3 Consent After Montgomery: Clinical Considerations 17
1. Where treatment is provided out of necessity 3.4 ourt Decisions Since

C
in an urgent situation Montgomery
2. The therapeutic privilege exception—this is the
rare situation where a doctor has the right to 3.4.1 A
v East Kent Hospitals
withhold information about risks if it is believed University NHS Foundation
that the patient will be seriously harmed by Trust [2015] EWHC 1038
knowledge of that risk. This only applies in
very exceptional cases, and withholding infor- Mrs. A brought a claim alleging that her obste-
mation just to prevent upsetting or worrying a tricians had failed in their duty to warn her of
patient is not acceptable, as upset and worry do the possibility that her child may have a chro-
not constitute serious harm. mosomal abnormality. Routine screening tests
3. The right of the patient not to know—a
for trisomy 13, 18 and 21 had estimated a very
patient can decide that they do not wish to low risk of abnormality, and there were no
be aware of the risks, and a doctor is not structural anomalies at her 20-week scan. The
obliged to discuss them when a patient fetus was shown to be small on scan measure-
makes it clear that she does not wish to dis- ments and subsequently she underwent serial
cuss the matter. The GMC guidance pro- growth scanning and monitoring until delivery
vides further advice on how to manage by caesarean section at 37+6 weeks.
patients in this situation [5]. Although Unfortunately the baby was born with severe
patients have the right not to know, this can disabilities secondary to a rare unbalanced
be problematic, as the patient doesn’t know chromosome translocation. Mrs. A claimed
what they do not want to know. that had she been advised of the risk then she
would have elected for amniocentesis, thus
detecting the abnormality, and consequently
3.3.2 Birth Choices she would have chosen to terminate the preg-
Post-Montgomery nancy. The key issue in this case was resolving
whether or not there was evidence that there
Mrs. Montgomery won her case because she had was a material risk that the baby may be suffer-
not been advised of the risks of vaginal birth or ing from a chromosomal abnormality. If so, in
offered the option of caesarean section. She had keeping with the Montgomery case, it was
not specifically enquired about caesarean section, agreed that the doctors ought to have raised
however the judge ruled that her obstetrician still that material risk with Mrs. A. However, on
had a duty of care to discuss this option with her. review of the evidence presented by the defen-
In her ruling, the judge intimated that the medical dants and expert witnesses the court concluded
team may have viewed vaginal delivery as mor- that there was no material risk that the baby
ally superior than caesarean section, and that this had a chromosomal abnormality, over and
view had dominated their thinking. She also stated above the background risk. There was nothing
that ‘gone are the days when it was thought that, to suggest that this was a risk to which a rea-
on becoming pregnant, a woman lost, not only her sonable patient, in the position of Mrs. A,
capacity, but also a right to act as a genuinely would have attached any significance. Indeed,
autonomous human being’ [1]. It remains to be the judge noted that Mrs. A had already
seen what impact Montgomery will have on future accepted the very low background risk given in
litigation. However, obstetricians must be mindful her screening tests and continued with the
of a woman’s right, now enshrined in case law, to pregnancy. Medical practitioners do not have
decide which type of delivery she wishes. to warn patients about theoretical risks.
18 H. Bolton
3.4.2 S
pencer v Hillingdon
Hospitals NHS Trust [2015] • Doctors must take reasonable care to
EWHC 1058 ensure the patient is made aware of any
material risk involved in the proposed
Although not strictly concerning consent, this treatment.
case is of relevance because the judge applied the • The materiality test is individual to the
Mongtomery materiality test in determining the specific patient and their circumstances,
duty to provide advice to a patient during the and requires dialogue between patient
post-operative period. Mr. Spencer brought a and doctor.
case claiming that the hospital had failed in its • Written information, and/or over-
duty to warn him of the possibility of post- whelming the patient with excessive
operative venous thromboembolic events (VTE). information does not constitute proper
He underwent elective surgery to repair an ingui- consent.
nal hernia. Shortly after discharge he experi- • Doctors must discuss alternative
enced calf pain. He attributed this to inactivity options with the patient, including the
due to being generally unwell after surgery, and risks and benefits associated with those
did not specifically seek medical attention until options.
several weeks later when he presented with • Detailed documentation of discussions
severe shortness of breath and palpitations. He is essential to avoid litigation. A written
was diagnosed with bilateral pulmonary emboli. consent form alone is insufficient
It was proven in court that the hospital had failed documentation.
to provide him with any specific information, • When considering birth options, women
either oral or written, with respect to the risks must be informed of the material risks
and symptoms of VTE. Instead he had simply associated with vaginal delivery, includ-
been advised to report ‘any problems’ after his ing risks to the mother as well as the
discharge. The judge acknowledged that Mr. baby.
Spencer was in a low risk group for VTE, and
that VTE is a rare event. However, in applying
the basic principles defined in Montgomery, the
References
judge concluded that a reasonable patient, such
as in Mr. Spencer’s case, would expect to be 1. Montgomery v Lanarkshire Health Board [2015]
advised about the symptoms and signs of VTE UKSC 11.
given the potential seriousness of the condition. 2. Bolam v Friern Management Committe [1957] WLR
582.
By not warning Mr. Spencer of specific signs and
3. Sidaway v Board of Governors of the Bethlem Royal
symptoms of VTE, the Trust had failed in its duty Hospital [1985] AC 871.
of care. He was awarded £17,500 in damages, as 4. RCS. Consent—Supported Decision Making—a
the judge also concluded that had Mr. Spencer good practice guide. 2016.
5. GMC. Consent: patients and doctors making deci-
been properly advised (confirming causation), he
sions together. 2008.
would have sought medical attention earlier. 6. GOV.UK. Mental Capacity Act 2005 Code of Practice.
2007.
Key Points: Consent After Montgomery

• The Montgomery judgment requires a
patient-centered approach to consent,
and is entirely in keeping with GMC
guidance on consent.
Consent After Montgomery: Legal
Considerations 4
Elizabeth Thomas and Bertie Leigh
4.1 Introduction and abbreviations that mean nothing to most lay

people. For example, most forms mention the
The present law of consent is shaped by the 2015 risk of bleeding: patients will think they are likely
judgment of Montgomery [1]. The Supreme to bleed if their skin is cut; we have no record that
Court in Montgomery relied heavily on guidance they were told how much bleeding there might be
published by the GMC in 2008 [2]. However, and whether it might be difficult to arrest. Such a
Mrs. Montgomery was treated in 1999. This sug- form may be a useful aide memoir to the doctor
gests that in order to advise practitioners how to of what they have said in relation to that specific
counsel their patients today we have to anticipate procedure, but it does not provide objective evi-
the position of the regulators and courts many dence that the patient understood what was
years hence, something we attempt to do by ana- meant, had time to assimilate the information or
lysing whether the current system of consent that it was conveyed in an appropriate fashion.
reflects optimal medical practice. Sometimes the evidence we need is haphaz-
ardly recorded in clinic letters describing
Montgomery discussions and the decision to pro-
4.2 Use of a Consent Form ceed. But we need a structured record of the deci-
sion process. The current focus on consent forms
The consent form was devised as a defence to is because it is the only place where the patient
battery i.e. unlawful touching, to prove the patient makes a physical entry in the notes by their sig-
consented to the doctor’s touch. It is now used as nature - a reassuring but often empty disclaimer
evidence of an informed choice to a specific for the doctor that it is the patient‘s informed
treatment. For that consent to be Montgomery- choice to proceed.
compliant the form should evidence discussions For the avoidance of doubt, should the consent
of alternatives, including various material risks form (currently seen as the pinnacle of the con-
and benefits including no treatment. However, sent process) be presented to a patient shortly
typically the information the patient is given on before an intervention we say it is prima facie
the form is specific to the agreed treatment and evidence of malpractice, if not professional mis-
recorded in untidy handwriting with acronyms conduct. This is because:
E. Thomas (*) · B. Leigh 1. It implies that consent was sought at the

Hempsons, London, UK wrong time. The patient has long since
e-mail: e.thomas@hempsons.co.uk; already made their decision, they have
b.leigh@hempsons.co.uk

https://doi.org/10.1007/978-3-319-78683-4_4
20 E. Thomas and B. Leigh
arranged to take time off work and made 4.4 The Decision Record
arrangements for their domestic responsi-
bilities to be disposed of. They have men- Lawyers work on the principle that if it is not writ-
tally adjusted themselves so as to undergo an ten down it did not happen. Therefore, we need to
intervention and it is quite wrong to suppose find a way for doctors to record not only the infor-
that a Montgomery explanation of risks/ben- mation that has been conveyed to the patient but
efits/alternatives can sensibly be presented also the fact that the patient has understood what
to them long after the decision to proceed has been said. To fend off future litigation sur-
has been taken. rounding consent we need to replace the current
2. Such consent is sought at the wrong time
system with a decision record. However, it seems
emotionally. The patient will be anxious if not to us that an optimal process will not take place in
frightened by the imminence of surgery, and most time-poor NHS clinics. If the matter is to be
so it is unlikely that they will be able to absorb done properly it has to be done without time pres-
significant information that is of relevance to sure, probably in the comfort of the home.
the important decision that they are being We suggest that a great deal of the information
asked to take. Mentally they are already com- that needs to be conveyed as well as the recording
mitted to the operation. of the patient’s understanding can best be
achieved with technology. For example, an
online/downloaded programme could contain the
4.3 Future Law information that the doctor wishes to convey,
with the opportunity for patients to learn even
We suggest that when the Supreme Court next more. If the process were linked to the treating
considers a case of consent to treatment it will centre there could be a record of the information
go beyond analysing whether all the appropri- accessed and that spurned.
ate risks/benefits and alternatives were men- An algorithm could be written so as to high-
tioned: it will be considering how and when light anomalous answers with alarms triggering
they were described. It will examine the doc- invitations to attend an additional clinic. This
tor’s discharge of their role as a teacher. It will could require the presence of the treating clini-
be asking whether the necessary information cian but equally it could be with a nurse-
was given in an appropriate fashion. If the counsellor—the process of learning must be
patient was counselled in the wrong language, recorded and scribbled notes avoided.
or at the wrong time, or if the information was Alternatively it could all be done online with an
unlikely to have been understood because the invitation to access further information. The vari-
doctor was rushed or spoke in a technical fash- ations that could be devised are vast.
ion, then the process will be found wanting Such a programme could utilise cartoons, dia-
even if all the right risks and alternatives were grams and videos describing the anatomy, the
mentioned. lesion or the disease and the modalities of treat-
Simple utterance of Montgomery informa- ment. There could be graphs and statistical tables
tion does not discharge the doctor’s duty of presenting data that the patient may want to
care. For a decision system to be fit for purpose understand. Crucially the system could be in the
it needs to be able to identify objective evi- patient’s own language.
dence that the individual patient has under- Not all medical decisions call for this pattern
stood the information provided and made a of counselling. In dire emergencies all that the
decision based on that understanding. patient really needs to know is that if they do not
Counselling may need as much skill as diagno- consent to the proposed treatment imminent
sis or performing a procedure. death is a certainty. There are also patients who
4 Consent After Montgomery: Legal Considerations 21
are so cognitively impaired that we stray into best evidence of an informed choice to a specific
interests territory and those unable to access treatment. However, we do not need a record
technology will need assistance. However, we of what is self-evident from the fact that the
have to describe an optimal process of counsel- patient is willingly lying on the bed, but a
ling before we identify the deviations that will be record of the process by which they came to
appropriate in certain circumstances. take the decision to be there. We need a record
We advocate that the profession should develop of the fact that the hospital has played its part
these procedure-specific decision records. If the in helping the patient to take that decision in a
text is agreed by the profession through the Royal Montgomery-compliant fashion. We also need
Colleges and the professional societies then we a process that reflects the importance of
will have the advantage of consistency in different recording advice given to patients when sur-
centres as well as avoiding multiple repetitions of gery is not in issue or an alternative to surgery
the work of preparation. That does not mean that is chosen. It is our opinion that the current sys-
it should be immutable. Through use we antici- tem of discussions in rushed clinics with the
pate it would be re-written and adapted - it should handing out of leaflets and consent evidenced
be a living, growing thing, responding to the way by a scribble on a consent form is not fit for
in which it is used by patients and to reflect chang- purpose and will not withstand future forensic
ing science and treatment options. scrutiny by the courts. This is not because
Incidentally the technology could also use- there is anything in the law that says it is
fully record the patient’s view of the process in wrong, but because it is not part of an optimal
retrospect; recording whether the treatment and medical practice. Trying to shoe-horn a
the outcome corresponded to the patient’s expec- defence to battery into a decision record is
tations. This would of course provide a means of simply misguided.
reviewing both the counselling provided and the
skill of the clinician and so allowing the continu-
ing development of both. References
1. Montgomery v Lanarkshire Health Board [2015]
Conclusion
UKSC 11.
The consent form was devised as a defence to 2. GMC, Consent: patients and doctors making deci-
battery—unlawful touching—the patient con- sions together. 2008.
sented to the doctor’s touch. It is now used as
Duty of Candour
5
Helen Bolton
5.1 Background and midwives work closely together, the GMC

and the Nursing and Midwifery Council (NMC)
The duty of candour is about being open and hon- have published more detailed joint guidance on
est when things go wrong. There are two types of the matter setting out clear expectations for
duty, professional and statutory. The professional health care professionals [2]. The joint guidance
duty of candour is defined by the General Medical covers both the professional’s individual duty to
Council (GMC) as ‘a professional responsibility to patients, and the professional’s responsibilities to
be honest with patients when things go wrong’. In the organisation for which they work. The duty to
contrast, the statutory duty of candour is a legal the patient arises when something goes wrong
duty to be open and honest, and applies to all health during a patient’s treatment or care, that causes,
and social cares organisations that are registered or has the potential to cause, harm or distress. In
with the regulator, the Care Quality Commission such a case the healthcare professionals must:
(CQC) in England. Although there is considerable
overlap, there are important distinctions between • Tell the patient (or, where appropriate, their
the two. Clinicians must understand these differ- family or carer) that something has gone
ences to ensure they can fulfill both their profes- wrong
sional and legal responsibilities to their patients. • Apologise—stating what happened, what can
be done to deal with any harm caused, and
what will be done to prevent this happening
5.2 Professional Duty again
of Candour • Offer an appropriate remedy or support to put
matters right, if possible
It is well established that healthcare professionals • Provide a full explanation of the short and
have an ethical responsibility to be open and hon- long term effects of what has happened
est with their patients, and this is enshrined in the
GMC’s guidance for doctors ‘Good Medical As was noted immediately above, the profes-
Practice’ [1]. Recognising that doctors, nurses sional duty of candour applies whenever patients
have suffered harm or distress when something
has gone wrong with their care. Unlike the statu-
H. Bolton tory duty of candour (see below), there is no
Hospitals NHS Foundation Trust, Cambridge, UK defined threshold of harm that needs to be met for
e-mail: helenbolton@me.com the duty to arise. In circumstances, where a ‘near

https://doi.org/10.1007/978-3-319-78683-4_5
24 H. Bolton
miss’ has occurred (i.e. care has gone wrong, but these incidents as any event that has appeared to
fortunately the patient came to no harm) the have caused, or has the potential to cause, moder-
GMC advises clinicians to use their professional ate or severe harm, death, or prolonged psycho-
judgement when deciding whether to tell patients logical harm. Prolonged psychological harm
about the error. When there is uncertainty it may means that it must be experienced for 28 days or
be helpful to seek advice from senior colleagues more.
or healthcare teams. Once a notifiable safety incident has been
The patient should be spoken to as soon as identified, the statute requires that:
possible after it has been realized that some-
thing has gone wrong. Doctors should not be • The patient should be informed, in person, as
afraid of apologizing to patients when things soon as reasonably practical
have gone wrong. An apology does not automat- • A full explanation is given, including what
ically mean that the clinician is taking personal further investigations will be carried out
responsibility for the error, nor is it an admis- • Offer an apology and provide reasonable sup-
sion of legal liability. The NHS Litigation port to the patient
Authority actively encourages healthcare organ- • Organisations must keep a written record of
isations to apologise, and will never withhold the notification to the patient
legal cover for a claim because an apology of • The patient must be provided with a written
explanation has been given [3]. Any uncertain- account of the discussion and copies of corre-
ties must be explained and all questions spondence must be kept by the organisation
answered honestly. Discussions should be fully
documented, with notes made contemporane- Although the ultimate responsibility for com-
ously whenever possible. plying with the statutory duty of candour resides
The GMC also mandates doctors that the duty with the healthcare organisation, individual
of openness and honesty extends beyond just healthcare professionals have a key role in work-
patients, to include candour with their colleagues, ing with their organisation to ensure the legal
employers, organisations and regulators. This obligations are fulfilled. Senior doctors are most
includes an expectation to report adverse inci- likely to be the organisation’s representative, and
dents, to cooperate fully with reviews and inves- to lead the discussions with the patient. All CQC-
tigations, and to express concerns where registered healthcare organisations should have a
appropriate. Doctors must support and encourage named manager responsible for statutory duty of
each other to be open and honest, and not to stop candour.
others from raising concerns. In some cases it can be difficult to determine if
an incident reaches the threshold of harm for stat-
utory notification. Guidance suggests that harm
5.3 tatutory Duty of Candour
S should be assessed in the ‘reasonable opinion of
(CQC-Registered Healthcare a healthcare professional’ with the emphasis on
Organisations, England) being open if there is any doubt [5]. Individual
clinicians should be encouraged to seek advice
Healthcare organisations in England that are reg- from appropriate colleagues and their organisa-
istered with the regulator, the Care Quality tion’s managers in cases where there is uncer-
Commission (CQC) have an organizational duty tainty. Clinicians must be mindful that their
to be open and honest when things go wrong [4]. professional threshold for duty of candour is low,
In contrast to the professional duty, the statute and that they are obliged to be open and honest
applies only when a ‘notifiable safety incident’ with their patients even when the harm caused
has occurred, where a threshold of moderate may seem insignificant, or does not meet the
harm or worse is met. The regulations define threshold for statute.
5 Duty of Candour 25
5.4 Consequences of Not nal fistula. This had occurred as a consequence of

Complying with Duty unrecognized bladder injury.
of Candour The attending registrar informed the duty con-
sultant of the events. They immediately went
For the patient a lack of openness and honesty together to see the patient, and explained her
erodes trust and can cause significant distress. bladder had been damaged during her caesarean,
Doctors who fail to act in accordance with the and advised that she would need further treat-
GMC guidance on candour may find themselves ment to fix the injury. They explained that it
with sanctions from the GMC, including restric- appeared there had been a delay in recognising
tions on their licence to practice. Organisations the injury, and that in hindsight the presence of
that do not comply with the statutory duty of can- blood in her urine should have triggered earlier
dour will incur regulatory action from the CQC, investigations, which may have avoided her
and in serious or persistent cases could even face developing the fistula. In keeping with their pro-
criminal prosecution. fessional duty of candour, they offered her an
apology, and answered her questions. She was
also advised that her case would be reviewed at
5.5 Case Study: Bladder Injury the local governance meeting, and that she would
be kept informed of the results of the review. A
A patient attended the delivery unit at 4 am with midwife was present throughout the conversa-
contractions. She had previously had one caesar- tion, who then stayed with her to provide addi-
ean section. Shortly after emptying her bladder, tional support to ensure she had fully understood
her membranes ruptured. The CTG showed an the explanation. Contemporaneous notes of the
acute bradycardia, and vaginal examination discussions were recorded in the clinical notes.
revealed that she was 5 cm dilated with a cord The clinicians reported the injury as a patient
prolapse. The attending midwife kept the fetal safety incident, following their hospital’s gover-
head elevated manually by upward vaginal pres- nance guidelines.
sure and she was transferred immediately to the- The Consultant then notified the manager
atre for delivery by category I (immediate) responsible for statutory duty of candour.
caesarean section under general anaesthesia. An Referring to the CQC guidance, it was confirmed
attempt by the midwife to catheterise the bladder that the injury was a notifiable safety incident, and
failed, so the registrar decided to proceed to that the degree of harm had reached the threshold
delivery of the baby, and to insert the catheter required for notification under the statutory duty
after delivery, reasoning that the patient had just of candour. It was agreed that the discussion and
been to the toilet and that further delays should apology that had already taken place were appro-
be minimized. Apart from some scarring due her priate and sufficient to have complied with the
previous caesarean, the procedure was apparently statutory requirements. It was also agreed that the
uncomplicated, and the baby was born in good consultant would write to the patient, summariz-
condition within 20 min of the initial cord pro- ing what had happened. The local governance
lapse. Frank haematuria was noted in recovery, meeting concluded that the injury may have been
but no action was taken and she was later trans- avoided if the bladder had been catheterised, and
ferred to the post-natal ward. The midwives identified earlier if the staff had acted on the frank
expressed concerns that the haematuria persisted, haematuria. As a consequence, teaching sessions
but were reassured by the junior medical staff and were arranged to ensure the medical, midwifery
advised to remove the catheter the following day. and theatre staff were aware of the importance of
She was discharged home on day 3. On day 10 catheterisation prior to caesarean delivery and of
she re-presented with constant leakage of urine, the potential significance of blood in the urine.
and further investigations revealed a vesico-vagi- This outcome was included in the letter, along
26 H. Bolton
with another apology, and she was invited back to

see the consultant in clinic to debrief several • The statutory duty applies when a notifi-
weeks later. The patient had made a good recov- able safety incident has occurred that
ery and expressed her thanks to the staff for their have (or have the potential to) resulted
honesty. She was grateful that her baby had been in moderate harm or worse.
delivered safely. The consultant documented the • Offering an apology does not mean that
discussion, and copied correspondence to the the healthcare professional is accepting
manager to ensure the hospital’s notification pro- personal responsibility for the error, and
cess was complete. must not be a barrier to saying sorry.
• Where there is any doubt, the profes-
sional and statutory duties advise that
Key Points: Duty of Candour clinicians err on the side of being open
• Professional duty of candour is an indi- and honest.
vidual responsibility. The statutory duty
is an organisational responsibility.
• The professional duty of candour References
requires doctors to be open and honest
with their patients when things go 1. GMC. Good Medical Practice. 2013.
wrong, and also within their organisa- 2. GMC, NMC. Openness and honesty when things go
tion by reporting and learning from wrong: the professional duty of candour. 2015.
3. NHSLA. Saying sorry. 2014.
adverse incidents. 4. CQC. Regulation 20: Duty of candour. Information
• The statutory duty of candour (England) for all providers: NHS bodies, adult social care,
applies to care organisations registered primary medical and dental care, and independent
with the CQC. Individual professionals healthcare. 2015.
5. AVMA. The duty of candour. The legal duty to be
have a responsibility to cooperate with open and honest when things go wrong. What it
the organisation to ensure the legal obli- means for patients and their families. 2015.
gations are met.
Leading Cases
6
Fiona Paterson
The aim of this chapter is to provide the reader have that special skill. A man need not possess
with an overview of the leading cases in relation the highest expert skill; it is well established law
to two matters; namely negligence (or breach of that it is sufficient if he exercises the ordinary
duty) and causation. They are the two compo- skill of an ordinary competent man exercising
nents of liability or put simply, if a patient is to that particular art.”
sue a healthcare professional successfully, he/she That definition was refined by the House of
must first prove that the care was negligent and Lords in Sidaway v Governors of Bethlehem
second, that the negligence in question caused Royal Hospital [2] who recognised that in many
him/her harm. Many of the leading cases arise situations there may be a range of acceptable
from treatment in areas of clinical care other than practice. The judgment stated,
obstetrics. Nevertheless, they remain relevant to “a doctor is not negligent if he acts in accor-
obstetrics and midwifery care. dance with a practice accepted at the time as
proper by a responsible body of medical opinion
even though other doctors adopt a different
6.1 Negligence practice.”
But a note of caution was sounded subse-
6.1.1 What Constitutes Negligence? quently by the House of Lords in Bolitho v City
and Hackney Health Authority [3]—finding an
Bolam v Friern Hospital Management Committee expert who was supportive of his/her actions was
[1] is often cited as the seminal case in medical not enough for a clinician facing allegations of
negligence, Mr. Justice McNair, negligence to escape liability. Lord Browne—
“…where you get a situation which involves Wilkinson stated,
the use of some special skill or competence, then “…the court has to be satisfied that the expo-
the test as to whether there has been negligence nent of the body of opinion relied upon [by the
or not is not the test of the man on the top of a clinician facing an allegation of negligence] can
Clapham omnibus, because he has not got this demonstrate that such opinion has a logical
special skill. The test is the standard of the ordi- basis… the judge before accepting a body of
nary skilled man exercising and professing to opinion as being responsible, reasonable or
respectable, will need to be satisfied that, in
forming their views, the experts have directed
F. Paterson their minds to the question of comparative risks
Serjeants’ Inn Chambers, London, UK and benefits and have reached a defensible
e-mail: FPaterson@serjeantsinn.com

https://doi.org/10.1007/978-3-319-78683-4_6
28 F. Paterson
c onclusion on the matter…in some cases, it can- sent a doctor’s role is to inform rather than deter-
not be demonstrated to the judge’s satisfaction mine or influence what should happen to a
that the body of opinion relied upon is reasonable patient. Patients should now be treated as autono-
or responsible. In the vast majority of cases the mous individuals allowed, possibly even encour-
fact that distinguished experts in the field are of a aged to take an active role in any decisions about
particular opinion will demonstrate the reason- their care. The ultimate arbiter of how far they
ableness of that opinion…. But if, in rare case, it should be allowed to inquire and insist is now the
can be demonstrated that the professional opin- court rather than the clinician. Understandably,
ion is not capable of withstanding logical analy- that may be a somewhat sobering message for
sis, the judge is entitled to hold that the body of clinicians and a departure from an approach with
opinion is not reasonable or responsible…” which they are accustomed. For advice on how to
The law has continued to evolve from these approach matters of consent in light of this, see
judgments in response to the specific circum- the chapter “Why doctors get sued”.
stances of individual cases which have come
before the courts, the most significant of which
has been Montgomery v Lanarkshire Health 6.2 Causation
Board (General Medical Council intervening)
[4]. The judgment is now regarded as pivotal in It is sometimes easier to recognise a causal link
matters of consent. The facts are particularly per- between a doctor’s alleged negligence and any
tinent to obstetrics and midwifery. The Supreme harm suffered by the patient, rather than to define
Court (formerly the House of Lords) recognising what the legal test for causation actually is. Over
the social and legal developments, which the years, the courts have formulated various
meant that medical paternalism was no longer tests, all of which have subsequently evolved
condoned, stated that at the heart of obtaining a through amendment and sometimes erosion by
patient’s consent must lie a recognition that he/ the later decisions of other courts.
she is entitled to decide what risks he/she is will- The following two cases (decided by the Court
ing to take. Critically, defining the ambit of how of Appeal) have been selected due to their semi-
far a clinician had to go in enumerating and nal nature.
explaining the risks associated with any proce- In Bailey v Ministry of Defence [5] the patient
dure was now a matter for the courts and not the had undergone an unsuccessful procedure in a
medical profession: Ministry of Defence Hospital to remove a gall-
“…The doctor’s advisory role cannot be stone. Her problems were compounded by inad-
regarded as solely an exercise of medical skill equate care post-operatively. She then developed
without leaving out of account the patient’s enti- pancreatitis and continued to deteriorate and was
tlement to decide on the risks to her health which transferred to the Intensive Care Unit where she
she is willing to run (a decision which may be underwent two further procedures. The patient
influenced by non-medical considerations). was then moved to the renal ward of another hos-
Responsibility for determining the nature and pital, where she aspirated on her vomit, which in
extent of a person’s rights rests with the courts, turn, led to a cardiac arrest that caused her to suf-
not with the medical professions.” fer hypoxic brain damage. The court had to grap-
The decision undoubtedly represents a sea- ple with whether there was a sufficiently strong
change from the deference by the courts towards causal link between the inadequate post-operative
the medical profession which was seen in cases care at the Ministry of Defence Hospital.
such Bolam and Sidaway. A clear signal was sent The Court of Appeal acknowledged that the
by the Supreme Court; that when obtaining con- cardiac arrest which caused the hypoxic brain
6 Leading Cases 29
damage had been caused by a combination of Both the parties (in the proceedings) agreed
negligent care and bad luck. But was that suffi- that, if the child had been admitted to hospital
cient for the patient to win or did she have to 2 days earlier, and given the same treatment as she
show that the negligent care had been the domi- ultimately received, it was very likely that there
nant cause? The Court of Appeal decided that if would have been significantly less permanent
the patient could prove that “but for” the impact damage and possibly no permanent damage.
of the negligence (as opposed to the bad luck), However, the damage suffered as a result of GP’s
the injury would probably not have occurred, the negligence was identifiable and divisible from the
claimant should win. The issue was then, what damage caused by the hospital’s negligence.
did the evidence actually demonstrate or prove Consequently, there was no way that the hospital
on the facts of the patient’s case? In a dose of could be held liable for the earlier damage and the
judicial pragmatism, the Court of Appeal decided GP should not be liable for the whole damage.
that where medical science could not establish The Court of Appeal went even further and
the probability that “but for” a negligent act the looked at the case in terms of a loss of opportu-
injury, would not have happened, but could estab- nity to secure a better outcome. It held that where
lish that the contribution of the negligent cause a doctor had negligently failed to refer his patient
“was more than negligible,” the patient should to a hospital, and, as a consequence, she had lost
succeed. In the present case, the patient had the opportunity to be treated as she should have
crossed that hurdle. been by a hospital, the doctor could not escape
In Wright v Cambridge Medical Group [6] a liability by establishing that the hospital would
child, aged 11 months, had developed a bacterial have negligently failed to treat the patient appro-
superinfection in hospital and been discharged priately, even if promptly referred.
home undiagnosed. Her mother contacted a GP, The implications of these two cases has been
who negligently failed to refer the child to hospi- the subject of much discussion and debate
tal until 2 days later. It was not until three further within the legal press and in subsequent deci-
days later that the child was correctly diagnosed sions. In most cases, causation will be consider-
in hospital, by which time her hip had become ably simpler and will turn largely on a
infected. As a result, she had permanently combination of expert evidence and a judge’s
restricted movement, and a leg length discrep- sense of what is fair, just and reasonable in the
ancy. Proceedings were brought on behalf of the circumstances.
child against the GP only. In conclusion, the leading cases summarised
Perhaps surprisingly, the judge decided that above should give the reader a snap shot of how
GP’s negligence had not caused the child any the law currently stands. What is clear though, is
harm, as, even if she had been admitted to hospi- that the tectonic plates of judicial reasoning are
tal 2 days earlier, she would not have been treated shifting in relation to the practice of medicine.
properly and would have suffered the same per- Even 10 years ago the idea of a court making the
manent damage. The child’s litigation friend bold statements made by the Supreme Court in
appealed to the Court of Appeal who decided Montgomery would have been unthinkable. The
that the GP’s negligence was a causative factor decisions of the appellate courts over the next
of the child’s permanent injury. The reasoning decade, (particularly in an area as emotive as
behind the decision was that the hospital’s treat- obstetrics), are likely to involve a judicial balanc-
ment of the child (even though it was negligent) ing act of the patient’s rights and a recognition
was not so serious or unusual as to destroy the that clinicians do not offer a consumer service,
causative link between the GP’s negligence and but care to the sick and vulnerable, in often highly
the child’s injury. pressured circumstances.
30 F. Paterson
Conclusion References
Clinicians need to familiarise themselves
with the rulings of these landmark cases as 1. [1957] 1 WLR 582.
2. [1985] AC 871.
they have a bearing on patient care and man- 3. [1998] AC 232.
agement, and will continue to be the leading 4. [2015] AC 1430.
authorities in respect of all areas of clinical 5. [2008] EWCA Civ 883; [2009] 1 WLR 1052.
practice. 6. [2011] EWCA Civ 669 [2013] QB 312.
The Claim Journey
7
Karen Ellison and Emma Ferriman
7.1 Introduction 7.2 Letter Before Action
In a recent poll of all doctors in the United States The first step in the litigation process will be a
60% of them had been through the medical litiga- letter from a patient’s solicitor, this usually occurs
tion process at some point in their career. When without warning and is often unpleasant contain-
this was broken down by specialty 85% of obstet- ing criticism of the doctor and is usually written
rics and gynaecology doctors had been sued. Of in an aggressive and adversarial style. It is impor-
the cases that went forward 35% were settled tant to keep this in perspective, to acknowledge
prior to trial, 21% were withdrawn by the the emotions experienced and to seek support and
Claimant, 14% ruled in favour of the doctor, 11% advice from a colleague. When faced with this
were dismissed by the court, 3% settled at the situation it is important that the doctor seeks
trial; leaving only 3% where the court ruled advice from their defence organisation and does
against the doctor [1]. Litigation seriously affects not respond directly [3]. The defence organisa-
doctors leaving them feeling hopeless, doubting tion will provide a buffer between the doctor and
their own competence with a fear of exposure and the claimant’s solicitor in the legal process. It is
humiliation by their peers. This can lead to isola- important that the doctor provides their full co-
tion and loneliness with negative effects on rela- operation with the process to enable it to progress
tionships and their family. In addition, the process [2].
is often lengthy taking doctors away from their For a clinical negligence claim to be success-
patients [1, 2]. ful the claimant has to prove on the balance of
probabilities that the doctor owed a duty of care,
that there was a breach in that duty and that harm
occurred as a result of that breach (causation).
The clinical management in a case is assessed by
independent experts in the relevant field using the
Bolam standard. This standard considers the clin-
K. Ellison (*)
Medical Protection Society, Leeds, UK ical management of the doctor against that of a
e-mail: ellisonkaren@ymail.com reasonable body of doctors practicing in the same
E. Ferriman field. The claimant must prove that the doctor’s
Department of Obstetrics and Gynaecology, Jessop care fell below a reasonable standard and that this
Wing, Sheffield Teaching Hospitals NHS Trust, resulted in the claimant sustaining harm. Experts
Sheffield, UK are therefore required to provide both reasonable
e-mail: Emma.Ferriman@sth.nhs.uk

https://doi.org/10.1007/978-3-319-78683-4_7
32 K. Ellison and E. Ferriman
and logical evidence that will stand up to scru- tor cannot recall the precise nature of their
tiny. A doctor must respond quickly to any com- involvement the doctor should document this and
plaint and provide medical records within a describe their usual clinical practice. Where the
timely manner. Following this however, there doctor does have a good recollection of events
may be a long period of waiting, months or even the account should be as detailed as possible.
years, when the claimant takes advice and makes Remember the claimant has a number of years to
a decision on whether to proceed with their case. bring their claim and recollections will fade with
If the claimant does proceed with the case, then a time, so the time spent preparing the account may
strict timetable will be drawn up which must be be invaluable at a later date.
followed. Formal proceedings must be brought
within a three-year timescale. This three-year
period may run either from the date of the inci- 7.4 The Response
dent or from the date of knowledge. The date of
knowledge is the date at which the patient became The legal process will begin with a pre-action
aware that the injury sustained could be attribut- protocol where disclosure of the medical records
able to clinical negligence. There are two excep- is requested (Fig. 7.1) [4]. Following disclosure
tions to this; in the case of children and in those of the medical records the claimant will take
patients with reduced mental capacity for exam- expert advice and make a decision whether to
ple as a result of cerebral palsy. A child has up to proceed. In these cases, the trust or their repre-
their twenty-first birthday (i.e. 18 years plus sentatives will receive a letter of claim and this
3 years) to issue proceedings. In the case of a will be forwarded to the doctor involved. The let-
minor legal action is usually brought by a close ter of claim gives a detailed description of the
relative who becomes the child’s litigation friend. alleged failings of the doctor. The claimant
For claimants with impaired mental capacity should not issue formal proceedings until
there is no time limitation on claims. 4 months after the letter of claim. The trust’s rep-
resentatives are obliged to issue a formal letter of
response within 4 months of the letter of claim. A
7.3 Letter of Claim doctor involved in this process may take advice
from the hospital’s representatives or from their
When a doctor is notified of a claim it is impor- own defence organisation regarding preparation
tant to contact their defence organisation and the of a suitable response. For those claims that are
litigation department within their trust. The letter denied, clear and detailed reasons will be pro-
of claim should be shared with the defence union vided to the claimant in order for them to con-
as well as any medical records and a record of the sider their position. Arguments should be
doctor’s involvement in the case. Medical records reasoned and logical in an attempt to facilitate a
should be available within 40 days of their request withdrawal of the claim and to settle any dispute
from the claimant’s solicitors. Having instructed informally. For those claims that are not resolved
a defence organisation all correspondence should the claimant will issue formal proceedings.
be directed through them so that the doctor has
no direct contact with the claimant’s solicitors.
Any documentation received directly should be 7.5 Formal Proceedings
forwarded immediately to the doctor’s represen-
tative whilst maintaining a photocopy of any rel- A doctor involved in a case where formal pro-
evant information. Accurate record keeping is ceedings have been issued will be supported by
essential. The doctor should write a factual the hospital’s representatives if the case has
account of the event for their own records. This occurred in the NHS or by the legal representa-
record should detail their involvement in the inci- tives of agencies working in the private sector. In
dent and their direct recollection. Where the doc- the NHS, all claims are ultimately overseen by
7 The Claim Journey 33
REQUEST FOR LETTER OF

INCIDENT
RECORDS NOTIFICATION
• Claimant(s) suffers adverse • C requests copies of medical • C sends Letter of Notification

outcome and seeks legal records from D and any (LoN) to D explaining that
advice. relevant third parties claim is contemplated
• C’s adviser considers • D provides records - or an • D acknowledges LoN and
limitation explanation as to any delay confirms where Letter of
• C’s adviser considers within 40 days Claim (LoC) should be sent
rehabilitation • If D fails to provide records • D considers whether to
• C’s adviser considers use of or explanation C makes commence investigation and/
complaints process pre-action application for or obtain expert evidence
disclosure • Both parties consider
• C paginates and files any rehabilitation
received records • Both parties consider
limitation
Fig. 7.1 The legal process simplified
the NHS Litigation Authority (NHSLA) in expert reports in the exchange of evidence and to
England, the NHS Wales shared services part- attend conferences with counsel. They are
nership in Wales, the Central Legal Office (CLO) obliged to sign a statement of truth as part of the
in Scotland and The Directorate of Legal documentation.
Services (DLS) in Northern Ireland. In addition, The reports of experts instructed by the
the doctor can be supported by a representative defense and claimants are exchanged, and either
from their defence organisation. A detailed may present questions to the other about their
defence document will be produced with the report. Experts may be required to meet and pre-
doctor’s own witness statement as a key compo- pare a joint statement. The objective of such
nent. The witness statement is the doctor’s meetings is to resolve as much of the case before
signed factual account of their involvement in trial as possible to save on time and costs. Where
the case and will be lodged with the court, so it the defense is persuasive the claim may be dis-
is imperative that the doctor involved is entirely continued by the claimant.
happy with the contents of the statement. The
doctor is also required to sign a statement of
truth as part of this document. 7.7 Trial
Some cases will be settled out of court usually

7.6 Doctors Witness Statement without admitting liability, but on occasion a
and Exchange of Witness breach of duty will be admitted to achieve an out
Statements of court settlement.
For those few cases that do proceed to trial
The process of medical litigation is lengthy and (less than 1%) [5] the process can be lengthy
time-consuming. Any doctor involved in this pro- depending on the complexity of the case and it is
cess will be expected to liaise directly with the important that a doctor involved in this process
hospital’s representatives and to provide informa- has adequate professional and personal support.
tion in a timely manner. This information may Doctors involved in medical litigation com-
consist of evidence of adequate accreditation and monly ask whether all cases are referred to the
training and so it is imperative that a doctor keeps General Medical Counsel (GMC). GMC referral
detailed evidence in their appraisal documenta- rarely occurs [5]. The GMC will investigate those
tion. As the process proceeds the doctor will be cases where there are significant concerns regard-
asked to comment upon any allegations, to read ing patient safety and where a doctor’s fitness to
34 K. Ellison and E. Ferriman
13%
Orthopaedic surgery
Casualty/A&E
Obstetrics
34% 12% General surgery
Gynaecology
Total number of General medicine
clinical claims 10,686
Urology
Radiology
10%
Psychiatry/Mental health
Ophthalmology
3% Other (aggregated specialties)
8%
3%
3%
3% 5% 5%
Fig. 7.2 The number of clinical negligence claims received in 2016/2017 by specialty
practice may be impaired. Another issue for some the patient and their family especially in the face
doctors involved in litigation is where the claim- of complications or adverse outcome. Time spent
ant remains a patient of the doctor thus providing explaining in detail is invaluable and although this
a potential conflict. The GMC states that a doctor process wont completely dispel all medical litiga-
must not allow a complaint to prejudice a patient’s tion it may help to alleviate a patient’s concerns
care. There are instances however, where the or anxieties. Adverse incidents can be reduced, but
doctor-patient relationship is deemed to be irre- not eradicated by clinical risk management. For
vocably damaged and where the patient may be an individual doctor this means practicing within
better receiving care form an alternative health- their own area of expertise, knowing their personal
care professional [6]. limitations, and communicating effectively with
Doctors will never avoid being sued. It is highly patients and colleagues and writing good contem-
likely in a high-risk specialty such as obstetrics poraneous notes [8].
and gynaecology (see Fig. 7.2) [7] that a doctor
will become involved in a formal patient complaint
and medical litigation. What a doctor can do is put References
themselves in a stronger position by being able to
defend their treatment for example by following 1. The doctor weighs in.com. What happens when
doctors get sued. https://thedoctorweighsin.com/
local and national guidelines. Good record keeping what-happens-when-doctors-get-sued/.
and detailed correspondence regarding a patient’s 2. Bowen-Berry D. The physicians guide to medi-
care is imperative. Cases where documentation is cal malpractice. Proc (Bayl Univ Med Cent).
poor are more difficult to defend whereas cases 2001;14(1):109–12.
3. Medical Defence Union. Medicolegal guide to clini-
in which the documentation is of a high standard cal negligence.
are more difficult for the claimant to dispute [5]. 4. Ministry of Justice. Pre-action protocol for the reso-
Another key factor is good c ommunication with lution of clinical disputes. 30 Jan 2017. https://www.
7 The Claim Journey 35
justice.gov.uk/courts/procedure-rules/civil/protocol/ 7. NHS Resolution. Five years of cerebral palsy

prot_rcd. claims. A thematic review of NHS resolution
5. Debono J. When patients sue. BMJ Careers. 16 April data. September 2017. http://resolution.nhs.uk/
2011. http://careers.bmj.com/careers/advice/view- five-years-of-cerebral-palsy-claims/.
article.html?id=20002645. 8. Panting G. How to avoid being sued in clinical prac-
6. General Medical Council. Good medical practice. tice. Postgrad Med J. 2004;80:165–8.
London: GMC; 2001.
GMC Referral
8
Katherine Sheldrick and Angela Pilling
8.1 Background and performance; safety and quality; communica-

tion, partnership and team work; maintaining
The General Medical Council (“GMC”) is the trust). In addition, the GMC publish more detailed
regulatory body responsible for maintaining the explanatory guidance which shows how the prin-
register of medical practitioners, setting stan- ciples of GMP apply in specific circumstances. All
dards in medical education and practice, 5 year registered medical practitioners are expected to be
revalidation, and investigating concerns which aware of and follow the GMC’s current guidance
may put patient safety or the public’s confidence and to maintain their continuing professional
in the profession at risk. It regulates all registered development. The standards set out in its guidance
medical practitioners across the UK. Since 2012 are applied by its investigators and experts in
the investigatory and hearing (or adjudication) determining the seriousness of any alleged depar-
functions of the GMC have been separated. If ture from GMP and whether it may call into ques-
you are subject to a GMC investigation and your tion a practitioner’s fitness to practise medicine.
case is referred for a hearing, the hearing will
take place before a Panel of the Medical
Practitioners Tribunal Service (“MPTS”). The 8.3 MC Statistics on Number
G
MPTS is a Statutory Committee of the GMC and Outcome of Referrals
established under the Medical Act 1983 [1].
The most recently published data for 2016 [2]
records the GMC reviewed 9140 concerns or
8.2 GMC Guidance referrals in the context of almost 240,000 licensed
and registered medical practitioners. The annual
The GMC publishes and updates its guidance and level of referrals has remained fairly constant
standards periodically. Its overarching guidance is over the last 5 years, at between 9 and 10,000. Of
entitled “Good Medical Practice” (GMP) (last these concerns in 2016, almost 74% were closed
updated in 2014). It sets out the duties and core at the initial triage stage without further investi-
professional standards of all registered doctors gation. This may be because they do not raise a
broken down into four domains (knowledge, skills serious concern or the concern does not relate to
a doctor’s fitness to practice. If a concern is
K. Sheldrick (*) · A. Pilling closed at the initial triage stage, you are unlikely
Hempsons, Manchester, UK to be informed of the fact or be made aware that
e-mail: k.sheldrick@hempsons.co.uk; there was a concern.
a.pilling@hempsons.co.uk

https://doi.org/10.1007/978-3-319-78683-4_8
38 K. Sheldrick and A. Pilling
Fig. 8.1 GMC 1451

investigation of concerns 16%
in 2016. Data from
GMC Annual Report
2016
Investigated
459
5% Closed following
provisional enquiries
Referred for employer
resolution
477 Closed at initial triage
5% without investigation
6753
74%
Of the remaining 2387 concerns which were 8.5 When You Should
not closed at triage, just over 60% (1451) were Self-Report?
investigated, 20% (477) were referred to the doc-
tor’s employer for local resolution and the balance GMP identifies three situations [4] in which prac-
(459) closed following provisional enquiries. titioners should self-refer where:
Of the investigations concluded by the GMC
in 2016, 54% were concluded with no further 1 . their health may put patients at risk;
action. Just over 13% (245) cases were referred 2. they have been cautioned or convicted by the
for an MPTS hearing. The remainder of the cases police anywhere in the world: and/or
concluded with advice, a warning or undertak- 3. where they have been criticised by an official
ings. Warnings and undertakings are recorded on inquiry (including by a Coroner).
the doctor’s registration (see Sanctions section
below) (Fig. 8.1). Practitioners must protect patients and col-
leagues from any risk posed by their health. A
practitioner cannot rely upon their own assess-
8.4 Sources of Referral ment of risk but must consult a suitably qualified
colleague and follow their advice about any
Anyone can refer a medical practitioner to the changes/limitation to their practice or to refrain
GMC. Thus a referral can be made by a colleague/ from work while they are unwell.
whistleblower, patient (or their Solicitor), relative,
member of the public, Coroner, their employer’s
Responsible Officer, Police, pharmacist, CQC or 8.6 hat Type of Concerns Are
W
NHS Protect amongst others. In addition, a medi- Investigated?
cal practitioner may be under a regulatory duty to
self-report or the GMC may commence an inves- The concerns:
tigation in the absence of referral, for example,
where there has been adverse press reporting. • Must raise issue of impairment of fitness to
If you are a manager, colleague or responsible practise
officer and are considering making a referral, you • Be made within the last 5 years (unless in pub-
may wish to consider the GMC thresholds guid- lic interest to investigate older cases)
ance [3] before doing so. • Single clinical incidents may be investigated
8 GMC Referral 39
• Repeated/pattern of concerns about clinical competence, a practitioner is likely to be invited

care and practice likely to lead to invitation for to undergo a performance assessment. Such an
performance assessment assessment will include written examinations,
• Concerns of lack of knowledge of English lan- observed simulated clinical examinations
guage will lead to invitation for formal (OSCEs) and interviews with the practitioner and
assessment other third parties.
• Concerns regarding a practitioner’s own Concerns may be referred about a practitio-
health will usually lead to assessment by two ner’s knowledge of the English language either
independent health assessors spoken and/or written. Such concerns will lead to
• Presumption that five categories of serious an invitation to sit further examinations to test the
concern will be fully investigated practitioner’s language skills. The current GMC
criteria require a valid (taken within the last
The GMC will only investigate concerns 2 years) IELTS certificate showing:
which raise an issue of impaired fitness to prac-
tise. Within their guidance they give examples of • A score of at least 7.0 in each testing area
concerns which will not be investigated including (speaking, listening, reading and writing), and
minor motoring offences not involving drugs or an overall score of 7.5.
alcohol, a delay of less than 6 months in provid- • You got these scores in the same test
ing a medical report, a minor non-clinical matter • You took the academic version of the test
or a complaint about the cost of private medical • The original stamp and test report form (TRF)
treatment. number
They cannot investigate concerns which took • You obtained the scores in your most recent
place over 5 years ago unless they determine sitting of the test.
there is a public interest in doing so despite the
fact it has been made late [5]. Similarly concerns about physical or mental
Isolated concerns which do not raise an issue health will be investigated by inviting the practi-
of impairment, for example, about the quality of tioner to undergo an independent assessment
treatment where there is no serious risk to the usually by two specialists who are instructed to
patient or a poor attitude to a patient, will not be provide their opinion on the practitioner’s health,
fully investigated but are likely to be disclosed to diagnosis and fitness to practise with or without
the practitioner and RO to be dealt with at restriction.
appraisal to ensure there is no repetition. There are some categories of concerns that
Single clinical incidents which resulted in will inevitably be investigated fully. These
patient harm will be investigated and usually an include allegations of:
expert opinion obtained to determine whether the
management falls below or seriously below the 1. Sexual assault, indecency or sexually moti-
standard to be expected of a reasonably compe- vated examination
tent practitioner. Where it is alleged that the prac- 2. Violence
titioner has fallen seriously below the standard to 3. Inappropriate relationships with patients
be expected, the threshold for presumption of 4. Dishonesty including fraud
impairment will be reached which means the 5. Practising without a licence
level has been reached for imposition of a sanc-
tion (see below for an explanation of the sanc- Practitioners need to be aware that any allega-
tions which are available to the GMC Case tions (including those arising in their personal
Examiners/MPT). lives) which fall into any of the categories 1, 2 or
Where any further concerns are notified, they 4 above will be fully investigated by the GMC
will also be investigated fully. If there is a pattern irrespective of whether they directly involve
or area of concern identified relating to clinical patients or their care as they give rise to a pre-
sumption of impaired fitness to practice because permitted except in exceptional circumstances

of their seriousness. but oral representations are made on behalf of the
GMC and the practitioner to the IOT Panel. In
addition, documentary evidence can be submitted
8.7 otification of Criminal
N in advance or at the hearing, for example, refer-
Investigations ences from colleagues, CV, appraisal documents.
The hearing is held in private unless the practitio-
In accordance with the Common Law Police ner requests it is held in public. All IOT hearings
Disclosure arrangements [6], the police will dis- are routinely listed at the MPTS offices in
close to the GMC details of any practitioner who Manchester.
is arrested or charged with an offence where they To make an interim order restricting a practi-
consider there is a “pressing social need” to do so tioner’s registration, the Panel must determine it
and there is a public protection risk. In such is necessary for protection of members of the
cases, police notification to the GMC is usually public and/or otherwise in the public interest and/
the source of the concern and their investigation. or in the doctor’s own interests. The latter ground
Having received such information the GMC will is usually applied in cases of health concerns.
ask a Case Examiner to decide whether a practi- The “public interest” includes maintaining public
tioner should be referred for an MPT Interim confidence in the profession and good standards
Orders Tribunal (IOT) hearing (see below) to of conduct and performance. The IOT cannot
consider whether interim restrictions should be accept undertakings offered by the practitioner.
placed on the practitioner’s registration whilst an If conditions are imposed by the Panel, they
investigation is ongoing. The IOT can make no will be taken from the suite of “standard condi-
order, impose conditions or suspend the practitio- tions” set out in IOT conditions bank available on
ner’s registration. the GMC and MPTS websites [7].
The maximum length of interim order which
can be imposed by the Panel is 18 months. Any
8.8 IOT Hearings further extensions require High Court approval.
Further interim order hearings will be listed at 3
If a practitioner receives correspondence listing or 6 monthly intervals (depending on the circum-
an IOT hearing they should seek urgent advice. stances). They may not require attendance at a
The minimum notice period is 24 h in urgent hearing and may be dealt with on the papers in
cases but usually a practitioner will be given a certain circumstances. A practitioner or the GMC
week or 10 days notice. It is important to ensure can request an early review hearing if there has
that your registered address is kept up to date so been a change in circumstances.
that you receive correspondence in a timely man-
ner. A bundle of papers will be disclosed which
sets out the concerns raised with the GMC. This 8.9 GMC Investigation
may be the first indication a practitioner has
received of any concern. Ordinarily, the practitio- Once a GMC investigation is opened, the GMC
ner will be expected to attend the hearing and/or will notify you of the fact and disclose (some)
attend with their legal representative. The hearing details to you of the concern(s) raised. This is
can proceed in the absence of the practitioner if known as a “Rule 4” letter. The GMC may
the Panel is satisfied the doctor has been served anonymise the concern. You will be asked to pro-
with notice of the hearing. The GMC will instruct vide information about your current work/
a lawyer to attend the hearing and present their employer(s) (called a Work Details Form) and
case. The GMC should confirm what order they invited to respond to the concern.
seek in advance of the hearing to assist prepara- You should notify your medical defence
tion of the practitioner’s case. No oral evidence is organisation immediately upon receipt of any
8 GMC Referral 41
GMC correspondence. You should also notify depend on the nature of the allegations and may
your employer(s) (and Deanery if you are a doc- include testimonial references, evidence of
tor in training) of the GMC investigation. The focussed CPD, appraisal documents, reflective
GMC will contact them on receipt of your com- statement and/or expert evidence.
pleted form, disclose the complaint and ask them Once a response has been served or the dead-
to confirm whether they have any concerns about line has passed, two GMC Case Examiners (one
you. It is, therefore, in your interests that they are medically qualified and the second lay) will be
aware prior to receiving GMC correspondence. asked to review the case and determine whether
The GMC will set a deadline for you to provide a the case should be referred for a hearing before a
completed Work Details Form and if you fail to Medical Practitioners Tribunal (MPT) or con-
do so without good reason, the failure may be cluded in another way (see below). Both Case
included as an additional concern as you are Examiners must agree to any decision. If the
expected to cooperate with your regulator. The Case Examiners are unable to agree, the matter
form includes a declaration that the information will be referred to the Investigation Committee.
is complete and accurate and it is therefore Where cases fall within one of the following
important that you ensure that it is. Incorrect or seven headings, unless there are exceptional rea-
incomplete information may give rise to addi- sons, a referral for a hearing will be made:
tional concerns about your probity and honesty.
You should take advice from your medical 1 . Sexual assault or indecency
defence organisation and/or solicitor about 2. Violence
whether it is in your interests to provide a response 3. Improper sexual/emotional relationships
at this very early stage of the GMC investigation. 4. Knowingly practising without a licence
You are not obliged to respond at this stage. 5. Unlawfully discriminating
The GMC will undertake investigations to 6. Dishonesty
obtain documentary and witness evidence to sup- 7. Gross negligence or recklessness about a risk
port the concern(s) and expert evidence to con- of serious harm to patients
firm their seriousness. If the concerns relate to the
practitioner’s health or performance, the GMC The Courts have determined that cases in
will usually invite the practitioner to undergo an these categories where the practitioner has not
assessment. Any unreasonable refusal to agree to been prosecuted or has been acquitted in a crimi-
undergo an assessment is likely to be included in nal court can still be investigated by the GMC,
the allegations against the practitioner and will be referred for hearing and sanctioned [8].
considered as demonstrating a lack of insight. It
may also lead to an IOT referral (see above).
Once the GMC have concluded their investi- 8.10 Referral to a MPT Hearing
gation, they will determine whether the evidence
they have obtained supports an allegation of Following notification of the Case Examiners
impaired fitness to practise. If the evidence does decision to refer your case, a timetable will be set
not, the GMC investigation will be concluded at telephone hearings for steps (known as direc-
and you will be notified. Where the evidence sup- tions) to be taken to prepare the case for hearing.
ports an allegation of impairment, the GMC will A hearing date will be set within 6 months of the
set out formal allegations in what is referred to as first telephone hearing.
a “Rule 7 letter”. The practitioner has 28 days to The directions may include deadlines for dis-
respond to the allegations. An extension of time closure of evidence (documentary, witness and
may be needed to prepare the practitioner’s expert) by each party, a meeting of experts,
response. You should take advice on what (if any) exchange of documents setting out legal argu-
allegations should be admitted and what evidence ments to be raised at the beginning of the hearing
should be submitted with any response. This will (called preliminary arguments). These hearings
are in public and do attract press attendance and • Conclude the case with no further action
publicity. The GMC will present their case first • Conclude the case with written advice to the
by calling witnesses and introducing documents. practitioner
Usually a witness’s statement will be taken as • Agree undertakings with the practitioner
their evidence in chief. Witnesses will then be • Invite the practitioner to accept a warning
cross examined by the other party and asked
questions by the Panel. When the GMC has called Undertakings are promises made by the prac-
all of it’s evidence (subject to any legal argu- titioner usually to take certain steps or restrict
ments), the practitioners case will then be pre- their practice. They are of unlimited duration and
sented. The practitioner may give evidence or are reviewed at least annually by the GMC. On
choose not to do so. Evidence can be called on average, they remain in place for 2–3 years. Any
his/her behalf to rebut the allegations and sub- breach of undertakings will be investigated by the
missions on facts. GMC and may result in further action being
At the conclusion of the practitioner’s case, taken. The undertakings will appear on the medi-
the Panel will go into private session to decide cal register except those relating to health which
what facts are found and which allegations they remain private.
find proved. They will then announce their find- Warnings can be offered where the Case
ings and hear submissions from both parties, first Examiners decide that there is no impairment but
on whether or not the findings amount to impair- there has been a serious departure from
ment and secondly, if they do, what sanction is GMP. The GMC will provide a draft of the pro-
appropriate. The Panel can impose a warning (see posed warning. Representations can be made
below) even if they determine that there is no about the contents of any proposed warning. If
impairment. The sanctions available to them you do not agree to accept a warning or the pro-
where impairment is found are: posed terms of any warning, you can elect for a
hearing before the GMC Investigation
• Acceptance of undertakings (see below) Committee. They have the power to impose a
• Conditions for up to 3 years warning.
• Suspension for up to 12 months or If a warning is accepted, it will be published
• Erasure from the medical register on the medical register in the terms agreed for a
period of 5 years and will be disclosed on request
The practitioner may appeal a decision of the by any employer indefinitely.
FTP Panel to the Administrative Court. Any
appeal must be lodged at Court within 28 days of
the determination. 8.12 Things to Remember
Before the expiry of any conditions or suspen-
sion period, a review hearing will be listed to 1 . Don’t ignore correspondence from the GMC
determine whether the practitioners fitness to 2. Keep your registered address up to date to
practise remains impaired (in which case further ensure you receive correspondence
sanctions may be imposed) or is unimpaired and 3. Be aware of GMP and the GMC’s updated
the sanction will expire. guidance
4. Seek advice and assistance as soon as

possible
8.11 R
esolution of Cases Not 5. Notify your employer(s)
Referred to a MPT Hearing 6. Keep everything you are sent and copies of
any documents you provide to the GMC
Where the Case Examiners determine that a case 7. Seek support—it is likely your colleagues

should not be referred to a MPT hearing they have been part of a GMC investigation or
may: know someone who has
8 GMC Referral 43
References 6. Which replaced the Notifiable Occupations Scheme

(NOS) in 2015.
7. GMC: www.gmc.org.uk MPTS: www.mpts.org.uk.
1. Schedule 1, Part III, section 19 F of the Medical Act
8. Rv Metropolitan Police Commisioner ex parte
1983.
Redgrave [2003] 1 WLR 1136 and clarified in Bhatt v
2. GMC Annual Report 2016.
GMC [2011] EWHC 783 (Admin) and Ashraf v GDC
3. GMC Thresholds guidance July 2016 www.gmc-uk.
[2014] EWHC 2618 (Admin).
org.
4. GMP guidance April 2014, paragraphs 28 and 75.
5. GMC Guidance for decision makers on Rule 4(5) 11
January 2016.
Report Writing
9
Eloise Powers and Sallie Booth
9.1 Introduction Key Legal and Ethical Principles

• Experts owe a duty to exercise reason-
This chapter contains advice and guidance for able skill and care to those instructing
clinicians who are instructed to provide expert them, and to comply with any relevant
reports for use in civil legal proceedings. It will professional code. However, they have
encompass the following areas: the legal and eth- an overriding duty to help the court.
ical framework for expert witnesses; pitfalls and • Experts must provide opinions that are
risks for expert witnesses; positive advice and independent, regardless of the pres-
guidance for expert witnesses. sures of litigation. A useful test of inde-
pendence is that the expert would
express the same opinion if given the
9.2 Legal and Ethical Framework same instructions by another party.
Experts should not see themselves as
All expert witnesses should familiarise them- advocates.
selves with Part 35 of the Civil Procedure Rules • Experts should confine their opinions to
[1], the Practice Direction to Part 35 of the Civil matters which are material to the
Procedure Rules [2], and the Civil Justice disputes.
Council’s Guidance for the instruction of experts • Experts should only provide opinions in
in civil claims [3]. These documents are publicly relation to matters which lie within
available online and should be read in full. What their expertise.
follows is a summary of some of the most impor- • Experts should take into account all
tant principles: material facts before them.
• Experts should inform those instructing
them without delay of any change in
their opinions on any material matter
and the reasons for this.
• An expert’s report must comply with the
E. Powers (*) formal requirements set out at Practice
Serjeants’ Inn Chambers, London, UK Direction 35, 3.1–3.3.
e-mail: EPower@serjeantsinn.com
• Where there is a range of opinion on
S. Booth matters dealt with in the report, experts
Irwin Mitchell LLP, Sheffield, UK
e-mail: Sallie.Booth@IrwinMitchell.com

https://doi.org/10.1007/978-3-319-78683-4_9
46 E. Powers and S. Booth
should summarise the range of opinion that he was suffering from post-
ions and give reasons for the expert’s traumatic stress disorder (PTSD). In a
own opinion. second report, she gave the opinion that the
• Experts should keep facts and opinion claimant was still suffering from depres-
separate. sion and some of the symptoms of
• Where the facts are in dispute, experts PTSD. The defendant in the road accident
should express separate opinions case contended that the claimant was
based upon each version of the facts. deceptive and deceitful.
• Experts should not express a view in A joint meeting took place between the
favour of one or other version of the experts for both sides. Ms. K signed a joint
facts, unless they regard one set of facts statement in which she confirmed agree-
as being less probable based upon their ment to the following: (a) the claimant’s
own particular expertise and psychological reaction to the accident was
experience. no more than an adjustment reaction, and
• A summary of conclusions is (b) she agreed that the claimant’s behaviour
mandatory. was suggestive of “conscious mechanisms”
that raised doubts about whether his report-
ing was genuine.
9.3 Pitfalls and Risks Ms. K thereafter gave the following
account of what had happened: (a) She had
In extreme cases experts can face criminal sanc- not seen the reports of the opposing expert
tions if they commit perjury, or can face sanctions at the time of the telephone conference; (b)
for contempt of court if they mislead the court. The joint statement, as drafted by the oppos-
Experts can also be reported to their professional ing expert, did not reflect what she had
body. Such cases will by their nature be unusual, agreed in the telephone conversation, but
and are unlikely to arise unless an expert acts she had felt under some pressure in agree-
unethically. However, the existence of such sanc- ing it; (c) Her true view was that the claim-
tions serves to underline the importance of being ant had been evasive rather than deceptive;
aware of the overriding duty to the court. (d) It was her view that the claimant did suf-
Prior to 2011, expert witnesses enjoyed an fer PTSD which was now resolved; (e) She
“immunity from suit” in relation to their partici- was happy for the claimant’s then solicitors
pation in legal proceedings. Following the to amend the joint statement.
Supreme Court’s judgment in Jones v Kaney [4], The road traffic case subsequently set-
expert witnesses are no longer immune from tled at an undervalue, and the claimant
being sued for breach of duty in relation to the issued proceedings against Ms. K. At first
evidence which they give in court or for the opin- instance, the proceedings were struck out
ions which they have expressed in anticipation of on the basis that Ms. K enjoyed immunity
court proceedings. from suit. The Supreme Court reversed this
decision and held that expert witnesses no
longer benefit from immunity from suit;
Jones v Kaney: The Facts this judgment allowed the claim against
In Jones v Kaney, a claimant suffered phys- Ms. K to proceed.
ical and psychiatric injuries in a road acci-
dent. Ms. K, a clinical psychologist, was
instructed by the claimant’s solicitors. She A practical consequence of the judgment in
examined the claimant and gave the opin- Jones v Kaney is that it becomes even more impor-
tant for expert witnesses to have professional
9 Report Writing 47
indemnity insurance in place which specifically

covers their work as an expert witness. • If your opinion is honestly and genu-
At a more fundamental level, the decision in inely held, you should not change it
Jones v Kaney underlines the importance of tak- merely because you are put under pres-
ing reasonable care when providing a profes- sure to do so (in the absence of any
sional opinion as an expert witness. Lord Brown good reason).
observed as follows: “Suffice to say that in my • Avoid “cutting and pasting” text from
opinion the most likely broad consequences of one opinion into another. At worst, cut
denying expert witnesses the immunity… will be and paste mishaps could lead to Data
a sharpened awareness of the risks of pitching Protection Act proceedings. At best, cut
their initial views of the merits of their client’s and paste mishaps will cast doubt upon
case too high or too inflexibly lest these views whether you have paid sufficient atten-
come to expose and embarrass them at a later tion to the case.
stage.”
Reassuringly for experts, Lord Brown also
observed as follows: “I would urge the courts to
be alert to protect expert witnesses against spe- 9.4 Positive Advice
cious claims by disappointed litigants – not to
mention to stamp vigorously upon any sort of Bearing in mind all of the caveats above, what
attempt to pressurise experts to adopt or alter positive steps are experts able to take in order to
opinions other than those genuinely held.” assist those who instruct them? Answering this
Notwithstanding this reassurance, what follows question will require some understanding of the
is some practical advice for experts in avoiding reasons why expert reports are obtained and the
risks and pitfalls: purposes to which they are put. In medical negli-
gence cases, we can divide expert reports into
three main categories: (1) breach of duty, (2) cau-
Avoiding Pitfalls: Advice for Experts sation, (3) condition and prognosis.
• Ensure that you have read the relevant Breach of duty: A breach of duty report
documents. Be prepared to ask for any addresses the question of whether or not the care
relevant documents which are miss- received by a claimant fell below a reasonable
ing, or refer in your report to key docu- standard of care. Lawyers will make use of the
ments which you have not received. breach of duty report when drafting pleadings,
• Ensure that the opinion which you reach such as the Particulars of Claim or Defence.
is well-founded right from the start. When writing a breach of duty report, it is helpful
Have you thought it through? Have you to bear the following points in mind:
considered the counter-arguments and
the other side’s case? • For all the reasons set out above, it is crucial
• A well-founded opinion should be based that your opinion is well-founded and sustain-
upon an understanding of the facts of able. Contrary to popular belief, responsible
the case and upon any relevant scientific lawyers would rather be presented with a
literature and guidelines, as well as well-founded negative opinion than a poorly-
upon your own professional opinion. founded positive opinion. In addition to the
Reasons in support of your own opinion overriding ethical considerations which are set
should be provided. out above, there are practical considerations:
• It can be useful to ask yourself whether it can cost the client a significant amount of
you would be prepared to defend your money and time to bring, or to defend, a weak
opinion under oath in court. claim, so the client needs to know from the
outset if their position is weak.
48 E. Powers and S. Booth
• If you are identifying a breach of duty, you answer this question. When answering this
should pinpoint a specific act (or acts) upon a question, it is important to present a clear and
specific date (or dates) which fall below a rea- well-founded opinion.
sonable standard of care. If you are critical of
a delay, you should identify the point in time Condition and Prognosis: A condition and
at which the delay becomes unjustifiable. This prognosis report is usually based upon an exami-
information makes it easier to draft nation of the claimant. It addresses the claimant’s
pleadings. present condition and medical prognosis.
• If there are relevant authoritative guidelines in Lawyers will make use of the condition and prog-
place (NICE, RCOG or similar), you should nosis report when quantifying the claim and
cite the material parts of the guidelines. when instructing further experts (such as a care
expert, occupational therapist or accommodation
Causation: A causation report addresses the expert). It is helpful to bear the following points
question of whether the identified breach of duty in mind:
made a material difference to the course of
events. Lawyers will make use of the report when • When examining the claimant, please set out
drafting pleadings and also as a basis for quanti- and explain the methodology which you are
fying damages. When writing a causation report, using. Your conclusions upon issues such as
it is helpful to consider the following points: future treatment needs and ongoing
assistance needs should be consistent with
• You are likely to be asked to comment upon the history and your findings upon
what “would have happened” but for the neg- examination.
ligence. This question is inherently hypotheti- • It is extremely important to be as precise as
cal, and can pose difficulties for possible when addressing issues such as the
scientifically-trained experts. In answering costs of further treatment or the particular
this question, you should be aware that the restrictions upon activity faced by a claimant.
civil standard of proof is the balance of prob- Providing detail and justification is essential:
abilities: in other words, you are only being your report is likely to be used as the basis for
asked to provide the most likely scenario. bringing or defending a claim for significant
• In answering the hypothetical question of amounts of money.
what “would have happened”, it is helpful to • Where a claimant has co-morbidities, it is
take a step-by-step approach, going through important to distinguish between the effects of
the treatment which would normally be pro- the negligence and the effects of the co-
vided and the outcome which would nor- morbidities. Where appropriate, you may need
mally be expected. Medical literature which to defer to other expert opinion; alternatively,
provides outcome data is often of great you may be in a position to address this issue
assistance. yourself. You should address the question of
• You will sometimes be faced with the task of what needs the claimant has which are “quali-
reporting on causation in a case where the tatively or quantitatively” different from the
claimant has multiple medical conditions. In needs which s/he would have had in any event
such a case, you will be asked to distinguish [5].
between the symptoms which can be causally • It is helpful to be as specific as possible about
linked to the negligence and the symptoms the severity and duration of any symptoms
which cannot be causally linked to the negli- caused by the breach of duty (even where these
gence. It is helpful to consider whether exami- symptoms have resolved) as this will assist the
nation of the claimant is necessary in order to lawyers tasked with quantifying the case.
9 Report Writing 49
References
Key Points: Report Writing
• Experts have an overriding duty to the 1. https://www.justice.gov.uk/courts/procedure-rules/
court and should provide opinions civil/rules/part35.
2. https://www.justice.gov.uk/courts/procedure-rules/
which are independent, regardless of the civil/rules/part35/pd_part35.
pressures of litigation. 3. h t t p s : / / w w w. j u d i c i a r y. g o v. u k / w p - c o n t e n t /
• Experts can be sued for breach of duty in u p l o a d s / 2 0 1 4 / 0 8 / ex p e r t s - g u i d a n c e - c j c - a u g -
relation to the evidence they give in court 2014-amended-dec-8.pdf.
4. [2011] UKSC 13; [2011] 2 AC.
or in anticipation of court proceedings. 5. Reaney v University Hospital of North Staffordshire
• Experts should have “a sharpened NHS Trust and another [2015] EWCA Civ 1115.
awareness of the risks of pitching their
initial views of the merits of their client’s
case too high or too inflexibly”.
• When writing a breach of duty report, it
is helpful to pinpoint any breaches of
duty by identifying specific acts and
specific times.
• When writing a causation report, it is
helpful to take a step-by-step approach
when addressing what would have hap-
pened but for the breach of duty.
• When writing a condition and prognosis
report, it is particularly important to per-
form a thorough examination and pro-
vide detail about any restrictions or
needs which the claimant may have.
• Above all, expert opinions should be
well-founded and supported by reasons.
Being an Expert Witness
10
John Reynard
10.1 Background 10.2 D

efinition of an Expert
Witness
For a court to accept expert evidence, it must be
assured that the criteria of admissibility (when The pragmatic approach adopted by the
should expert evidence be accepted) and compe- English Courts in determining expertise means
tence (is the expert qualified to give it) have been that there is no general requirement for expert wit-
fulfilled. nesses to have formal qualifications or to be
For the criterion of admissibility to be ful- accredited by professional bodies. By virtue of
filled, the evidence must be outside the experi- the formalized process of acquiring entry to the
ence of the tribunal—the judge in a civil case and established professions, it is easy for the Courts to
the judge and jury in a criminal case. Evidence assess expertise. Consequently, the “…
that is not sufficiently intelligible to judge and academically-based sciences such as medicine,
jury, because it relates to a field of specialised geology or metallurgy, and the established profes-
knowledge, requires the input of the expert wit- sions such as architecture, quantity surveying or
ness in order that it can be made intelligible to the engineering, present no problem. The field will be
judge and/or jury. Evidence that is within the regarded as one in which expertise may exist and
experience of the ‘man on the street’, and there- any properly qualified member will be accepted
fore by definition can be understood by judge and without question as expert” [Bingham LJ 1991 in
jury, requires no such input. R. v Robb [1991] 93 Cr. App. R. 161] [1].
The competence of an expert witness to give
evidence lay at the heart of arguably one of the
UK’s worst miscarriages of justice and so it is an
issue of great importance. In the case of Sally
Clark, wrongly accused of murdering her two
sons, Professor Sir Roy Meadow, expert though
J. Reynard he was in matters of child abuse, was not an
Department of Urology, Oxford University Hospitals
NHS Trust, Oxford, UK expert in the interpretation of statistical data. His
misinterpretation of statistical data led to her
Nuffield Department of Surgical Sciences, Oxford
University Hospitals NHS Trust, Oxford, UK wrongful conviction for murder:
“Even when an infant dies suddenly and unex-
The National Spinal Injuries Centre, Stoke
Mandeville Hospital, Aylesbury, UK pectedly in early life and no cause is found at
e-mail: John.Reynard@ouh.nhs.uk autopsy, and the reason for death is thought to be

https://doi.org/10.1007/978-3-319-78683-4_10
52 J. Reynard
an unidentified natural cause (Sudden Infant both died from unnatural causes. He knew that he
had no such experience and should have expressly
Death Syndrome) … it is extremely rare for that disclaimed any. To my mind, that amounts to seri-
to happen again within a family … such a hap- ous professional misconduct”.
pening may occur in 1:1000 infants, therefore the
chance of it happening twice within a family is The Clark and Meadow cases thus highlight
1:1 million. Neither of these two deaths can be the importance of experts constraining their opin-
classified as SIDS. Each of the deaths was ions to areas in which they are genuinely expert,
unusual and had the circumstances of a death but it also raised the important question of princi-
caused by a parent” (Clark (Sally) [2004] EWCA ple of whether an expert witness should be enti-
Crim 1020) [2]. tled to immunity from disciplinary, regulatory or
Professor Meadows failed to appreciate fitness to practise proceedings in relation to evi-
(because he was not an expert in statistics) that dence given by the expert in legal proceedings.
squaring the odds of deaths of 1:1000 for one In Pearce v Ove Arup [2001] EWHC Ch 455
death to 1:1 million for two deaths, is only valid Justice Jacob J concluded [4]:
if each of the deaths is truly independent of the “I see no reason why a judge who has formed an
other without the shared genetic and environmen- opinion that an expert had seriously broken his Part
tal circumstances of the children being members 35 duty should not, in an appropriate case, refer the
of the same family. Professor Meadow later went matter to the expert’s professional body… Whether
there is a breach of the expert’s professional rules
on to conclude that the chances of two natural and if so what sanction is appropriate would be a
deaths, given the social circumstances of Mrs. matter for the body concerned”.
Clark’s family, were actually even slimmer at
1 in 73 million, likening this to the chances of Normally, evidence given honestly and in
winning at the Grand National 4 years in a row on good faith would not merit a referral. It is unlikely
a horse with odds of winning of 1 in 80. At the that a single case involving a poor report or evi-
initial trial this wrongly interpreted ‘evidence’ dence would on its own show that the practitioner
proved compelling and the jury concluded that was unfit to practise and so a danger to the public.
she was guilty of murder. However, criticism of an expert by a judge quite
Mrs. Clark’s father complained to the GMC apart from being a most serious matter in its own
alleging serious professional misconduct on the right may well discourage solicitors from
part of Professor Meadow. A Fitness to Practise instructing that expert again. Such matters have a
Panel of the GMC concluded in July 2005 that habit of spreading rapidly, and a hitherto success-
Professor Meadow was guilty of serious profes- ful Medicolegal career may be ruined.
sional misconduct and ordered that his name be
erased from the register. Professor Meadow
appealed to the High Court and in February 2006 10.3 Duty of the Expert Witness
Collins J allowed his appeal and quashed the
order of the GMC. The expert is therefore well advised to take
The GMC in turn appealed against that judg- heed of the Civil Procedure Rules (CPR 35.3)
ment (GMC v Meadow [2006] EWCA Civ 1390) which state:
[3]. The appeal was dismissed, but only by a 2-1
majority and Sir Anthony Clarke MR’s dissent- 1. It is the duty of experts to help the court on
ing judgment is instructive: matters within their expertise;
“Professor Meadow is not a statistician and had no 2. This duty overrides any obligation to the per-
relevant expertise which entitled him to use the sta- son from whom experts have received instruc-
tistics in the way he did … he made a mistake tions or by whom they are paid.
which other non-statisticians have made … He
gave the evidence as part of his expert evidence
and, moreover, did so in a colourful way which The basis of the Civil Procedure Rules is that
might well have been attractive to a jury … to sup- it would be contrary to the public interest for the
port the prosecution’s case that the children had expert to undertake to confine an opinion that
10 Being an Expert Witness 53
was in the client’s interest only and to refrain kindly to changes in opinion when your opinion
from saying anything to the court to which the has initially been supportive of the case, espe-
client might take objection. cially when such changes occur late in the day. If,
At one time experts were immune from pros- however, the other side comes up with a compel-
ecution for the views expressed in their reports or ling and well-reasoned argument that is contrary
in Court. However, the Court of Appeal in the to your initial opinion, then of course be prepared
Meadow case indicated that there was no abso- to give ground and concede a point.
lute immunity. Some expert witnesses are tempted to please
The absence of immunity from prosecution their instructing solicitors by preparing a report
was further emphasized in Jones v Kaney [2011] weighted in favour of the claimant’s or defen-
UKSC 13 [5]. The background was that Dr. dant’s case, and refuse to budge from this opin-
Kaney, instructed on behalf of the claimant, ion. The expert is well advised to avoid such an
expressed an initial view that the claimant Mr. approach. At the very least if the case cannot hold
Jones was suffering from post-traumatic stress up to reasoned argument your instructing solici-
disorder or ‘PTSD’. The psychiatrist instructed tor and his or her barrister will be irritated to have
by the insurers defending the claim opined that wasted hours of effort in prosecuting a case, only
Mr. Jones was exaggerating the effects of his to find this out in court.
physical injuries. In the joint statement signed by Worse than this though is for the expert to face
both experts after a joint discussion, Dr. Kaney criticism from a judge for a partisan report. Such
conceded ground on a number of issues, so weak- criticism has the potential to destroy your medi-
ening the claim considerably. Specifically, Dr. colegal practice, for who will wish to instruct you
Kaney agreed that the claimant’s psychological again.
reaction was only an adjustment reaction, not In the recent case of Harris v Johnston [2016]
PTSD. Mr. Jones therefore had to settle the claim EWHC 3193 an expert witness for the Claimant
for significantly less than he had been seeking. was described by Andrews J as having an “intran-
Dr. Kaney then herself became the subject of a sigent mind set” [8]. The judge found that the
claim by Mr. Jones who accused her of having reasoning of one of the Claimant’s expert wit-
negligently signed the joint from statement, the nesses “was unreliable” and that the expert’s
allegation being that she did not have sufficient “general intransigence … sloppy attention to
reason to retreat from her diagnosis that Mr. Jones detail and … failure to abide by [the] duties …
was suffering from PTSD. The Supreme Court [of] … an independent expert did not just lead me
concluded that experts do not enjoy immunity to question [the expert’s] reliability, it left me
from civil claims arising out their preparation and with no confidence in [the expert]”. Accordingly,
presentation of evidence for the purpose of court the judge could not rely on any of the expert’s
proceedings: Jones v Kaney [2011] UKSC 13 [5]. evidence and unsurprisingly the claimant lost.
It is therefore essential that you are objective The judge described the Defence expert on the
and are careful to both sides of the argument, as other hand as “the model of an independent and
advised by Cresswell J in The Ikarian Reefer impartial expert, balanced, fair and objective”.
([1993] 2 Lloyd’s Rep. 68) [6, 7]: It is crucial to declare any potential conflict of
“An expert witness should provide indepen- interest from the outset, to your instructing solici-
dent assistance to the court by way of objective tor and to make this very clear in any report. In
unbiased opinion in relation to matters within his EXP v Barker [2015] [9] EWHC 1289 (QB) it
expertise… He should not omit to consider mate- transpired during the court case that the defen-
rial facts which could detract from his concluded dant’s neuroradiology expert had a long and close
opinion”. relationship with the defendant, having trained
Formulate your opinion only on the basis of him, written a paper together and having assisted
reasoned argument, for once you have convinced him in securing a job. The judge concluded:
your instructing solicitor and the appointed bar- “Failure to make early disclosure [of a pre-
rister of the merits of the case, they may not take existing relationship between an expert and a
54 J. Reynard
party] may lead to the kind of chaotic situation as the judge. The expert’s opinion must be
that has arisen in this case, where the nature and logical and capable of withstanding reasoned
extent of the conflict became clear only in the argument.
course of the trial and led to a submission, after
all the evidence was heard, that the evidence of
the defendant’s expert, upon which the defence in
the event ultimately depended, should be ruled References
inadmissible by the court”.
1. R. v Robb [1991] 93 Cr. App. R. 161.
2. Clark (Sally) [2004] EWCA Crim 1020.
Conclusion 3. GMC v Meadow [2006] EWCA Civ 1390.
None of the above ‘rules’ of being a good 4. Pearce v Ove Arup [2001] EWHC 481.
expert are difficult. The critical thing for the 5. Jones v Kaney [2011] UKSC 13.
6. National Justice Compania Naviera SA v Prudential
medical expert is to remember that their role is
Assurance Co Ltd (The Ikarian Reefer) [1993] 2
to interpret evidence that lies outside the expe- Lloyd’s Rep 68, 81.
rience of the judge and/or jury and to provide 7. The Ikarian Reefer [1993] 2 Lloyd’s Rep. 68.
an objective and unbiased opinion, expressing 8. Harris v Johnston [2016] EWHC 3193 (QB).
9. EXP v Barker [2015] EWHC 1289 (QB).
the pros and cons of each view. It is not to act
The Obstetrician/Gynaecologist
in Coroner’s Court 11
A. R. W. Forrest
11.1 History Coroners and Justice Act 2009. Strictly speak-

ing, it is not the death which is reported, but
The Office of Coroner was first established in rather the presence of a dead body in the coro-
1194 as a means of maximising the revenue of ner’s area. Where the coroner has reason to sus-
the Crown at a time when the Treasury was bur- pect that the deceased died either a violent death
dened with finding a ransom, some 2½ times the or unnatural death, or the cause of death is
annual revenue of the Crown, for King Richard I unknown, or the deceased died in custody or oth-
who was being held captive by the Duke of erwise in state detention then he must open an
Vienna. The original duties of the coroner were investigation into the death. At present, only the
as custodian of the pleas of the crown (custos Registrar of Births, Deaths and Marriages has a
placitorum coronae). This involved the collection statutory duty to report such a death to the coro-
of a variety of fines and fees, including fines of a ner. A typical example where the Registar
community where a person was found dead and it makes such a report would be where the medi-
could not be proved he was English rather than cal certificate indicates that the death was due
Norman. The coroner’s role was crystallised in to industrial disease, which is regarded as an
the next century by an act of Edward I [1]. unnatural death, and the death has not been
Arguably, not much changed until the passage of reported to the coroner. There is a common law
the Coroners and Justice Act 2009. duty on householders and others who may be
about the person at the time of death to report a
death, which engages the coroner’s duty to
11.2 C
urrent Position in England investigate, to the coroner. It is a GMC require-
and Wales ment to report such a death [2]. Section 2 of the
Coroners and Justice Act 2009 deals with
The coroner is a judge in a court of record who reform of the death certification process and
investigates deaths reported to him which require includes provisions mandating the reporting of
investigation in the circumstances set out in the certain deaths to the coroner. The reforms also
include the appointment of Medical Examiners
who will review all medical certificates of the
A. R. W. Forrest
Assistant Coroner, South Yorkshire West and East cause of death. However, some 9 years after the
Yorkshire, Kingston-upon-Hull, UK Act was passed these reforms have yet to be
Sheffield University School of law, Sheffield, UK implemented. Early 2019 has been suggested as
e-mail: robertforrest@mac.com a possible implementation date [3].

https://doi.org/10.1007/978-3-319-78683-4_11
56 A. R. W. Forrest
11.3 The Investigation experts. The questioning of witnesses must be

confined to the matters the inquest has to deter-
Once informed of a death the coroner initiates a mine—who the deceased was, where, when and
three-stage process; first preliminary enquiries to how they came to their death and, where it is an
establish whether an investigation should be initi- “Article 2” inquest, the broad circumstances of
ated, then an investigation which may show that the death. Advocates for the family may try to
the cause of death is natural in which case an extend the questioning into other areas to gather
inquest is not required and finally the inquest. evidence for adversarial proceedings in other
The inquest is an enquiry in court to establish courts. The coroner should not allow this.
who the deceased was, when they died and how When the evidence has been heard, the coro-
they came to their death. If the circumstances of ner will ask the interested persons if they wish to
the death require an investigation into a possible address him on matters of law. He will then sum
breach of the rights set out in the European the evidence up, briefly if he is sitting without a
Convention on Human Rights (ECHR), which jury, addressing the jury on the conclusions that
are incorporated into English law in the Human are available. These can be either short form con-
Rights Act 1998, then the inquest is extended to clusions, such as “accident”, “natural causes” or
inquire into the circumstances of the death. Most “stillbirth”, or a narrative verdict. A narrative ver-
of the developments in judge made coronial law dict is a succinct, neutral, account of how the
over the last few years have involved such deceased came to their death. However, the con-
extended inquests. They are often referred to as clusion is formulated it must not include opinion
“Article 2” or “Middleton inquests” [4], Article 2 on anything other than how, or in what circum-
of the European Convention on Human Rights stances in an Article 2 inquest, the deceased came
being the “right to life” section, which gives a to their death and must not appear to determine
right to have one’s death independently investi- any question of criminal liability on the part of a
gated when the State, by omission or positive named person or civil liability.
action, has contributed to the mechanism of Once the conclusion has been announced the
death. This right has been interpreted quite Coroner will consider if the evidence has dis-
widely [5]. closed a situation that, unaddressed, may lead to
future deaths [6]. If it has he has a non-
discretionary duty to make a report to a person
11.4 The Inquest who can do something about it. This is known as
a Regulation 28 Report. The addressee of the
The coroner occupies an unusual position in report has 56 days to respond, saying what
English law. He is a judge, appointed by, and action they propose to take, or, if they are going
funded by, the local authority for his coroner’s to take no action, why not. The response is pub-
area. His court is an inquisitorial one. Unlike a lished on the Judiciary website. In general,
civil or criminal court there are no parties trying Hospital Trusts will try to argue against the sub-
to make their case with the judge holding the mission of such a report if it relates to a situa-
ring. The coroner oversees the investigation and tion within their Trust.
in court takes the witnesses through their evi-
dence. When the coroner has concluded his ques-
tioning, then “properly interested persons” or 11.5 Conclusions
their legal representatives, may question the wit-
ness. Among those classified as properly inter- What used to be described as the “Verdict” is
ested persons are persons whose conduct might now known as the “conclusion”. Whilst there is a
be called into question in respect of the death. statutory list of short form conclusions [7], the
That may include clinicians who are called to coroner has a discretion to use other formula-
give evidence other than as witnesses to fact or as tions, provided they do not impugn criminal
11 The Obstetrician/Gynaecologist in Coroner’s Court 57
responsibility or civil liability. Some conclu- unintended consequence of a human act, whilst
sions of concern in obstetrics and gynaecology misadventure is an unintended consequence of an
practice are discussed below. intended human action. Misadventure may be
particularly relevant to deaths occurring in medi-
cal treatment. For example, where a patient is
11.6 Unnatural Death being treated for a condition that does not threaten
life and a mishap leads to death, then misadven-
An unnatural death will require an investigation ture may be the conclusion recorded. Coroners
by the coroner. But what is an unnatural death? vary in their approach to these two conclusions.
One definition is “Death wholly or partly caused
or accelerated by any act, intervention or omis-
sion, other than a properly executed measure 11.8 Unlawful Killing
intended to prolong life” [8]. So, during medical
care, acts of intervention or omission can convert The commonest reason for an unlawful killing
a natural cause of death into an unnatural cause conclusion in medical practice is gross negli-
requiring an inquest. For example, an unconscio- gence manslaughter. There are three elements to
nable delay in an ambulance attending a young this, there was a duty of care to the deceased,
girl with severe asthma was held to convert a there was a breach of that duty of care causing
death from natural disease into an unnatural death and the breach of the duty of care was so
death requiring an inquest [9]. A similar situation egregious that it requires punishment by the
was a case where a woman was delivered of State, not just monetary compensation. There
twins, did not have her blood pressure taken after may be a fine margin in a particular case between
delivery and went on to die of fulminant eclamp- misadventure and gross negligence manslaugh-
sia [10]. ter. In fact, such cases rarely reach the coroner’s
Deaths occurring as a result of a well-known court, the matter typically being dealt with by the
complication of treatment can still be considered criminal courts. After a criminal trial where the
an unnatural death in coroner’s law [11]. In prac- facts that would be explored at an inquest have
tice coroners may take into consideration the been canvassed, the coroner has a discretion as to
opinion of the pathologist in deciding whether or whether or not to proceed to an inquest. Where
not the death is a natural one in the circumstances. the facts haven’t been fully explored in the trial,
The decision is the coroner’s not the pathologist’s for example if there is a guilty plea, the coroner
and pathologists and other experts should avoid may proceed to an inquest.
the phrase “this is a death due to natural causes” When the inquest is being heard with a jury, in
in their reports to the coroner. When a person is his summing up the coroner will explain that a
suffering from a fatal condition and medical conclusion of “natural causes” does not imply the
treatment simply does not prevent death from the clinicians were without fault, just as a conclusion
condition then the appropriate conclusion is “nat- of “accident/misadventure” does not imply that
ural causes”. If the treatment causes death, say as the clinicians were at fault.
a result of an adverse drug reaction, then conclu-
sions of accident or misadventure may be
recorded. 11.9 Stillbirths
A still birth is defined as “a child which has

11.7 Accident/Misadventure issued forth from its mother after the twenty-
fourth week of pregnancy and which did not at
Whilst the higher courts have said that there is no any time after being completely expelled from
distinction between these two conclusions, there its mother breathe or show any other signs of
is a difference. An accident can be defined as an life” [12].
58 A. R. W. Forrest
In order to die you have to live in the first place There are a large range of conclusions that the
and in law a still born infant has never lived. So, a coroner might return after such a death. A narra-
stillborn child’s remains cannot be the subject of tive verdict may be appropriate.
an inquest. However, the coroner may inquire into
whether or not the infant showed any signs of life
after complete expulsion form the mother’s body. 11.11 Preparing for the Inquest
Whilst the coroner’s duty to investigate in such
circumstances has been established for nearly When a clinician is called to appear before the
200 years [13], it still generates controversy. The inquest, it is important to establish if it is to give
coroner’s right to inquire as to whether a child simply evidence of fact or if he is a “properly
was born alive or stillborn was recently confirmed interested person” whose conduct may be called
in a case where a 19 year old woman presented at into question at the inquest. In either case, the cli-
hospital with a dead baby in a shoe box after an nician should immediately contact their defence
unattended delivery 6 days earlier. The coroner organisation. The importance of properly com-
initiated an investigation to establish whether or pleted, contemporaneous case notes that are dated
not the child was born alive. The Court of Appeal and signed cannot be over emphasised. Moreover,
confirmed he was correct [14]. making sure the case notes and any relevant labo-
There is a view that the coroner’s jurisdiction ratory reports do not disappear into a hospital
should be extended to encompass deaths in utero oubliette is very important. When going to the
in the last trimester of pregnancy. This would Inquest, be sure to get there in plenty of time,
require new legislation. Whilst a submission has dress appropriately, make sure you have read and
been made to the Law Commission to that effect re-read any statement or report you have produced
such a change is unlikely for some time, if ever. and if you have referred to any papers or authori-
There can be disagreement between those tative texts in your report take them with you to
present at birth as to whether or not an infant has court. The advice from your defence organisation
shown any sign of life after complete expulsion about the specific case will be invaluable.
from its mother’s body. There can also be dis-
agreement as to whether or not an agonal e.c.g
rhythm can be regarded as a sign of life. My own Key Points: The Obstetrician/Gynaecologist
view is that it should be considered a sign of life. in Coroner’s Court
The legal definition is clear. “Any” sign of life • The Coroner’s main duty is to investi-
includes chaotic cardiac electrical activity. gate possibly unnatural deaths.
• Deaths that appear to a clinician to be
natural may be unnatural in law.
• The Procedure in the coroner’s court is
11.10 Abortion inquisitorial not adversarial. There are no
parties in the coroner’s court putting their
The short form conclusion “Abortion” refers to sides of a case against each other. Rather
the cause of death of the mother, not the infant. it is an enquiry conducted by the coroner
A particularly difficult situation is where an to establish four simple truths, who the
infant shows signs of life on delivery after a ther- deceased was, where they died, when
apeutic termination of pregnancy. When this they died and how they came to their
occurs, those attending have a duty to care for the death. When Article 2 of the European
child and provide appropriate treatment in its best Convention on Human Rights is engaged
interests. In one case where treatment was the remit of the Inquest is extended to
delayed the gynaecologist involved was prose- exploring the circumstance of the death.
cuted for attempted murder. The magistrates held • The Inquest is not a forum where crimi-
that there was no case to answer [15]. When a nal responsibility or civil liability are
death occurs in such circumstances the coroner canvased.
must be informed. An inquest will usually result.
11 The Obstetrician/Gynaecologist in Coroner’s Court 59
References 6. The Coroners (Investigations) Regulations 2013 Part 7.

7. Coroners (Inquests) Rules 2013 r.34.
8. Pilling HH. Natural and unnatural deaths. Med Sci
1. Waldo FJ. The ancient office of coroner. Trans
Law. 1967;7(2):59–62.
Medico-Legal Soc. 1910;VIII:101–33.
9. R v Poplar Coroner, ex parte Thomas [1993] QB 610.
2. http://www.gmc-uk.org/guidance/ethical_guidance/
10. R (Touche) v Inner North London Coroner [2001]
end_of_life_certification_post-mortems_and_refer-
Q.B. 1206.
ral.asp. Accessed 17 June 2017.
11. “Doctor blames the pill for woman’s death.” Times
3. https://www.rcpath.org/discover-pathology/news/
[London, England] 21 Jan 1969: 4. The Times Digital
medical-examiner-delay.html. Accessed 17 June
Archive.
2017.
12. Births and Deaths Registration Act1953 s.41.
4. R (Middleton) v HM Coroner for West Somerset
13. Jervis J. On the office and duties of coroner. S. Sweet,
[2004] 2 AC 182.
London; 1829, p 380.
5. Thomas L, Shaw A, Machover D, Friedman
14. R(T) v HM Senior Coroner for West Yorkshire [2017]
D. Inquests—a practitioner’s guide: Legal Action
EWCA Civ 318.
GroupCh. 18 Inquests and the European convention
15. Rupert Morris. Abortion doctor cleared by JPs. Times
on human rights; 2014, pp. 373–472.
[London, England] 16 Sept 1983.
Intimate Examinations
and Chaperones 12
Janesh K. Gupta
12.1 Background –– Reassure the patient if they demonstrate signs

of distress/discomfort
It is every clinician’s duty to provide a good stan- –– Familiarise themselves with what the proce-
dard of care when assessing, diagnosing and dure involves
treating patients. As part of this duty we are –– Be present for the duration of the examination
sometimes obliged to conduct intimate examina- and be able to see what the doctor is doing
tions. These include examination of breasts, geni- (where practical)
talia and rectum, but for some patients other close –– Be willing to raise concerns if necessary
contact may also be regarded as intimate. Intimate
examinations can be embarrassing and distress- In addition to intimate examinations, other
ing for patients and we are obliged as a result to situations where a chaperone may be beneficial
respect their dignity and privacy [1, 2]. are as follows:
A chaperone is an independent person, appro-
priately trained, whose role is to observe the –– Anxious or vulnerable patients
examination/procedure undertaken by the doctor/ –– Patients with whom there may have been a
health professional to assist in maintaining the misunderstanding or difference of recollection
appropriate doctor–patient relationship. of events in the past
When an intimate examination is to be con- –– Patients reviewed by trainee doctors or
ducted, the patient should be offered the option of students
having a chaperone present. This applies irre- –– Where religious or cultural issues which may
spective of the genders of the doctor and patient. affect the physical examination
A chaperone should fulfill the following criteria:
Having a chaperone present has several advan-
–– Usually be a health professional (do not have tages, including:
to be medically trained)
–– Be sensitive and respect the patient’s dignity –– Provides assistance to the health professional
and confidentiality in the examination including passing instru-
ments when required
–– Provides emotional comfort and reassurance
J. K. Gupta to the patient
Obstetrics and Gynaecology, Birmingham Women’s –– Acknowledges a patient’s vulnerabilities and
and Children’s Hospital, Birmingham, UK ensures the patient’s dignity is preserved.
e-mail: J.K.Gupta@bham.ac.uk

https://doi.org/10.1007/978-3-319-78683-4_12
62 J. K. Gupta
–– Add a layer of protection for the doctor: it If the patient refuses a chaperone a clear
would be rare for an allegation of impropriety explanation should be given why a chaperone is
be made when a chaperone was present. required and this fact recorded in the medical
records. When a patient continues to refuse a
In order to avoid litigation in this area, the chaperone, it is at the discretion of the doctor
GMC has provided clear guidance for practising whether or not to proceed and will be a decision
clinicians, and it is important that clinicians fol- based on both clinical need and the requirement
low these principles carefully. for protection against any potential allegations of
an unconsented examination/improper conduct.
It is imperative to document that a chaperone was
12.2 Minimal Standards offered and declined.
and Clinical Governance As the treating doctor if you are unwilling to
Issues proceed consideration should be given to refer-
ring the patient to another doctor/colleague. This
Before performing any intimate examination, may be a doctor of the same gender as the patient
explain why it is required and the nature of the if this is the basis for refusing the examination.
examination to allay any fears. The patient should Any delay should not adversely affect the
be given the opportunity to ask questions. It is patient’s health.
important to explain what the examination There is a duty to report any inappropriate
involves, including the fact that it may cause pain sexual behaviour of a colleague with a patient
or discomfort. The patient should have a clear (Sexual behaviour and your duty to report col-
idea of what to expect before starting. leagues (2013).
The patient’s permission to proceed should Where an intimate examination is required on
be obtained and documented in the notes. an anesthetised patient or when supervised stu-
Patients should be offered a chaperone for all dents wish to carry out such an examination,
intimate examinations. A relative or a friend is written patient consent should be obtained in
not a suitable chaperone, but where the patient advance.
requests the presence of a friend or relative they Where the examination involves a child or
may be present in addition to a chaperone. The young person, their capacity to consent should be
chaperone’s identity should be recorded in the assessed and where this is lacking, permission
medical notes. from the parents should be obtained. At 16 a
To ensure a patient’s dignity, she should be young person should be presumed to have the
allowed to undress herself in a private room, she capacity to consent.
should be provided with a cover and she should There may be exceptions to when a chaperone
not be helped to undress, unless she specifically is not required, i.e., in an emergency, when the
asks for assistance. If the examination is obvi- patient’s clinical needs must be the priority.
ously too uncomfortable or if the patient asks for
the examination to be stopped it must be ceased
immediately. No personal comments should be 12.3 Reasons for Litigation
made during the examination. All discussions
during the examination should be relevant. The main reasons for litigation are patient com-
Where a chaperone is not available (home vis- plaints and allegations of inappropriate sexual
its or in the out of hours setting) it is important to behaviour or sexually motivated intimate exami-
consider the clinical urgency of the examination. nations, usually because there is an absence of a
The examination can be postponed to a later date chaperone. It should be remembered that there is
as long as there is no adverse impact on the a duty to report any inappropriate sexual behav-
patient’s clinical needs. iour of a colleague with a patient [3].
12 Intimate Examinations and Chaperones 63
Where an allegation of sexual misconduct has

been made the local police force is duty bound to Key Points: Intimate Examinations and
investigate. Such investigations may result in a Chaperones
criminal case being brought against the doctor. • Chaperones should be used wherever
Because of the seriousness of the offences that possible, for the protection of both the
are likely to have been alleged the trial will nor- patient and doctor and patients should
mally take place in the Crown Court in front of a be offered a chaperone for all intimate
panel of 12 jury members and one Judge. In most examinations.
cases the doctor’s defence organisation will pro- • Ensure training for all chaperones.
vide a defence. • Although it is not mandatory for a chap-
erone to be present, the presence of a
chaperone decreases the risk of an alle-
12.4 Avoidance of Litigation gation of inappropriate behaviour.
• If a patient refuses to have a chaperone,
It is important that the above guidance from the the doctor can refer to a colleague.
GMC is followed and to maintain professional • If the doctor continues with the examina-
boundaries between patient and doctor [4]. In tion without a chaperone, the offer of a
addition to offering patients a chaperone, the chaperone and the reasons for continuing
doctor must be competent in performing the rel- with the examination should be clearly
evant examination and must be clear that it will documented in the medical records.
help the diagnosis. • Be sensitive to a patient’s ethnic/reli-
gious and cultural background. The
patient may have a cultural dislike to
12.5 Case Study being touched by a person of another sex
or undressing in front of such a person.
A 25-year-old woman had a vulval abscess that
was treated by incision and drainage at the local
hospital. She was followed up by her General
Practitioner, who performed examinations of
the vulva and vagina on three separate occa- References
sions, 1 week apart. At each of these examina-
1. General Medical Council (GMC). Good Medical
tions a chaperone was not present. As the
Practice. London. 2013. http://www.gmc-uk.org/
abscess resolved, the patient alleged that the guidance/good_medical_practice.asp.
examinations became more sexually motivated, 2. General Medical Council (GMC). Intimate exami-
as each examination became more prolonged nations and chaperones. London. 2013. http://www.
gmc-uk.org/static/documents/content/Maintaining_
and the last examination allegedly involved boundaries_Intimate_examinations_and_chaperones.
stimulation of the clitoris. In a criminal court pdf.
hearing the doctor was cross-examined and 3. General Medical Council (GMC). Sexual behaviour
eventually acquitted as he was able to convince and your duty to report colleagues. London. 2013.
http://www.gmc-uk.org/static/documents/content/
the court that a chaperone was offered at each Maintaining_boundaries_Sexual_behaviour_and_
visit but refused by the patient. However, the your_duty_to_report_colleagues.pdf.
doctor had failed to record these offers in the 4. General Medical Council (GMC). Maintaining a pro-
medical records and despite his acquittal his fessional boundary between you and your patient.
London. 2013. http://www.gmc-uk.org/static/docu-
case was referred to the General Medical ments/content/Maintaining_a_professional_bound-
Council for further investigation into his Fitness ary_between_you_and_your_patient.pdf.
to Practice.
Part II
Anaesthesia in Obstetrics and Gynaecology
Swati Jha and Danny Bryden
Pain Relief
13
Jeremy P. Campbell and Felicity Plaat
13.1 Background [2] and the National Institute for Health & Care
Excellence (NICE) [3] describe standards of care
Provision of pain relief in labour has humanitarian for the provision of regional analgesia for labour.
intent but additional medicolegal considerations. Failure to achieve these standards increases vul-
The indications, contraindications and complica- nerability to litigation.
tions of non-regional (pharmacological and non-
pharmacological methods) and regional techniques
for labour analgesia are discussed below. The issue 13.3 Reasons for Litigation
of informed consent and the implications of ante-
natal birth plans are also described. 13.3.1 Non-pharmacological
Analgesia in Labour
13.2 Minimum Standards A variety of psychological and physical methods

and Clinical Governance are available. Although apparently safe, evidence
Issues of efficacy is lacking. Such methods can be pro-
moted by care-givers and offered by Trusts.
Attitudes towards pain relief in labour are influenced Anaesthetists should be aware of what is avail-
by cultural factors, peer group pressure and personal able and provide unbiased information. A sum-
expectations. The woman’s partner and other family mary of the existing evidence can be found in the
members are frequently involved in the choice of Cochrane Database of systematic reviews [4].
pain relief. If expectations are not met or complica-
tions arise, complaints and litigation are likely. It is
essential that appropriate information is given and 13.3.2 Pharmacological Analgesia
analgesia is tailored to the individual parturient. in Labour
The Royal College of Anaesthetists (RCoA)
[1], Obstetric Anaesthetists’ Association (OAA) 13.3.2.1 Inhalational Analgesia
(Entonox)
Entonox (a mixture of 50% nitrous oxide in oxygen)
J. P. Campbell · F. Plaat (*) is widely used as an analgesic in labour. It may cause
Imperial College Healthcare NHS Trust, Queen nausea, light-headedness and drowsiness. Although
Charlotte’s and Chelsea Hospital, London, UK
e-mail: Jeremy.Campbell@imperial.nhs.uk; not a potent analgesic, studies have suggested that it
Felicity.Plaat@imperial.nhs.uk provides sufficient analgesia for many women [5].

https://doi.org/10.1007/978-3-319-78683-4_13
68 J. P. Campbell and F. Plaat
13.3.2.2 Systemic Opioids Table 13.1 Indications and contraindications for

regional analgesia in labour
Pethidine remains the most commonly used opi-
oid for labour analgesia, although use of diamor- Indications for regional analgesia
phine is increasing. Both are given intramuscularly 1. Maternal request
2. Maternal cardiovascular and respiratory disease
and are predominately sedative and anxiolytic
Regional analgesia reduces the cardiovascular
rather than analgesic [6] and up to three quarters stress associated with painful uterine contractions.
of women require additional analgesia. Pethidine 3. Obstetric indications
readily crosses the placenta and may cause neo- (a) Pre-eclampsia.
natal respiratory depression if delivery occurs Effective analgesia helps reduce blood pressure
within 1–2 h of administration. Its use has been and improves renal and placental blood flow.
(b) Multiple pregnancy.
associated with subsequent neonatal behavioural
Use of regional analgesia is associated with
and feeding problems. improved acid-base status of the second twin and
facilitates operative delivery if required.
13.3.2.3 Patient Controlled Analgesia 4. Anaesthetic indications
Patient controlled opioid analgesia (PCA) may (a) Obesity
Early establishment of regional analgesia can be
be offered if regional analgesia is contraindi-
extended to provide anaesthesia in an emergency
cated. Both fentanyl and remifentanil have been reducing the need for general anaesthetic.
used. Remifentanil is potentially superior because (b) Predicted difficult airway
it has a rapid onset and a short duration of action, Reduces the need for general anaesthesia (and
providing rapid analgesia with quick recovery therefore the risk of failed tracheal intubation) in
an emergency.
between contractions [7]. Fetal exposure is mini-
Contraindications to regional analgesia
mal due to rapid metabolism. The woman • Maternal refusal
requires supplemental oxygen and continuous • Allergy to local anaesthetic or opioid drugs
oxygen saturation monitoring. There have been • Lack of resuscitation equipment and trained staff to
case reports of life-threatening respiratory care for the woman
depression in labour. • Inability to gain large-bore (16-G) intravenous access
• Local infection at site of insertion
• Significant coagulopathy or anticoagulation (see
later)
13.3.3 Regional Analgesia • Cardiovascular instability
• Raised intracranial pressure (intrathecal injection or
Regional analgesia provides better pain relief in accidental dural puncture with an epidural needle
labour than other methods. Combined spinal- may cause coning)
epidurals (CSE) provide quicker pain relief than Special circumstances:
epidurals. Indications and contraindications are 1. Anticoagulants or aspirin
Aspirin: this is not a contraindication to regional
given in Table 13.1.
analgesia.
Low molecular weight heparin (LMWH), e.g.
13.3.3.1 Timing of Analgesia enoxaparin, dalteparin:
A common cause of complaint by women is that Following a prophylactic dose of LMWH, an
they did not receive regional analgesia when epidural should not be sited, or an epidural catheter
removed, for 12 h. After a treatment dose of LMWH
requested, or that it did not work adequately.
24 h should elapse before siting a regional block or
Both the RCoA and the OAA suggest that the removing a catheter. If LMWH is to be given after
anaesthetist should attend within 30 min of a removal of an epidural catheter, a minimum of 4 h
request for analgesia in units providing a 24-h should elapse.
13 Pain Relief 69
Table 13.1 (continued) Table 13.2 Factors associated with inadequate regional

analgesia in labour
2. Thrombocytopenia
If a patent has thrombocytopenia secondary to Patient factors
pre-eclampsia, the platelet count can fall rapidly. It Spinal deformity/spinal surgery
is therefore essential to have a recent platelet count Obesity
before siting an epidural, (within 6 h). A platelet Anaesthetic/management factors
count above 80 × 109/L is considered sufficient if Failure of the initial dose
associated with normal coagulation studies. A lower
Length of catheter in epidural space <2 cm or
threshold may be safe in women with idiopathic
>8 cm
thrombocytopenia as platelet function is normally
good. A haematologist should be consulted if in Lack of operator experience
doubt. Continuous infusion to maintain analgesia
3. Infection Inadequate frequency of top-ups
If a woman is systemically septic, epidural Inadequate volume of top-ups
analgesia may exacerbate hypotension due to Obstetric factors
peripheral vasodilatation, as well as risk Duration of labour >6 h
introduction of micro-organisms into the neuraxial Malposition of fetus
space. We avoid regional analgesia in women who
are overtly septic with hypotension. Woman who
are asymptomatic but pyrexial should receive when speed is essential [3]. There is some evi-
intravenous antibiotics prior to epidural placement.
It may be prudent to avoid dural puncture in these dence that a CSE is associated with greater
circumstances. maternal satisfaction, fewer re-sites and less need
for rescue top-ups compared with an epidural.
Insertion of the block in the sitting position is
epidural service [1, 2]. Frequently, factors associated with a higher success rate although
beyond the control of the anaesthetist are respon- the incidence of venous puncture (bloody tap) is
sible for delays in providing analgesia. The need increased. Use of ultrasound for insertion may
to transfer a woman, staffing and communication improve success rates. 4–5 cm of the catheter
issues may be responsible. It advisable that the should be inserted into the epidural space: too
anaesthetist record the time of the request, the little and the risk of displacement is increased;
time he or she attended, and whether there were too much and the likelihood of a one-sided
factors delaying the provision of analgesia. block (the most common cause of inadequate
There is no evidence for withholding regional analgesia) is increased. Addition of opioids to
analgesia in early labour. NICE states that it should local anaesthetic improves the quality of anal-
be provided to women in the latent stage who gesia. Low concentrations of local anaesthetic
request it [3]. Equally, regional analgesia should (<0.25% bupivacaine) should be used [3] and
not be withheld in the second stage of labour. analgesia maintained with intermittent epidural
top-ups. Top-ups may be staff-administered, or
13.3.3.2 Preventing Inadequate given via a patient controlled device (patient
Analgesia controlled epidural analgesia [PCEA]). Both
Studies suggest up to 24% of epidurals provide reduce the incidence and intensity of motor block
less than adequate analgesia at some point during compared with epidural infusions, and PCEA
labour. Table 13.2 lists factors associated with may increase maternal satisfaction. Motor block
inadequate analgesia. reduces maternal satisfaction and contributes to
The CSE technique provides more rapid anal- the increased length of the second stage of labour
gesia than plain epidurals, and is recommended and the higher incidence of instrumental delivery.
13.3.3.3 Management of Inadequate the mechanics of labour or fetal pressure on nerves.

Analgesia Permanent neurological damage due to regional
Units should have guidelines on the management techniques occurs in 1 in 80,000–1 in 320,000 [9].
of inadequate analgesia. Regular monitoring of Delay in obtaining imaging and referral for sur-
the adequacy of analgesia as well as the block gery when compressive lesions are present may
level is recommended. lead to permanent neurological deficit which is
If analgesia is inadequate, the woman should hard to defend and a tragedy for the new mother.
be reassured that analgesia can be improved.
Larger volume, low concentration top-ups may
help inadequate spread of the epidural block. 13.3.4 Consent for Regional
Additional opioids may help when the spread of Analgesia in Labour
the block is adequate but pain relief is not. One-
sided blocks may be corrected by lying the As with any procedure, it is essential to seek con-
woman on the unblocked side and topping up the sent for regional analgesia. For consent to be
epidural, and/or withdrawing the epidural valid, adequate information should be provided,
catheter by 1 cm. However, if these measures are the woman must have capacity and not be coerced.
not successful they should not be repeated and Although someone in great pain or under the
instead the epidural should be re-sited. influence of analgesic drugs may be considered to
lack capacity, the extent in the obstetric setting
13.3.3.4 Side Effects has yet to be determined. In a case involving a
and Complications woman refusing caesarean section in labour, the
of Regional Analgesia Court ruled that despite receiving opioids she
These are largely the same for regional anaesthe- remained competent to make that decision [10].
sia and are discussed in the following chapter. It is inappropriate to burden women suffering
Hypotension is rarely a problem with the painful contractions with large amounts of
low-dose regimens recommended for labour as information. This should be provided antena-
long as aorto-caval compression is avoided. tally instead. However, at the time of a request
Serious sequelae from accidental intravenous for analgesia, the anaesthetist should provide
injection of local anaesthetic and high block are the woman with basic details which should be
also less likely. documented. Table 13.3 lists the risks and com-
Accidental dural puncture occurs in 0.5–2% plications which are commonly discussed. An
of epidurals. Approximately 70% of women who information card, produced by the OAA (includ-
have an accidental dural puncture with a 16-G ing translations in over 40 foreign languages)
epidural needle will suffer a low pressure head-
ache, which may be extremely debilitating. Table 13.3 Risks and complications discussed and doc-
Long-term sequelae include cranial nerve palsies umented prior to instituting regional analgesia in labour
and subdural hematomata [8]. It is essential that Failure/one-sided block/re-site
any woman who suffers a dural puncture be Motor block/immobility/urinary catheter
actively followed up by an anaesthetist to assess Hypotension/nausea and vomiting
for headache. Litigation is likely if the woman Prolonged second stage of labour/increased risk of
assisted vaginal delivery
had not been warned of this complication, if she
Headache
was not properly followed up and was not offered
Temporary/permanent neurological damage
an epidural blood patch in a timely manner. Infection
When neurological symptoms present postna- NB It is worth pointing out that whilst backache is com-
tally there is a tendency to implicate anaesthetic mon after childbirth, the evidence shows no causal rela-
interventions, but the majority of cases are due to tionship to regional analgesia in labour
13 Pain Relief 71
can be downloaded to facilitate discussion 13.5 Case Study

(labourpains.com).
A multiparous woman requested regional
analgesia for labour. The cervix was 5 cm
13.3.5 Birth Plans dilated when she had last been examined 1 h
previously. She was very distressed. An anaes-
The NHS Choices website describes a birth plan thetic core trainee attempted to site the epi-
as ‘a record of what you would like to happen dural. He was finishing his second week on
during your labour and after the birth’ including Delivery suite in preparation to beginning a
pain relief. Women are advised to ‘keep an open job at ST1 level. He made 3 attempts to site
mind’ as ‘you may find that you want more pain the epidural and there was an obvious dural
relief that you’d planned’ [11]. tap at the final attempt. The supervising con-
A particular challenge is a birth plan that states sultant attended promptly and sited an epi-
the woman should not be given an epidural even if dural with difficulty in the space above that
she requests one in labour, and then presents in provided good analgesia for the remainder of
labour desperate for one. If she is deemed to have the labour. Subsequntly the woman developed
capacity it is appropriate to proceed, although it a disabling, positional headache. Blood patch-
may be wise to ask for written consent. Postnatally ing was delayed for 48 h. Although it relieved
or even once the epidural is effective the woman the headache, the woman claimed to have sub-
(and her partner) may be resentful of the anaes- sequently suffered recurring headaches, back-
thetist who aided her ‘labouring self’ to overrule ache and brought a case against the anaesthetist
the wishes expressed in her birth plan. A debrief and Trust.
may help the woman to accept events [12]. If the Solicitors for the woman claimed that the
woman lacks capacity, the birth plan (if written initial procedure for siting the epidural had
clearly, signed and witnessed) should be consid- been carried out negligently, the trainee anaes-
ered evidence of an Advance Decision, and must thetist was not qualified to undertake the proce-
be respected. In such circumstances, it is wise to dure and had been inadequately supervised.
make sure that a witness (usually the midwife) is Furthermore it was claimed that the woman had
present, everyone agrees with the decision and not been warned of the possibility of PDPH and
that this is documented. If a trainee is faced with a would not have had an epidural had she been
situation such as this, it is advisable to involve told. Finally it was claimed that by delaying the
senior input early. blood patch, the woman’s suffering was pro-
longed increasing the risk of developing long
term problems.
13.4 Avoidance of Litigation There was clear documentation of the risks
discussed, including PDPH and the issue of con-
Risks of litigation can be reduced by ensuring sent was dropped. The trainee involved had had
that labouring women and attendants are pro- a run of dural taps in the week previously was
vided with appropriate information and analgesia supposed to be directly supervised but at the
in a timely manner. Labouring women should be time the consultant was in theatre with a cate-
presumed to have capacity and discussions of gory 2 CS. On the basis of this the allegation
treatment or any delays should be carefully docu- that the trainee was inadequately supervised
mented. Analgesic inadequacy or complications could not be defended and the case was settled
should be acted upon as soon as you become for a modest sum as the delay in blood patch is
aware of them. Follow-up after delivery can be accepted practice, and the evidence for long
helpful and may avoid later complaints. term sequelae uncertain.
for Obstetric Anaesthetic Services. London: AAGBI;

Key Points: Pain Relief 2013.
3. National Institute for Health and Care Excellence
• Management of pain needs to be indi- (2014). Intrapartum care for healthy women and
vidualised to suit patient expectations. babies. NICE guideline (CG190).
• Patients should be made aware of the 4. Jones L. Pain management for women in labour: an
various options so that they can make an overview of systematic reviews. J Evid Based Med.
2012;5(2):101–2.
informed decision. 5. Rosen MA. Nitrous oxide for relief of labor
• For invasive procedures which have pain: a systematic review. Am J Obstet Gynecol.
risks, adequate consent is necessary. 2002;186:S110–26.
• Timely provision of analgesia (within 6. Tsui MH, Ngan Kee WD, Ng FF, Lau TK. A double
blinded randomised placebo-controlled study of intra-
30 minutes of the request being made) muscular pethidine for pain relief in the first stage of
and good documentation of reasons for labour. BJOG. 2004;111:648–55.
delay should be made. 7. Schnabel A, Hahn N, Broscheit J, et al. Remifentanil
• When analgesia is inadequate, this for labour analgesia: a meta-analysis of randomised
controlled trials. Eur J Anaesthesiol. 2012;29:177–85.
should be appropriately topped up. 8. MacArthur C, Lewis M, Knox EG. Accidental dural
• Complications should be identified and puncture in obstetric patients and long term symp-
managed promptly. toms. Br Med J. 1993;306:883–5.
9. Cook TM, Counsell D, Wildsmith JAW. Major
complications of central neuraxial block: report on
the Third National Audit of The Royal College of
Anaesthetists. Br J Anaesth. 2009;102:179–90.
10. Re MB (Caesarean section) [1997] EWCA Civ 1361.
References 11. NHS Choices: Your Birth Plan. http://www.nhs.uk/
conditions/pregnancy-and-baby/pages/birth-plan.
1. Royal College of Anaesthetists. Raising the standard: aspx. Accessed 12 Mar 2017.
a compendium of audit recipes. 3rd ed. London: 12. Combeer, E, Iqbal R, Yentis S. Medicolegal issues. In:
RCoA; 2012. Clark V, Van de Velde M, Fernando R, editors. Oxford
2. Association of Anaesthetist of Great Britain & Ireland textbook of obstetric anaesthesia. Oxford: Oxford
and Obstetric Anaesthetists’ Association. Guidelines University Press; 2016.
Regional Anaesthesia
14
Sujata Handa and David Bogod
14.1 Background precautions. Ultrasound scanning provides real-

time images and can be useful to guide placement
Regional anaesthesia techniques have revolution- of needle for central neuraxial blockade. Opioids
ised surgical approaches and pain relief in are very commonly mixed with local anaesthetics
Obstetrics & Gynaecology. In obstetric anaesthe- to improve the quality and duration of analgesia.
sia, the trend towards regional techniques over gen- Absolute contraindications to central neurax-
eral anaesthesia for caesarean section has been one ial blocks include coagulation disorders, local
of the leading causes of reduction in maternal mor- site infection or severe sepsis, known allergy,
tality. Effective postoperative pain relief allows raised intracranial pressure and patient refusal.
enhanced recovery as a result of early mobilisation Spinal anaesthesia—Spinal anaesthesia
and reduces the likelihood of post-operative com- results in a rapid onset of block, thought to act
plications; e.g. infection, deep vein thrombosis. mainly at the spinal nerve roots. Hypotension and
Regional anaesthesia techniques include spinal, post-dural puncture headache are common com-
epidural, combined spinal-epidural (CSE) and plications. Early recognition and treatment is key
transverse abdominis plane (TAP) blocks. to treatment. The spinal cord ends at the level of
first lumbar vertebra. The spinal needle should be
introduced below this level to avoid damage to
14.2 Minimum Standards the spinal cord.
and Clinical Governance Epidural anaesthesia—Main advantages of an
Issues epidural are related to the use of an epidural cathe-
ter allowing control over the onset, extent and dura-
Intravenous access and standard AAGBI tion of blockade. However, the likelihood of missed
(Association of Anaesthetists of Great Britain and segments and local anaesthetic toxicity is higher
Ireland) monitoring should be in place before when compared to a spinal. The risk of inadequate
commencing any procedure. Regional anaesthe- block or failure is higher in patients with morbid
sia techniques are performed in sitting or lateral obesity, previous back surgery and anatomical
position. The procedure is done with strict aseptic abnormalities of the musculoskeletal system.
Combined Spinal Epidural—CSE technique
S. Handa (*) · D. Bogod combines the benefits of both procedures. The
Queens’ Medical Centre, Nottingham University spinal component provides a rapid onset of a pre-
Hospitals NHS Trust, Nottingham, UK dictable block, while the indwelling epidural
e-mail: sujata.handa@nuh.nhs.uk; catheter provides the ability to extend the block
david.bogod@nuh.nhs.uk

https://doi.org/10.1007/978-3-319-78683-4_14
74 S. Handa and D. Bogod
by titrating the dose of local anaesthetics to the options available along with their risks. Statistical
desired effect. significance should not be used to decide disclo-
Transversus abdominis plane block—TAP sure, but a severe risk, however rare should be
block has been shown to reduce the need for post- mentioned, especially if, when it materialises, it
operative opioid use and provide more effective will affect the patient’s life or livelihood.
pain relief after general anaesthesia, while Paraplegia, vertebral canal abscess, vertebral
decreasing opioid related side effects such as canal haematoma, meningitis, spinal cord isch-
sedation and postoperative nausea and vomiting. aemia and death must be mentioned during con-
It is a useful technique for postoperative analge- sent. Uncommon complications such as failure,
sia following abdominal and gynaecological pro- severe headache and significant drop in blood
cedures involving T6-L1 distribution, the pressure should also be mentioned.
innervation of the abdominal wall. Regional anaesthesia information leaflets
should be given to all patients in the anaesthetic
preoperative or antenatal clinic.
14.3 Reasons for Litigation Information given should be adequate in its
scope, content and presentation and the anaesthe-
The reasons for litigation following regional tist should take steps to make sure it is under-
anaesthesia are most commonly related to stood and documented.
Nerve damage—The incidence of neurologi-
• Inadequate information disclosure during the cal complications after a spinal block is estimated
process of consent to be 1:13,000 and 1:25,000 after an epidural
• Pain during caesarean section block [1]. National Audit Project 3 estimated the
• Nerve damage rate of permanent harm after central neuraxial
• Failure to diagnose, investigate and treat block in the obstetric population to be between
complications 1:320,000 (optimistically) and 1:80,000 (pessi-
• Failure to follow-up mistically) [2]. Pain and/or paraesthesia during
needle or catheter insertion should alert the
anaesthetist to stop. A change of direction of nee-
14.4 Avoidance of Litigation dle or use of a different inter-spinous space may
be required. Neuropraxia or neuropathy can be
• Document all options discussed with the coincidental due to lithotomy or head down posi-
patient at the time, including general tion during laparoscopic procedures, fetal head
anaesthesia. position or forceps during instrumental delivery
• Check and document level of block achieved and peripheral nerve compression by tissue
to cold and light touch as well as motor oedema.
blockade. A thorough neurological examination is man-
• Listen to and empathise with the patient— datory and ‘red flag’ signs such as progressive
believe she is in pain, if she so states. Discuss motor block should prompt urgent radiological
options available—supplement anaesthetic or investigations to rule out spinal cord compression
conversion to GA. causing nerve damage. Compression as a result
• Postoperative follow-up and debrief with of haematoma or abscess warrants immediate
patient, partner and midwife. surgical treatment.
Pain during caesarean section—a thorough
Consent—As it is the patient who carries the assessment of the adequacy of the block before
burden of risk, it is imperative that she is fully surgery, with confirmation of a block extending
informed of all material risks and alternative above the T6 dermatome (underside of breasts)
14 Regional Anaesthesia 75
to a fine touch stimulus usually avoids this situ- she would therefore be unable to experience the
ation. However, if pain occurs, patients should birth of her baby.
be offered different options of supplementing Documentation of the block height was mini-
the anaesthetic. The options can be in the form mal on the anaesthetic chart and there was no
of Entonox, bolus doses of intravenous short mention of the pain during insertion of CSE.
acting opioids, Ketamine, local anaesthetic The case went to court, however, settlement
infiltration by surgeon or institution of general (in the order of £60,000) was reached between
anaesthetic. If a patient feels significant pain the parties before the evidence was concluded.
even before delivery, this is a strong indication
that general anaesthesia will be necessary.
General anaesthesia should not be withheld in
Key Points: Regional Anaesthesia
this situation unless it carries significant mater-
• Adequate preoperative assessment
nal hazard well beyond the ‘usual’ risks associ-
should include discussion of all options
ated with the technique.
of anaesthetic techniques available.
• Key elements of the discussion should
be recorded on the anaesthetic chart.
14.5 Case Study
• Patient choice based on information dis-
closed about risks and benefits of each
Mrs. ABC was scheduled for an elective caesar-
technique.
ean section. She consented to a combined spinal-
• Strict adherence to asepsis and maintain
epidural as the anaesthetic technique. During the
AAGBI standards for monitoring and
insertion of CSE, she felt severe low back pain
conduct of anaesthesia.
and electric shock type pain in her right leg. This
• Prompt recognition and treatment of
lasted for almost a minute and she was extremely
complications.
distressed with the experience. The block height
• Adequate follow up of patients.
was tested with ethyl chloride spray for sensation
of cold, followed by a pair of forceps used to test
sharp pain. The patient could feel the forceps on
her lower abdominal wall; albeit a slightly dulled
sensation as compared to sensation on the upper
References
abdomen or lower part of chest. 1. Loo CC, Dahlgren G, Irestedt L. Severe neuro-
She felt severe pain with the surgical inci- logical complications after central neuraxial
sion and the epidural component was topped up blockade in Sweden 1990-1999. Anaesthesiol.
at this stage. Despite three attempts at topping 2004;101:950–9.
2. Cook T. Major complications of central neuraxial
up the epidural, adequate block height was not block in the UK. Report and findings from the 3rd
achieved. She was in pain and extremely upset National Audit Project (NAP3). London: RCoA;
that general anaesthesia was needed and that 2009. hhtp://www.rcoa.ac.uk/node/1428.
General Anaesthesia
15
Samuel Hird and Rehana Iqbal
15.1 Background 15.2 M

inimum Standards and
Clinical Governance Issues
General anaesthesia is still commonly used for
gynaecological surgery but its use in obstetric sur- There are a number of relevant guidelines.
gery has largely been replaced by regional anaes- Consent must be given and documented before
thesia due to a lower maternal risk. In spite of this anaesthesia [6]. Material risks should be discussed to
decline litigation has increased. Recognised stan- which a reasonable person in the patient’s position
dards exist to reduce the risk of complications. would attach significance. This may be challenging
General anaesthesia was used for 50% of cae- in emergency obstetric anaesthesia with time critical
sarean sections in the 1970s [1] compared with decisions needing to be made when there may be
8% in 2013 [2]. In obstetric practice general pain, distress and concern over fetal wellbeing.
anaesthesia is now mostly administered in emer- The Association of Anaesthetists of Great
gency situations, due to adverse maternal or fetal Britain and Ireland (AAGBI) produce minimum
physiology, or where regional anaesthesia has standards for monitoring and staffing [7, 8].
failed [3]. This selects a cohort of increasingly Local hospital guidelines may also exist and be
comorbid and technically challenging patients in used in cases of litigation to define expected stan-
which medicolegal issues are more likely to arise. dards of local practice [9].
Despite the dramatic reduction in general anaes- The Obstetric Anaesthetists Association
thesia use in obstetrics the absolute number of (OAA) website [10] publishes several examples
claims for obstetric general anaesthesia has of hospital guidelines in relation to obstetric gen-
increased [4] to an average of 2.5 claims per year. eral anaesthesia and highlight that the following
These claims are more likely to lead to a cost areas should be considered and addressed:
when compared to regional anaesthesia and result
in a higher cost per claim [5]. A pre operative assessment of the airway
This chapter will outline the standards for Antacid prophylaxis
general anaesthesia and present the common rea- Rapid sequence induction with preoxygenation
sons for litigation and how to avoid it. and cricoid pressure
Measures to avoid awareness particularly before
skin incision
S. Hird (*) · R. Iqbal Planning of extubation
St Georges University Hospitals NHS Foundation
Trust, London, UK Reduction in the hypertensive response to
e-mail: Drhird1@me.com; Rehana.iqbal@nhs.net intubation

https://doi.org/10.1007/978-3-319-78683-4_15
78 S. Hird and R. Iqbal
15.3 Reasons for Litigation Claims have been made for AAGA attributable
and Avoidance to inappropriately low doses of induction agents
due to disconnection or reflux back up intrave-
Common reasons for litigation include the nous lines. As IV induction agents such as thio-
following: pentone tend to be short acting, prolonged
attempts at intubation may have contributed up to
30% of cases of awareness in the Royal College
15.3.1 Accidental Awareness under of Anaethetists (RCoA) 5th National Audit Project
General Anaesthesia (AAGA) on AAGA (NAP 5) [2]. Inhaled maintenance
anaesthetic agents take time to ‘wash in’ so an
AAGA is a distressing experience existing on a adequate gas flow and availability of an additional
spectrum from brief episodes of awareness with- syringe of IV hypnotic is recommended [2].
out pain to prolonged episodes of paralysis and Preoperative communication of the risk of
surgical pain [2]. Late severe psychiatric sequale AAGA is appropriate in those with risk factors
may develop in up to a third of those who experi- and is specifically recommended by the NAP 5
ence AAGA [11]. report [2, 11]. If a patient is led to believe they
The incidence of AAGA is approximately 1 in will be unconscious without question then should
8000 when neuromuscular blockade is used [2]. AAGA occur they are more likely to feel a duty
However, AAGA is over represented in obstetric of care has been breached [2].
anaesthesia by a factor of 10 [2] with an inci- Management of a suspected case of AAGA
dence of up to 1 in 670 for caesarean section [2]. should include:
Twenty-three cases were reported via the NHS
litigation authority (NHSLA) over a 12-year • Documentation of the presence or absence of
period [11] with obstetric anaesthesia represent- common aspects of recollection which may
ing 30% of all AAGA claims [11]. include conversations heard, sensations of
Risk factors for awareness are common in choking, breathlessness or pain.
obstetrics and include emergency surgery, rapid • The anaesthetic chart should be reviewed to
sequence induction with neuromuscular block- determine any likely cause.
ade and a short interval from induction of anaes- • An apology and an explanation should be
thesia to start of surgery [2]. Detection of AAGA given to the patient as soon as possible, ideally
in the parturient may be difficult with differing before discharge.
baseline physiological variables and an absence • Appropriate follow up which may include
of tachycardia and hypertension in 20% of cases counselling should be arranged. Appropriate
of AAGA [2]. At present there is no gold standard follow up reduces the psychological disease
depth of anaesthesia monitor with NICE and burden of AAGA and potential medicolegal
AAGBI guidance only going as far as suggesting issues. The NHSLA claims database specifi-
EEG based monitoring as an option in high risk cally mentioned a lack of interest, concern
cases [7, 12]. Depth of anaesthesia monitors may or emotional support in five cases of
become the standard of care in the future. litigation [11].
Failure to provide a state of unconsciousness
when providing general anaesthesia is most com- Medical expert review would determine the
monly due to human error and is considered unac- satisfactory conduct of the following
ceptable with few exceptions [13]. Dosing errors
are the most common and tend to be reflective of • Patient monitoring
substandard care [2], most commonly simple • Intraoperative management of signs of
syringe swaps [11] (e.g. antibiotic with thiopen- distress
tone) [2]. These errors tend to result in brief awake • Timing and dose of drugs used including vola-
paralysis and universally result in a payout. tile end tidal concentrations and flows
15 General Anaesthesia 79
• Appropriateness of choosing a general most (73%) anaesthetists continue and this has
anaestehtic technique increased over time [3] however the individual
• Documentation of this information is situation must be taken into account.
essential In the event of litigation, it will need to be
established if an airway assessment occurred and
an appropriate strategy for securing the airway
15.3.2 Airway performed with minimization of the risk of com-
plications e.g. aspiration. The sequence of events
Airway management is fundamental to adminis- following complications would be scrutinised
tering safe general anaesthesia. Issues may arise against national guidelines for failed intubation/
from failed intubation or ventilation, aspiration ventilation. Data from critical monitoring such as
or damage to local structures via end tidal CO2 would need to be documented
instrumentation. along with strategies used to maintain anaesthe-
Preoperatively an airway assessment should sia and oxygenation.
include a review of previous anaesthetics for Blood pressure should be well controlled prior
intubation difficulties and an examination of the to induction of anaesthesia however in emer-
airway. In an emergency a verbal history and gency situations this may not always be possible.
examination may be all there is time for. If the balance of risk favours proceeding with
Failed intubation occurs in 1 in 2000 [14] surgery, drugs to blunt the hypertensive response
elective cases which rises to approximately 1 in to laryngoscopy include short acting opiates and
390 in the obstetric population [3]. There are well IV betablockers [17]. Magnesium has antihyper-
recognised guidelines for its management in the tensive properties but should not be seen as an
general adult population [15] with specific obstet- adequate antihypertensive in women with severe
ric guidelines [16]. Failed intubation may be hypertension [18] Invasive arterial monitoring
associated with difficult or failed ventilation dur- may be required to obtain beat to beat analysis.
ing which hypoxia may ensue. Task fixation over Aspiration of gastric contents into the lungs is
intubation is a risk and repeated unsuccessful a risk when consciousness is reduced with anaes-
attempts at intubation may make ventilation more thesia. Risk factors include lack of fasting, intra
difficult and hypoxia more likely. In this situation abdominal pathology and masses including preg-
guidelines describe techniques to facilitate venti- nancy. The standard of care in those with risk fac-
lation and oxygenation which culminate in an tors is to induce general anaesthesia with a rapid
emergency surgical airway. Preoxygenation is sequence induction (RSI) technique to minimise
important to prolong the time before hypoxia the risk of aspiration [19] and administration of
occurs. antacids preoperatively to minimise damage
In the event of failed intubation but successful should aspiration occur.
ventilation the patient can be woken up and an Oesophageal intubation may occur due to dif-
alternative plan for anaesthesia made. In the case ficult laryngoscopy and may be associated with
of emergency caesarean section, the decision damage or perforation of the oesophagus.
whether to proceed or wake the mother must be Subsequent ventilation will fail to ventilate the
made. Theoretical scenarios on whether to pro- lungs and will instead inflate the stomach increas-
ceed with an unsecured airway divides opinion ing the risk of aspiration. Failure to obtain a cor-
[3]. The latest obstetric failed intubation guide- rect capnography trace should prompt doubt over
lines include a list of factors to consider rather the position of the endotracheal tube. If left
than a didactic algorithm [16] which includes the unrecognized morbidity and mortality due to
threat to the mother and fetus, difficulty of sur- hypoxia is high [18, 20–22]. Four claims for
gery, risk of aspiration and potential for alterna- oesophageal intubation were made in the 12 years
tive regional anaesthesia or airway strategies. to 2007 to the NHSLA [20]. Of these 3 died and
When faced with reality, case series suggest that 1 suffered memory loss [1]. Oesophageal intuba-
tion regularly comes up on the CMACE report as the non pregnant patient. Inappropriate delay in
a cause of death [21, 22]. administrating anaesthesia either as a reluctance
Hypoxic injury resulting in brain damage or to perform general anaesthesia or inappropriately
death may be the common end pathway from a long attempts at regional anaesthesia have been
failure to mitigate from the above complications. reported [4]. Other causes of delay are a failure to
Damage to surrounding structures typically communicate the urgency of delivery to the
includes the oropharynx and teeth however the anaesthetist. Fetal monitoring until the adminis-
trachea and oesophagus may also be involved. tration of general anaesthesia is essential.
Anaesthetists should be familiar and trained on Complications of maternal anaesthesia with
the airway equipment and adjuncts available in inability to oxygenate the mother may result in
their department. fetal hypoxia [4] causing brain damage or neona-
tal death.
15.3.3 Hypertensive Intracranial

Haemorrhage 15.3.6 Nerve Injury
A specific cause of maternal brain injury is General anaesthesia is not without neuronal risk.
hypertensive intracranial haemorrhage which Poor patient positioning can result in neuropa-
may be precipitated by the hypertensive response thies, [13] most commonly involving the ulnar
to laryngoscopy. Poor perioperative blood pres- nerve [25]. The lithotomy position is associated
sure control is a contributing factor [22]. with a 1 in 3600 rate of long standing lower limb
neuropathies. The common peroneal nerve is the
most frequently injured in the lower limb but sci-
15.3.4 Patient Deaths atic and femoral injuries may also occur. Risk of
injury increases with prolonged positioning over
Anaesthesia is not a disease but an intervention 4 h, increasing age, smoking and diabetes [26].
and harm or death as a result of anaesthesia can
be considered iatrogenic and potentially avoid-
able [23]. Death can result in the physician facing 15.3.7 Post Operatively
criminal charges e.g. manslaughter. Anaesthetists
have been convicted of manslaughter for gross Anaesthetic duty of care extends into the post
negligence administering general anaesthesia operative period [13] with the need for appropri-
[24] and the number of doctors charged with ate disposition and planning. Following surgery
manslaughter is increasing [24]. In order to dem- strong opioids may be required. Post operative
onstrate a doctor is guilty of manslaughter it must deaths from opiate toxicity have appeared in mul-
be established that there was a duty of care that tiple CMACE reports [23, 27] as well as deaths
was breached by standards that fell so far below due to bronchospasm in obese asthmatics [28].
expected that it amounted to a crime. Breaches The record of intra and post operative observa-
may be via acts or omissions and must have made tions may be scrutinised to assess if the appropri-
a significant contribution to the death [9]. ate post operative level of care was selected along
with appropriate post operative management.
15.3.5 Neonatal Harm

15.4 Case Study
This can occur due to either a delay in adminis-
tering general anaesthesia or maternal complica- As most cases are settled out of court this is an
tions resulting from general anaesthesia. adapted case. J (Claimant), a 25 year old obese
It is widely acknowledged that general anes- primip in labour underwent a category 1 caesar-
thesia in the parturient poses a greater risk than in ean section in 2001 for cord prolapse. R (defen-
15 General Anaesthesia 81
dant) induced anaesthesia with thiopentone and

rocuronium and established maintenance with • Careful consideration is required on
sevoflurane in an oxygen nitrous mixture. whether to proceed with caesarean sec-
Intubation was documented as difficult requiring tion in the event of an unsecured airway
two separate attempts. Alfentanil and morphine taking into account maternal, fetal and
were given for analgesia after delivery and rever- surgical factors.
sal was administered at the end. • Antacid prophylaxis and rapid sequence
The next day J became increasingly distressed induction with cricoid pressure should
due to a recollection of awareness during the be used in those at risk of aspiration, as
operation. She was seen by the anaesthetist who in obstetrics
documented her experiences along with an apol- • Strategies to blunt hypertensive
ogy, explanation and plans for followup. J recalls response to laryngoscopy in those at
the sensations of her abdomen being cleaned fol- risk include opiates and IV beta block-
lowed by a sharp severe pain and pulling before ers. Invasive arterial monitoring may
blacking out due to the pain. be required.
Expert opinion considered the following: It was • Appropriate Induction drug dosing, vol-
likely that Js recollection of cleaning occurred atile anaesthesia concentrations and
before the induction of anaesthesia. It is possible flows must be administered and docu-
the experiences of pain and pulling may have mented. Vigilance is required at induc-
occurred on emergence of anaesthesia however in tion for human error and equipment
this case they were thought to be a true reflection malfunction to avoid AAGA.
of intraoperative awareness as they were supported • An apology, explanation, follow up and
by a documented rise in heart rate and blood pres- counselling is essential for those who
sure to above her baseline. The choice of general experience AAGA.
anaesthesia and the doses of induction drugs used • Patients must be positioned with care
were appropriate. There was a failure to document whilst anaesthetised to avoid nerve
the end tidal concentrations of sevoflurane which damage.
was used for maintenance of intraoperative anaes- • Emergence and extubation requires con-
thesia. It was likely that due to the prolonged time sideration of potential difficulties.
at intubation there was a delay in establishing vol- Stomach decompression should be con-
atile anaesthesia allowing the induction drug to sidered in non fasted cases.
wear off. There was also the possibility of inade- • Appropriate post operative level of care
quate dosing of intraoperative anaesthesia although should be considered.
the lack of documentation could not support or
refute this. The case was settled out of court.
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16. Mushambi SM, Kinsella SM, Popat M, Swales H, ter from saving mothers’ lives; reviewing mater-
Ramaswamy KK, Winton AL, Quinn AC. Obstetric nal deaths to make pregnancy safer. Br J Anaesth.
Anaesthetists’ Association and Difficult Airway 2008;100(1):17–22.
Part III
Obstetrics
Emma Ferriman and Swati Jha
Prenatal Screening and Diagnosis
16
16.1 Background non-invasive prenatal testing (NIPT). Women

deemed to be at risk of chromosomal abnormali-
In the United Kingdom, it is mandated that all ties may then opt for a diagnostic test such as an
pregnant women are offered fetal screening tests amniocentesis or chorionic villus sample (CVS).
that meet agreed standards for the three major Failure to avail women of information and
chromosomal abnormalities—trisomy 18, 13 and options for fetal screening may lead to litigation
21. They should also be offered an ultrasound should an adverse fetal outcome result. In a recent
scan between 18 and 21 weeks’ gestation to 10-year report of medicolegal claims published by
check for fetal structural abnormalities. The UK the National Health Service Litigation Authority
National Screening Committee which is respon- (NHSLA) in 2012, there were 230 claims as a
sible for setting the standards for the national result of antenatal investigations, comprising 4.5%
screening programme mandates that all women of the total claims for maternity services, and cost-
are provided with information regarding their ing £144,811,665 (4.8%) of all claims [3].
prenatal fetal screening options. The screening
programme is implemented by the fetal anomaly
screening programme (FASP) which ensures uni- 16.2 Minimum Standards
form and equal access to high quality fetal
screening services across the UK, so that women Minimum standards set to assure high quality
can make informed choices regarding which fetal screening services emphasise the need to
screening tests they want to undergo [1]. identify the target population for screening, pro-
NICE guidance for antenatal care for uncom- vide them with accurate information, and to
plicated pregnancies recommends the combined periodically assess coverage or uptake of screen-
test (a combination of ultrasound and blood marking tests. Services are also required to attain
ers) in the first trimester and the quadruple or tri- high rates of predictive accuracy of screening as
ple test in the second trimester [2]. In addition, well as follow-on diagnostic tests, all of which
there is an increasing demand for highly accurate should be provided in a timely fashion.
Standards to minimise harm through accurate
E. Ferriman · D. Anumba (*) reporting, staff education and training are also
Department of Obstetrics and Gynaecology, stipulated. For instance, a standardised detec-
Jessop Wing, Sheffield Teaching Hospitals NHS Trust, tion rate of 85% for Trisomy 21 and 80% for
Sheffield, UK
e-mail: Emma.Ferriman@sth.nhs.uk; Trisomy 18 and 13 are currently stipulated and a
D.O.C.Anumba@sheffield.ac.uk screening test turnaround time of three working

https://doi.org/10.1007/978-3-319-78683-4_16
86 E. Ferriman and D. Anumba
days is recommended. Women deemed to be 16.4 Reasons for Litigation

screen positive on the basis of a threshold (cur-
rently a risk greater than 1 in 150) should be • Failure to provide access to screening in the
offered a diagnostic test. For women undergoing first trimester due to delayed referral to the
invasive tests, turnaround times should be within midwife or the hospital.
three calendar days for rapid diagnostic tests • Failure to appreciate that screening is not
and within 14 days for full karyotyping [1]. For diagnostic and that even with a low-risk result
diagnostic tests women should be informed that there is a chance that the baby may be affected.
the miscarriage rate for both CVS (performed • Failure to provide patients with all the infor-
from 11 weeks) and amniocentesis (performed mation regarding available screening tests
from 15 weeks) is between 0.5% and 1%. The • Failure to give patients all the available options
operator should perform enough procedures per once a high-risk result is identified
year to maintain proficiency and should keep • Failure to obtain informed consent regarding
records of procedure-related loss rates [4]. invasive procedures including miscarriage
rates
• Failure to counsel patients regarding mosaic
16.3 Clinical Governance Issues results
• Failure to provide genetic counselling in
The sources of error in prenatal screening and pre- patients with chromosomal abnormalities with
natal diagnosis have been recently reviewed [5]. an impact on future pregnancies
Although data is sparse, mistakes may occur in • Failure to provide results of screening or diag-
relation to counselling, tissue sampling, laboratory nostic tests promptly, or not at all.
testing and quantification, or pregnancy dating. • Incorrect pregnancy dating leading to wrong
Healthcare providers may fail to offer recom- screening risk estimation.
mended screening tests to a pregnant woman or to
manage the uptake of such tests. Women undergo-
ing first trimester screening should be made aware 16.5 Avoidance of Litigation
of all the available options for screening, including
more accurate tests which may need to be privately Claims for “wrongful birth” are typically
funded (such as NIPT at present) and the implica- brought by a parent or guardian on behalf of a
tions of having a positive test. They should also be minor child with a congenital disorder. The
made aware of the difference between a screening claimant usually alleges negligence of the health
and a diagnostic test. Women should enter the care provider in the prenatal period by failing to
screening pathway early so that they can access all diagnose the congenital condition. Such a
available tests. Patients with positive screening breach of duty must directly result in the birth of
results should be given the relevant information on an affected baby in a situation where the parents
how to proceed further. NIPT has a high detection would have opted to discontinue the pregnancy
rate and a low false positive rate, but parents had the abnormality been detected. Claims of
should still be counselled that this is a screening “wrongful birth” are highly emotive and are
test for which a positive result would require con- typically of significant financial cost as they
firmation by a diagnostic test. Patients who opt for involve the long-term care of the child as well as
an invasive diagnostic test should be made aware potential loss of earnings and lifestyle changes
of the two tests available—either CVS from for the parents. To minimise the chance of suc-
11 weeks or amniocentesis from 15 weeks. These cessful litigation parents should be provided
procedures should be performed in centres with with good information regarding the screening
appropriate facilities and staffing, and by practitio- options and approaches, as early during preg-
ners who maintain competence by performing nancy as practicable. Screening services must
enough procedures annually. ensure that they practice to the minimum stan-
16 Prenatal Screening and Diagnosis 87
dards and “fail-safe” guidelines recommended the NIPT. She alleged that she had not been
by the FASP. Ideally screening information told of the false positive rate of 0.1% and the
should be written and available in the parents’ potential reasons for a false positive result such
own language. In view of the high profile of as placental mosaicism. A preliminary ruling
NIPT and its proposed introduction into the was given that Mrs. P had been counselled and
NHS for women screening high risk on first tri- signed a consent form that clearly stated the
mester screening in October 2018, patients who test was not diagnostic and had a false positive
wish to receive information regarding NIPT rate. No breach of duty was identified in this
should have access to it. When there is a failure case.
of the screening system this should be reported
and fed back to providers. This may involve
auditing services to ensure national standards
Key Points: Prenatal Screening and
are met and to ensure that results are communi-
Diagnosis
cated to patients in a timely manner so that
• Early entry to the screening pathway to
prompt referrals may be made to access tertiary
ensure access to all available tests
centres where applicable. Claims are often made
whether NHS or private sector tests
in situations where there are no unit protocols.
• Accurate information regarding screen-
Each unit should therefore, adopt into their local
ing and prenatal testing including detec-
protocol the minimum national standards for
tion rates
Down’s syndrome screening and anomaly scan-
• Ensure parents are aware of the differ-
ning. Regular audit and service evaluations by
ences between a screening test and a
provider units will help identify systematic
diagnostic test
errors and gaps in practitioner knowledge that
• Ensure efficient communication of
need addressing [5].
abnormal results
• Ensure a robust risk management sys-
tem to highlight detection rates and
16.6 Case Study screening failures
• Ensure prompt referral for parents need-
Mrs. P was a 42-year-old lady in her first preg-
ing tertiary centre investigations
nancy who attended a private clinic for a non-
• Ensure informed consent for women
invasive prenatal test (NIPT). She was
undergoing diagnostic procedures
counselled, and she signed a consent form. The
consent form clearly stated that the test was a
screening test with a 99% detection rate for
Trisomy, 21, 18 and 13 and a 0.1% false posi-
tive rate. In addition, Mrs. P opted to have fetal References
sex chromosome testing and wished to know
the gender of her baby. Blood was taken at 1 . Fetal anomaly screening programme—standards.
13 weeks gestation and sent for analysis. The 2. NICE clinical guideline CG62. Antenatal care for

uncomplicated pregnancies. Published March 2008.
NIPT result showed the baby had a high risk of Latest update January 2017.
Turner’s syndrome (45 XO). Following coun- 3. NHSLA. Ten years of maternity claims. An analysis of
selling the patient opted to have an amniocen- NHS Litigation Authority Data. October 2012.
tesis. The long-term culture confirmed a normal 4. Royal college of Obstetricians (RCOG) green top

guideline No.8. June 2010.
female karyotype 46XX. Mrs. P proceeded 5. Anumba DO. Errors in prenatal diagnosis. Best Pract
with a litigation case based on the fact that she Res Clin Obstet Gynaecol. 2013;27(4):537–48. https://
had been inadequately counselled regarding doi.org/10.1016/j.bpobgyn.2013.04.007.
The 20-Week Anomaly Scan
17
17.1 Background sonography service, whether the ultrasound scan

was carried out in the context of a secondary level
In the United Kingdom, it is mandated that all screening service or of a tertiary level diagnostic
pregnant women are offered an ultrasound scan and therapeutic unit [1]. Detection rates may also
between 18 and 21 weeks’ gestation to check for vary with the gestational time point at which the
fetal structural abnormalities. Such screening scan was carried out, and with the severity of the
offers women the choice to discontinue pregnan- malformation screened for.
cies affected by serious fetal abnormalities. Where Failure to recognise the complexities of
they opt to continue the pregnancy antenatal detec- detecting structural anomalies leads to consider-
tion of a serious anomaly may enable parents and able litigation in the UK. Fetal anomaly scans
care-givers to prepare better for the birth of a baby were examined in the National Health Service
with congenital abnormalities. The non-detection Litigation Authority (NHSLA) report published
of a serious fetal abnormality can lead to claims of in October 2012. There were a small number of
“wrongful birth” by parents who would have opted claims compared to the total number of scans
to terminate the pregnancy had they been informed performed, but the litigation costs were substan-
of an anomaly in early pregnancy. tial. At the time of the report £10,080,500 had
However, it should be realised that it may not been paid in damages to claimants and a further
always be possible to distinguish between non- £39,994,773 was reserved for claims yet to be
detection of a fetal abnormality owing to a negli- concluded. In addition to this, legal costs of
gently conducted ultrasound scan and non-detection £1,793,735 had been paid to claimants’ solici-
of an abnormality that does not lend itself to easy tors and experts, and £667,746 had been paid to
visualisation despite a carefully conducted imaging solicitors and experts acting on behalf of the
examination. Some fetal abnormalities lend them- NHSLA [2]. The medical negligence claims all
selves to easier detection by ultrasound than others. centred around failure to diagnose a severe
Published detection rates for fetal abnormalities abnormality on the 20-week scan, but claims are
vary with organ of affectation, the nature of the usually unsuccessful unless the issue of ‘wrong-
ful birth’ can be proven, and the parents are able
to demonstrate that if the abnormality had been
E. Ferriman · D. Anumba (*)
Department of Obstetrics and Gynaecology, Jessop detected they would have terminated the preg-
Wing, Sheffield Teaching Hospitals NHS Trust, nancy, and that they were denied the option of
Sheffield, South Yorkshire, UK this decision by the non-detection of the
e-mail: Emma.Ferriman@sth.nhs.uk; anomaly antenatally.
D.O.C.Anumba@sheffield.ac.uk

https://doi.org/10.1007/978-3-319-78683-4_17
17.2 Minimum Standards an anomaly scan if they do not wish to be informed

if anomalies are found. Where image quality of the
The fetal anomaly scan forms part of the NHS first scan is suboptimal (reasons for this will
Fetal Anomaly Screening Programme (FASP). include, raised maternal BMI, poor fetal position,
This programme sets minimum standards for the uterine anomalies such as fibroids or previous sur-
provision of a high-quality screening service gery), a further scan may be offered by 23+0 weeks
against which performance is often judged. The gestation in order to complete the fetal anomaly
over-arching aim is to provide all pregnant women scan. Failure to obtain adequate views should be
access to high quality, but uniform screening tests. clearly documented and the reason stated.
In addition, all eligible women should be provided The required images for the 20-week anomaly
with high quality ultrasound screening informa- scan are listed in the FASP handbook in appendix
tion in order that they can make informed choices 1 [3].
in a timely manner [1]. Women may opt to undergo
ultrasound screening for fetal anomaly or they
may chose to opt out of screening. The ultrasound 17.3 Clinical Governance Issues
examination is usually performed between 18+0
and 20+6 weeks to check for a base-set of 11 struc- Errors relating to ultrasound screening for struc-
tural fetal anomalies (see Table 17.1). tural fetal anomalies often result from failure to
The minimum standards set to assure high offer women fetal scans, and to counsel them
quality fetal anomaly scanning require that con- about its fallibility. Women should be made
sent is sought and documented to conduct the aware of ballpark scan detection rate estimates
scan, and that the limitations of the scan are clearly for common significant abnormalities, as missed
explained. Women should be advised not to opt for or incorrect diagnosis of fetal abnormalities dur-
ing any pregnancy trimester can occur despite
Table 17.1 This is taken from The Fetal Anomaly
scrupulous fetal imaging evaluation.
Screening Handbook and shows the 11 conditions Operator-dependent errors can occur when
screened for as a minimum on the 20-week scan operators have insufficient training or skill to per-
Detection form an anomaly scan. They may be at an early
Conditions rate (%) phase of a learning curve for providing such a
Anencephaly 98 service independently. Pressures on a service
Open spina bifida 90 with severely limited allotted scan times for
Cleft lip 75 sonographers may also contribute to errors. An
Diaphragmatic hernia 60
anomaly scan should be scheduled to last no less
Gastroschisis 98
Exomphalos 80
than 30 min for a singleton pregnancy.
Serious cardiac anomalies include the 50 Obesity is associated with an increased risk of
following: some congenital abnormalities, and also contrib-
• Transposition of the Great Arteries utes to errors in the detection of fetal abnormali-
(TGA) ties. The compromised acoustic window resulting
• Atrioventricular Septal Defect
(AVSD) from adipose tissue markedly attenuates ultra-
• Tetralogy of Fallot (TOF) sound signals, requiring optimum ultrasound
• Hypoplastic Left Heart Syndrome machine settings to facilitate the anatomic survey.
(HLHS)
Bilateral renal agenesis 84
Lethal skeletal dysplasia 60
Edwards’ syndrome (Trisomy 18) 95a
17.4 Reasons for Litigation
Patau’s syndrome (Trisomy 13) 95a
Overall there are a small number of claims annu-
a
Detections rates will be reviewed following implementa-
tion of screening as part of the combined screening ally arising from the 20-week scan compared to
strategy the large number of ultrasound examinations
17 The 20-Week Anomaly Scan 91
p erformed. This is primarily because ultrasound 4. Referral policy—in cases where there is a

is a good screening tool and will detect approxi- concern, operators should have access to a
mately 80% of severe or lethal abnormalities in a second opinion from a senior colleague.
low risk population [4]. In the NHSLA report Trainee sonographers should have a period of
there were recurring themes for litigation and supervision until they are competent to per-
these included: form examinations unaided. Finally, there
should be a robust referral pathway for spe-
1. Non-adherence to local protocols detailing
cialist fetal medicine opinion.
minimum standards for the examination 5. Equipment—all equipment should be fit for
2. Human error featured in 72.5% of claims purpose, regularly serviced and updated to
3. Poor training and education provide adequate imaging.
4. Failure to get a second opinion 6. Documentation—in 52.5% of cases reviewed
5. Substandard equipment in the NHSLA report, documentation was
6. Inadequate documentation inadequate. Although the previous recom-
mendation was that only abnormal images
should be stored, the current FASP recom-
17.5 Avoidance of Litigation mendation is that all the images required as a
baseline for a complete 20-week scan (both
Litigation in this area will always be a feature of normal and abnormal) should be stored as an
obstetric practice and this is because ultrasound electronic record. The images should have an
is a screening tool that is not infallible. It is also accompanying electronic report. Both of
highly operator dependent and open to interpreta- which should be accessible on an electronic
tion. However, there are some strategies that will reporting system for review and audit.
make the screening system more robust and help
to reduce error.
17.6 Case Study
1. Adherence to local and national guidelines—
in the NHSLA report only 60% of units had A 28-year-old woman in her second pregnancy
undertaken scans according to guidelines. was referred to a specialist fetal medicine unit at
Local guidelines should reflect national rec- 20 weeks following diagnosis of an abdominal
ommendations. Every unit should have a pro- wall defect on the anomaly scan. The scan con-
tocol in accordance with local guidance to firmed a small exomphalos containing bowel
ensure minimum standards are reached. only. The couple were counselled regarding the
2. Prevention of human error—all units should association with chromosomal abnormality and
have systems in place to audit all examinations other structural defects. The couple opted for
and compare detection rates to national stan- amniocentesis which showed a normal male
dards. Where the diagnosis is missed, these karyotype. A fetal echocardiogram confirmed a
cases should be reviewed within the department structurally normal heart. It was recommended
as per local clinical governance pathways and that the claimant delivered in the tertiary centre
investigated accordingly to determine whether where the baby would have surgery to repair the
the error was knowledge or protocol-based. hernia. As part of a multi-disciplinary approach
3. Education and training—all personnel per-
the Claimant also received prenatal counselling
forming the ultrasound examinations should by the Paediatric Surgeons. Further scans con-
be adequately trained. The heath provider ducted every 4 weeks in the tertiary unit showed
must ensure education and training occurs good fetal growth and unchanged appearances of
within the department and that personnel are the exomphalos. Labour was induced at 39 weeks
also funded to participate in external continu- gestation. At delivery, it was noted that the baby
ing professional development (CPD). not only had an exomphalos, but a small bladder
exstrophy and ambiguous genitalia. The baby have opted for termination. The Claimant and her
was transferred to a supra-regional centre for husband had been counselled that an uncompli-
ongoing treatment. The Claimant successfully cated exomphalos with normal chromosomes and
sued the Trust for wrongful birth based on the no other structural anomalies would do well in
fact that had the full extent of the fetal abnormal- 90% of cases and require one operation. The
ity been detected antenatally the Claimant would baby required multiple operations, some of which
were complex, at a supra regional centre neces-
sitating that the Claimant leave her job and move
Key Points: 20-Week Anomaly Scan her home. The judge in the case ruled in the
• Offer an anomaly scan between Claimant’s favour because although the abnor-
18+0 weeks and 21+6 weeks mality was rare and complex, the fetal medicine
• Written information should be provided scan was targeted to detect complex anomalies.
regarding the limitations of ultrasound The judge also ruled that although the baby was
• For those patients in whom the first much loved he believed that the Claimant would
examination is incomplete offer a sec- have opted for termination had the full extent of
ond scan at 23 weeks the anomalies been detected antenatally.
• Ensure the examination is performed by
trained personnel
• Agreed protocols for second opinions References
and specialist referral
• Maintain and update ultrasound equip- 1. Anumba DO. Errors in prenatal diagnosis. Best Pract
Res Clin Obstet Gynaecol. 2013;27(4):537–48. https://
ment according to agreed standards doi.org/10.1016/j.bpobgyn.2013.04.007.
• Provide adequate documentation and 2. NHS Litigation Authority. Ten years of mater-

electronic reports for the examination nity claims: an analysis of NHS litigation authority
• Ensure required images are taken, cap- data. October 2012. http://www.nhsla.com/Safety/
Documents/Ten%20Years%20of%20Maternity%20
tured and stored on an electronic Claims%20-%20An%20Analysis%20of%20the%20
system NHS%20LA%20Data%20-%20October%202012.pdf.
• Regular audit of examinations should be 3. NHS England. Fetal anomaly screening programme
performed and compare the unit’s per- handbook. June 2015.
4. Chitty LS, Hunt GH, Moore J, Lobb MO. Effectiveness
formance to agreed national standards of routine ultrasonography in detecting fetal struc-
• Report all missed diagnoses as per local tural abnormalities in a low risk population. BMJ.
clinical governance protocols 1991;303(6811):1165–9.
Induction of Labour
18
Myles J. O. Taylor
18.1 Background tion of labour. For example, a previous history of

caesarean section will increase the risk of scar
Induction of labour is the process whereby the rupture, or a very large baby may increase the
uterus is stimulated to deliver prior to the sponta- risk of a failed induction. Such reasons may be
neous onset of labour. Over the last decade, the persuasive in making a decision to avoid induc-
incidence of induction has increased from tion altogether, instead opting for elective cae-
approximately 1 in 5 to over 1 in 4 of all pregnan- sarean section.
cies in England [1]. Critics argue that this repre- From the fetal perspective, the gestation of
sents an adverse development reflecting an induction is of particular importance. For exam-
ever-increasing medicalisation of labour when ple, a clinical presentation of mild tailing off of
labour should be regarded as a normal physiolog- fetal growth may be all that is required to trigger
ical process. They also argue that increased rates a recommendation of induction of labour at term
of induction will inevitably result in increased where the risks of neonatal morbidity and mortal-
rates of interventions such as emergency caesar- ity are low. In contrast, at gestations less than 28
ean section. On the other hand, recent evidence weeks, the same clinical features would probably
suggests that induction of labour, in all condi- prompt close surveillance of the pregnancy in the
tions studied, improves perinatal outcome whilst hope of achieving a higher gestation of delivery,
also being associated with unchanged or reduced hence reducing the substantial neonatal risks at
medical intervention rates. this early gestation.
The main reason underlying a decision to
induce labour is that on balance, at that stage of
the pregnancy, it is appreciated that the risks to 18.2 Minimum Standards
the mother or fetus of continuing with the preg-
nancy exceed those of delivery. In reaching this Prior to offering induction of labour women
decision, the pregnancy needs to be regarded should be informed about the reasons for induc-
from both fetal and maternal perspectives. tion, when, where, and how the induction process
From the maternal perspective, factors which will be carried out, and the arrangements for
need to be assessed include the safety of induc- analgesia. They should also be aware of the alter-
native arrangements if the mother does not opt
M. J. O. Taylor for induction and the risks and benefits of induc-
Department of Fetal and Maternal Medicine, Royal tion of labour in specific circumstances (e.g.
Devon and Exeter NHS Foundation Trust, Exeter, UK when there has been a previous caesarean
e-mail: Myles.taylor@nhs.net

https://doi.org/10.1007/978-3-319-78683-4_18
94 M. J. O. Taylor
s ection). Women also need to be made aware that and fetus, in which part of all of the uterine wall
induction of labour may not be successful and is disrupted, is rare in the unscarred uterus (less
what the mother’s options would be under these than 1 in 10,000 pregnancies). However, after a
circumstances. Indications and contraindications previous caesarean section, the incidence of this
for induction of labour are documented in complication is increased to approximately
Table 18.1. 0.68% and 1.91% in induced or augmented
The complications of induction of labour labours respectively [2].
should be explained. This is commonly achieved For many women, however, there are concerns
by patient information leaflets. Complications that induction of labour will inevitably lead to a
include hyperstimulation of the uterus in which more medicalised and less natural or physiologi-
uterine contractions are either too frequent cal end to their pregnancy. For example, women
(greater than 5 contractions in 10 min) or too are often concerned about induced labour being
strong. Under these circumstances, there is a risk more painful than spontaneous labour and also of
that impaired blood supply to the uterus and pla- feeling less in control [3]. Mothers may also be
centa will result in fetal distress. Even without disappointed that labour and delivery is advised
hyperstimulation, the use of oxytocin can result in an Obstetrician-led maternity unit rather than
in fetal distress, particularly if the baby is vulner- at or home or in a low risk midwifery-led birthing
able, for example in growth restricted babies who centre.
may not able to withstand the stress of labour. All methods of labour induction are designed
Uterine rupture, a life-threatening event to mother to either ripen the cervix or stimulate uterine con-
tractions, recognising that labour is essentially a
Table 18.1 Indications and contraindications for induc- combination of uterine contractions in the pres-
tion of labour
ence of a dilating cervix. Methods of induction of
Indications labour can be divided into non-pharmacological
Prolonged pregnancy and pharmacological [4]. Non-pharmacological
Prolonged rupture of membranes
methods include stretching and sweeping the cer-
Chorioamnionitis
vix, artificial rupture of membranes (ARM) and
Multiple pregnancy
Maternal disease—Diabetes, hypertension, cardiac use of intra-uterine balloons which both stretch
disease, sickle cell disease, deteriorating mental and stimulate the cervix. Pharmacological meth-
health, malignancy ods include the use of synthetic oxytocinon or
Fetal compromise—Fetal growth restriction, prostaglandin analogues.
non-reassuring CTG, reduced fetal movements, rhesus
Once the uterus is contracting, the cervix dilat-
disease
Oligohydramnios/polyhydramnios ing, and labour is established, both mother and
Fetal death fetus are monitored according to established care
Previous stillbirth pathway guidelines. Observations are designed to
Previous precipitate delivery ensure that sufficient progress in labour is being
Severe symphysis pubis dysfunction achieved. Oxytocin, if not already being used, can
Social indications including partner overseas or be employed to augment labour. Women undergo-
childcare logistics
ing induction of labour with oxytocin require con-
Contraindications
tinuous electronic fetal monitoring.
Placenta praevia/accreta or vasa praevia
Transverse fetal lie
Previous adverse reaction to induction agent
Cord prolapse in a viable pregnancy 18.3 Clinical Governance Issues
Previous classical uterine incision
Previous myomectomy where uterine cavity breached Before the availability of cervical ripening
Previous uterine perforation agents, the use of ARM and oxytocin were asso-
Active genital herpes ciated with a very high risk of a failed induction—
Invasive cervical carcinoma defined as not having delivered vaginally within
18 Induction of Labour 95
24 h. Thus, in nulliparous women whose induc- example, in many units, despite the lack of any
tion was commenced with a very unripe cervix, national guidance to recommend it, mothers are
or low “Bishop” score, the incidence of emer- routinely offered induction of labour for increased
gency Caesarean section for failed induction of maternal age [6] (>40 years at booking) or if a
labour exceeded 45% [5]. In contrast, with mod- large baby is suspected (>5 kg anticipated birth
ern ripening agents, the failure rate, even in the weight in non-diabetic pregnancies). As a result,
presence of an unfavourable cervix is only around there is an increasing debate on whether all
15% [4]. women should be offered induction of labour at
The chief advantage of induction of labour is 38–39 weeks gestation, principally to avoid the
that it reduces the length of time that the fetus or risk, albeit low, of late still-birth. A catalyst for
mother is exposed to the risks of pregnancy itself this change in clinical practice has been the recent
or to the complications that have arisen. For most Montgomery ruling by the Supreme Court [7] on
women, the decision to opt for induction of informed consent which suggests that doctors
labour to avoid adverse consequences of mater- and midwives should inform mothers of the
nal or fetal disease is straightforward. Similarly, “material” risks of continuing with the pregnancy
the offer of induction of labour when the preg- and awaiting spontaneous labour versus the risks
nancy goes overdue (i.e. between 41 + 0 and of induction of labour or having an elective cae-
42 + 0 weeks) has become routine and uncontro- sarean section.
versial as there is widespread recognition that a When assessing the risks of stillbirth at term, it
pregnancy which goes beyond 40 weeks of gesta- is important to consider the risks as a proportion
tion is associated with increased prenatal risks of the ongoing pregnancies at a particular gesta-
which can be largely avoided by induction of tion [8]. If one simply regards the risks of still-
labour. In any event, women at this late gestation birth at a particular gestational age, this misses the
frequently find the burden of pregnancy increas- point that the population at risk from continuing
ingly challenging and often welcome the relief the pregnancy comprises all ongoing pregnancies
that delivery will bring. rather than just the babies born that week. The
Routine induction of labour before 41 weeks risks of stillbirth vary according to gestational age
gestation is not currently offered or recom- with a peak at 41–42 weeks gestation (Fig. 18.1)
mended in the UK. However, this situation is and also increase according to maternal age. Thus,
changing, with some clinicians now lowering the risk of still birth per 1000 pregnancies at 41
their threshold for induction of labour as the weeks gestation for women younger than 35
methods of induction have improved and the years, 35–39 years and over 40 years old are 0.75,
risks of late still-birth are better appreciated. For 1.29 and 2.48, respectively [9]. In the UK, Cotzias
<20 years
2.50
Hazard of fetal death per 1,000 ongoing
20-24 years
25-29 years
2.25 30-34 years
2.00 35-39 years
>=40 years
1.75
pregnancies
1.50
1.25
1.00
0.75
Fig. 18.1 Risk of
0.50
stillbirth for congenitally
normal singleton births 0.25
by gestational age, 0.00
2001–2002 (from Reddy 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42
et al. [9]) Gestation (Weeks)
96 M. J. O. Taylor
et al. [10] found that the overall prospective risk • Failure to follow local protocols or guidelines
of still-birth after 38 weeks is 1 in 529—similar to for induction of labour
the risk of perinatal death in pregnancies that con- • Failure to inform women of the potential risks
tinue beyond 41 weeks when delivery is usually of induction of labour
offered or recommended (2–3/1000) [4]. However, • Failure to instigate appropriate monitoring
the principal argument against the routine offer of once labour is established
induction of labour at term to all women is that • Failure to recognise and treat uterine
this would not be feasible and would overload hyperstimulation
already hard-pressed maternity units. Strategies to • Failure to abandon induction when labour is
reduce workload include induction of labour in an not progressing
out-patient setting. In addition, many maternity
units allow low risk mothers in whom the induc-
tion process has commenced, but who then labour 18.5 Avoidance of Litigation
without ARM or oxytocin, to labour in a low-risk
setting without continuous CTG monitoring. In Many complaints arise from delayed induction.
addition, the use of oral rather than vaginal agents Women are not informed of the potential length
may make induction of labour more acceptable to of the induction process and have unrealistic
mothers and the use of mechanical rather than expectations of the timescales involved. Ideally
pharmacological techniques may also increase the this issue should be managed through a docu-
safety by reducing the risk of uterine mented discussion regarding the induction pro-
hyperstimulation. cess and its potential complications as well as
With modern methods of induction, far from through patient information leaflets. It is good
increasing it, induction of labour probably practice for maternity units to audit their induc-
reduces or makes no difference to the emergency tion policies including indications for induction,
caesarean rate. Thus in a randomised controlled failed induction rates and delay between induc-
trial of women induced for maternal age (≥35 tion and delivery. In most hospitals inductions are
years) [6], the emergency Caesarean section rate prioritised on a daily basis to ensure that those
was not increased in the induction group pregnancies with the most pressing needs are pri-
compared to controls. Similarly, recent meta-
oritised above less urgent indications.
analysis of randomised trials for induction of In low-risk pregnancies, ensure that guide-
labour at or beyond term [11, 12], emergency lines on the management of post maturity are fol-
Caesarean section rates [11] were reduced by lowed. In low risk pregnancies, induction of
11–17% in women induced compared with labour is normally only offered if the pregnancy
expectant management. goes overdue. Thus, failure to offer induction of
Overall with the improved safety and efficacy labour at 41–42 weeks is substandard. Conversely,
of the induction process the day may approach if a woman, declines induction of labour, proper
when all women will be offered induction of counselling and good documentation about the
labour at 38 weeks gestation. risks of fetal demise and the need for increased
fetal surveillance in such cases is mandatory.
In high-risk pregnancies ensure that the pros
18.4 Reasons for Litigation and cons of continuing with the pregnancy ver-
sus induction of labour or caesarean section are
• Failure to recognise when induction of labour properly assessed and discussed with the
is indicated mother. Failure to recommend induction in high
• Failure to offer or recommend induction of risk situations, or to recognise that the preg-
labour nancy has become high risk, and hence induc-
• Failure to expedite induction of labour in a tion should be recommended, are common areas
timely manner of litigation. On the other hand, if a mother,
18 Induction of Labour 97
despite the identified risks to herself or her baby 18.6 Case Study
declines induction of labour, then proper coun-
selling must be given, and good documentation Mrs. A conceived dichorionic diamniotic
of this decision made. (DCDA) twins in her second ongoing pregnancy
When complications arise, such as hyperstim- having had a normal vaginal delivery previously
ulation, or uterine rupture, close inspection of the which was complicated by the development of
management of the case may reveal substandard pre-eclampsia. At 33 weeks gestation, an ultra-
care; either in failing to follow local protocols or sound scan was performed which demonstrated
in failing to respond properly to the complica- significant growth discordance of 24% but nor-
tions when they arose. All such cases should be mal liquor volumes and normal umbilical artery
examined as part of the risk management process Dopplers. At 36 weeks, Mrs. A developed pre-
with an opportunity for staff education and train- eclampsia. Despite national guidance on hyper-
ing. Where an adverse outcome has occurred, the tension in pregnancy, national guidance on the
parents should be involved in the process and any management of DCDA twins, and also the devel-
reports fed back to them open and honestly. opment of significant growth discordance, the
When a late still-birth occurs—particularly pregnancy was allowed to continue to 39 weeks
after 38 weeks gestation—it is inevitable that gestation. When Mrs. A presented at 39 weeks
bereaved mothers will question the wisdom of for delivery, one twin had demised. The Trust
maternity services not offering induction of concerned admitted that there was a failure to
labour routinely at this earlier stage—choosing recommend and expedite delivery by induction
instead to offer induction of labour only until of labour, or Caesarean section, at 37 weeks. This
2–3 weeks later at 41–42 weeks gestation. case was settled on the grounds that the clinician
Currently, there are no national guidelines to failed to recognise that induction of labour was
suggest that women over the age of 40 years or indicated in accordance with national guidelines
indeed that all women after 39 weeks should be and the clinician failed to offer delivery or induc-
offered induction of labour. This means that tion of labour in a DCDA twin pregnancy at 37
according to the Bolam test, it remains the case weeks gestation.
that since a reasonable body of Obstetricians
would not routinely offer induction of labour to
women over the age of 40 years, let alone to all
women, it cannot be said that failure to offer Key Points: Induction of Labour
induction of labour to such women represents • Documentation regarding the indication
substandard care. On the other hand, it seems for induction of labour
logical that if the increase in perinatal mortality • Discussion regarding the pros and cons
after 42 weeks is sufficient to prompt an offer of of induction of labour versus abdominal
induction of labour, it follows that at 38 weeks, delivery
where the prospective risk of still-birth is simi- • Document possible complications
lar, then the material risks of continuing with including failed induction, hyperstimu-
the pregnancy >38 weeks should also be dis- lation and uterine rupture
cussed with mothers and the option of induction • Expedite induction in those women
of labour discussed, in keeping with the requiring urgent delivery
Montgomery ruling. Viewed from this perspec- • In women declining induction arrange
tive, failure to offer all women induction of suitable monitoring of mother and baby
labour at 38 weeks gestation, particularly those • Ensure continuous fetal monitoring in
over 40 years, should be regarded as substan- high-risk inductions
dard care. Time will tell whether the Court will
favour a Bolam or Montgomery viewpoint in
such cases.
98 M. J. O. Taylor
References 8. RCOG. Induction of labour at term in older mothers.

2013.
9. Reddy UM, Ko CW, Willinger M. Maternal
1. Digital N. Hospital maternity activity, 2015 to 2016.
age and the risk of stillbirth throughout preg-
2017.
nancy in the United States. Am J Obstet Gynecol.
2. RCOG. Birth after Caesarean section. 2007.
2006;195(3):764–70.
3. NCT. Overdue baby – what happens if my baby is
10. Cotzias CS, Paterson-Brown S, Fisk NM. Prospective
late? https://www.nct.org.uk/birth/what-happens-if-
risk of unexplained stillbirth in singleton preg-
my-baby-%E2%80%98late%E2%80%99.
nancies at term: population based analysis. BMJ.
4. NICE. Induction of labour. 2008.
1999;319(7205):287–8.
5. Arulkumaran S, Gibb DM, TambyRaja RL, Heng SH,
11. Gulmezoglu AM, Crowther CA, Middleton P, Heatley
Ratnam SS. Failed induction of labour. Aust N Z J
E. Induction of labour for improving birth outcomes
Obstet Gynaecol. 1985;25(3):190–3.
for women at or beyond term. Cochrane Database
6. Walker KF, Bugg GJ, Macpherson M, Thornton
Syst Rev. 2012;6:CD004945.
J. Induction of labour at term for women over 35
12. Wood S, Cooper S, Ross S. Does induction of labour
years old: a survey of the views of women and
increase the risk of caesarean section? A systematic
obstetricians. Eur J Obstet Gynecol Reprod Biol.
review and meta-analysis of trials in women with
2012;162(2):144–8.
intact membranes. BJOG. 2014;121(6):674–85.
7. Montgomery (Appellant) v Lanarkshire Health Board
(Respondent). 2015.
Diabetes in Pregnancy
19
Alexander M. Pirie
19.1 Background 19.2 Minimum Standards
Diabetes in pregnancy significantly increases 19.2.1 Pre-existing Diabetes

the risks of miscarriage, fetal abnormality, pla-
cental dysfunction, preeclampsia, sepsis, still- These women should be seen for preconceptual
birth, cerebral palsy, macrosomia, shoulder counselling regarding the risks associated with
dystocia, birth injury, operative delivery and pregnancy and provided with information and
maternal death. Diabetes mellitus affects about advice. This patient education programme should
1 in 20 pregnancies: 87.5% of which are gesta- start from booking and continue throughout preg-
tional diabetes (with later-life risk of type II nancy. The aim is to stabilise preconceptual glu-
diabetes), 7.5% have type I diabetes and 5% cose levels between 5 and 7 mmol/L on wakening
have type II diabetes. As obesity increases and or 4–7 mmol/L before meals. The glycosylated
women become older, both gestational and haemoglobin levels (HbA1c) should be less than
type II diabetes are becoming much more 6.5% to reduce the risk of congenital abnormality.
common. Patients should be advised to take 5 mg daily of
The Hyperglycaemia and Adverse Pregnancy folic acid preconceptually until 12 weeks gestation.
Outcomes (HAPO) study [1], since adopted by All patients should have a nephropathy screen prior
the World Health Organisation, has lowered the to pregnancy and be referred to a renal physician if
threshold for the diagnosis of gestational diabe- there is evidence of significant renal compromise.
tes. NICE updated their 2008 guidelines in 2015 At booking Aspirin 75 mg should be recom-
[2] to reflect this and these should be consulted mended to reduce the risk of preeclampsia. For
for full details. those women with pre-existing hypertension on
angiotensin converting enzyme (ACE) inhibi-
tors and angiotensin receptor antagonists these
medications should be converted to alternative
medications with a good safety profile in preg-
nancy to minimise the risk of teratogenesis.
Any women on statins should be discontinued
before pregnancy or soon as confirmed.
A. M. Pirie Metformin can be used preconceptually and
Birmingham Women’s and Children’s Hospital,
Birmingham, UK throughout pregnancy either singularly or as an
e-mail: alexander.pirie@nhs.net adjunct to insulin. Other oral hypoglycaemic

https://doi.org/10.1007/978-3-319-78683-4_19
100 A. M. Pirie
agents should be stopped and exchanged for used in conjunction with an additional insulin
insulin. HbA1c levels should be performed at regime to control maternal glucose levels.
booking to determine glycaemic control and the Betamimetics should not be used for tocolysis in
level of risk for congenital abnormality. Women diabetic pregnancy.
should be offered nephropathy and retinopathy In the postnatal period infants born to dia-
screening if these have not been performed betic mothers should be screened for neonatal
within the last 3 months. hypoglycaemia. Mothers should be aware that
Patients should monitor their capillary glu- the initiation of breastfeeding improves glucose
cose levels and aim for fasting levels of 5.3 and control.
7.8 mmol/L, 1 hour after meals or 6.4 mmol/L,
2 hours after meals. Isophane (NPH) insulin is
the preferred long acting insulin; long acting 19.2.2 Gestational Diabetes
insulin analogues can be used if there is good
glucose control before pregnancy. For women Gestational diabetes (GDM) should be diag-
where multiple injections are failing to control nosed if the fasting glucose is above 5.6 mmol/L
their blood sugars an insulin pump should be or above 7.8 mmol/L, two hours after a 75 g glu-
offered. Unwell patients with hyperglycaemia cose load (glucose tolerance test). Women should
require urgent testing for ketonaemia to exclude be screened for GDM if their body mass index
ketoacidosis. Patients should be warned about the (BMI) exceeds 30 kg/m2, they have a first degree
risk of hypoglycaemia and advised to keep a glu- relative with diabetes, a previous pregnancy
cose source available. Glucagon should be con- complicated by GDM, a previous baby weighing
sidered for type 1 diabetics. greater than 4.5 kg or they are in a high risk eth-
Obstetric care should be structured with nic group. New recommendations state that gly-
review one to two weekly in a joint obstetric dia- cosuria of 1+ on two or more occasions or a
betes clinic. A 20-week detailed fetal anomaly single occasion of 2+ or more, should lead to
scan should be offered to include a detailed car- further testing for GDM. Women with GDM in a
diac scan and thereafter serial ultrasound assess- previous pregnancy should be offered self-moni-
ments for fetal growth and liquor volume at 28, toring of capillary glucose levels and a GTT as
32, 36 and 38 weeks gestation. soon as possible. Delivery should be planned no
The mode of delivery should be discussed, later than 40 + 6 weeks for uncomplicated ges-
highlighting the pros and cons of vaginal versus tational diabetes. Following delivery, a fasting
abdominal delivery. A detailed plan for the man- glucose level should be taken at between six and
agement of glycaemic control in labour should thirteen weeks and they should be advised to
be documented aiming to maintain capillary glu- have annual HbA1c estimations. For women
cose measurements between 4 and 7 mmol/L in with gestational diabetes whose blood sugars
labour. Delivery should be planned for between return to normal after birth they should be coun-
37 + 0 and 38 + 6 weeks for uncomplicated type selled regarding their future lifestyle including
I or type II diabetes, but delivery should be con- weight optimisation, diet and exercise.
sidered before 37 weeks if maternal, fetal or
metabolic complications arise. For women
attempting vaginal delivery there should be con- 19.3 Clinical Governance Issues
tinuous CTG monitoring in labour and it should
be noted that diabetes is not a contraindication to Women with diabetes in pregnancy should be
attempting vaginal birth after caesarean section managed in a specialist obstetric diabetic clinic
(VBAC). In women who present with preterm with a multi-disciplinary team including an
labour or require delivery prior to 36 weeks ges- obstetrician, endocrinologist, specialist mid-
tation, steroids for fetal lung maturation can be wife, specialist diabetic nurse and dietician.
19 Diabetes in Pregnancy 101
There should be local protocols for the manage- 19.5 Avoidance of Litigation
ment of both pre-existing diabetes in pregnancy
and gestational diabetes based on national guid- In diabetes, periods of maternal hyperglycaemia
ance. Women should be managed in accordance are associated with fetal hyperinsulinemia caus-
with these guidelines. Patients should have ing fetal plasma potassium and glucose to fall as
access to a specialist Midwife or a diabetic these are driven intracellularly, with risks of fatal
nurse specialist to ensure adequate blood sugar fetal cardiac arrhythmia and intrauterine death,
monitoring and enable early access to the mater- hence one benefit of good glucose control.
nity unit if required. Likewise, when the umbilical cord is cut at deliv-
ery, the hyperinsulinaemic fetus is now cut off
from the maternal glucose oversupply and can
19.4 Reasons for Litigation become neuro-hypoglycaemic. Fetal osmotic
polyuria can cause polyhydramnios with risks of
• Consent: Montgomery case (see below) preterm labour and cord prolapse. Macrosomic
upholds earlier GMC guidance on ensuring babies in maternal diabetes are not just large with
patient is aware of all ‘material risks’ and can higher oxygen and energy requirements, but they
decide her options use oxygen less efficiently and so are more sensi-
• Failure or delay in stopping teratogenic drugs tive to injury by transient hypoxaemia.
such as ACE inhibitors The Confidential enquiries into maternal
• Failure to screen for or to diagnose gestational deaths as published by MBRRACE(UK) [3]
diabetes remind us:
• Failure to inform the women of risks and
options for pregnancy and delivery • Diabetes is a risk factor for maternal death
• Failure to diagnose placental insufficiency • Hypertension due to nephropathy, pre-
• Failure to diagnose macrosomia and recognise eclampsia and, subarachnoid haemorrhage are
risks of sensitivity to hypoxia and birth injury, commoner in diabetic pregnancy
especially shoulder dystocia • Diabetes is a risk factor for sepsis
• Failure to deliver by appropriate mode at • Ischaemic heart disease is commoner at any
appropriate time age in diabetes
• Instrumental operative birth, attempted or • Chest pain requires careful evaluation
actual, and birth injury and cerebral palsy • Breathlessness requires careful evaluation for
• Prolonged labour, delay in recognition of sig- pulmonary oedema, cardiomyopathy, heart
nificance of CTG abnormality and timely failure.
delivery by appropriate means and cerebral
palsy
• Continuous CTG monitoring should be con- 19.6 Case Study
tinued during transfer to theatre for emergency
Caesarean section and appropriate fetal heart Montgomery v Lanarkshire Health Board
rate monitoring during siting of epidural [2015] UKSC 11 radically complements the
anaesthesia Bolam test (‘body of reasonable medical opin-
• Delays in acting on concern, delays in transfer ion’) and Bolitho principle (‘rational course of
to theatre or delays in theatre, including action’) in the standard of care around consent.
dynamic reassessment of risk to baby and The seven judges in this Supreme Court Judgment
mother indicate that Bolam is the correct standard for
• Failure to institute appropriate postnatal medical negligence, but the standard for consent
thromboprophylaxis at dose appropriate to is not what a body of reasonable medical people
weight do, but rather what the ‘person in the street’
102 A. M. Pirie
would want to know about all of their options and would have chosen caesarean section had she
all ‘material’ risks involved. (For accuracy, been made aware of the risks, thus upholding the
Hunter v Hanley is the reference case law in case for causation. On breach of duty, they deter-
Scotland rather than Bolam). mined that the wrong standard had been applied
Mrs. Nadine Montgomery had studied molec- for judging issues of consent. This is best illus-
ular biology at Glasgow University, and worked trated by the following quotes from the Supreme
in the pharmaceutical industry. She was a woman Court Judgment:
with insulin-dependent diabetes when she had ‘An adult person of sound mind is entitled to decide
her first baby on 1st October 1999. She had small which, if any, of the available forms of treatment to
stature and the baby was suspected to be large. undergo, and her consent must be obtained before
Although it was known that there was an approxi- treatment interfering with her bodily integrity is
undertaken. The doctor is therefore under a duty to
mately 10% risk of shoulder dystocia, she was take reasonable care to ensure that the patient is
not offered a caesarean section but endured a aware of any material risks involved in any recom-
vaginal birth by forceps after a prolonged induced mended treatment, and of any reasonable alterna-
labour. Shoulder dystocia occurred lasting around tive or variant treatments. The test of materiality is
whether, in the circumstances of the particular
12 min, and her son suffered brachial plexus case, a reasonable person in the patient’s position
injury and hypoxia. He was later diagnosed with would be likely to attach significance to the risk, or
cerebral palsy, and he has grown up with severe the doctor is or should reasonably be aware that
disabilities. the particular patient would be likely to attach sig-
nificance to it.’ Paragraph 87
The risk of shoulder dystocia in this case is
around 10%. The risk of a significant brachial ‘The doctor is however entitled to withhold from
plexus injury, in cases of shoulder dystocia the patient information as to a risk if he reasonably
involving diabetic mothers, is about 0.2%. In a considers that its disclosure would be seriously
very small percentage of cases of shoulder dysto- detrimental to the patient’s health. The doctor is
also excused from conferring with the patient in
cia, the umbilical cord becomes compressed circumstances of necessity, as for example where
within the mother’s pelvis. This can cause pro- the patient requires treatment urgently but is
longed hypoxia, particularly in a macrosomic unconscious or otherwise unable to make a deci-
baby with higher oxygen requirements, thus sion. It is unnecessary for the purposes of this case
to consider in detail the scope of those exceptions.’
resulting in cerebral palsy or death. The risk of Paragraph 88
this happening is less than 0.1%.
Initially, the Scottish Court did not find breach ‘…it follows from this approach that the assess-
of duty in keeping with the medical expert testi- ment of whether a risk is material cannot be
mony, as not offering caesarean section was reduced to percentages. The significance of a
given risk is likely to reflect a variety of factors
within the range of practice of many obstetricians besides its magnitude: for example, the nature of
of the time, and therefore not a breach of duty. the risk, the effect which its occurrence would
The Court also concluded that her case failed also have upon the life of the patient, the importance
on causation, because even if Mrs. Montgomery to the patient of the benefits sought to be achieved
by the treatment, the alternatives available, and
had been given advice about the risk of serious the risks involved in those alternatives. The
harm to her baby, it would have made no differ- assessment is therefore fact-sensitive, and sensi-
ence in any event, since she would probably not tive also to the characteristics of the patient.’
have elected to have her baby delivered by cae- Paragraph 89
sarean section. That decision was upheld by the
‘…the doctor’s advisory role involves dialogue, the
Inner House of the Court of Session, which is the aim of which is to ensure that the patient under-
Appeal Court in Scotland. stands the seriousness of her condition, and the
Mrs. Montgomery proceeded to take her case anticipated benefits and risks of the proposed
to the Supreme Court, where seven judges upheld treatment and any reasonable alternatives, so that
she is then in a position to make an informed deci-
her appeal, 16 years after the birth. They said that sion. This role will only be performed effectively
as an intelligent woman, it is probable that she if the information provided is comprehensible.
19 Diabetes in Pregnancy 103
The doctor’s duty is not therefore fulfilled by bom-

barding the patient with technical information
which she cannot reasonably be expected to grasp,
• Ensure appropriate glucose monitoring
let alone by routinely demanding her signature on and control
a consent form.’ Paragraph 90 • Arrange serial ultrasound assessments
for fetal growth
‘…the guidance issued by the General Medical • Counsel women fully regarding the tim-
Council has long required a broadly similar
approach. It is nevertheless necessary to impose
ing and mode of delivery
legal obligations, so that even those doctors who • Maintain continuous electronic fetal
have less skill or inclination for communication, or heart monitoring in labour
who are more hurried, are obliged to pause and • Monitor babies of diabetic mothers for
engage in the discussion which the law requires.
This may not be welcomed by some healthcare pro-
neonatal hypoglycaemia
viders; but the reasoning of the House of Lords in • Offer postnatal screening for diabetes
Donoghue v Stevenson [1932] AC 562 was no and lifestyle advice
doubt received in a similar way by the manufactur-
ers of bottled drinks. The approach which we have
described has long been operated in other jurisdic-
tions, where healthcare practice presumably
adjusted to its requirements.’ Para 93
References
2. The HAPO Study Cooperative Research Group.

The Montgomery judgment sent shock waves Hyperglycemia and adverse pregnancy outcomes. N
through much of the medical profession because Engl J Med. 2008;358:1991–2002.
it adds legal muscle to drive fully informed 1. National Institute for Health and Clinical Excellence.
Diabetes in pregnancy: management from preconcep-
patient choice; it is no longer ‘doctor knows tion to the postnatal period, NICE guideline NG3.
best’. The three domains of the patient’s values, 2015.
the patient’s risk preferences and patient’s per- 3. Knight M, Nair M, Tuffnell D, Kenyon S, Shakespeare
sonal gut-feeling should be carefully explored to J, Brocklehurst P, Kurinczuk JJ, editors. On behalf of
MBRRACE-UK. Saving lives, improving mothers’
make an acceptable shared decision. Arguably, care - surveillance of maternal deaths in the UK 2012–
the best medicine was always about working in 14 and lessons learned to inform maternity care from
partnership with patients: matching choices to the UK and Ireland confidential enquiries into mater-
each individual patient’s profile of values, spe- nal deaths and morbidity 2009–14. Oxford: National
Perinatal Epidemiology Unit, University of Oxford;
cific risk adversity and intuition. 2016.
Key Points: Diabetes in Pregnancy

• Ensure patients have access to precon-
ception counselling, information and
education
• Inform patients regarding the potential
risks involved with diabetes in pregnancy
• Offer high-dose folic acid and low dose
aspirin.
• Stop ACE, AR antagonists and statins
• Screen for GDM in high-risk women
• Offer additional GTT for women with
glycosuria
Cardiac Disease in Pregnancy
20
Philip J. Steer
20.1 Background courage pregnancy in women with certain severe

cardiac conditions such as pulmonary hyperten-
Cardiac disease is currently the major cause of sion and advise termination should pregnancy
death associated with pregnancy in the United occur [1]. However, the development of drug
Kingdom. This places a premium on giving therapies such as sildenafil and prostenoids has
accurate preconception advice, and ensuring improved the prognosis [2], as has a multidisci-
management during pregnancy which is consis- plinary approach to care involving obstetricians,
tent with current standards. This is best done by cardiologists, anaesthetists and midwives [3].
the multidisciplinary team including an obstetri- Recent papers have suggested a substantial
cian, cardiologist, anaesthetist, midwife, and improvement in prognosis, with mortality rates
cardiac nurse. The principles of management possibly falling to as low as 5% [4–6].
focus on minimising avoidable stress in preg- Clinical practice is constantly being updated.
nancy, particularly during delivery. These Cardiac disorders are not a homogeneous group,
patients require an agreed management plan for and management varies substantially depending
pregnancy and delivery that is accessible to all on the specific diagnosis, so that there are no ran-
healthcare professionals involved in their care. It domised clinical trials. It is therefore necessary to
is essential to respect patient autonomy, even keep up-to-date by reading all reported case
when they make decisions about their care which series relevant to individual patients. It is manda-
carry avoidable risk. tory to maintain regular communication and dis-
cussion with colleagues looking after similar
groups of patients. A clinician looking after a
20.2 Minimum Standards high-risk patient with a relatively uncommon
and Clinical Governance condition will be expected to either have signifi-
cant personal experience of management of such
Up to the mid-2000s it was customary for cases, or at least take extensive advice from col-
authorities such as the American College of leagues who have such experience. The recent
Cardiology/American Heart Association/ UKOSS survey of women with mechanical heart
European Society of Cardiology to strongly dis- valves who went through pregnancy reported a
9% mortality and 47% poor fetal outcome [7]. In
P. J. Steer an associated commentary Cauldwell and Steer
Department of Obstetrics and Gynaecology, Imperial highlighted the fact that 19% were not referred to
College London, London, UK either tertiary care or to a specialist obstetric
e-mail: p.steer@imperial.ac.uk

https://doi.org/10.1007/978-3-319-78683-4_20
106 P. J. Steer
c ardiology service during their pregnancy [8]. An lesion. The clinician has a moral and legal duty to
obstetrician without the relevant experience who give up-to-date and accurate information about
fails to refer such a patient for appropriate care is prognosis for the individual and the implications
likely to be found guilty of substandard practice. for the fetus, including the risks of preterm birth,
In patients with impaired cardiovascular func- fetal growth restriction, and recurrence of con-
tion a key point in their management is the main- genital heart disease. A thorough review of the
tenance of a stable cardiovascular system at times most recent literature on each particular condi-
of acute stress. This is particularly important tion is therefore imperative. This can often be
around the time of delivery, for example using done effectively using the internet during the
slow incremental epidural anaesthesia to relieve consultation. A valuable source is OMIM -
pain (to avoid sudden hypotension). Delivery, Online Mendelian Inheritance in Man—https://
whether by assisted vaginal delivery or caesarean www.omim.org/. The importance of accurate
section, needs to be done as gently as possible, preconception counselling has recently been
avoiding unnecessary manipulation such as man- emphasised in a number of publications [9–11].
ual removal of the placenta (controlled cord trac- It is important to stress the value of the multi-
tion is preferred), and minimising traction on the disciplinary team approach. Ideally patients with
peritoneum at caesarean section. It is important complex cardiac disease should attend a joint
to have an experienced obstetrician involved in consultation with all the relevant team members
the care who recognises the need to take care at present. This means that patient, cardiologist,
delivery and to avoid procedures likely to pro- anaesthetist, midwife and cardiac nurse all hear
voke acute cardiovascular collapse. exactly what the obstetrician is saying, and each
of the professionals and the patient can contrib-
ute to the discussion in their turn. Opinions on
20.3 Reasons for Litigation cardiac function coming from a cardiologist are
always more authoritative than those from an
• Failure to give accurate, up to date informa- obstetrician, however experienced. Only the
tion to women with congenital heart disease patient has a full perspective on her preferences
• Failure to allow women autonomy in decision and priorities. Such an approach requires hon-
making in their pregnancy esty and openness, and far from causing concern
• Failure to refer women with complex cardiac or alarm to the patient or her family instils a
disease to a tertiary centre greater confidence in patient care, knowing that
• Failure to provide care as part of a multidisci- no issues are being hidden, and that the entire
plinary team team is comfortable with the advice being given.
• Failure to document a detailed plan of care Joint consultation ensures unanimity in policy-
both antenatally and for delivery making and avoids inadvertent conflicts of
• Failure to nominate a contactable lead for the advice. Moreover, each member of the team has
patient their knowledge of the other specialties regularly
• Failure to maintain the most stable cardiovas- updated, which benefits all members. This
cular environment during delivery approach will also allow the opportunity to make
• Failure to recognise the haemodynamic a detailed plan of care in both the hospital
changes involved in the postnatal period records and in the woman’s handheld maternity
records. This detailed contemporaneous record-
ing of the issues discussed is of substantial medi-
20.4 Avoidance of Litigation colegal value. It helps the individual professionals
to cope with the responsibility for any decisions
Litigation may arise as a result of preconception that are made, because they know that any inad-
counselling, or when a woman presents in early vertent error in advice or management is likely
pregnancy with a previously undiagnosed cardiac to have been picked up by colleagues. Moreover,
20 Cardiac Disease in Pregnancy 107
in the event of a poor outcome, the responsibility complain of mild breathlessness and soon there-
for any decision made is shared, which is not after she was admitted for observation. At 34
only comforting to the individual but is also a weeks she had a brief period of unconsciousness.
great strength if the decision is subsequently However, she was very concerned about the
questioned in court. effect of early delivery on the baby, and therefore
The issue of autonomy in decision-making is a expectant management was continued despite
major medicolegal issue in relation to pregnancy repeated episodes of unconciousness. At thirty
in women with heart disease. The traditional six weeks there was spontaneous rupture of the
approach to care has been paternalistic, often amniotic membranes. Although good contrac-
with strong recommendations being made to tions were generated by a low-dose oxytocin
women about the decisions they should make. infusion, the cervix failed to dilate and a caesar-
Such an approach is no longer acceptable, and ean section was performed. The baby was deliv-
this has been emphasised by the Montgomery ered in good condition but following their usual
ruling [12]. The responsibility of the doctor is to practice, the delivering obstetrician performed a
make sure that the facts that they provide to manual removal of the placenta and immediately
enable their patients to make decisions appropri- afterwards the mother developed a supraventricu-
ate for them as individuals are correct. If the out- lar tachycardia which progressed to cardiac
come is adverse, failure to ensure that they have arrest. Resuscitation failed.
given accurate and up-to-date advice is likely to At the subsequent inquest, there was consider-
result in successful litigation against them. able discussion about the level of risk posed by
pregnancy in women with pulmonary hyperten-
sion. In the 1980s and 1990s, the risk of maternal
20.5 Case Study mortality was estimated to be between 30 and
56% [13]. There was some criticism of the rela-
Mrs. A knew that she had pulmonary hyperten- tively low level of risk quoted in this case.
sion and so in the late 1990s attended a meeting However, the supervising cardiologist pointed
of the Grown-Up Congenital Heart charity out that Mrs. A had a number of favourable fea-
(GUCH, now replaced by the Somerville tures including good exercise tolerance, and that
Foundation, www.thesf.org.uk). The meeting detailed antenatal care had been provided. The
was addressed by an obstetrician with experience coroner in summing up pointed out that a 5% risk
of managing pregnancy in women with heart dis- of maternal mortality was still 1 in 20, some 500
ease, who explained the risk of mortality but also times higher than the average for a pregnant
emphasised the importance of informed choice. woman, and for that 1 in 20, death was 100%.
She subsequently attended the obstetrician’s However, he also stressed the importance of giv-
clinic for detailed preconception counselling. A ing the most accurate information possible to
letter from the GP said that Mrs. A was an intel- enable women to make fully informed choices.
ligent woman who was “making a brave decision
to go ahead with pregnancy”. She had seen a car-
diologist at a tertiary level centre who had written Key Points: Cardiac Disease in Pregnancy
that the course of pulmonary hypertension in • Offer pre-pregnancy counselling to
pregnancy is very unpredictable and “there is a women with cardiac disease
possibility she could lose her life”. However, it • Ensure information provided is the most
also stated that there was a “low risk of death, up to date and accurate
perhaps it could be 5%”. Mrs. A became pregnant • Provide accurate documentation of all
and antenatal echocardiograms were reassuring counselling and consultations
although they confirmed a pulmonary artery • Best results are achieved with a multi-
pressure of 50 mmHg. She was asymptomatic disciplinary team approach
until 32 weeks gestation, when she started to
108 P. J. Steer
in patients with pulmonary arterial hypertension

associated with congenital heart disease. Heart.
• Inform the patient and her family of all 2017;103(4):287–92.
the material risks 6. Vause S, Clarke B, Tower CL, Hay C, Knight
• Provide a detailed individualised care M. Pregnancy outcomes in women with mechani-
plan for pregnancy and delivery with a cal prosthetic heart valves: a prospective descriptive
population based study using the United Kingdom
named lead professional Obstetric Surveillance System (UKOSS) data collec-
• During childbirth maintain as stable a tion system. BJOG. 2016;124(9):1411–9.
cardiovascular environment as possible 7. Cauldwell M, Steer PJ. Care in the UK for pregnant
• Incremental epidural anaesthesia may women with mechanical prosthetic valves needs
urgent improvement. BJOG. 2017;124(9):1420.
be useful https://doi.org/10.1111/1471-0528.14502. [Epub
• Shorten the second stage of labour/ ahead of print]
assisted delivery if indicated 8. Cauldwell M, Steer PJ, Johnson M, Gatzoulis
• Avoid manual removal of placenta M. Counselling women with congenital cardiac dis-
ease. BMJ. 2016;352:i910.
where possible 9. Cauldwell M, von KK, Uebing A, Swan L, Steer PJ,
Babu-Narayan SV, et al. A cohort study of women
with a Fontan circulation undergoing preconception
counselling. Heart. 2016;102(7):534–40.
References 10. Cauldwell M, Steer PJ, Swan L, Patel RR, Gatzoulis
MA, Uebing A, et al. Pre-pregnancy counseling for
1. Macchia A, Marchioli R, Marfisi R, Scarano M, women with heart disease: a prospective study. Int J
Levantesi G, Tavazzi L, et al. A meta-analysis of trials Cardiol. 2017;240:374–8. https://doi.org/10.1016/j.
of pulmonary hypertension: a clinical condition look- ijcard.2017.03.092. pii: S0167-5273(16)34302-9.
ing for drugs and research methodology. Am Heart J. [Epub ahead of print]
2007;153(6):1037–47. 11.
Montgomery (Appellant) v Lanarkshire Health
2. Stewart R, Tuazon D, Olson G, Duarte AG. Pregnancy Board (Respondent) (Scotland) [2015] UKSC 11).
and primary pulmonary hypertension: success- Montgomery (Appellant) v Lanarkshire Health Board
ful outcome with epoprostenol therapy. Chest. (Respondent) (Scotland) [2015]UKSC 11). 2015.
2001;119(3):973–5. https://www.supremecourt.uk/decided-cases/docs/
3. Curry RA, Fletcher C, Gelson E, Gatzoulis MA, UKSC-2013-0136-Judgment.pdf.
Woolnough M, Richards N, et al. Pulmonary hyper- 12. Beckett H, Radford J. ‘Montgomery consent’: deci-
tension and pregnancy--a review of 12 pregnancies in sion of the UK Supreme Court. Montgomery v
nine women. BJOG. 2012;119(6):752–61. Lanarkshire Health Board [20151. [2015] UKSC 11;
4. Kiely DG, Elliot CA, Sabroe I, Condliffe [2015] WLR 768. Pract Midwife. 2016;19(6):27–29.
R. Pulmonary hypertension: diagnosis and manage- 13. Oakley C, Child A, Jung B, Presbitero P, Tornos P,
ment. BMJ. 2013;346:f2028. Klein W, et al. Expert consensus document on man-
5. Ladouceur M, Benoit L, Radojevic J, Basquin A, agement of cardiovascular diseases during pregnancy.
Dauphin C, Hascoet S, et al. Pregnancy outcomes Eur Heart J. 2003;24(8):761–81.
Pre-eclampsia and Hypertension
21
Alexander M. Pirie
21.1 Background better care [1]. In the most recent 2013–2015

report there were eighty eight direct maternal
Preeclampsia is the commonest medical disor- deaths of which three were attributable to pre-
der of pregnancy. It can manifest as no symp- eclampsia and eclampsia.
toms, odd symptoms, or the classical headache,
epigastric pain, swelling, nausea and visual
aura. Worldwide, it’s a major cause of maternal 21.2 Minimum Standards
death, neonatal brain damage and litigation.
Outcomes have significantly improved in the In 2010, NICE produced national guidelines for the
UK with better antenatal monitoring, multidis- Investigation and Management of Hypertensive
ciplinary team working, and the consistent use Disorders of Pregnancy [2]. The diagnosis of hyper-
of antihypertensive agents, antenatal steroids tension in pregnancy includes new hypertension
and early delivery. This has largely been driven occurring after 20 weeks (gestational hypertension),
by the NICE guidelines published in 2010, and new hypertension with proteinuria (pre-eclampsia)
the Confidential Enquiries into Maternal Deaths and chronic hypertension (present before 20 weeks).
published triennially since 1952, now run by Chronic hypertension may have unknown aeti-
MBRRACE (UK). Between 2009 and 2014, ology (sometimes unhelpfully referred to as essen-
there were 14 maternal deaths in the UK associ- tial hypertension) or a specific cause such as
ated with hypertensive disorders, compared nephropathy, Cushing’s and Conn’s disease, coarc-
with 37 deaths in each of the two previous tation of the aorta, renal artery stenosis or phaeo-
6-year periods. Of those 88 hypertensive deaths, chromocytoma. Women with pre-existing medical
41 were due to intracranial hemorrhage, 18 conditions should be managed by an obstetrician
hepatic necrosis, 15 acute fatty liver, 9 eclamp- with experience in maternal medicine and an
sia/cerebral oedema, 3 hepatic rupture, and 3 appropriate general physician. Ideally these women
pulmonary oedema (one mother in two catego- should be seen for pre-conception counselling.
ries). Confidential assessors found that almost There should be accurate risk assessment at
all those deaths may have been prevented by booking. Women at high risk of hypertension in
pregnancy include those with a previously affected
pregnancy, chronic hypertension, chronic renal dis-
A. M. Pirie
ease, diabetes, systemic lupus erythematosus (SLE)
Birmingham Women’s & Children’s Hospital,
Birmingham, UK and antiphospholipid syndrome (APS). In chronic
e-mail: alexander.pirie@nhs.net hypertension, patients should be counselled regard-

https://doi.org/10.1007/978-3-319-78683-4_21
110 A. M. Pirie
ing the embryopathic effect of angiotensin convert- tion. If preterm delivery is anticipated there
ing enzyme (ACE) inhibitors and aim to convert to should be neonatal involvement and a discussion
labetalol, methyldopa or nifedipine within 2 days, regarding the pros and cons of vaginal versus
under expert guidance. In women with chronic abdominal delivery and the timing of delivery.
hypertension, the blood pressure should be kept For acutely unwell patients with unstable blood
below 150/100 mmHg, or below 140/90 mmHg if pressure not responding to oral therapy, intrave-
there is target organ damage. More recent evidence nous labetalol or hydralazine may be required
from the CHIPS trial suggests that a diastolic of with the addition of magnesium sulphate.
85 mmHg is more protective against the effects of Monitoring of these patients should occur in an
severe hypertension [3]. obstetric high dependency setting with staff
Women with two or more moderate risk fac- appropriately trained in acute medical emergen-
tors for hypertension at booking should also be cies. Careful attention should be paid to both
offered aspirin 75 mg from 12 weeks until birth. adequate blood pressure control and fluid moni-
Moderate risk factors include first pregnancy, toring, avoiding fluid overload and the precipita-
maternal age greater than 40 years at delivery, tion of pulmonary oedema. Clinicians should be
pregnancy interval of more than 10 years, family aware that the postnatal patient remains at high
history of preeclampsia, multiple pregnancy, body risk of eclampsia.
mass index (BMI) of more than 35 kg/m2. Blood
pressure and urinalysis should be checked at each
antenatal clinic visit. Women should be made 21.3 Clinical Governance Issues
aware of the importance of hypertension-related
symptoms including headache, visual aura, swell- The booking assessment should included an
ing, pain below the ribs, vomiting and reduced appropriate risk assessment for hypertension
fetal movements, and the need to seek advice. and aspirin prescribed accordingly. Blood pres-
In mild gestational hypertension (140/90– sure and urinalysis should be performed at every
149/99 mmHg), no treatment is required other than antenatal visit and should be documented. Blood
monitoring weekly. This should be twice weekly if pressure should be measured using an approved,
there is a high risk of preeclampsia or if the preg- appropriately calibrated device by a standard
nancy is less than 32 weeks. In moderate gesta- method. Two measurements of blood pressure
tional hypertension (150/100–159/109 mmHg), of >140/90 mmHg or a single blood pressure
labetalol is the first line agent and twice weekly measurement of >160/110 mmHg constitute
monitoring is appropriate. Other agents used with hypertension and warrants investigation and
apparent safety in pregnancy are nifedipine and treatment. There should be recognition and
methyldopa (although methyldopa should be dis- prompt escalation of referral if the blood pres-
continued postnatally due to its association with sure exceeds 140/90 mmHg, if proteinuria
tiredness and postnatal depression). In severe ges- develops or relevant symptoms are reported.
tational hypertension (160/110 mmHg or higher), There should be patient education regarding the
hospital admission is required with four times daily recognition of symptoms and appropriate inves-
BP monitoring. A diagnosis of significant protein- tigation of any potential signs for hypertension.
uria is made when the Protein-Creatinine Ratio For women diagnosed with hypertension in
(PCR) is more than 30 mg/mmol. Antenatal corti- pregnancy there should be good communication
costeroids should be given if preterm delivery is with the woman and shared decision making
anticipated. regarding pregnancy management. It is impor-
A care plan should be agreed between a senior tant to recognise the risk of psychological
obstetrician and the woman and documented in ‘threshold avoidance’ by medical and midwifery
the notes. This should cover the frequency and staff; this is where important symptoms are dis-
type of monitoring required and the treatment counted or dismissed, or where the blood pres-
and side effect profile of any prescribed medica- sure is re-checked until a normal reading is
21 Pre-eclampsia and Hypertension 111
obtained to avoid crossing the thresholds for • Failure to respond appropriately to patient
action in a patient who doesn’t want to be admit- symptoms including headache, oedema and
ted. Outpatient monitoring by either the com- epigastric pain
munity midwife or in an antenatal day unit • Failure to instigate appropriate treatment
setting may reduce the numbers of women • Failure to recognise the need for both mater-
requiring hospital admission although these nal and fetal monitoring
modalities should be used appropriately. It is • Failure to offer delivery in women with wors-
also essential that the results of any investiga- ening pre-eclampsia or essential hypertension
tions performed in these settings are followed with superimposed pre-eclampsia
up in a timely manner and escalated where • Failure to offer monitoring in an obstetric high
necessary. dependence unit post delivery
All midwifery and medical staff should be • Failure to continue to observe women with
aware of the need for an appropriate response to hypertension in the postnatal period including
any women with hypertension in pregnancy pre- blood pressure and fluid input/output
senting with reduced fetal movements or any • Failure to instigate a follow up plan for women
degree of antepartum haemorrhage. There should discharged back to primary care
be appropriate use of serial ultrasound assessment
of fetal growth, liquor volume assessment and
Doppler studies. Abnormal fetal growth may 21.5 Avoidance of Litigation
prompt referral to a specialist for ongoing preg-
nancy care. The pregnancy should be managed Most claims arise from delay in diagnosis, delay
according to both maternal and fetal well-being. At or failure of treatment or negligent treatment.
gestations, less than 28 weeks this may present dif- They relate either to maternal or neonatal injury,
ficult decisions for clinicians and patients, but all cerebral palsy, loss of a baby or loss of maternal
decisions should be made in collaboration with the life. These events require formal investigation as
wider team and clearly documented. Consideration per local and national guidance.
to thromboprophylaxis may also be required based The commonest cause of maternal death in
on risk stratification, BMI, intervention status and hypertensive pregnancy is subarachnoid haemor-
hypostasis during hospital admissions [4]. rhage (SAH). The most sensitive and specific
Adverse outcomes should be reported and symptom for SAH is the suddenness of the onset
investigated in a robust manner with sharing of of the headache, rather than its severity or loca-
learning for all staff involved and dissemination tion. Small herald subarachnoid bleeds present
to the wider team for ongoing education. Any with sudden-onset headache hours to days before
investigation reports should be shared with par- the fatal bleed, and the clinical art is to detect the
ents in an open and honest manner. herald bleed allowing the neurosurgeon or vascu-
lar radiologist to secure the small berry aneurysm
and prevent the big bleed. Only 10% of sudden
21.4 Reasons for Litigation onset headaches will turn out to be SAH, but all
sudden-onset headaches require investigation by
• Failure to appropriately risk assess at CT and lumbar puncture if the latter is negative.
booking This means accepting that 90% of your CT/LP
• Failure to offer low dose aspirin in high-risk investigations will be negative, but that this is
women worthwhile to detect the 10% which are positive.
• Failure to manage women with underlying All headaches in pregnancy requires careful eval-
medical problems jointly with an appropriate uation, especially in hypertension. Some causes
physician of headache are listed in Table 21.1.
• Failure to measure blood pressure and per- For patients presenting with hypertension in
form urinalysis at each antenatal visit pregnancy consideration must be given to the pos-
112 A. M. Pirie
Table 21.1 Causes of headache in pregnancy with symp- gastritis, gastric ulcer, pancreatitis or gallstone
tom clues
disease). There may be evidence of haemolysis in
Pre-eclampsia (but beware sudden onset headache) the form of rising bilirubin, falling haemoglobin,
Migraine (visual or epigastric aura) rising reticulocyte count (with rising MCV and
Tension headache
RDW), falling haptoglobin and the presence of
Dehydration
haemoglobin in the urine. Haemoglobinuria will
Post dural headache (worse on standing)
Head trauma show on a dipstick as a smooth positive on the
Cerebral venous thrombosis blood window, not to be confused with haematu-
Intracranial hypertension (vomiting) ria which shows as a speckled positive. In pre-
Subarachnoid haemorrhage (sudden onset) eclampsia, the transaminases may be elevated
Ischaemic stroke due to hepatocyte structural damage, whereas
Vasculitis hepatocyte functional damage may be seen in
Brain tumour (worse on wakening) abnormal glucose, bilirubin, albumin levels and
Benign intracranial hypertension (obesity, pulsatile deranged clotting indices.
tinnitus)
Meningitis/encephalitis (neck stiffness, pyrexia or
In women with orthopnea and paroxysmal
hypothermia, altered consciousness) nocturnal dyspnea consideration should be given
Sinusitis to pulmonary oedema. In preeclampsia, this
Cranial neuralgias results from the reduced oncotic pressure from
Pituitary apoplexy (tunnel vision) the hypoalbuminaemia of haemodilution and
impaired hepatic synthesis combined with myo-
sibility of hypertension secondary to an undiag- cardial dysfunction and increased vascular per-
nosed medical condition. Clinicians should look meability, and can be fatal if excess fluid is given.
out for the characteristic sodium/potassium pat- Once a diagnosis of hypertension in preg-
terns in Cushing’s, Conn’s, primary and secondary nancy has been made a clearly documented man-
hyperaldosteronism and renal artery stenosis. agement plan should be constructed detailing
Consider radio femoral delay and ventricular frequency of monitoring for both mother and
heave in coarctation of the aorta and consider the baby, treatment regimens and the timing and
palpitations and diaphoresis of phaeochromocy- mode of delivery. A multi-disciplinary approach
toma. All clinicians should be aware that the with early involvement of anesthetic staff, inten-
increased blood flow and haemodilution of preg- sivists, haematologists and neonatologists will
nancy resets the normal reference range down- improve outcome in sick patients. Most impor-
wards for urea and creatinine when assessing renal tantly delivery should be planned with stabilisa-
glomerular function. In ultrasound, look out for tion of the maternal condition prior to
the small smooth kidneys of chronic glomerulone- commencement of surgical intervention.
phritis or the small irregular scarred kidneys of
‘chronic pyelonephritis’ (chronic vesioc-ureteric
reflux). Adult polycystic kidneys carry an addi- 21.6 Case Study
tional risk of subarachnoid haemorrhage.
Appropriate investigations need to be insti- AW v Greater Glasgow Health Board [2015]
gated in these scenarios with involvement from ScotCS CSOH_99
other non-obstetric physicians. Common preg- Mrs. AW was a 30-year-old healthy non-
nancy symptoms may also mimic more sinister smoker in her first pregnancy whose antenatal
diagnoses. For example, epigastric pain is com- care was booked with the community midwives.
mon in normal pregnancy presumably due to Around 30 + 6 weeks, she developed tiredness,
mechanical and hormonal factors. But foregut headaches, facial swelling and blurred vision.
structures like the liver refer pain to the epigas- Community midwives made an appointment
trium, so it may be due to liver involvement in to visit her at home at 31 + 2 weeks but they did
pre-eclampsia or HELLP syndrome (as well as not appear. A new home visit appointment was
21 Pre-eclampsia and Hypertension 113
made for 2 days later, when they phoned to say delivery would have improved the outcome.
they would be delayed but again did not appear. The four eminent obstetric experts had vastly
The midwives attended a further 2 days later, different opinions. The outcome was upheld at
and Mrs. AW explained her symptoms, as well appeal in 2017. The enormous time, emotion
as an altered pattern of fetal movements. The and expense could have been avoided by the
midwife reassured her that many of these symp- simple recording of blood pressure and
toms were common in pregnancy. The patient urinalysis.
and her husband noted that the two attending
midwives had just been attending a home birth,
and that their mood was ‘jokey with lots of ban-
ter’, with them referring to Mrs. AW as the ‘bor- Key Points: Pre-eclampsia and Hypertension
ing patient’. • Familiarity with national and local
Both Mrs. AW and her husband stated that no guidelines by midwifery and obstetric
measurement of blood pressure or urinalysis was staff
performed by the midwives, and there is no • Appropriate care pathways for commu-
record of blood pressure in the case notes. The nity midwives and GPs
urinalysis section of the notes has the abbrevia- • BP and urinalysis at every visit for all
tion ‘c/c’ which the midwife stated in Court pregnant women
meant ‘clear of sugar, clear of protein’. On hear- • Recognition of relevant symptoms
ing evidence under cross-examination in Court, • Appropriate investigation of sudden
the Judge determined that the Claimant was cor- onset headache
rect in that no blood pressure or urinalysis was • Exclude other neurological causes of
performed by the midwives, despite the mid- headache
wives’ insistence to the contrary. • Orthopnea and paroxysmal nocturnal
At 32 + 2 weeks, Mrs. AW reported her dyspnoea may suggest pulmonary
symptoms to the physiotherapist at an antenatal oedema
class, who arranged immediate medical assess- • Timely follow up and response to blood
ment. Mrs. AW had an ultrasound scan of the results
baby showing growth restriction, abnormal • Appropriate escalation pathway for BP
Dopplers and an impaired biophysical profile. or symptoms crossing thresholds
She was also found to be hypertensive with sin- • Senior Obstetrician to make care plan in
gle plus proteinuria on dipstick testing. conjunction with woman
Immediate delivery was performed by caesar- • Appropriate timing and mode of
ean section after stabilisation of her blood pres- delivery
sure. Unfortunately, her son went on to develop • Accurate documentation and retention
cerebral palsy. of data
After hearing 51 days of evidence, from 30
witnesses, including four obstetric experts, as
well as experts in midwifery, neonatology, pae-
diatric neurology and neuroradiology, the Judge References
decided that there was a clear breach of duty on
1. Knight M, Nair M, Tuffnell D, Kenyon S, Shakespeare
the part of the midwives for not measuring and J, Brocklehurst P, Kurinczuk JJ, editors. on behalf
recording blood pressure, urinalysis or respond- of MBRRACE-UK. Saving lives, improving moth-
ing to Mrs AW’s symptoms. However, the case ers’ care – surveillance of maternal deaths in the UK
failed on causation as the Judge found the cause 2012–14 and lessons learned to inform maternity care
from the UK and Ireland confidential enquiries into
of the cerebral palsy was longstanding fetal maternal deaths and morbidity 2009–14. Oxford:
growth restriction, and that the Claimant had National Perinatal Epidemiology Unit, University of
not successfully proven to the Court that early Oxford; 2016.
114 A. M. Pirie
2. National Institute for Health and Clinical Excellence. Hypertension. 2016;68:1153–9., Originally pub-
Hypertension in pregnancy: diagnosis and manage- lished September 12, 2016. https://doi.org/10.1161/
ment. In: NICE guideline CG107; 2010. HYPERTENSIONAHA.116.07862.
3. Magee LA, Dadelszen PV, Singer J, Lee T, Rey 4. Knight M, Nair M, Tuffnell D, Shakespeare J, Kenyon
E, Ross S, Asztalos E, Murphy KE, Menzies J, S, Kurinczuk JJ, on behalf of MBRRACE-UK, editors.
Sanchez J, Gafni A, Helewa M, Hutton E, Koren Saving lives, improving mothers’ care—lessons learned
Lee SK, Logan AG, Ganzevoort W, Welch R, to inform maternity care from the UK and Ireland con-
Thornton JG, Moutquin JM, for the CHIPS Study fidential enquiries into maternal deaths and morbidity
Group. The CHIPS randomized controlled trial 2013–15. Oxford: National Perinatal Epidemiology
(control of hypertension in pregnancy study). Unit, University of Oxford; 2017.
Umbilical Cord Prolapse
22
Susana Pereira and Edwin Chandraharan
22.1 Background artery. This appears to be an all or nothing event,

either causing a major neurodevelopmental
Umbilical cord prolapse (UCP) occurs when the impact or little in the way of cerebral injury [2].
umbilical cord descends through the cervix and Perinatal death is also seen in term babies espe-
either lies beside the presenting part (occult) or cially when a diagnosis of UCP is made at home.
beyond it (overt) in the presence of ruptured Adverse outcomes are reported when transfer to
membranes [1]. Cord presentation occurs when the hospital is delayed. The management of UCP
the cord is present between the presenting part is one of the labour ward minimum data set skills
and the cervix with or without ruptured mem- required by the Clinical Negligence Scheme for
branes. The overall incidence varies between 0.1 Trusts (CNST) in England, Welsh Risk Pool in
and 0.6% of pregnancies [2]. The incidence may Wales and the Clinical Negligence and Other
be as high as 1% in breech presentations. There is Risks Indemnity Scheme (CNORIS) in Scotland.
some evidence that the incidence has reduced
over the last 40 years due to the reduction in
grand multiparity and the rising rates of caesar- 22.2 Minimum Standards
ean section [2]. UCP is a major obstetric emer-
gency and may be associated with increased rates There are a number of risk factors for UCP that
of perinatal morbidity and mortality. Perinatal are listed in Table 22.1. Obstetric interventions
mortality is associated with prematurity and con- are a significant factor and may play a part in up
genital fetal malformations. Perinatal morbidity
is primarily due to fetal birth asphyxia. Birth Table 22.1 Risk factors for umbilical cord prolapse
asphyxia occurs by either compression of the
General Procedure related
umbilical cord and/or vasospasm in the umbilical Multiparity ARM with high
Low birthweight <2.5 kgs presenting part
S. Pereira (*) Preterm labour Manual rotation with
Feto-Maternal Medicine, Kingston Hospital NHS <37 weeks gestation ruptured membranes
Foundation Trust, Surrey, UK Congenital fetal anomaly External cephalic version
e-mail: susana.pereira@nhs.net Breech presentation Internal podalic version
Transverse, oblique, Stabilising induction of
E. Chandraharan unstable lie labour
St. George’s University Hospitals NHS Second twin Insertion of intrauterine
Foundation Trust, London, UK Polyhydramnios pressure catheter
St. George’s University of London, London, UK Free presenting part Balloon catheter
e-mail: edwin.c@sky.com Low lying placenta induction of labour

https://doi.org/10.1007/978-3-319-78683-4_22
116 S. Pereira and E. Chandraharan
to 50% [3]. There is an increased risk associated management is usually the main stay of manage-
with external cephalic version (ECV), internal ment. There is no evidence for manually replac-
podalic version, manual rotation and artificial ing the umbilical cord within the uterine cavity.
rupture of membranes when the presenting part
is free. These interventions should be discussed
with the woman and the associated risks clearly 22.3 Clinical Governance Issues
documented. For those women at an increased
risk of UCP, hospital admission is recom- The diagnosis and acute management of an UCP
mended; unstable or transverse lie from 37 can be a very traumatic event for the woman and
weeks gestation or prelabour rupture of mem- her family. The parents should be fully debriefed
branes where the baby is not cephalic. Clinicians by the obstetrician explaining the reasons why
should avoid performing amniotomy when the the UCP occurred whether it was predictable and
presenting part is high. Amniotomy with a high the reasons for emergency management.
presenting part should be performed where All staff caring for pregnant women should
there is immediate recourse to emergency cae- receive regular emergency drill training in the man-
sarean section. When there is a cord presenta- agement of all obstetric emergencies including
tion with intact membranes delivery by UCP [5]. Emergency drill training will reduce the
caesarean section is usually indicated. decision to delivery interval and improve neonatal
The management of UCP will depend on the outcomes [6]. All cases should be reported via the
setting in which it occurs. In the hospital environ- risk management pathway as a clinical incident.
ment when UCP is diagnosed before full dilata- This is a CNST requirement in England. The NHS
tion of the cervix caesarean delivery is indicated. resolutions report looking at the litigation cases
There should be minimum handling of the umbil- where babies developed cerebral palsy were criti-
ical cord to prevent vasospasm of the umbilical cal of route cause analysis investigations. Their rec-
artery. The presenting part can be elevated manu- ommendations included increased involvement in
ally or by filling the bladder and a knee-chest the investigation process for patients and their fam-
position may also alleviate cord compression. ilies, improved support for staff involved in diffi-
For cases where there are fetal heart rate abnor- cult cases, polarisation of reports focusing on
malities in the presence of uterine activity toco- system changes that are more likely to improve
lytics agents such as terbutaline can be used [4], outcomes and for independent external reviews to
however these manoeuvres should not delay occur to ensure a robust and fair process [7].
delivery. When UCP occurs at full dilatation the Litigation cases are much more difficult to
practitioner has the option of instrumental deliv- defend where there is evidence of poor documen-
ery if this can be performed safely and quickly. If tation as often occurs in an acute emergency situ-
cord prolapse occurs following internal podalic ation. The RCOG advocate the use of preformatted
version of the second twin, breech extraction scribe sheets to improve the documentation in
may be indicated. Due to the risks of fetal acido- obstetric emergency scenarios. These accurately
sis a neonatal team should be present at delivery record the personnel present and the timings for
and paired umbilical cord gases should be taken. the individual manoeuvres [1].
In a community setting immediate transfer to the
nearest consultant unit in the knee-chest position
with either manual elevation of the presenting 22.4 Reasons for Litigation
part or elevation by filling the urinary bladder
should occur. • Failure to recognise antenatal risk factors
Where UCP occurs at the limits of viability • Failure to recommend hospitalisation in high
between 23 and 24 + 6 weeks detailed discus- risk cases
sions should occur between the parents and both • The performance of amniotomy with a high
the obstetrician and the neonatal team. Expectant presenting part or in breech presentations
22 Umbilical Cord Prolapse 117
• Failure to document risks of UCP as a result of been reported to contribute to approximately

obstetric manoeuvres such as ECV, internal 80% of serious incidents in obstetric practice [8].
podalic version and manual rotation Intense staff training to reduce ‘workmanship’
• Failure to perform controlled ARM in high errors, learning from root cause analysis to avoid
risk cases such as polyhydramnios ‘omissions’, improving effective team working
• Delayed in the diagnosis of UCP and communication and appropriate and timely
• Excessive handling of the cord leading to senior input are essential to reduce the adverse
vasospasm impact of human factors.
• Delayed transfer to theatre for delivery Regular skills and drills, improvement in
• Delay in achieving delivery knowledge of fetal physiology and detailed
• Failure to ensure neonatal resuscitation team record keeping and documentation as well as
present at delivery addressing the human factors may help minimise
the errors and the likelihood of litigation. Many
of these incidents may be preventable by identi-
22.5 Avoidance of Litigation fying system failures during intrapartum care and
then ensuring timely and appropriate corrective
It is important to anticipate umbilical cord pro- action. In order to achieve a ‘medico-legal risk
lapse when risk factors are identified, which free’ environment, it is vital to have an open cul-
include polyhydramnios, preterm delivery, ture towards human error, to investigate the inci-
breech delivery, multiple pregnancy or a ‘non- dents and learn from them (Fig. 22.1) [9].
engaged presenting part’ during labour (i.e. cases
where there is an ‘ill-fitting’ presenting part).
Careful examination immediately after rupture of 22.6 Case Study
membranes may help in timely diagnosis. The
CTG trace may show repetitive atypical variable Mrs. P was in her third pregnancy having had two
deceleration or a single prolonged deceleration, previous uncomplicated vaginal deliveries. At 38
which may culminate in a terminal bradycardia weeks, she was found to have an unstable lie and
secondary to the total occlusion of the umbilical was admitted to hospital due to the risk of umbili-
cord. If the cervix is fully dilated, an urgent oper- cal cord prolapse. Mrs. P went into spontaneous
ative vaginal delivery should be carried out labour at 39 + 6 weeks gestation, her baby was in
immediately. If this is not possible or if the cervix a transverse lie. A specialist registrar examined
is not fully dilated, an immediate ‘Category 1’ Mrs. P in view of regular uterine contractions
caesarean section should be carried out. Measures every 5 min. On vaginal examination, the cervix
to improve fetal oxygenation by avoiding com- was 3 cm dilated, with the membranes intact. The
pression of the prolapsed umbilical cord should doctor contacted the Consultant on call by tele-
be attempted if the fetus is found to be alive. The phone who recommended an external cephalic
umbilical cord should not be handled to avoid version (ECV) followed by artificial rupture of
causing spasm of the umbilical blood vessels. If membranes. The specialist registrar attempted an
the operating theatre is occupied or if there is an ECV and the membranes ruptured leading to an
anticipated delay in transferring to the operating umbilical cord prolapse. The doctor attempted to
theatre, acute tocolysis should be employed to push the fetal head up to reduce the risk of cord
abolish ongoing uterine contractions so as to compression. The case was again discussed with
relieve repetitive or sustained compression of the the on-call Consultant. The Consultant advised
umbilical cord [4]. he would attend with a view to perform either an
Human factors play a crucial role in optimis- instrumental delivery or a caesarean section.
ing intrapartum outcomes and the Human There was 40-min delay from the time of the
WORM (deficiencies in Workmanship, diagnosis of cord prolapse to delivery by emer-
Omissions, Relationships and Mentorships) have gency caesarean section.
Is the fetus viable?
YES NO
1. Confirm intrauterine death

Is the cervix fully dilated? with ultrasound
2. Await spontaneous delivery
YES NO
Consider instrumental Emergency

Instrumental delivery not
delivery if likely to be CS needed
likely to be easy or quick
easy
Is the fetal heart normal?
YES NO and delivery not

immediately possible
Proceed to expedite delivery by CS Turn off any Syntocinon; turn the

but continue to monitor fetal heart rate woman into the left lateral,
carefully Trendelenberg or all fours; place
Foley catheter
Fill bladder with 500ml

normal saline
Monitor fetal heart rate on CTG
Transfer to theatre for CS
Before skin incision, release clamp

on catheter and drain bladder
Fig. 22.1 Algorithm for management of umbilical cord prolapse. MOET Handbook third edition 2014 [10]
22 Umbilical Cord Prolapse 119
The baby was born in poor condition with

Apgar scores of 4 at 1 min, 6 at 5 min and 7 at ECV, internal podalic version and stabi-
10 min. The baby was admitted to the neonatal lising induction
unit and suffered seizures within the first 12 h of • For women at risk of UCP where
life. The baby required transfer to a tertiary neo- amniotomy is indicated ensure imme-
natal unit for cooling. He suffered profound birth diate access to category 1 caesarean
asphyxia and has consequently developed athe- section
toid cerebral palsy. • Be familiar with the manoeuvres
The Judge ruled in the Claimant’s favour due required to reduce cord compression
to a failure of the obstetric team to arrange ade- • If UCP occurs at full dilatation consider
quate plans for delivery following Mrs. P’s instrumental delivery
admission. It was alleged that had an experienced • If UCP occurs at incomplete cervical
obstetrician devised a management plan for the dilatation perform category 1 caesarean
delivery, an elective caesarean section would section
have been advised. In that event, neither cord • Ensure neonatal team present at
prolapse nor any brain injury would have delivery
occurred. In the alternative, it was alleged that if • Accurate documentation using a prefor-
a stabilising induction and artificial rupture of matted scribe sheet
membranes was appropriate, proper preparations • Ensure staff training in obstetric
for delivery by caesarean section would have emergencies
been made. In that scenario, it was alleged that
had umbilical cord prolapse occurred, the baby
would have been delivered by caesarean section
well before any injury to his brain. As a conse- References
quence of the negligence the boy now suffers
from involuntary movements affecting his arms 1. Royal College of Obstetricians and Gynaecologists
and legs and cannot stand and walk. Nor can he (RCOG) Green-top guideline No. 50. Umbilical cord
prolapse. 2014. https://www.rcog.org.uk/globalas-
use his arms effectively in many circumstances.
sets/documents/guidelines/gtg-50-umbilicalcordpro-
The hospital admitted that the actions of the doc- lapse-2014.pdf.
tors were negligent. During the course of the 2. Chandraharan E, Arulkumaran S. Obstetric and intra-
legal action, various offers were made that culmi- partum emergencies. A practical guide to manage-
ment. Cambridge: Cambridge University Press; 2012,
nated in an offer of £5 million. As the Claimant
ISBN: 9780521268271.
preferred a periodical payment scheme, the hos- 3. Gibbons C, O’Herlihy C, Murphy JF. Umbilical cord
pital made an alternative offer in the form of a prolapse: changing patterns and improved outcomes.
£1.3 m sum, together with periodical payments BJOG. 2014;121:1705–9.
4. Usta IM, Mercer BM, Sibai BM. Current obstetrical
of £120,000 each year.
practice and umbilical cord prolapse. Am J Perinatol.
1999;16:479–84.
5. Chandraharan E, Arulkumaran S. Acute tocoly-
sis. Review article. Curr Opin Obstet Gynecol.
2005;17:151e6.
Key Points: Umbilical Cord Prolapse
6. Crofts JF, Ellis D, Draycott TJ, Winter C, Hunt LP,
• Identify antenatal risk factors for UCP Akande VA. Change in knowledge of midwives and
• Hospitalise women with unstable and obstetricians following obstetric emergency train-
transverse lie from 37 weeks ing: a randomised controlled trial of local hospital,
simulation Centre and teamwork training. BJOG.
• Ensure amniotomy is indicated and the
2007;114:1534–41.
presenting part is fixed in the pelvis 7. Siassakos D, Hasafa Z, Sibanda T, Fox R, Donald F,
• Be aware that certain obstetric interven- Winter C, et al. Retrospective cohort study of diagno-
tions increase the risk of UCP such as sis–delivery interval with umbilical cord prolapse: the
effect of team training. BJOG. 2009;116:1089–96.
8. Coroyannakis C, Chandraharan E. Impact of ‘Human uploads/2017/09/Five-years-of-cerebral-palsy-claims_

Worm’ on serious adverse incidents in obstetric prac- Athematic-review-of-NHS-Resolution-data.pdf.
tice. Int J Gynecol Obstet. 2012;119:S312. 10. Paterson Brown S, Howell C. Managing obstetric

9. Magro M. NHS resolution. Five years of cerebral emergencies and trauma. The MOET course manual.
palsy claims. A thematic review of NHS Resolution 3rd ed. Cambridge: Cambridge University Press;
data. 2017. https://resolution.nhs.uk/wp-content/ 2014.
Fetal Growth Restriction (FGR)
23
William L. Martin
23.1 Background It is the identification of genuine FGR that is

the holy grail of antenatal care. Once identified,
In essence, fetal growth restriction (FGR) may be underlying causes for FGR need to be sought.
placentally mediated, or not. FGR due to non- Ultimately timely delivery is the aim of manage-
placental problems is likely to have an early onset ment, after steroids and magnesium sulphate, if
and thus lead to a symmetrically small baby, with appropriate. These currently remain the only
the head circumference (HC), abdominal circum- treatment options.
ference (AC), femur length (FL) and estimated In managing these cases, it is important to fol-
fetal weight (EFW) all below the 10th centile. low local guidelines, which should be based on
The aetiology is more likely to be a genetic or the Royal College of Obstetricians and
chromosomal issue, or congenital infection with Gynaecologists (RCOG) Green-top guideline
early onset FGR. Placentally mediated problems Number 31 [1]. Irrespective of the underlying
usually manifest later and thus are more likely to cause of FGR, the diagnosis and management
lead to asymmetric FGR with the HC and FL pre- may be difficult. The majority of FGR babies will
served but the AC and EFW measuring less than be normal, small babies that will survive to term.
the 10th centile. To over-investigate may medicalise a pregnancy
Babies born weighing less than the 10th cen- and cause a couple significant psychological
tile for gestation are referred to as small for ges- stress. To under-investigate, however, could lead
tational age (SGA). Of these, the majority will be to intrauterine death or delivery of a compro-
constitutionally small but around 30% will have mised baby that failed to cope with labour due to
FGR or intrauterine growth restriction (IUGR) placental insufficiency. This would clearly be a
and be at higher risk of adverse outcome. It is much worse outcome for a couple. If accepted
important to appreciate that some babies born practice is followed, then litigation through mis-
over the 10th centile will have failed to reach hap will be minimised, and any actions taken
their full growth potential and thus are at similar defensible.
risk of adverse outcome as a baby with FGR born
below the 10th centile.
23.2 Minimum Standards
W. L. Martin The causes of FGR are many and varied and the
Fetal and Maternal Medicine, Birmingham Women’s definitions used are similarly diverse, making for
and Children’s Hospital, Birmingham, UK abundant, but often confusing literature. The
e-mail: BILL.MARTIN@bwnft.nhs.uk

https://doi.org/10.1007/978-3-319-78683-4_23
122 W. L. Martin
standard of management of these babies has thus established SGA should be managed. There is
been variable. Babies with FGR feature dispro- also an algorithm that summarises the manage-
portionately in perinatal mortality statistics, with ment of these patients (please see Fig. 23.2).
50% of unexplained stillbirths being less than the Screening of all pregnant women should be
10th centile. Reducing still birth is a mandated offered. The optimal methods of screening are
directive from the government to NHS England crude meaning that only 50–60% of cases will be
forming part of the NHS business plan 2015– identified at best. Screening utilises history (for
2016. The NHS England “Saving Babies’ Lives” example of a previous FGR baby, maternal smoking
care bundle is an integral part of reducing still- or maternal medical problems); examination using
birth rates with risk assessment and surveillance symphysis-fundal height (SFH) plotted on popula-
for FGR a key element of the care bundle [2]. tion or customised growth charts; and investigation,
The RCOG green-top guideline is a compre- such as serial growth scans and Doppler velocime-
hensive distillation of the current evidence avail- try. Once FGR is suspected, further management
able at the time of writing, relating to SGA babies should be directed to establishing a cause, monitor-
and thus should be the basis for local guidelines ing the pregnancy; treating with steroids and mag-
for the detection and management of SGA. Any nesium sulphate and timing the delivery.
reasons for variance in those guidelines from
established practice, should be clearly docu-
mented and agreed at senior level in the Trust. 23.3 Clinical Governance Issues
The guidelines propose an assessment tool to
be applied to all pregnancies at booking to aid Adherence to the local guidance should be
identification of pregnancies at high risk for FGR audited to include detection rates. Accepting that
(Fig. 23.1). The guideline also discusses how ultrasound for estimated fetal weight has a sub-
Booking assessment
(first trimester)
Minor risk factors

Assessment of
Maternal age > 35 years
IVF singleton pregnancy fetal size and
Nulliparity umbilical
al
BMI <20 Uterine rm artery Doppler
3 or more No
BMI 25–34.9 artery in third trimester
Smoker 1 - 10 cigarettes per day 3 or more
Doppler at Ab
Low fruit intake pre-pregnancy no
20-24 weeks rm Reassess
Previous pre-eclampsia al
Pregnancy interval <6 months during
Pregnancy interval >6 months Reassess third trimester
at 20 weeks
Institute serial
PAPP-A <0.4 assessment of
Major risk factors
MOM (major) fetal size and
Maternal age >40 years
Smoker > 11 cigarettes per day umbilical artery
Paternal SGA Fetal echogenic Doppler
Cocaine bowel (major) Serial if develop:
Daily vigorous excercise One risk factor One risk factor assessment
Previous SGA baby of fetal size
Severe pregnancy
Previous stillbirth and umbilical
induced
Maternal SGA artery Doppler
hypertension
Chronic hypertension from
Consider Pre-eclampsia
Diabetes with vascular disease 26-28 weeks
Renal impairment aspirin at Unexplained APH
< 16 weeks abruption
Antiphospholipid syndrome
if risk
Heavy bleeding similar to menses factors for
PAPP-A <0.4 MoM pre-eclampsia
Women unsuitable for monitoring of

growth by SFH measurement
e.g. Large fibroids, BMI > 35
Risk assessment must always be individualised (taking into account previous medical and obstetric history and current pregnancy historyl. Disease progression or institution of
medical therapies may increase an individual’s risk.
Fig. 23.1 Screening pathway for the small for gestational age baby (RCOG Green-top guideline No. 31)
23 Fetal Growth Restriction (FGR) 123
APPENDIX III: The Management of the Small–for–Gestational–Age (SGA) Fetus
SFH High risk of SGA fetus/neonate

th
Single measurement <10 customised centile Based on history, biochemistry or uterine
&/or serial measurements indicative of FGR artery Doppler
Fetal biometry
Single AC or EFW <10 th customised centile
Serial measurements indicative of FGR
UA Doppler
Refer for
fetalmedicine
specialist
opinion
Normal PL or RI > 2 SDs, EDV present AREDV
Repeat ultrasound Repeat ultrasound Repeat ultrasound

(Fortnightly) Weekly Twice Weekly Weekly Daily
AC & EFW1,2 UA Doppler AC&EFW1,2 UA Doppler AC&EFW
1,2
UA Doppler
MCA Doppler after 32 weeks DV Doppler
[cCTG]3
Delivery Delivery Delivery

Offer delivery by 37 weeks with the Recommend delivery by 37 weeks Recommend delivery before 32 weeks after
involvement of a senior dinidian Consider steroids if delivery by CS steroids if:
Recommend delivery by 37 weeks if Consider delivery > 34 weeks if static growth – abnormal DV Doppler and/or cCTG
MCA Doppler Pl< 5th centile over 3 weeks provided> 24 weeks & EFG > 500g
Consider delivery > 34 weeks if static growth Recommend steroids if delivery is by CS Recommend delivery by 32 weeks after steroids
over 3weeks (as per RCOG guidance) Consider delivery at 30–32 weeks even when
Consider steroids if delivery is by CS DV Doppler is normal
(as per RCOG guidance
1 Weekly mwasurement of fetal size is valuable in predicting birth weight and determining size-for-gestational age
2 If two AC/EFW measurements are used to estimate growth, they should be at least 3 weeks apart
3 Use cCTG when DV Doppler is unavailable or results are inconsistent – recommend delivery if STV < 3ms
Abbreviations: AC, abdominal circumference; EFW, estimated fetal weight; Pl, pulsatility index; RI, resistance index; UA, umbilical artery; MCA, middle
cerebral artery; DV ducts venosus; SD, standard deviation; AREDV, Absent/reversed end–diastolic velocities; cCTG, computerised cardiotography;
STV, short term variation; SFH, symphysis-fundal height; FGR, fetal growth restriction; EDV, end-diastolic velocities.
Fig. 23.2 Management of the small for gestational age baby (RCOG Green-top guideline No. 31)
stantial error of ±15–20%, then detection cannot suspected SGA, should be taught to relevant staff
be 100%, but is likely to be improved with regu- throughout an organisation by appropriately
lar image review, feedback to staff, and ongoing trained staff.
training of sonographers.
Regular, on-going audit of the detection of
SGA should be carried out within every mater- 23.4 Reasons for Litigation
nity unit. Benchmarking nationally would be
ideal but relevant data collection is difficult and The number of claims related to SGA is small but
thus robust national detection rates (including potentially very costly if wrongful birth can be
false positive and negatives) do not currently proved.
exist. As such local targets are generally (and Reasons for litigation may include:
somewhat arbitrarily) developed.
Risk reporting is an important part of estab- • Not following guidelines thus inadequate
lishing a culture of clinical governance within an detection/management of SGA
organisation. Staff should feel they can report • Lack of appropriate investigation
missed cases without risk of recrimination, and • Failure to identify SGA leading to stillbirth
learn from feedback on their practice. • Failure to identify fetal anomaly or congenital
Training in the detection methods such as infection as a cause of SGA
SFH use in screening for SGA or more advanced • Inadequate training of staff
Doppler measurements in the management of • Failure to refer for a second opinion
124 W. L. Martin
• Not referring in a timely manner to an appro- Ultimately the only “treatment” for FGR is
priate level of neonatal unit delivery. After 32 weeks, this decision is rela-
• Poor documentation tively easy and the outcome likely to be favour-
able. However, perinatal outcome is
predominantly determined by gestational age and
23.5 Avoidance of Litigation fetal weight. They are especially important at
early gestational age (<26 weeks); or when the
There are many controversial areas in the man- estimated fetal weight is low, around 500 g.
agement of this group of patients, a full discussion These are difficult circumstances in which the
of all of these is not possible here. Before discuss- decision whether to deliver or not will need to be
ing a couple of examples, it is worth considering considered. Where time and availability permits,
that there are circumstances where management counselling should involve senior colleagues,
is not a source of significant debate but care is fetal medicine subspecialists and especially neo-
often found wanting. For example, the RCOG natal colleagues. This will provide valuable
guideline makes the care of women at 37 weeks information to help a couple come to an informed
with a baby below the 10th centile quite clear. decision. Depending on the availability of the
Once term is reached (at 37 weeks), induction appropriate level of neonatal care, the place of
should be offered. If this advice is not given and birth is also important. It is well accepted that in
fetal or neonatal complications arise, there is little utero transfer is better in terms of outcome than
defence to offer. In the event that the patient ex utero. The use of steroids and magnesium sul-
declines the offer, a clear discussion of the risks phate also should be discussed [3]. These are
including explicitly stating that stillbirth is a pos- interventions for which there is a well-established
sible outcome by not following the advice should neonatal benefit and to fail to use them appropri-
be undertaken. As always, contemporaneous doc- ately (which may include not giving them too
umentation for that discussion should be recorded. early) may be regarded as substandard care.
Two examples of more controversial areas for A decision in obstetrics is often dynamic and
further consideration here are: so should be reviewed regularly. A decision made
a few days previously, may no longer be appro-
• very early onset FGR (<23 weeks) or sus- priate as a scan may demonstrate fetal growth
pected structural anomalies. over 500 g or a gestation is reached where it may
• delivery at extreme prematurity (<26 weeks) be considered appropriate to give steroids, mag-
or very low (estimated) birth weight (<500 g) nesium sulphate and to deliver.
Finally, on the often-repeated basis that: “If
In the first instance, the RCOG guideline rec- it’s not recorded, it didn’t happen” discussions
ommends a referral for a detailed anomaly scan should be comprehensively documented. A recur-
by a fetal medicine specialist to be offered. This rent theme in unsuccessful defences is that docu-
may lead to the offer of further tests (invasive and mentation was poor and patient information and
non-invasive) and consultations with other spe- understanding was inadequate. The converse
cialists such as a geneticist, paediatric neurolo- does not always hold true, but well recorded (leg-
gist or neonatal surgeon. Findings may lead to ible), contemporaneous notes will aid a defense
difficult choices for the couple. Throughout, the case.
counselling needs to be frank and comprehensi-
ble, with the various courses of action which may
include continuing with or termination of preg- 23.6 Case Study
nancy being made clear. It is important to ensure
the couple understand the counselling, with the A 38-year-old woman in a consanguineous mar-
help of translators (not including relatives) where riage (1st cousins) presented in the index preg-
necessary. Failure to do so (and fully document), nancy at 12 weeks for booking. This was her
may lead to law suits for wrongful birth. second pregnancy; her first baby was well grown.
23 Fetal Growth Restriction (FGR) 125
She underwent an amniocentesis for maternal

age, the result was normal. The 20-week anomaly ment options in suspected FGR. Where
scan was normal with all measurements above the baby is suspected to be very small or
the 5th centile. At 26 weeks, a SFH measurement very early in gestation, the decision to
was 23 cm and at 30 weeks was 27 cm. In neither deliver will need to be made in consulta-
case was the measurement plotted on a custom- tion with the family, senior obstetrician
ised growth chart (although there was one in the (s) with referral to other specialists
notes). There were normal fetal movements. At (such as fetal medicine and neonatal
34 weeks, the SFH was 31 cms, again the growth colleagues) as deemed necessary.
was not plotted. A junior doctor arranged for a • Counselling should be comprehensive
growth scan but due to lack of availability it was and comprehensible. Appropriate lan-
done 2 weeks later. The HC, AC and FL were all guage should be used including, where
on the 5th centile. Liquor volume was reduced necessary, translators.
(maximum pool depth 1.5 cm) and there was • Documentation of all discussions and
absent end diastolic velocity on Doppler exami- the decisions arising from them should
nation of the umbilical artery. The patient was be made. These decisions need to be
admitted and delivered by Caesarean section that reviewed regularly in light of any new
day as the cervix was unfavourable. The baby’s information.
birthweight was less than the 10th centile. The
child developed cerebral palsy.
A case was brought against the Trust for mis-
References
management of the pregnancy. Whilst it is clear
that there were missed opportunities to offer ultra- 1. Royal College of Obstetricians and Gynaecologists
sound and the antenatal care was substandard, green-top guideline No. 31. The investigation and
developmental delay was not felt by the neonatal management of the Small-for-gestational-age baby.
2nd ed. February 2013. Minor revisions January 2014.
expert to be due to antenatal events rather the
https://www.rcog.org.uk/globalassets/documents/
likely diagnosis was a metabolic condition, thus guidelines/gtg_31.pdf
the case was settled in favour of the Trust. 2. O’Connor D on behalf of NHS England. Saving
babies’ lives. A care bundle for reducing stillbirth.
2016. https://www.england.nhs.uk/wp-content/
uploads/2016/03/saving-babies-lives-car-bundl.pdf
3. NICE guideline NG25. Preterm labour and
Key Points: Fetal Growth Restriction
birth. Published 20th November 2015. https://
• Each pregnancy should be assessed for w w w. n i c e . o rg . u k / g u i d a n c e / n g 2 5 / r e s o u r c e s /
risk factors for FGR and appropriate preterm-labour-and-birth-pdf-1837333576645
monitoring instituted to screen for and
then manage FGR if identified.
• In early onset FGR (<23 weeks) or
where fetal structural anomalies are sus-
pected, referral should be made to a spe-
cialist in fetal medicine.
• Pregnancies may start as low risk and
change to high risk, thus each antenatal
contact should be used as an opportunity
to reassess the assigned risk for that
pregnancy.
• Steroids, magnesium sulphate, timing
and place of delivery are the only treat-
Placenta Praevia, Placenta Accreta
and Vasa Praevia 24
Jeremy Brockelsby
24.1 Background Table 24.1 Classification of the morbidly adherent

placenta
Placenta praevia occurs when the placenta is Type Findings
inserted wholly or in part into the lower segment Accreta Invasion into the inner third of the
of the uterus. If the placenta lies over the internal myometrium
Increta Invasion through the myometrium and
os it is a major praevia, but if the leading edge of serosa
the placenta is in the lower segment, but not cov- Percreta Invasion through the myometrium and
ering the internal os it is a minor or partial prae- serosa and into adjacent organs such as
via. The reported incidence of placenta praevia is the bladder
about 0.5% at term.
The morbidly adherent placenta describes tected by placental tissue or umbilical cord. This
three pathological variants where part of or all of can occur secondary to a velamentous cord
placenta invades into the uterine wall (see insertion or when the vessels run between the
Table 24.1); if this occurs then the placenta will lobes of a bipartite placenta. The incidence is
then not undergo the normal physiological sepa- between 1 in 2000 and 6000 pregnancies [2].
ration at the time of delivery. The incidence of Both placenta praevia and placenta accreta can
placenta accreta is increasing and is reported to lead to obstetric haemorrhage and its complica-
be around 1:550; studies have observed this is tions; coagulation defects, effects of massive
mirroring a rising caesarean section rate [1]. As transfusion, multi- organ failure, hysterectomy
well as previous caesarean section, other risk and surgical injury to adjacent structures.
factors include any surgical interventions that Maternal death can occur despite optimal plan-
increases damage to the uterine architecture ning, transfusion management, and surgical care.
including myomectomy, vigorous dilatation and Vasa praevia carries a significant risk to the fetus
curettage and Asherman’s syndrome. Vasa prae- if the vessels are ruptured.
via occurs when fetal vessels pass through the
fetal membranes over the internal cervical os and
below the presenting part of the baby unpro- 24.2 Minimum Standards
All women should be offered placental site

J. Brockelsby screening as part of their routine anomaly scan to
Fetal and Maternal Medicine, The Rosie Maternity exclude a low-lying placenta. In women with a
Hospital, Addenbrookes NHS Trust, Cambridge, UK low-lying placenta on ultrasound scan and a
e-mail: jeremy.brockelsby@addenbrookes.nhs.co.uk

https://doi.org/10.1007/978-3-319-78683-4_24
128 J. Brockelsby
previous caesarean section, placenta accreta Three-dimensional power Doppler are added the
should be excluded. In asymptomatic women detection rates increase further [3]. Over the last
with a minor praevia on scan a follow up scan decade there has been increased utilisation of
should be arranged at 36 weeks gestation. For magnetic resonance imaging (MRI) as a diagnos-
asymptomatic women with a major praevia on tic tool. However, studies comparing these
the 20-week scan a further scan should be per- modalities have failed to demonstrate any added
formed at 32 weeks. If the placenta remains maternal benefit over ultrasound [3]. It may be
within the lower segment these women should be useful where ultrasound is technically difficult
seen and counselled by a senior obstetrician such as in the obese patient.
regarding the implications and possible risks Any cases where the diagnosis of placenta
including mode and timing of delivery. Women accreta has been raised and there are suspicious
with a placenta more than 2 cms form the internal ultrasound or MRI findings, should be managed
cervical os can opt for vaginal birth [2]. as such. Caution at the time of operation is pref-
The main screening method is transabdominal erable to being unprepared. The diagnosis of the
ultrasound, although this has a false positive rate morbidly adherent placenta prior to delivery
of up to 25% for placenta praevia. This has led to allows multidisciplinary planning with the aim of
transvaginal ultrasound becoming the gold stan- minimising both the maternal and neonatal mor-
dard for accurate localisation of placental site bidity and mortality.
where there is diagnostic uncertainty on transab- For both placenta praevia and placenta accreta
dominal scanning. The ultrasound report must the antenatal prevention and treatment of mater-
accurately document the relation of the placenta nal anaemia is recommended by the RCOG [2],
to the internal cervical os in cms and whether the in view of the risks of haemorrhage at the time of
placenta is anterior or posterior. This is important delivery. Outpatient management is the preferred
as the location of the placenta may influence the option for women and has been shown to be safe
surgical approach and outcome. The anteriorly [3]. However, both the RCOG [2] and Royal
orientated placenta increases the risk of excessive Australian and New Zealand College of
blood loss and transfusion, as the surgeon may be Obstetricians and Gynaecologists [4] recom-
required to cut through it at the point of delivery. mend that women at risk of antepartum haemor-
Placenta praevia is important to diagnose, rhage should remain close to the hospital in the
because it inevitably requires a caesarean section third trimester. However, neither defines a geo-
and potentially more radical surgical interven- graphical limit and this remains the decision of
tions such as hysterectomy. It is imperative that the clinician and the patient. As a rule, asymp-
the patient is fully counselled for these tomatic women who have a minor placenta prae-
complications. via may be managed as an outpatient and women
Anterior placenta praevia with a previous cae- with a major praevia who have bled previously
sarean section scar will also increase the risk of a are advised admission from 34 weeks.
morbidly adherent placenta. The risks of a mor- For both placenta praevia and placenta accreta
bidly adherent placenta increase with the number problems arise when these patients present out of
of caesarean sections or uterine surgery and the hours, either due to haemorrhage or a missed
presence of a low-lying placenta; therefore, all antenatal diagnosis. For those women in whom
women should be offered screening if they have the diagnosis is known there should be a clear
these risk factors. This initial screening should be management plan outlined in the antenatal and
with ultrasound and be undertaken by an operator maternity notes. Consultant staff should be
with experience in assessment of the placenta and informed and attend as soon as possible.
its abnormalities. Grayscale ultrasonography has Resuscitation follows the basic principles of air-
been demonstrated to be sensitive enough and way, breathing, and circulation. Two large bore
specific enough for the diagnosis of morbidly cannulas should be inserted to allow rapid blood
adherent placenta. When colour Doppler and transfusion and fluid resuscitation. The
24 Placenta Praevia, Placenta Accreta and Vasa Praevia 129
a vailability of blood and blood products is man- Vasa praevia is unlikely to be diagnosed clini-
datory with a low threshold for escalation to the cally in women who are asymptomatic although
major obstetric haemorrhage protocol. occasionally the fetal vessels are palpated through
Although risk factors allow the identification the membranes on vaginal examination. In the
of most cases during the antepartum period, the presence of bleeding following membrane rup-
diagnosis is occasionally discovered at the time ture delivery should not be delayed as rapid fetal
of delivery. If this is the case then the surgical exsanguination will occur. Vasa praevia can be
team has no option but to expedite delivery, diagnosed reliably with colour Doppler ultra-
unless there are no maternal or fetal concerns sound [6]. The diagnosis should be confirmed on
when it would be reasonable to halt and summon transvaginal ultrasonography and repeated in the
the appropriate personal to attend theatre, with third trimester as 15% of cases may resolve [7].
the aim of reducing the maternal morbidity. Even Cases of vasa praevia confirmed in the third tri-
when it is not safe to pause it is essential that all mester should have antenatal admission from 28
relevant on call staff are summoned as a matter of to 32 weeks [2]. Delivery should occur by elec-
urgency as these cases can become complicated tive caesarean section.
from an early stage.
There are a number of surgical approaches
that may be employed for placenta praevia and 24.3 Clinical Governance Issues
placenta accreta. In general, opening the uterus at
a site distant from the placenta and delivering the Detailed consent should be taken antenatally and
baby without disturbing the placenta is preferred should include the RCOG guidance for consent
[2]. This will allow conservative management of to caesarean section [8], but in addition women
the placenta or elective hysterectomy if placenta should be warned that the risk of massive haem-
accreta is confirmed [2]. Delivering through the orrhage is approximately twelve times more
placenta results in increased blood loss and a likely with a placenta praevia. The risk of hyster-
higher chance of hysterectomy. In some instances, ectomy is also increased and rises when associ-
conservative management of placenta accreta ated with a previous caesarean section. In the
may be possible with local resection, however in pilot series of the RCOG care bundle [9] 33% of
women in whom there is already bleeding, con- women required a hysterectomy. Silver et al. doc-
servative treatment is unlikely to be successful. umented the link between the number of previous
In women where the placenta does not separate caesarean sections and the risk of placenta
following delivery it is preferable to leave the accreta, placenta praevia and hysterectomy docu-
placenta in situ and close the uterus. These mented in Table 24.2 [10].
women can be managed conservatively or by Any woman with a known placenta praevia
hysterectomy; both of these options are associ- should be delivered by the most experienced
ated with a reduction in blood loss [5]. Where the obstetrician and anaesthetist on duty. As a mini-
placenta partially separates the placenta will need mum requirement during a planned procedure, a
removal. Adherent portions may be left in situ, consultant obstetrician and anaesthetist should be
but blood loss can be torrential. For women in present on delivery suite. Junior doctors should
whom placental tissue is left behind they should not be left unsupervised when caring for these
be warned of the risks of infection and further women.
haemorrhage. Surgical management must be The diagnosis of morbidly adherent placenta
individualised and although, planned delivery is prior to delivery allows multidisciplinary planning
the goal, a contingency plan for an emergency with the aim of minimising the maternal and neona-
delivery should be developed for each patient, tal morbidity and mortality. Multidisciplinary ante-
which would incorporate a local protocol for the natal planning should include the following
morbidly adherent placenta and the management personnel; Consultant Obstetrician, Consultant
of massive obstetric haemorrhage. Anaesthetist, Consultant Haematologist, Consultant
130 J. Brockelsby
Table 24.2 Number of previous caesarean sections and risk of placenta accreta, placenta praevia and hysterectomy
[11]
No previous No of No with placenta Risk of placenta accreta if No of
caesarean sections women accreta placenta praevia (%) hysterectomies
0 6201 15 (0.24%) 3 40 (0.65%)
1 15,808 49 (0.31%) 11 67 (0.42%)
2 6324 36 (0.57%) 40 57 (0.9%)
3 1452 31 (2.13%) 61 35 (2.4%)
4 258 6 (2.33%) 67 9 (3.49%)
5 89 6 (6.74%) 67 8 (8.99%)
Gynae-Oncologist, Consultant Interventional Table 24.3 Care bundle for women with placenta prae-
via and placenta accreta
Radiologist. A Consultant Urologist (if the bladder
Consultant obstetrician planned and directly
is considered to be involved) and a Consultant
supervised delivery
Neonatologist if delivery is likely to be very pre- Consultant anaesthetist planned and directly
term. The use of a care bundle for placenta praevia supervised anaesthetic at delivery
and accreta is now considered good practice. The Blood and blood products available
key elements are documented in Table 24.3. All Multidisciplinary involvement in pre-op planning
obstetric units should have locally or regionally Discussion and consent includes possible interventions
devised protocols for the diagnosis, management (such as hysterectomy, placenta left in situ, cell
salvage and interventional radiology)
and treatment of these patients. These should out- Local availability of a level 2 critical care bed
line all the requirements for the safe delivery of this
group of women, with both personnel requirements,
surgical and radiological options. Ideally it would 24.4 Reasons for Litigation
have an accompanying check list of personnel and
equipment required for these births. 24.4.1 Placenta Praevia and Placenta
Clinical incident forms should be completed Accreta
for all adverse events these will include all cases
of massive obstetric haemorrhage, peri-partum • Failure of diagnosis.
hysterectomy and any unexpected admission to • Failure to adequately consent the patient.
the intensive care unit. All cases should be exam- • Failure to adequately prepare for the potential
ined after the event for learning and guidelines issues.
redesigned based on these observations. • Failure to prepare adequately for the surgery.
Postnatal follow up should include a debrief • Avoidable damage to adjacent organs—blad-
surrounding the delivery, any complications or der/bowel
unexpected events and any implications for future • Failure to involve a senior surgeon at an appro-
pregnancy and fertility. priate stage.
All staff involved in the care of these women • No follow up of the patient
should receive training with regard to massive
obstetric haemorrhage and acute fetal compro-
mise. Staff performing antenatal imaging should 24.4.2 Vasa Praevia
have adequate training in the screening, diagno-
sis and recognition of placental variants such as • Failure to perform TV scan to confirm
placenta praevia and placenta accreta, bi-lobed diagnosis
placenta, velamentous cord insertion and vasa • Failure to repeat TV scan in the third
praevia. There should be a robust referral path- trimester
way for the use of MRI where the ultrasound fea- • Failure to offer admission from 28 to 32 weeks
tures suggest a morbidly adherent placenta. gestation
24 Placenta Praevia, Placenta Accreta and Vasa Praevia 131
• Delay in performing category 1 caesarean sec- even with careful pre-operative planning but if
tion following membrane rupture planning has occurred and been comprehensively
documented then the patient will consider that all
has been done to reduce the risks.
24.5 Avoidance of Litigation Good communication with the patient during
the pre-operative period will reduce litigation as
Imaging for placenta praevia and placenta accreta patients will have their expectations managed;
should be performed according to local and they will appreciate that this is a serious compli-
national guidelines [2]. Sonographers should be cation of pregnancy, which carries a high level of
aware of the risk factors for placenta praevia and morbidity and potentially mortality. It is impor-
placenta accreta. Where appropriate images are tant that these patients are debriefed by a senior
not obtained transabdominally, a transvaginal clinician who can address any unresolved issues.
approach should be employed. MRI scanning
may aid diagnosis and a clear pathway for refer-
ral should be in place. Imaging for vasa praevia 24.6 Case Study
should include a colour Doppler transvaginal
scan with a repeat examination in the third A 34-year-old woman was booked in her second
trimester. on going pregnancy. A fetal anomaly scan was
Once the diagnosis has been made or sus- undertaken; this demonstrated that the placenta
pected, women should be referred to a consultant was within the lower uterine segment. Therefore,
Obstetrician for the detailed planning of delivery. a further ultrasound assessment was arranged for
Ideally there should be an agreed management 32 weeks. At this scan the placenta was
pathway in place involving the multidisciplinary documented as now not being low lying, however
team. a succenturiate lobe was noted on the posterior
The pathway should detail management wall of the uterus with the main body of the pla-
options that would allow any competent clinician centa on the anterior uterine wall. The fetal ves-
to manage these cases. These guidelines should sels connecting the two parts of the placenta
have a clear list of the required personnel. Any appeared to pass over the uterine cervix; there-
case where placenta accreta has been raised as a fore, the possibility of vasa praevia was raised. In
potential and there are suspicious findings on view of these ultrasound findings a further ultra-
either ultrasound scan or MRI, should be man- sound assessment was arranged for 34 weeks, at
aged as such. These cases require a multidisci- this scan the question of a vasa praevia was again
plinary approach with a planned caesarean raised but no referral was made to the Obstetric
section when all available staff can be present. team. At 39 weeks, the women went into sponta-
Women should receive detailed explanation of neous labour where upon she started to bleed per
all the possible complications and management vaginum; she was rushed to hospital, where on
strategies including massive obstetric haemor- arrival the fetal heart rate demonstrated a patho-
rhage, cell salvage, blood transfusion, tamponade logical pattern. An emergency Caesarean section
balloons, interventional radiology in women was undertaken, at birth the baby was pale and
declining blood products, hysterectomy, reten- unresponsive; fetal bloods demonstrated that the
tion of placental tissue and surgery to adjacent baby was profoundly anaemic. Resuscitation was
structures including bladder and bowel. The pre- initiated and the baby transferred to the neonatal
ferred management options should be detailed unit; unfortunately, despite prolonged resuscita-
and written consent for any additional procedures tion the baby died 2 hours after birth. Placental
obtained. Women generally seek compensation histology demonstrated a placenta with a succen-
in view of the long-term complications that occur turiate lobe, connected with fetal vessels that had
as a direct result of the surgical interventions that ruptured. The diagnosis of vasa praevia was
may be necessary. These may be unavoidable confirmed.
132 J. Brockelsby
Expert evidence was obtained to support the

case that Defendant trust had negligently failed in • Where possible these procedures should
its duty of care to the mother for the following be undertaken electively with all rele-
reasons: vant staff either in theatres or directly
available.
(a) To perform a transvaginal scan at either the
32 or 34 weeks scan that would have con-
firmed the diagnosis References
(b) To plan an elective caesarean section at 37/38
weeks gestation following the diagnosis. 1. American College of Obstetricians and Gynecologists.
(c) Arranged inpatient management of this case Placenta accreta. Committee opinion no. 529. Obstet
Gynecol. 2012;120:207–11.
from 34 weeks. 2. RCOG Green Top Guideline No 27: ‘Placenta prae-
via, placenta praevia accreta and vasa praevia: diag-
The Defendant Trust settled the case. nosis and management’. 2011.
3. Shih JC, Palacios JM, Su YN, Shyu MK, Lin CH, Lin
SY, et al. Role of three-dimensional power Doppler
in the antenatal diagnosis of placenta accreta: com-
Key Points: Placenta Praevia, Placenta parison with gray-scale and color Doppler techniques.
Accreta and Vasa Praevia Ultrasound Obstet Gynecol. 2009;33:193–203.
• All women should be screened for pla- 4. Wing DA, Paul RH, Millar LK. Management of the
symptomatic placenta previa: a randomized, controlled
centa praevia trial of inpatient versus outpatient expectant manage-
• Screening for vasa praevia is not ment. Am J Obstet Gynecol. 1996;175:806–11.
appropriate 5. Royal Australian and New Zealand College of
• Vasa praevia should be confirmed on Obstetricians and Gynaecologists. College Statement:
C-Obs. Placenta Accreta. 2003. www.ranzcog.edu.au/
TV colour Doppler ultrasound with a publications/statements/C-obs20.pdf.
repeat in the third trimester 6. Baulies S, Maiz N, Muñoz A, Torrents M, Echevarría
• Women with confirmed vasa praevia M, Sierra B. Prenatal ultrasound diagnosis of vasa
should be offered antenatal admission in praevia and analysis of risk factors. Prenat Diagn.
2007;27:595–9.
the third trimester and be delivered by 7. Nelson LH, Melone PJ, King M. Diagnosis of vasa
elective caesarean section previa with transvaginal and color flow Doppler ultra-
• All women with risk factors for placenta sound. Obstet Gynecol. 1990;76:506–9.
accreta should have a detailed scan con- 8. Eller AG, Porter TF, Soisson P, Silver RM. Optimal
management strategies for placenta accreta. BJOG.
ducted by a person with the relevant 2009;116(5):648–54.
expertise. 9. Royal College of Obstetricians and Gynaecologists.
• All women with a placenta praevia Consent advice no. 7: caesarean section. London:
should be counselled by an obstetrician RCOG; 2009.
10. Paterson-Brown S, Singh C. Developing a care bundle
with regard to risks and mode of for the management of suspected placenta accreta.
delivery. Obstet Gynecol. 2010;12:21–7.
• All women where the diagnosis of a pla- 11. Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong
centa accreta is raised should be man- CY, Thom EA, et al. National Institute of Child Health
and Human Development Maternal-Fetal Medicine
aged as such. Units Network. Maternal morbidity associated with
• All women with either a placenta prae- multiple repeat cesarean deliveries. Obstet Gynecol.
via or accreta should have blood prod- 2006;107:1226–32.
ucts readily available.
• Consent for either praevia or placenta
accreta should document all the risks for
the procedure.
CTG Interpretation
25
Vikram Talaulikar and Sabaratnam Arulkumaran
25.1 Background cations for continuous fetal monitoring. These

include:
The NHS Litigation Authority (NHS LA) report
‘Ten Years of Maternity Claims’ has highlighted –– Fetal growth restriction or fetal abnormality
cardiotocograph (CTG) interpretation as a major –– Maternal BMI >35
source of litigation, with the main allegations –– Previous caesarean section
focusing on the failure to recognise an abnormal –– Preterm labour
CTG and act on it [1]. Failure to refer appropri- –– Maternal diabetes
ately and poor documentation were also com- –– Multiple pregnancy
monly recognised in the report. In the UK –– Maternal pulse >120 beats per minute
litigation arising from Obstetrics accounts for 60 –– Severe chorioamnionitis, sepsis or a tempera-
to 70% of the total sum paid out by the NHSLA, ture greater than 38 degrees in labour
but comprises only 26% of the workload. This –– Severe hypertension (160/110 mmHg or
disproportion occurs because claims relating to above)
cerebral palsy and hypoxic damage may total in –– Syntocinon use
excess of £1 million due to the cost of lifelong –– The presence of meconium stained liquor
care for a child with a severe brain injury. –– Vaginal bleeding occurring in labour
–– Prolonged membrane rupture exceeding 24 hours
–– Delay in the first or second stage in labour
25.2 Minimum Standards –– Regional anaesthesia
–– Fetal heart rate below 110 beats per minute or
Continuous fetal monitoring by CTG should not above 160 beats per minute
be performed on low risk women in labour. It is –– Polyhydramnios or oligohydramnios
essential that Obstetricians be aware of the indi- –– Decelerations heard on intermittent fetal
auscultation
V. Talaulikar (*) For women in whom continuous monitoring is

Reproductive Medicine Unit, University College required any decisions in labour should be made
London Hospital, London, UK
e-mail: Vikram.Talaulikar@nhs.net assessing the whole clinical picture rather than
on the CTG alone. This will include antenatal and
S. Arulkumaran
St. George’s University of London, London, UK intrapartum factors, current fetal and maternal
e-mail: sarulkum@sgul.ac.uk wellbeing as well as the progress of labour. The

https://doi.org/10.1007/978-3-319-78683-4_25
134 V. Talaulikar and S. Arulkumaran
woman should have one to one care and an CTG tracings need to be of good quality and
assessment of the CTG should be made regularly; this may be affected by maternal body mass
hourly if the trace is reassuring, but more fre- index or pain in labour. More advanced fetal
quently if there are concerns. monitoring systems such as Monica or STAN
The main principle for intrapartum CTG inter- may help to achieve better quality tracings. In
pretation is to categorise the trace based on base- addition these systems are more helpful in distin-
line fetal heart rate, variability greater than 5 guishing between maternal and fetal pulse rate, a
beats per minute, the presence or absence of common error encountered in litigation cases. It
decelerations and the presence or absence of may be that external monitoring is not possible
accelerations. CTGS should be categorised and that a fetal scalp electrode will improve the
according to the NICE guidelines [2]; quality of fetal monitoring.
CTG tracings need to be adequately stored
1 . Normal or reassuring features and kept as part of the patient record for up to 21
2. Non-reassuring features years. With the advent of the electronic patient
3. Abnormal features record this will become more efficient allowing
safer storage and a reduction in the deterioration
(See Table 25.1 for CTG classification accord- of CTG traces over time. In addition CTGs need
ing to NICE and management guidance) to contain unique patient identification with
If a CTG has abnormal features the clinician accurate timings and dates. This requires the
should try and establish possible causes and insti- CTG machine’s inbuilt clock to be regularly
gate corrective measures in an attempt to nor- checked and updated. CTGs must also have any
malise the trace. Such measures will include a significant events recording accurately upon
change in maternal position or mobilisation, them including examinations, bleeding, the pres-
encouraging fluid intake, administration of anti- ence of meconium, the placement of epidural
pyretics, modification of contraction frequency in anaesthesia etc.
patients on oxytocin and consideration of tocoly- Any maternity unit employing CTG monitor-
sis with Terbutaline. If the CTG continues to be ing must have twenty-four access to accurate
suspicious or pathological the clinician should fetal blood sampling via a microblood gas analy-
consider fetal blood sampling or to expedite ser. An abnormal fetal heart rate pattern may war-
delivery. rant fetal blood sampling and indeed serial
samples if initial readings are normal, but the
CTG abnormality persists.
25.3 Clinical Governance Issues Finally paired umbilical cord samples should
be taken from all deliveries where there is con-
CTG traces need appropriate interpretation and this cern for fetal wellbeing. These will include cae-
can only be achieved with implementation of edu- sarean section in labour, instrumental deliveries
cation and training. This training and education and babies born with poor Apgar scores.
will form part of all mandatory training for both
Midwives and Obstetricians annually. This may be
achieved by Obstetric induction packages, monthly 25.4 Reasons for Litigation
departmental morbidity or mortality meetings
based on CTG review or via e-learning programmes The reasons for litigation with CTG interpreta-
such as StratOg by the RCOG or K2 teaching sys- tion includes [2]:
tems or by face-to-face workshops such as The
CTG Master class. Where a CTG is difficult to –– Misinterpretation of CTG traces
interpret early involvement of senior colleagues –– Inappropriate or delayed response
should be encouraged. Strategies such as telemetry –– Failure to provide one to one care once a CTG
may allow earlier review of abnormal CTGs. is required due to inadequate staffing
25 CTG Interpretation 135
–– CTG recordings of inferior quality making –– Calling for senior input when the CTG is
accurate interpretation difficult abnormal or difficult to interpret
–– Managing the patient according to the CTG and –– Failing to appreciate changes in the clinical
not taking into account the whole clinical picture scenario for example progress in labour,
–– Failing to perform regular reviews even on bleeding in labour or meconium staining of
normal CTG traces the liquor
Table 25.1 The NICE guidance for CTG classification is summarised in the tables below
Feature
Baseline variability
Description Baseline (beats/min) (beats/min) Decelerations
Normal/reassuring 100–160 5 or more None or early
Non- reassuring 161–180 Less than 5 for Variable decelerations:
30–90 min • Dropping from baseline by 60 beats/
min or less and taking 60 s or less to
recover,
• Present for over 90 min
• Occurring with over 50% of
contractions
OR
Variable decelerations:
• Dropping from baseline by more than
60 beats/min or taking over 60 s to
recover
• Present for up to 30 min
contractions
OR
Late decelerations:
• Present for up to 30 min
contractions
Abnormal Above 180 Less than 5 for over Non-reassuring variable decelerations
Or 90 min (see row above):• Still observed 30 min
Below 100 after starting conservative measures
contractions
OR
Late decelerations
• Present for over 30 min
• Do not improve with conservative
measures
contractions
OR
Bradycardia or a single prolonged
deceleration lasting 3 min or more
NICE make the following recommendations for the management of CTG traces
Category Definition Interpretation Management
CTG is normal/ All three features are Normal CTG, no • Continue CTG and normal care.
reassuring normal/reassuring non-reassuring or • If CTG was started because of
abnormal features, concerns arising from intermittent
healthy fetus auscultation, remove CTG after 20 min if
there are no non-reassuring or abnormal
features and no ongoing risk factors.
(continued)
Table 25.1 (continued)
Feature
Baseline variability
Description Baseline (beats/min) (beats/min) Decelerations
CTG is non- 1. non-reassuring Combination of features • Think about possible underlying
reassuring and feature that may be associated causes.
suggests need for AND with increased risk of • If the baseline fetal heart rate is over
conservative 2. normal/reassuring fetal acidosis; if 160 beats/min, check the woman’s
measures features accelerations are temperature and pulse. If either are
present, acidosis is raised, offer fluids and paracetamol.
unlikely • Start 1 or more conservative measures:
– Encourage the woman to mobilise or
adopt a left-lateral position, and in
particular to avoid being supine
– Offer oral or intravenous fluids
– Reduce contraction frequency by
stopping oxytocin if being used and/or
offering tocolysis.
• Inform coordinating midwife and
obstetrician.
CTG is abnormal 1. abnormal feature Combination of features • Think about possible underlying causes.
and indicates need OR that is more likely to be • If the baseline fetal heart rate is over
for conservative 2. non-reassuring associated with fetal 180 beats/min, check the woman’s
measures AND features acidosis temperature and pulse. If either are
further testing raised, offer fluids and paracetamol.
• Start 1 or more conservative measures
(see ‘CTG is non-reassuring...’ row for
details).
– Inform coordinating midwife and
obstetrician.
– Offer to take a FBS (for lactate or
pH) after implementing conservative
measures, or expedite birth if an FBS
cannot be obtained and no
accelerations are seen as a result of
scalp stimulation
– Take action sooner than 30 min if
late decelerations are accompanied by
tachycardia and/or reduced baseline
variability.
• Inform the consultant obstetrician if any
FBS result is abnormal.
• Discuss with the consultant obstetrician
if an FBS cannot be obtained or a third
FBS is thought to be needed.
CTG is abnormal Bradycardia or a An abnormal feature • Start 1 or more conservative measures
and indicates need single prolonged that is very likely to be (see ‘CTG is non-reassuring...’ row for
for urgent deceleration with associated with current details).
intervention baseline below 100 fetal acidosis or • Inform coordinating midwife
beats/min, persisting imminent rapid • Urgently seek obstetric help
for 3 min or morea development of fetal • Make preparations for urgent birth
acidosis • Expedite birth if persists for 9 min
• If heart rate recovers before 9 min,
reassess decision to expedite birth in
discussion with the woman.
Abbreviations: CTG cardiotocography, FBS fetal blood sample
a
A stable baseline value of 90–99 beats/min with normal variability may be a normal variation (having confirmed that
this is not the maternal heart rate); obtain a senior obstetric opinion if uncertain
25 CTG Interpretation 137
–– Inappropriate use of Oxytocin of membranes (ARM) and oxytocinon infusion.

–– Poor documentation During labour the CTG was categorised as nor-
–– Poor communication and team working mal despite some periods where there was
reduced variability. Mrs. T made good progress
to full dilatation, she pushed for 1 hour and as
25.5 Avoidance of Litigation delivery was not imminent was delivered by
uncomplicated vacuum assisted delivery. A live
Litigation in this area will never be completely female baby was delivered. The baby was noted
avoided, but there are some strategies to reduce to have poor tone at delivery with Apgar scores
risk. These include regular education and train- of 6 at 1 min and 7 at 5 min. Cord gases were
ing for all staff either through mandatory train- normal. The baby was breathing spontaneously
ing or external courses. Any CTG in labour and did not require intubation. On examination,
needs to be formally classified according to there was a small mark from the ventouse cup,
NICE recommendations [2]. Suspicious or path- but no evidence of subgaleal haemorrhage or
ological CTGS need to be assessed and appro- cephalohaematoma. Subsequently the baby was
priate management instigated. It is of paramount found to have an absence of primitive reflexes
importance that communication occurs between and tendon reflexes, was dysmorphic and had a
health professionals and when there is doubt small ventricular septal defect. The baby
escalation to a senior Midwife or Obstetrician showed seizures in the first 12 hours of life. The
should occur at an early stage. Other strategies to baby was diagnosed with severe hypotonic
ensure more robust CTG interpretation include cerebral palsy with global developmental delay.
the introduction of ‘buddying’ systems and CTG A CT scan at 3 months of age showed no sig-
stickers. In these cases CTGs are reviewed regu- nificant abnormalities in the brain parenchyma,
larly by two professionals to ensure agreement but the suggestion of a small interventricular
with regard to classification and ongoing man- haemorrhage.
agement, and a sticker in the patient’s case The parents brought a claim against the hospi-
record documents this review. Where there is a tal based on:
difference in opinion this will prompt a more
senior review. 1. Failure to consider placental calcification as
abnormal and deliver by caesarean section
2. Failure to interpret the intrapartum CTG cor-
25.6 Case Study rectly and deliver by caesarean section
3. Failure to offer caesarean section due to

Mrs. T was a 26-year-old teacher in her first meconium-stained liquor
pregnancy. During the antenatal period, she had
a number of ultrasound scans that showed no The claim was successfully defended. The
obvious fetal abnormality with an appropriately expert opinion was divided regarding the inter-
grown baby with normal liquor and Doppler. At pretation of the CTG, but overall the Judge
the final ultrasound scan at 38 weeks gestation believed there was no evidence to suggest an
a comment on the ultrasound suggested the pla- intra partum insult and that the baby had an
centa showed some calcification. The estimated underlying neurological condition that predated
fetal weight was on the 15th centile for gesta- the pregnancy. The evidence for this was the nor-
tional age. Mrs. T underwent induction of mal CTG in labour, normal cord gases at delivery
labour for post maturity. She was induced with and an MRI and CT scan postnatally showing no
prostaglandin gel followed by artificial rupture evidence of hypoxic injury.
References
Key Points: CTG Interpretation
• Classification of CTGs into normal, sus- 1. NHS Litigation Authority. Maternity claims. Ten
years of maternity claims: An analysis of NHS
picious and pathological is essential to Litigation Authority Data. October 2012.
plan appropriate management. 2. National Institute for Health and Care Excellence.
• Employment of simple measures such Intrapartum care for healthy women and babies
as change in maternal position, rehydra- (NICE guidelines [CG190]). Published Dec 2014.
Lasted amended Feb 2017.
tion, treatment of pyrexia, reduction or
stopping syntocinon infusion may con-
vert the CTG to normal.
• Use of tocolytics may be indicated to
improve uteroplacental bed perfusion
and prevent the baby becoming hypoxic
• Immediate delivery is indicated in pro-
found fetal bradycardia in excess of
9 min
• All staff members should have annual
CTG updates
Operative Vaginal Birth
26
Stephen O’Brien, Mohamed ElHodaiby,
and Tim Draycott
26.1 Background may limit maternal choices in future pregnancies,

increases the risk of abnormal placentation that
Operative vaginal birth (OVB) as an intervention carries significant maternal risks [5] and is asso-
is undertaken with the purpose of enabling better ciated with an increased risk of unexplained still-
maternal and/or neonatal outcomes than would birth in future pregnancies with a hazard ratio of
result from the alternatives—a caesarean section 1.5 [6].
or not intervening at all. OVB, when performed The rate of OVB in the UK is stable at around
correctly, in an appropriate setting by an experi- 12% of total births per annum. This correlates to
enced and trained practitioner, usually results in around 70,000–80,000 women having an OVB
better outcomes for women and their babies than within the UK every year—a significant group of
a caesarean section. Compared to OVB, caesar- women and babies and it is therefore important
ean section performed at full cervical dilatation is that obstetricians know how to, and are able to,
associated with increased rates of; major haemor- provide good patient care in this high-risk envi-
rhage (RR 2.8), prolonged hospital stay (RR 3.5) ronment. Furthermore, poorly performed OVB
and admission to the neonatal intensive care has a significant litigation cost: each case settled
(NICU) (RR 2.6). However caesarean section is by NHS Resolution, between April 2000 and
associated with lower rates of neonatal trauma March 2010, had a mean value in excess of
(RR 0.6) [1]. Moreover, operative vaginal birth, £580,000 [7], and accounted for 3% of all mater-
when successful requires reduced analgesia nity claims by value (not including those in which
requirements, can be expedited more quickly [2] the baby developed cerebral palsy due to failures
and women are much more likely (>80%) to have in duty of care during an OVB).
a spontaneous vaginal birth in their next preg-
nancy [3, 4]. In addition, repeat caesarean section
S. O’Brien · M. ElHodaiby · T. Draycott (*)
Department of Obstetrics and Gynaecology, OVB can often be the best option for the mother
Southmead Hospital, North Bristol NHS Trust, and baby in the second stage of labour but it is
Bristol, UK essential that the accoucheur performs a careful,
Academic Women’s Health Unit, School of Clinical accurate and comprehensive clinical assessment
Sciences, University of Bristol, Bristol, UK to confirm that the prerequisite conditions are
e-mail: stephen.obrien@bristol.ac.uk;
s.obrien@promptmaternity.org;
met for safe vaginal operative delivery.
mohamed.elhodaiby@nbt.nhs.uk; Furthermore, an OVB should be performed by a
Tim.Draycott@bristol.ac.uk practitioner with the appropriate training,
https://doi.org/10.1007/978-3-319-78683-4_26
140 S. O’Brien et al.
experience and skills, who can formulate and put the woman and her family prior to starting the
in place appropriate back-up plans (such as procedure. The ventouse creates a negative pres-
access to a theatre), know when to discontinue sure seal on the fetal head and uses this as an
attempts at delivery, and anticipate and manage anchor point to apply traction. When compared
any potential complications. The prerequisites with forceps delivery the use of the ventouse is
for OVB have been identified by The Royal more likely to fail and therefore require a second-
College of Obstetricians and Gynaecologists ary caesarean section (RR 1.7). In addition, there
(RCOG) as seen in Fig. 26.1. is a risk of cephalohaematoma (RR 2.4) and reti-
The operator should be aware that there are nal haemorrhage (RR 2.0) [8]. However, a recent
higher rates of complications, including failure, systematic review has found that although com-
shoulder dystocia, haemorrhage and fetal injury mon, retinal haemorrhage at birth almost always
associated with a maternal body mass index resolves by 6 weeks of age [9]. The risk more
(BMI) >30, an estimated fetal weight > 4000 g, commonly associated with forceps is an increased
fetal malposition and a mid-cavity delivery or risk of maternal trauma (OR 1.6), however the
where head is 1/5th palpable per abdomen [8]. use of forceps is more likely to achieve a vaginal
Operative vaginal births where any of the birth than vacuum assisted delivery (OR 0.3) [8].
above factors are present should ideally be per- A rotational operative birth is any birth in
formed in an operating theatre where there is which the orientation (position) of the fetal head
immediate recourse to caesarean section. requires correction by the obstetrician prior to
A practitioner’s choice of instrument should delivery. These births are associated with a
be made on the basis of the clinical examination greater risk of failure [8, 10] and are acknowl-
and their own personal experience and training edged as being technically more complex requir-
[8]. However, within this there is considerable ing a sufficiently experienced operator [11].
scope for tailoring of the instrument to the clini- However, despite this background, there is good
cal situation, and a competent practitioner should evidence that in skilled hands rotational operative
be aware of the relative advantages and disadvan- births are safer than the alternative (a caesarean
tages of different instruments and communicate section) [12]. Therefore, it is reasonable for these
this, along with the rationale for choosing it, to births to be attempted, provided certain criteria
Full abdominal and Head is <1/5th palpable per abdomen

vaginal examination vertex presentation.
Cervix is fully dilated and the membranes ruptured.
Exact position of the head can be determined so proper placement of the instrument can be achieved.
Assessment of caput and moulding.
Pelvis is deemed adequate. Irreducible moulding may indicate cephalo–pelvic disproportion.
Preparation of mother Clear explanation should be given and informed consent obtained.
Appropriate analgesia is in place for mid-cavity rotation deliveries. This will usually be a regional block.
A pudendal block may be appropriate, particularly in the context of urgent delivery.
Maternal bladder has been emptied recently. In-dwelling catheter should be removed or balloon deflated.
Aseptic technique.
Preparation of staff Operator must have the knowledge, experience and skill necessary.
Adequate facilities are available (appropriate equipment, bed, lighting).
Back-up plan in place in case of failure to deliver. When conducting mid-cavity deliveries, theatre staff should
be immediately available to allow a caesarean section to be performed without delay (less than 30 minutes).
A senior obstetrician competent in performing mid-cavity deliveries should be present if a junior trainee is
performing the delivery.
Anticipation of complications that may arise (e.g. shoulder systocia, postparum haemorrhage)
Personnel present that are trained in neonatal resuscitation
* Adapted from the Society of Obstetricians and Gyneaecologists of Canada 200441 and the Royal Australian and New Zealand College of
Obstetricians and Gynaecologists 200927,28
Fig. 26.1 Prerequisites for OVB

26 Operative Vaginal Birth 141
are met. The delivery should be performed by a ciated with a caesarean section when the fetal
suitably trained and experienced operator, in the- head is deeply engaged within the pelvis. While
atre (dependent on operator experience) and the such a decision to proceed with a second instru-
operator should be aware of the potential compli- ment may be reasonable, it should be explicitly
cations (such as shoulder dystocia) that may arise justified and documented by the practitioner [8].
[13]. Rotational OVBs can be conducted using It would not usually be justifiable to use ventouse
either rotational (Kielland’s) forceps, rotational after the failure of an attempted forceps birth.
ventouse or using manual rotation followed by Following successful delivery, the condition
direct forceps application. There is no conclusive of the baby should be assessed with both Apgar
evidence as to which of these methodologies is scores and paired umbilical cord gases. The peri-
superior to each other, although some recent neal trauma should be accurately documented
studies and a meta-analysis have found that rota- and repaired accordingly. Where the procedure
tional forceps are superior to manual rotation fol- has resulted in a third or fourth degree tear this
lowed by direct forceps, and there is a lower should be repaired in theatre under appropriate
failure rate than ventouse delivery [13, 14]. conditions.
The RCOG recommends that the procedure
should be abandoned where there is no evidence of
progressive descent with moderate traction during 26.3 Clinical Governance Issues
each contraction or where birth is not imminent
following three contractions of a correctly applied Clinical governance issues will be focussed
instrument by an experience operator. around comparison of the operative vaginal
The RCOG guideline for OVB also explains delivery rate to the national figures, rates of failed
that the bulk of malpractice litigation results from procedures and the use of sequential instruments.
failure to abandon the procedure at the appropri- Where failure of operative delivery occurs, these
ate time, particularly the failure to eschew pro- cases should be reviewed by the risk manage-
longed, repeated or excessive traction efforts in ment team to ensure all prerequisites for safe
the presence of poor progress. If there is diffi- instrumental delivery have been met, that appro-
culty in applying the instrument correctly, no priate documentation exists for the use of sequen-
descent with each traction, birth is not imminent tial instruments and whether the procedure has
following three pulls and/or a reasonable time been abandoned appropriately. There should be
has elapsed since the decision for intervention documentation of women sustaining third and
has been made, then the attempt at operative vag- fourth degree perineal tears and investigation into
inal birth should be abandoned. those babies sustaining significant fetal trauma
Failure to deliver the baby using the primary such as subgaleal haemorrhage, brachial plexus
instrument will then necessitate the use of either injury, fractures, facial nerve palsies or intracra-
a second instrument or a caesarean section—both nial haemorrhage. In addition, all babies deliv-
of which are associated with significantly poorer ered with Apgar scores <7 at 5 min or an arterial
outcomes than a successful primary delivery cord gas of <7.1 should have a case review to
using any single instrument [1, 15]. The use of ensure appropriate management. Other themes to
sequential instruments is associated with greater be assessed may be appropriate analgesia and the
harm than either a successful primary OVB, or a number of pulls required to achieve the delivery.
primary caesarean section [15]. However, follow- Documentation remains a key issue. This
ing a failure to deliver using the first instrument should include informed consent. Deliveries
(usually a ventouse), if there has been significant occurring within the delivery room do not usually
descent of the head, it may be safer and therefore have documented consent forms whereas theatre
reasonable to proceed to use a second instrument deliveries have an appropriately completed con-
(usually forceps), due to the significantly sent form documenting all the material risks of
increased complexity and potential trauma asso- the procedure (Fig. 26.2). Obstetric practice
Fig. 26.2 Risks Serious risks

associated with Fetal
Maternal
operative vaginal birth Third and fourth degree tears
Subgaleal haematoma 3-6/1000
adapted from Consent Intracranial haemorrhage 5-15 in 10 000
Extensive or significant vaginal/vulval tear
Advice No. 11, Royal Facial nerve palsy (rare)
College of Obstetricians Frequent risks
and Gynaecologists Maternal Fetal
2010 Postpartum haemorrhage 1-4 in 10 (very Forceps marks on face (very common)
common) Chignon/cup marking on the scalp (practically
Vaginal tear/abrasion (very common) all cases of vacuum-assisted delivery) (very
Anal sphincter dysfunction/voiding dysfunction common)
Cephalohaematoma 1–12 in 100 (common)
Facial or scalp lacerations, 1 in 10 (common)
Neonatal jaundice /hyperbilirubinaemia, 5 – 15
in 100 (common)
Retinal haemorrhage 17–38 in 100 (very
common
appears to be moving away from procedures per- 26.4 Reasons for Litigation

formed without documented consent in an
increasingly litigious society. Documentation • Failure to obtain informed consent with full
regarding the procedure should ideally be explanation of the material risks
recorded on a pre-printed proforma that is com- • Inexperienced operator
pleted by the operator immediately after delivery • Use of sequential instruments
(Fig. 26.3). The documentation should be detailed • Allegations of excessive traction and multiple
and accurate especially in cases where operative pulls
vaginal delivery has failed leading to a full dilata- • Fetal trauma
tion caesarean section. • Maternal trauma
A recurring theme in obstetrics is the training • Baby born in poor condition as evidenced by
and experience of the operator. Experience will poor paired cord gases
be gained by direct supervision on the labour • Evidence of a significant birth asphyxia fol-
ward until competence is achieved, but also in the lowing the delivery
setting of formal skills training as provided by
such courses as ROBUST and MOET. For opera-
tors where there is a high incidence of failure, 26.5 Avoidance of Litigation
repeated use of sequential instruments and
repeated evidence of both fetal and maternal Failures to provide adequate explanation and
trauma this should raise concerns and further consent are major contributors to litigation asso-
support and supervision instigated until compe- ciated with operative birth [16]. In 2017, the
tence is achieved. General Medical Council Consent Guidelines
The importance of a comprehensive debrief recommended: “The doctor uses specialist
by a senior clinician cannot be stressed enough. knowledge and experience and clinical judge-
Women and their partners may find the delivery ment, and the patient’s views and understanding
traumatic and suffer psychological sequelae. A of their condition, to identify which investiga-
detailed explanation of the indications for the tions or treatments are likely to result in overall
procedure and the procedure itself may be help- benefit for the patient. The doctor explains the
ful to reduce concerns or complaints. Finally, options to the patient, setting out the potential
women who have experienced an operative vagi- benefits, risks, burdens and side effects of each
nal birth should be encouraged to attempt a vagi- option, including the option to have no treatment.
nal delivery in a subsequent pregnancy as 80% The doctor may recommend a particular option
will be successful. which they believe to be best for the patient, but
Patient Details
Date ..............................................................................
Operator Name ....................... ........................ Grade ................
Supervisor Name ....................... ...................... Grade ................
Indication(s)for delivery: ……………………………………………… ..................................................... .................

Classification of OVD: outlet / low / midcavity Rotation > 45o: yes / no
Fetal wellbeing: CTG: normal / suspicious / pathological Liquor: clear / meconium
Prerequisites: Examination
Place of delivery: room / theatre 1/5th per abdomen: .......................................
Analgesia: local / pudendal / regional Dilatation: ...…………………………………….
Consent: verbal / written Position: ……………………………………….
Catheterised: yes / no Station: ………………………………………...
Mou lding:………………………………………
Caput : …………………………………………
Multiple instrument use: yes / no

Procedure Examination before second instrument
Instrument used: 1/5th per abdomen:.............................
Vacuum extractor : silastic / Kiwi / metal anterior / metal Position: ..............................................
posterior Station: ................................................
Forceps: rotational / non-rotational / outlet Moulding: ............................................
Number of pulls: ............................. ................... Caput:..................................................
Traction: easy / moderate / strong Reasons for second instrument:
Maternal effort: minimal / moderate / good ............................................................
............................................................
Placenta: CCT/ manual
............................................................
Episiotomy: yes / no
Perineal tear: 1st degree
2nd degree
3rd / 4th degree (complete pro forma)
Other (complete suturing pro forma if necessary)
EBL:....................................................................
Baby: M / F Birth weight: .......... (kg) Apgar: 1..... 5..... 10..... Cord pH: Arterial......... Venous..........
Post-delivery care:
Level of care: routine / high dependency
Syntocinon infusion: yes / no
Catheter: yes / no Remove ............................
Vaginal pack: yes / no Remove ............................
Diclofenac 100 mg PR: yes / no Analgesia prescribed: yes / no
Thromboembolic risk: low/ medium / high
Thromboprophylaxis prescribed: yes / no
Signature: ................................................................................................ Date: ............................................
Fig. 26.3 Operative vaginal delivery record

they must not put pressure on the patient to accept 26.6 Case Study
their advice” [17].
In the post-Montgomery era the decision- Mrs. J, was a 29-year-old lady in her first preg-
making process is a shared process between the nancy. She was admitted in spontaneous labour at
patient and clinicians [18], which requires clini- term and made slow progress to full dilatation.
cians to both provide the information and also Mrs. J pushed for one and a half hours and the
assimilate it, as well as to explain the risks and baby was not delivered. The specialist registrar
benefits of a recommended course of action (and was asked to attend with a view to an instrumental
alternative options). This may not always be delivery. The doctor performed a vaginal delivery;
practicable given that most, if not all operative the cervix was fully dilated; the fetal head was at
births are performed as either an emergency, or spines in a left occipito transverse position. There
at least an urgent intervention. For this reason was a significant amount of caput and moulding
the RCOG recommends that women should be present. The CTG was normal. The doctor opted
informed in the antenatal period about operative to take Mrs. J to theatre for a trial of forceps deliv-
vaginal delivery, particularly during their first ery and if this was unsuccessful to proceed to cae-
pregnancy [8]. sarean section. Informed consent was obtained.
With this background, and in a post- Mrs. J has a spinal anesthetic. The doctor exam-
Montgomery context, while OVB is often ined Mrs. J and performed a manual rotation from
undertaken in an emergency, and can be safer left occipito transverse to a left occipito anterior
than a caesarean section, it is vital that women position. The doctor then applied Neville Barnes
receive appropriate counselling prior to the pro- Forceps that locked easily. The doctor then pro-
cedure. Appropriate counselling should include ceeded to deliver the baby with forceps over five
an explanation of the most severe, but uncom- contractions with five pulls. A live male baby was
mon complications as well as the most frequent delivered with evidence of extensive facial bruis-
for the procedure in question. In addition altering at delivery. Cord gases were normal at deliv-
native management options should be given and ery. A case was brought against the hospital for a
consent should ideally be provided in written forceps delivery that was prolonged and involved
form [17]. the use of excessive force. The baby had a perma-
Defending a potential claim can be extremely nent scar over the right eye, significant discolor-
difficult unless there is good documentation for ation to the right cheek bone and significant
the operative birth, including: indications, exami- indentations in front of both ears. The Judge was
nation findings and performance of the operative critical of the delivery for the following reasons:
vaginal birth.
Experts or judges reviewing a case often 1. There was poor documentation of the

deem that meticulous documentation reflects procedure
meticulous care and also ‘If it isn’t documented 2. The number of pulls was not documented by
then it didn’t happen’. The quality of documen- the doctor, but the Midwife in attendance
tation can reflect a clinician’s level of profes- noted five pulls.
sionalism and forms the basis of any successful 3. There was no documentation regarding the
defence of a claim or complaint. Claims are degree of decent of the fetal head within the
twice as likely to be successfully defended if pelvis over successive pulls.
documentation is judged to be adequate. Good 4. An appropriately performed procedure would
record keeping is also essential for education, not leave permanent scarring to a baby’s face
clinical audit and risk management purposes. In and from this evidence the Judge concluded
this respect, the use of a standardised proforma that the doctor had achieved the delivery with
may be of benefit. unnecessary force.
The Judge ruled in favour of the Claimant sup- 3. Bahl R, Strachan B, Murphy DJ. Outcome of subse-
quent pregnancy three years after previous operative
ported by his mother and legal friend. The case delivery in the second stage of labour: cohort study.
was settled on a full liability basis with £11,150 BMJ. 2004;328(7435):311.
being awarded to the Claimant. 4. Jolly J, Walker J, Bhabra K. Subsequent obstetric per-
formance related to primary mode of delivery. BJOG.
1999;106(3):227–32.
5. Clark EAS, Silver RM. Long-term maternal morbid-
Key Points: Operative Vaginal Birth ity associated with repeat cesarean delivery. Am J
• Ideally women should be counselled in Obstet Gynecol. 2011;205(6 Suppl):S2–10.
the antenatal period regarding OVB. 6. Moraitis AA, Oliver-Williams C, Wood AM,
Fleming M, Pell JP, Smith G. Previous caesarean
• Informed consent should be obtained delivery and the risk of unexplained stillbirth: ret-
detailing all the risks associated with the rospective cohort study and meta-analysis. BJOG.
procedure for both mother and baby. 2015;122(11):1467–74.
• All prerequisites for operative vaginal 7. NHS Litigation Authority. Ten years of maternity
claims. London: NHS Litigation Authority; 2012.
delivery should be met. 8. RCOG. Operative vaginal delivery. 2011. pp. 1–19.
• A suitably skilled operator should con- 9. Watts P, Maguire S, Kwok T, Talabani B, Mann M,
duct the delivery. Wiener J, et al. Newborn retinal hemorrhages: a sys-
• The decision for a trial of operative tematic review. J AAPOS Elsevier. 2013;17(1):70–8.
10. Senécal J, Xiong X, Fraser WD. Pushing early or
delivery in theatre should be guided by pushing late with epidural study group. Effect of fetal
factors that may increase the likelihood position on second-stage duration and labor outcome.
of failure. Obstet Gynecol. 2005;105(4):763–72.
• The choice of instrument should be 11. Bahl R, Murphy DJ, Strachan B. Qualitative analy-
sis by interviews and video recordings to establish
made according to the clinical situation the components of a skilled rotational forceps deliv-
and the operator’s experience. ery. Eur J Obstet Gynecol Reprod Biol Elsevier.
• There should be documented evidence 2013;170(2):341–7.
of continued decent of the fetal head 12. Aiken AR, Aiken CE, Alberry MS, Brockelsby JC,
Scott JG. Management of fetal malposition in the sec-
throughout the procedure. ond stage of labor: a propensity score analysis. Am J
• The decision to use sequential instruments Obstet Gynecol. 2015;212(3):355.e1–7.
should be documented appropriately. 13. O'Brien S, Day F, Lenguerrand E, Cornthwaite K,
• A paediatrician should be present at Edwards S, Siassakos D. Rotational forceps ver-
sus manual rotation and direct forceps: a retro-
delivery. spective cohort study. EJOG. Elsevier Ireland Ltd.
• Paired cord gases should be taken. 2017;212:119–25.
• An operative delivery proforma should be 14.
Wattar Al BH, Wattar BA, Gallos I, Pirie
completed immediately after delivery. AM. Rotational vaginal delivery with Kiellandʼs for-
ceps. Curr Opin Obstet Gynecol. 2015;27(6):438–44.
15. Murphy DJ, Macleod M, Bahl R, Strachan B. A

cohort study of maternal and neonatal morbidity in
relation to use of sequential instruments at opera-
References tive vaginal delivery. EJOG Elsevier Ireland Ltd.
2011;156(1):41–5.
1. Murphy DJ, Liebling RE, Verity L, Swingler R, 16. Hamasaki T, Hagihara A. A comparison of medical
Patel R. Early maternal and neonatal morbid- litigation filed against obstetrics and gynecology,
ity associated with operative delivery in sec- internal medicine, and surgery departments. BMC
ond stage of labour: a cohort study. Lancet. Med Ethics. 2015;16(1):72.
2001;358(9289):1203–7. 17. GMC. Consent: patients and doctors making deci-
2. Murphy DJ, Koh DKM. Cohort study of the decisions together. 2017. p. 1–66.
sion to delivery interval and neonatal outcome for 18. UKSC TSC. Montgomery (Appellant) v Lanarkshire
emergency operative vaginal delivery. Am J Obstet Health Board (Respondent). 2015. pp. 1–38.
Gynecol. 2007;196(2):145.e1–7.
Caesarean Section
27
James Johnston Walker
27.1 Background as hypoxic ischaemic encephalopathy (HIE) and

cerebral palsy (CP) [2, 3].
The medical legal problems of caesarean section
(CS) relate to complications of the procedure
itself or where there is a delay in delivery of the 27.2 Minimum Standards
baby in a situation of fetal compromise. There are
also potential long-term risks for both the mother There are various documents that cover aspects
and the baby. These various factors produce the of caesarean section and the decisions to carry
dilemma of the balance of risks and benefits to the them out, including NICE Clinical guideline
mother and the baby. This has been further com- (CG132) [1] and NICE Quality standard (QS32)
plicated by Montgomery v Lanarkshire Health [2, 3].
Board findings on the role of consent [1]. A consultant needs to be involved in the deci-
Advances in medical practice means that CS sion to carry out an elective or emergency
delivery is now almost as safe as vaginal birth CS. The mother needs to be involved in the
leading to a change in the balance of risks and ris- decision-making process and be fully informed
ing rates. CS is now seen as less of a medical proof the risks.
cedure and more of a treatment choice in which Planned caesarean sections should be carried
the mother has a significant role. Despite the rela- out at or after 39 weeks, unless an earlier delivery
tive safety, CS remains at the centre of maternity is necessary because of maternal or fetal
medical litigation. The NHSLA recently pub- indications.
lished figures showing that there have been 674 Much of the reasons behind litigation involv-
claims related to caesarean section since 2000. ing CS relates to delays in carrying out the proce-
This led to a litigation cost of £2,126,167,223 dure. The decision to delivery interval is based on
(Table 27.1). The majority of claims are for com- the classification of CS (Table 27.2) of which
plications of the procedure, but the costs are only the first two are relevant here. Category 1 is
related mostly to delay in the carrying out the pro- an emergency CS delivery as soon as possible.
cedure leading to complications for the baby such The aim is for a decision to delivery interval of
30 min. Category 2 is a CS requiring delivery
within a reasonable timescale without taking
J. J. Walker
risks. The aim is for a decision to delivery inter-
University of Leeds, St. James University Hospital,
Leeds, UK val of between 30 and 75 min depending on the
e-mail: j.j.walker@leeds.ac.uk level of concern.

https://doi.org/10.1007/978-3-319-78683-4_27
148 J. J. Walker
Table 27.1 Reasons, numbers and claims associated with caesarean section
Reason Number Litigation cost (£) Cost per claim (£)
Complications of procedure 533 45,099,097 84,614
Delay in procedure 115 154,736,115 1,345,531
Other 26 16,332,011 628,154
Total 674 2,126,167,223 320,589
Table 27.2 Classification for urgency of caesarean than pre-oxygenation, cricoid pressure and rapid
section [4] sequence induction should be carried out to reduce
Grade Definition the risk of aspiration. The WHO surgical safety
1. Emergency Immediate threat to life of woman or checklist for maternity cases should be used (see
fetus Fig. 27.1). The operating table should have a lateral
2. Urgent Maternal or fetal compromise which tilt of 15° to avoid aortocaval compression. Safe
is not immediately life-threatening
surgical practice should be followed to reduce the
3. Scheduled Needing early delivery but no
maternal or fetal compromise
risk of HIV infection of staff. Prophylactic antibiot-
4. Elective At a time to suit the woman and ics should be given before skin incision according
maternity team to local antibiotic guidelines. A risk assessment for
Lucas DN, Yentis SM, Kinsella SM, Holdcroft A, May venous thromboembolism (VTE) should be under-
AE, Wee M, Robinson PN. Urgency of caesarean section: taken and thromboprophylaxis given as per existing
a new classification. J R Soc Med. 2000;93:346–50 guidelines. The skin incision will vary according
to the clinical indication for the procedure, but in
In the classification system by Lucas et al the general a transverse abdominal incision should be
classification refers to the timing of the decision used, 3 cm above the symphysis pubis with sub-
to operate. For example if a case was booked as an sequent tissue layers opened bluntly and extended
elective procedure for malpresentation, the clas- with scissors. The lower uterine segment should be
sification would be a grade 4, but if she went into extended by blunt extension of the uterine incision.
labour before the chosen date (or even if she The baby will be delivered either manually or with
didn’t go into labour, but had delivery before the the use of Wrigley’s forceps. Both venous and arte-
scheduled date) the classification would change to rial cord pHs should be performed after all CS for
3. Similarly if there was fetal bradycardia which suspected fetal compromise, to allow review of fetal
responded to treatment and the patient needed wellbeing and guide ongoing care of the baby. The
subsequent delivery for failure to progress, it placenta should be removed using controlled cord
would be classified as grade 3 rather than a 2. traction and not manual removal as this reduces the
Caesarean section is a surgical procedure and as risk of post-partum complications including uter-
such is associated with the complications of any ine inversion. The uterine cavity should be checked
major surgery. Prior to surgery there should be an and ensured it is empty. The uterus should then be
assessment of haemoglobin to identify anaemia. closed in two layers with an absorbable suture with
If the risk of bleeding is high, blood transfusion closure in layers for the rectus sheath and the skin.
services should be available and cell salvage should A senior obstetrician should be present for
be considered. Regional anaesthesia is the pre- complicated caesarean sections including full dila-
ferred option although the decision will be based tation sections where there may be difficulty in
on both obstetric and anaesthetic considerations delivery of the baby’s head from the pelvis.
as well as taking into account maternal prefer- Pushing the baby’s head up from below may aid
ence where possible. An indwelling urinary cath- delivery, but it can also lead to a “ping-pong ball”
eter should be placed to prevent over-distension skull fracture in the baby. In addition, a section at
of the bladder and remain in situ until the patient full dilatation carries an increase in both maternal
is mobile. To prevent inhalation injury, antacids and fetal complications [6]. Other indications for a
and drugs to reduce gastric volumes and acidity senior obstetrician to be present include major pla-
should be given. If a general anaesthetic is used centa praevia or accreta, extreme prematurity with
27 Caesarean Section 149
Fig. 27.1 WHO surgical safety checklist for maternity cases only [5]
or without ruptured membranes, raised body mass 27.3 Clinical Governance Issues
index, previous difficult operative p rocedure and
large maternal fibroids. When a midline abdomi- All complications of caesarean section should be
nal incision is used, mass closure with slowly reported according to the maternity guidance.
absorbable continuous sutures should be used. The RCOG suggests a number of triggers for
Women undergoing caesarean section whether incident reporting in Obstetrics as detailed in
as an emergency or electively should be aware of Table 27.3 [8]. The clinical governance issues
the material risks [7]. The risk of fetal lacerations surrounding caesarean section can be broadly
is about 2%. Particular care should be taken when divided into maternal, fetal and organisational.
the CS is being carried out after rupture of the Maternal governance issues will include failed
membranes and at full dilatation when the uterine operative delivery leading to full dilatation cae-
wall is thin. Short term risks include wound infec- sarean section, blood loss greater than 1500 mls,
tion and breakdown sometimes leading to sepsis, caesarean hysterectomy, intensive care admis-
injury to the bladder, bowel and other structures sion, return to theatre, anaesthetic complications
and the potential need for blood transfusion. There including inadequate analgesia and uterine rup-
is increasing evidence of long term sequelae to CS, ture or dehiscence. Fetal complications will
with risk of infertility, ectopic pregnancy or rup- include fetal lacerations and birth trauma, low
ture of the uterus in subsequent labours. The Apgar scores, low cord gases and unexpected
explanation of these risks need to be part of any admission to the neonatal unit. Organisational
informed consent process. For category 1 caesar- issues may include delayed delivery, unavailabil-
ean sections where there is no time to get written ity of a theatre or theatre staff or equipment
consent, verbal consent is permissible. failures.
150 J. J. Walker
Table 27.3 RCOG Clinical governance advice No.2 [8]

Suggested trigger list for incident reporting in maternity
Maternal incident Fetal/neonatal incident Organisational incident
Maternal death Stillbirth > 500 g Unavailability of health record
Undiagnosed breech Neonatal death Delay in responding to call for
Shoulder dystocia Apgar score < 7 at 5 min assistance
Blood loss > 1500 mL Birth trauma Unplanned home birth
Return to theatre Fetal laceration at caesarean section Faulty equipment
Eclampsia Cord pH < 7.05 arterial or < 7.1 venous Conflict over case management
Hysterectomy/laparotomy Neonatal seizures Potential service user complaint
Anaesthetic complications Term baby admitted to neonatal unit medication error
Intensive care admission Undiagnosed fetal anomaly Retained swab or instrument
Venous thromboembolism Hospital-acquired infection
Pulmonary embolism Violation of local protocol
Third-/fourth-degree tears
Unsuccessful forceps or ventouse
uterine rupture
Readmission of mother
All such events should be examined by the • Failure to request a neonatal team at delivery
risk management process. The process of inves- • Inadequate resuscitation at delivery
tigation should include patients and their fami-
lies and there should be an open and honest
approach when things go wrong. Documentation 27.5 Avoidance of Litigation
is a key concern. There should be appropriate
documentation concerning the risks of caesarean Avoidance of litigation is based on the appropri-
section on the consent form and there should ate preparation starting with informed consent.
also be detailed operation notes for complicated The mother needs to understand the complica-
procedures. Claims are easier to defend where tions of the procedure and the risks of alternative
good documentation exists. Where themes are interventions. Hospitals need to have robust esca-
identified these should be investigated and are lation processes to allow for the identification of
particularly concerned with operative complica- fetal compromise, rapid escalation and transfer to
tion rates or returns to theatre that may identify theatre, with an aim to delivery within 30 mins.
an individual requiring support, supervision or Although speed is important, this should not be
further training. at a cost of increased risk to the mother or baby.
The operator should have the appropriate
skills and experience or supervision to carry out
27.4 Reasons for Litigation the procedure. Particular risks should be assessed,
and plans put in place to mitigate them. Such sit-
• The indication to perform a caesarean section uations include placenta praevia or accreta where
• The delay in carrying out the procedure preparation with the appropriate clinicians pres-
• Maternal complications of the procedure ent improves the response to complications.
• Fetal complications occurring during delivery Training should concentrate on good surgical
• Short and long-term sequelae practice and particularly on the delivery of the
• Failure to document all the material risks on baby’s head from the pelvis. The use of skills and
the consent form drills training help to provide experience of situ-
• Poor documentation of complicated procedures ations that are rare but that have potentially seri-
• Inadequate anaesthesia ous outcomes if not dealt with appropriately.
27 Caesarean Section 151
27.6 Case Study

• The risk of complications such as pla-
Jac Richards v Swansea NHS Trust (2007) cental position, full dilatation or a
EWHC 487 (QB) 13/3/07 [9, 10]. deeply impacted fetal head should be
Jac Richards was delivered by caesarean sec- assessed and plans put in place prior to
tion at 14:25 on 15 May 1996. At the age of 10 starting the procedure
years he was severely disabled resulting from an • Accurate documentation and operation
acute hypoxic ischaemic insult to the brain at or notes detailing all complications
around the time of delivery. The medical experts in • Appropriate use of antibiotics and
court agreed the ischaemic insult began 15–20 min thromboprophylaxis
before birth. The judgement relied heavily on the • The presence of a neonatal resuscitation
existing guidelines and the judge pragmatically team if there is evidence of fetal
determined that ‘once the decision had been taken compromise
to deliver Jac by emergency caesarean section, the • Appropriate follow up of patients
defendant owed a duty of care to Jac to deliver him
as quickly as possible with the aim of trying to
deliver him within 30 min. If the failure to deliver
him within 30 min had been shown to be due to the References
limited resources of the defendant or constraints
on those attending Mrs. Richards, e.g. the need to 1. Montgomery versus Lanarkshire Health Board. 2015.
deal with other pressing cases, the primary claim 2. NHS Litigation authority. Maternity claims. Ten years
would have failed, but no evidence of matters of maternity claims. An analysis of NHS Litigation
Authority Data. 2012.
affecting the speed of Jac’s delivery was placed 3. NICE, Caesarean Section Clinical guideline [CG132],
before the court. Therefore, the defendant had neg- in © National Institute for Health and Clinical
ligently failed to deliver the claimant as quickly as Excellence 2011. 2011.
possible whereas, had it not been negligent, the 4. NICE, Caesarean Section Quality standard [QS32], in
© National Institute for Health and Care Excellence
claimant would have been born without disability. 2013. 2013.
Therefore, the Claimant had established on the 5. National Patient Safety Agency (NPSA) and Royal
balance of probabilities that his delivery some College of Obstetricians and Gynaecologists (RCOG).
55 min after the decision had been taken to carry WHO surgical safety checklist for maternity cases
only. 2010.
out the Caesarean amounted to a breach of duty. 6. Vousden N, Cargill Z, Briley A, Tydeman G, Shennan
AH. Caesarean section at full dilatation: incidence,
impact and current management. Obstet Gynecol.
Key Points: Caesarean Section 2014;16:199–205.
7. Royal College of Obstetricians and Gynaecologists
• Adequate preparation before the proce- (RCOG). Consent advice No. 7. Caesarean section.
dure including patient choice 2009.
• Decision to delivery interval appropriate 8. Royal College of Obstetricians and Gynaecologists
to the risk (RCOG). Clinical governance advice No 2. Improving
patient safety: risk management for maternity and
• Procedure undertaken by adequately gynaecology. 2009.
trained surgeons with the appropriate 9. Lucas DN, Yentis SM, Kinsella SM, Holdcroft A,
supervision if required May AE, Wee M, Robinson PN. Urgency of cae-
• Good surgical technique with prompt sarean section: a new classification. J R Soc Med.
2000;93:346–50.
recognition of complications and their 10. Jac Richards v Swansea NHS Trust in Jac Richards v
management Swansea NHS Trust [2007] EWHC 487 (QB) 13/3/07.
2007.
Shoulder Dystocia
28
Tim Draycott and Jo Crofts
28.1 Background compensation over a decade from 2000 to 2009

for preventable harm associated with shoulder
Shoulder dystocia is defined as a vaginal cephalic dystocia [5]. Clearly, this is an enormous loss of
birth that requires additional obstetric manoeuvres resource to health care in general, and also a per-
to assist the birth of the infant after gentle traction verse incentive against best care [6].
has failed [1]. Shoulder dystocia occurs when Medical theories and expert opinions about
either the anterior shoulder impacts behind the the causal relationships between birth, manage-
maternal symphysis or, less commonly, the poste- ment of shoulder dystocia and neonatal brachial
rior shoulder impacts over the sacral promontory. plexus injuries have ebbed and flowed over the
There is wide variation in the reported inci- last two decades. Opinions have ranged from res
dence of shoulder dystocia. Recent data sets have ipsa loquitor, through the more recent propulsion
reported that there are significant differences in the theories to recent data that suggest that a substan-
rates of shoulder dystocia reported from the US tial majority of brachial plexus injuries related to
and outside the US: US rates were 1.4% whereas shoulder dystocia can be prevented with accurate
the reported rate was 0.6% outside the US [2]. management of the shoulder dystocia following
Shoulder dystocia remains a largely unpre- RCOG national guidance [7, 8].
dictable event and can result in serious long-term The literature on causation of obstetric bra-
morbidity for both mother and baby. This per- chial plexus palsy has influenced recent judicial
sonal harm notwithstanding; poor outcomes can decisions regarding the causation of obstetric
result in very significant litigation costs: in the brachial plexus injury. Based on this literature
USA shoulder dystocia is the second most com- and case law, a template was proposed to provide
monly litigated complication of childbirth [3]; it guidance for those assessing issues of causation
is the most commonly litigated problem in Saudi in clinical negligence claims [9].
Arabia [4], and in England the NHS Litigation
Authority paid more than £100 million in legal
T. Draycott (*) · J. Crofts
Department of Obstetrics and Gynaecology, Evidence based algorithms for the management
Southmead Hospital, North Bristol NHS Trust, of shoulder dystocia recommend resolution
Bristol, UK manoeuvres. A reduction in injury rates has been
Academic Women’s Health Unit, School of Clinical associated with an increase in correctly managed
Sciences, University of Bristol, Bristol, UK labours [10]. It is important to demonstrate that
e-mail: Tim.Draycott@bristol.ac.uk; jocrofts@me.com

https://doi.org/10.1007/978-3-319-78683-4_28
154 T. Draycott and J. Crofts
the correct manoeuvres were performed, ideally standard protocols, which require McRobert’s as
in the order of the RCOG algorithm [1] (Fig. 28.1). a first-line manoeuvre. McRobert’s positioning is
Best practice recommendations for the man- currently recognized as the single-most effective
agement of SD have led to the development of intervention, relieving up to 39% of SDs [8].
Algorithm for the management of shoulder dystocia

Discourage
CALL FOR HELP pushing
Midwife Coordinator, additional midwifery help, experienced
Lie flat and move
obstetrician, neonatal team and anaesthetist
buttocks to edge of
bed
McROBERTS’ MANOEUVRE
(Thighs to abdomen)
SUPRAPUBIC PRESSURE
(and routine axial traction)
Consider episiotomy if it will

make internal manoeuvres
easier
Try either manoeuvre first

depending on clinical
circumstances and
operator experience
DELIVER POSTERIOR INTERNAL ROTATIONAL

ARM MANOEUVRES
Inform consultant
obstetrician and
anaesthetist
If above manoeuvres fail to release impacted

shoulders, consider
ALL FOURS POSITION (if appropriate)
OR
Repeat all the above again
Consider cleidotomy, Zavanelli manoeuvre or symphysiotomy
Baby to be reviewed by neonatologist after birth and referred for Consultant Neonatal review if any concerns
DOCUMENT ALL ACTIONS ON PROFORMA AND COMPLETE CLINICAL INCIDENT REPORTING FORM.
Fig. 28.1 Algorithm for the management of shoulder dystocia [1]

28 Shoulder Dystocia 155
Lithotomy is not the same, as McRobert’s and the in 25.8% of SDs [12]. Furthermore, a recent
legs should be actively removed from the lithot- paper describes an increase in the performance of
omy supports. To perform McRobert’s manoeu- suprapubic pressure (27.8–60.3%) and internal
vre accurately requires one person to manage the manoeuvres from 14.5% of shoulder dystocias to
delivery and two to abduct and flex the hips into 47.8% in association with a 100% reduction in
the McRobert’s position and possibly another to brachial plexus injury and a reduction in the
apply suprapubic pressure. Therefore, where head-body delivery interval[13]. Therefore, ear-
there are less than three birth attendants it is lier recourse to internal manoeuvres may be
unlikely that the manoeuvres could have been protective.
executed properly. If first or second line manoeuvres are unsuc-
McRobert’s is often combined with suprapu- cessful consideration should be given to such
bic pressure (Rubin’s I) and the success rate techniques as cleidotomy, symphysiotomy and
improves to 54%. Suprapubic pressure was also the Zavanelli manoeuvre. These are rarely
originally described in isolation and therefore the required. A neonatologist should examine the
sequential use of these movements would be baby after delivery for evidence of brachial
acceptable. An episiotomy is not currently plexus or bony injury and paired cord gases
deemed necessary by the RCOG guideline [8] should be taken for acid base status. In addition,
unless internal rotational manoeuvres or delivery the operator should prepare for post-partum
of the posterior arm is anticipated. haemorrhage.
If simple manoeuvres fail, the options are
either internal manoeuvres or turning the women
into an all fours position. For internal manoeu- 28.3 Clinical Governance Issues
vres, vaginal access should be gained posteriorly
as the most spacious part of the pelvis is in the Some of the risk factors associated with shoul-
sacral hollow. The whole hand should be inserted der dystocia (SD) are seen in Fig. 28.2. However,
to perform either internal rotation or delivery of it is generally accepted that shoulder dystocia is
the posterior arm. The eponymous internal rota- notoriously difficult to predict antenatally. A
tional manoeuvres, Wood’s Screw and Rubin’s II previous shoulder dystocia is a risk factor for
can be very confusing, and difficult to execute subsequent shoulder dystocia. A prior history of
properly [11]. Mnemonics and eponyms should a birth complicated by shoulder dystocia con-
be avoided [12]. Delivery of the posterior arm fers a 6-fold to nearly 30-fold increased risk of
will reduce the diameter of the fetal shoulders, shoulder dystocia recurrence in a subsequent
however delivery of the posterior arm can be vaginal birth, with most reported rates between
associated with humeral fractures in between 2 12 and 17% [1]. Women should be informed
and 12% of cases [10]. that their birth was complicated by shoulder
McRobert’s (and/or suprapubic pressure) dystocia and should be counselled about their
alone is not as effective as previously thought. In options for place of birth and risks in a future
Hong Kong McRobert’s alone was only effective pregnancy [1].
Table 1. Factors associated with shoulder dystocia
Pre-labour Intrapartum
Previous shoulder dystocia Prolonged first stage of labour
Macrosomia >4.5kg Secondary arrest
Diabetes mellitus Prolonged second stage of labour
Fig. 28.2 Factors
Maternal body mass index >30kg/m2 Oxytocin augmentation
associated with shoulder
dystocia Induction of labour Assisted vaginal delivery
The RCOG Guidelines for shoulder dystocia for documentation of care provided during shoul-
(SD) [1] recommend consideration of elective der dystocia and this identifies the standard ele-
Caesarean section for two antenatal indications: ments that should be recorded (Fig. 28.3).
previous SD, and/or estimated fetal weight
(EFW) of more than 4.5 kg in the presence of
maternal diabetes or 5 kg without maternal 28.4 Reasons for Litigation
diabetes.
However, delivery by Caesarean section is not • Failure to recognise the signs suggestive of
without consequence and the risks are presented shoulder dystocia
in the contemporaneous national guidance for • Failing to state the problem and summon help
delivery by elective caesarean section [14]. It is • Failure to call a neonatologist to the delivery
important to present the risks and benefits, in a • Difficulty inserting the hand into the sacral
Montgomery compliant fashion, for the woman hollow
and her family to make the best decision for • Confusion over internal rotational manoeu-
them. vers, particularly the use of eponyms
Another proposed strategy to reduce the inci- • Resorting to excessive traction to release the
dence of shoulder dystocia would be to consider shoulders
induction of labour for women with an estimated • Using fundal pressure
weight greater than 4 kg at term. This signifi- • Poor documentation particularly with regard
cantly reduced the risk of shoulder dystocia com- to documenting the posterior arm and the head
pared with expectant management—relative risk to body delivery interval.
0.32 [15]. However, the rate of brachial plexus • Failure to anticipate the maternal risks post
injury was unaffected. delivery
All obstetric and midwifery staff should be • Failure to fully debrief the women and her
trained to deal with a shoulder dystocia. There family
are important differences between effective and
ineffective training for shoulder dystocia: ‘prac-
tice does not make perfect, if it is the wrong prac- 28.5 Avoidance of Litigation
tice’ [9]. For example, fundal pressure is
associated with a high rate of brachial plexus The cases that are more likely to proceed to litiga-
injury and rupture of the uterus. It should there- tion are those where babies are delivered with evi-
fore not be applied during shoulder dystocia [1]. dence of fetal injury including transient and
The current RCOG shoulder dystocia guideline permanent brachial plexus injury, bony fractures
[1], recommended: ‘Shoulder dystocia training and evidence of hypoxic damage due to a delayed
associated with improvements in clinical manage- interval between delivery of the head and the body.
ment and neonatal outcomes was multi- In addition, there are also some litigation cases
professional, with manoeuvres demonstrated and centred around the psychological trauma and post-
practiced on a high fidelity mannequin. Teaching traumatic stress suffered by birth attendants.
used the RCOG algorithm rather than staff being Not all brachial plexus injuries should be
taught mnemonics (e.g. HELPERR) or eponyms deemed the fault of the accoucheur. However,
(e.g. Rubin’s and Woods’ screw)’. This recommen- there is a small (<10%) subset that are related to
dation appears to be the same today: all staff should excessive traction by the accoucheur leading to
be trained locally, annually and provided with the permanent injuries to the anterior arm after
opportunity to practice all the manoeuvres required shoulder dystocia. The position regarding poste-
to release the shoulders using a high-fidelity model. rior injuries remains predominantly the same; if
Documentation of shoulder dystocia should be the injury is to the posterior shoulder, the injury
comprehensive and accurate. The RCOG shoulder is likely to have been caused by maternal propul-
dystocia guideline includes a pre-formatted sheet sion against the sacral promontory before the
SHOULDER DYSTOCIA DOCUMENTATION
Date Mother’s Name

Time Date of birth
Person completing form Designation Hospital Number
Signature Consultant
Called for help at: Emergency call via switchboard at:

Staff present at delivery of head: Additional staff attending for delivery of shoulders
Name Role Name Role Time arrived
Procedures used to Reason if not

By whom Time Order Details performed
assist delivery
McRoberts’ position
Suprapubic pressure From maternal left / right

(circle as appropriate)
Enough access / tear present / already performed
Episiotomy
Right / left arm
Delivery of posterior arm
Internal rotational
manoeuvre
Description of rotation
Routine axial
Description of traction (as in normal Other - Reason if not routine axial.
vaginal delivery)
Other manoeuvres used
Mode of delivery of head Spontaneous Instrumental – vacuum / forceps

Time of delivery of head Time of delivery of baby Head-to-body
delivery interval
Fetal position during Head facing maternal left Head facing maternal right
dystocia Left fetal shoulder anterior Right fetal shoulder anterior
Birth weight kg Apgar 1 min : 5 mins : 10 mins :
Cord gases Art pH : Art BE: Venous pH : Venous BE :
Explanation to parents Yes By AIMS form completed Yes
Neonatologist called? Yes Neonatologist arrived: Name:
If neonatologist not called or didn’t arrive, give reason:
Baby assessment after birth (maybe done by M/W): If yes to any of these questions for
Any sign of arm weakness? Yes No review and follow up by Consultant
Any sign of potential bony fracture? Yes No neonatologist
Baby admitted to Neonatal Intensive Care Unit? Yes No
Assessment by
Please copy x 2 copies: x1 maternal notes, x 1 attached ti AIMS form.
Fig. 28.3 Shoulder dystocia documentation [1]

fetal head is delivered, rather than excessive and Force in a downward direction appears to be
inappropriate traction. However, there is no reli- particularly injurious [19] as is force of a ‘jerk-
able evidence that a combination of maternal pro- ing’ nature [22]; both of which are avoidable with
pulsion and diagnostic traction alone causes reasonable care. Excessive traction definitely
significant and permanent injury to the anterior increases the risk of injury as does “jerking” or
shoulder after shoulder dystocia. non-axial traction: in simulated shoulder dystocia
It is widely recognised that not all cases of downward traction increases the stretch of the
shoulder dystocia are reported. There are several brachial plexus by 30% [23]. A group in Sweden
large series that demonstrate that between 44 and has published their prospectively collected data
56% of infants born with obstetric brachial plexus of 112 children diagnosed with obstetric brachial
injuries, there was no recorded or coded shoulder plexus palsy after 31,828 vaginal births between
dystocia [16–18]. Some authors have argued that 1999 and 2001 (35 per 10,000) [24]. The authors
this reflects a failure of diagnosis and/or docu- concluded that the persistent injuries were asso-
mentation, i.e. the shoulder dystocia was not ciated with a perceived higher level of downward
recorded, rather than a different causation. There traction on the head than the transient injuries. In
is also increasing evidence that shoulder dystocia addition, the transient injuries were associated
is under recognised [19]. A US group have with a perceived higher level of downward trac-
reported a similar under-reporting [20] and in our tion than used for a control set of uninjured
own most recent data the reduction of permanent infants. Moreover, permanent brachial plexus
injury from 0.38 per 1000 births to 0 in >17,000 injury after shoulder dystocia affecting more than
vaginal births has been associated with an one nerve root is very likely to be related to the
increase in the recorded shoulder dystocia rate actions of the accoucheur at birth and not a func-
from 2.04 to 3.24%. In the absence of shoulder tion of labour [24].
dystocia, it is difficult to imagine how the deliv- Where obstetric brachial plexus injury occurs
ery management could be improved to prevent in the absence of shoulder dystocia, a short sec-
obstetric brachial plexus injuries and therefore ond stage (<20 min) is more common than in
the injury is more likely to be due to a function of cases with antecedent shoulder dystocia. This
the labour rather than any failure of the suggests that propulsive forces may be responsi-
accoucheur. ble for injury in these instances. Poggi et al. iden-
Both the 2008 clinical template [9] and the tified a precipitous second stage is the most
recent American College of Obstetricians and prevalent labour abnormality prior to shoulder
Gynaecologists (ACOG) report [21] suggest dystocia complicated by subsequent brachial
that posterior brachial plexus injuries are likely plexus injury [25].
to be caused by impaction of the posterior Shoulder dystocia does have an associated
shoulder on the sacral promontory where the neonatal hypoxic morbidity, but it is rare and
uterine forces continue to push the baby down appears to be related to the duration of the head to
the birth canal, which stretches the fetal brachial body delivery interval. In a recent series from
plexus. In particular, the head travelling along Hong Kong, the risk of hypoxic ischaemic
the curve of Carus could cause the necessary encephalopathy (HIE) for head to body delivery
widening of the angle between the shoulder and intervals of less than 5 min was 0.5%, compared
head to cause the injury. However, it is accepted with 23.5% for intervals of greater than 5 min
that anterior arm injuries after shoulder dystocia (P < 0.001) [26]. There was a single infant with a
are more likely to be related to accoucheurs delivery interval of greater than 10 mins who
pulling on the head, once again widening the subsequently was diagnosed with HIE grade II
angle between the shoulder and head. This trac- who died age 3. Moreover, there was a drop in pH
tion is likely to be causative in different ways of 0.01 per minute of head to body delivery inter-
related to the force employed, its direction and val [26]. Training increased the rate of internal
also its nature. manoeuvres and there was an associated reduc-
tion in permanent brachial plexus injury [13]. diagnosed with symphysis pubis dysfunction
Moreover, in a recent paper documenting the (SPD), for which she attended hospital for
effects of a decade of shoulder dystocia training, physiotherapy. Measurements of the symphy-
the 75th centile for the head-body delivery inter- sis fundal height showed a consistently
val was reduced from 4 to 3 min. Therefore, increased measurement above the 90th centile
training can reduce the head to body delivery throughout the pregnancy. The second claim-
interval, but the overall risk of HIE is low before ant was tested for maternal diabetes but blood
5 min. tests came back as normal. She was referred to
Litigation for shoulder dystocia will never the Huddersfield Royal Infirmary where she
be completely avoided. Cases should focus on was seen by an Obstetric Registrar who told
the timely calling for help and the use of an her that she was having a big baby. No prob-
accepted algorithm with accurate documenta- lems were recorded. Two further antenatal
tion particularly with regard to the posterior ultrasounds were performed at 30 and 34 weeks
arm and the delay between delivery of the head showing the estimated fetal weight was just
and the body. above the 90th centile the second claimant was
reassured by the registrar about the size of her
baby, who also recorded that no induction of
28.6 Case Study labour was indicated, she should be treated as
normal and was referred back to the commu-
RE v Calderdale and Huddersfield NHS nity midwife. Because of the large size of her
Foundation Trust. baby, the Second Claimant rejected the com-
RE (the First Claimant) was born on 22nd munity midwife’s reassurance that there was
April 2011 at 39 weeks’ gestation at the no reason why she couldn’t deliver at the
Calderdale Birth Centre, a midwifery led unit Huddersfield Birthing Centre, and she and the
under the control and management of the Third Claimant chose to go to the Calderdale
Defendant. She weighed 4.7 kg (10 lbs. 6 oz.). A Birthing Centre which had an ‘alongside’ unit
claim was brought by her mother and litigation should obstetric assistance be required. On the
friend, LE (the Second Claimant), for personal morning of 22nd April 2011, the second claim-
injury arising out of the circumstances of her ant had spontaneous rupture of membranes and
birth. The Second Claimant together with the went into spontaneous labour. At 16:45 diffi-
Fourth Claimant, DE, who is the Second culty delivering the shoulders was noted and
Claimant’s mother and was present at the birth, the obstetric registrar was summoned. RE was
brought claims for personal injury caused by born at 16.53 h with the assistance of the
‘nervous shock’. RE’s father, AE, was the Third Obstetric Registrar. RE was pale, floppy and
Claimant but did not pursue his claim. without respiratory or heart rate. Resuscitation
was commenced, and a heart rate was noticed
after 10 min and a first gasp after 12 min. RE
28.6.1 Background suffered an acute hypoxic brain injury. Both
the Second and Fourth Claimants suffered
RE was the Second Claimant’s second child. post-traumatic stress disorder.
Her first child, a girl, was born on 8th June The Claimants’ case was that
2007 at 39 weeks’ gestation and weighed 7 lb.
4 oz. (3.288 kg). It was an uneventful preg- (a) RE’s delivery should have been achieved ear-
nancy. When, in August 2010, she became lier than it was;
pregnant again, she and the Third Claimant (b) Specifically, RE’s head was born but there
decided that their second baby could be deliv- was shoulder dystocia which delayed the
ered at the Huddersfield Birthing Centre. delivery of her body for longer than was
During the pregnancy, the second claimant was appropriate.
(c) Such delay was a consequence of failings by nurse-midwives. J Midwifery Womens Health.
2005;50(6):454–60.
the midwives and obstetricians in both the 4. Henary BY, et al. Epidemiology of medico-legal
planning for the birth and in the delivery. litigations and related medical errors in Central and
Northern Saudi Arabia. A retrospective prevalence
The Judge found in favour of the Claimant study. Saudi Med J. 2012;33(7):768–75.
5. NHS Litigation Authority. Ten years of maternity
that the delivery of RE had been negligent and claims: an analysis of NHS litigation authority data.
that the delay in summoning help was causative London: NHS Litigation Authority; 2012.
of hypoxic brain injury. The Judge also found in 6. Fox R, Yelland A, Draycott T. Analysis of legal
favour of the second and fourth claimants who claims--informing litigation systems and quality
improvement. BJOG. 2014;121(1):6–10.
suffered post-traumatic stress disorder (PTSD) as 7. Crofts J, et al. In: RCOG, editor. RCOG Greentop
a direct result of witnessing the difficulty deliv- Guideline 42: shoulder dystocia. London: RCOG;
ery of RE. 2012.
8. Draycott T, Fox R, Montague I. In: RCOG, editor.
RCOG Greentop Guideline 42: shoulder dystocia.
London: RCOG; 2005. p. 1–13.
9. Draycott T, et al. A template for reviewing the
Key Points: Shoulder Dystocia strength of evidence for obstetric brachial plexus
• Recognise risk factors present during injury in clinical negligence claims. Clin Risk.
2008;14(3):96–100.
labour 10. Draycott TJ, et al. Improving neonatal outcome

• Anticipate problems and call for help through practical shoulder dystocia training. Obstet
• Clearly declare a shoulder dystocia and Gynecol. 2008;112(1):14–20.
summon all members of the emergency 11. Crofts JF, et al. Observations from 450 shoulder dys-
tocia simulations: lessons for skills training. Obstet
team including a neonatologist Gynecol. 2008;112(4):906–12.
• Nominate a scribe to document events 12. Leung T, et al. Comparison of perinatal outcomes
on a proforma sheet of shoulder dystocia alleviated by different type and
• Go through he manoeuvres in a logical sequence of manoeuvres: a retrospective review.
BJOG. 2011;118(8):985–90.
and timed manner according to the 13. Crofts JF, et al. Prevention of brachial plexus injury-12
RCOG algorithm years of shoulder dystocia training: an interrupted
• Document the posterior arm time-series study. BJOG. 2016;123(1):111–8.
• Accurately record the head to body 14. RCOG. Choosing to have a caesarean section.

London: RCOG; 2015. p. 1–6.
delivery interval 15. Boulvain M, et al. Induction of labour versus expectant
• Assess baby at delivery for brachial management for large-for-date fetuses: a randomised
plexus and bony injury controlled trial. Lancet. 2015;385(9987):2600–5.
• Ensure cord gases are taken for fetal 16. Gherman R. A guest editorial: new insights to

shoulder dystocia and brachial plexus palsy. Obstet
acid base status Gynecol Surv. 2003;58(1):1–2.
• Debrief the women and her family and 17. Noble A. Brachial plexus injuries and shoulder dys-
counsel re future deliveries tocia: medico-legal commentary and implications. J
Obstet Gynaecol. 2005;25(2):105–7.
18. Sandmire HF, DeMott RK. Erb’s palsy: concepts of
causation. Obstet Gynecol. 2000;95(6 Pt 1):941–2.
19. Mollberg M, et al. Obstetric brachial plexus palsy:
a prospective study on risk factors related to manual
References assistance during the second stage of labor. Acta
Obstet Gynecol Scand. 2007;86(2):198–204.
1. Crofts J, Fox R, Draycott T. Shoulder dystocia. In: 20. Beall MH, Spong CY, Ross MG. A randomized con-
RCOG, editor. Greentop guidelines. London: RCOG; trolled trial of prophylactic maneuvers to reduce head-
2012. p. 1–18. to-body delivery time in patients at risk for shoulder
2. Chauhan S, Blackwell SB, Ananth CV. Neonatal bra- dystocia. Obstet Gynecol. 2003;102(1):31–5.
chial plexus palsy: incidence, prevalence, and tempo- 21. Gherman RB, et al. Neonatal brachial plexus injury.
ral trends. Semin Perinatol. 2014;38(4):210–8. Obstet Gynecol. 2014;123.
3. Angelini DJ, Greenwald L. Closed claims analy- 22. Metaizeau J, Gayet C, Plenat F. Les lesions obstetricales
sis of 65 medical malpractice cases involving du plexus brachial. Chir Pediatr. 1979;20(3):159–63.
23. Leung TY, Chung TK. Severe chronic morbid-

25. Poggi SH, et al. Intrapartum risk factors for perma-
ity following childbirth. Best Pract Res Clin Obstet nent brachial plexus injury. Am J Obstet Gynecol.
Gynaecol. 2009;23(3):401–23. 2003;189(3):725–9.
24. Mollberg M, et al. Comparison in obstetric man-
26. Leung TY, et al. Head-to-body delivery interval and
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obstetric brachial plexus palsy. J Child Neurol. lopathy in shoulder dystocia: a retrospective review.
2008;23(12):1424–32. BJOG. 2011;118(4):474–9.
Vaginal Birth After Caesarean
Section, Uterine Rupture 29
Kara Dent
29.1 Background tion. In just under half of the cases looked at, recog-
nition of possible uterine rupture was delayed, with
With an increasing number of caesarian sections 55–87% of the cases showing an abnormal fetal
occurring in the United Kingdom (26.2% of deliver- heart pattern on the cardiotocograph (CTG) [3].
ies were caesarian sections in 2013–2014) [1], a
greater number of women are facing the choice of
whether to plan a caesarean section or attempt a 29.2 Minimum Standards
vaginal delivery in their next pregnancy. For those
women who underwent an uncomplicated caesarean Planned VBAC may be offered to women with a
first time and have no complications in their current singleton, cephalic presentation at 37 weeks or
singleton pregnancy, most will be eligible for a beyond who have had a previous lower segment
Vaginal Birth after caesarean section (VBAC) [2]. caesarean section. Contraindications include a
Using English NHS statistics, we know that previous classical caesarean section scar or previ-
just over 50% of those women eligible attempt a ous uterine rupture as the latter carries a 5%
VBAC and of these, two thirds are successful [2]. recurrence rate in future labours. A VBAC is also
However uterine rupture is a rare but serious com- contraindicated if a vaginal birth is not appropri-
plications that can occur in these women with ate in its own right, for example a major placenta
maternal and fetal consequences and needs to be praevia irrespective of a previous uterine scar [4].
considered. Uterine rupture is described as the An epidural is not contra-indicated in labour.
“full thickness separation of the uterine wall and If a pregnancy is complicated by post-dates, twin
overlying serosa”. UKOSS studies estimate that gestations, fetal macrosomia, antepartum stillbirth
uterine rupture occurs in 2.1 in a 1000 maternities and maternal age, the data is not as clear regarding
in women with a previous section [3]. the safety and efficacy in these cases and the RCOG
From the 85 cases reported to the NHS Litigation guidelines advise a “cautious approach if VBAC is
Authority between 2000 and 2010 (which carry a being considered in such circumstances” [4].
total estimated value of over a million pounds) 19 In the case of preterm labours, success rates
were linked to a vaginal birth after caesarean sec- appear to be similar to a term VBAC but carry a
lower risk of uterine rupture [4].
A possible VBAC should be planned antena-
K. Dent tally with a senior clinician, before the onset of
Department of Obstetrician, Royal Derby Hospital,
Derby, UK labour with a documented discussion that outlines
e-mail: kara.dent@nhs.net the pros and cons of a VBAC compared to an

https://doi.org/10.1007/978-3-319-78683-4_29
164 K. Dent
elective caesarean section. Ideally this should take mother, the risks of uterine rupture (0.5%) and an
place around 36 weeks, before the onset of labour. emergency caesarean section should also be clearly
This discussion may be recorded in the form of a outlined (See Table 29.1 for recognised risks).
checklist that reflects how the woman was part of For those women who have undergone two
the decision-making process and was thereby mak- previous sections, the RCOG guidance states
ing informed consent. Whilst a successful VBAC that they “may be offered VBAC after counsel-
carries the least complications overall for the ling with a senior obstetrician. This should
Table 29.1 Risks and benefits of opting for VBAC versus ERCS from 3940 Weeks of gestation
Planned VBAC ERCS from 3940 weeks
Maternal • 72–75% chance of successful • Able to plan a known delivery date in select patients.
outcomes VBAC. If successful shorter hospital This may however change based on circumstances
stay and recovery surrounding maternal and fetal wellbeing in the
antenatal period
• Approximately 0.5% risk of uterine • Virtually avoids the risk of uterine rupture (actual risk is
scar rupture. If occurs, associated extremely Low: less than 0.02%
with maternal morbidity and fetal • Longer recovery
morbidity/mortality • Reduces the risk of pelvic organ prolapse and urinary
incontinence in comparison with number of vaginal
births (dose–response effect) at least in the short term69
• Option for sterilisation if fertility is no longer desired.
Evidence suggests that the regret rate is higher and that the
failure rate from sterilisation associated with pregnancy
may be higher than that from an interval procedure. If
sterilisation is to be performed at the same time as a
caesarean delivery, counselling and agreement should have
been given at least 2 weeks prior to the procedure70
• Increases likelihood of future vaginal • Future pregnancies-likely to require caesarean delivery,
birth increased risk of placenta praevia/accreta and adhesions
with successive caesarean deliveries/abdominal surgery
• Risk of anal sphincter injury in
women undergoing VBAC is 5%-and
birthweight is the strangest predictor
of this. The rate of instrumental
delivery is also increased up to 39%?
• Risk of maternal death with planned • Risk of maternal death with ERCS of 13/100,000 (95%
VBAC of 4/100,000 (95%CI CI 4/100,000 to 42/100,000)?
1/100,000 to 16/100,000)?
Infant • Risk of transient respiratory • Risk of transient respiratory morbidity of 4–5% (6% risk
outcomes morbidity of 2–3% if delivery performed at 38 instead of 39 weeks).The
risk is reduced with antenatal corticosteroids, but there
are concerns about potential long-term adverse effects72
• 10 per 100,000 (0.1%) prospective
risk of antepartum stillbirth beyond
3940 weeks while awaiting
spontaneous labour (similar to
nulliparous women)
• 8 per 100,000 (0.03%) risk of hypoxic • <1 per 100,000 (<0.01%) risk of delivery-related
ischaemic encephalopathy (HIE) perinatal death or HIE
• 4 per 10,000 (0.04%) risk of
delivery-related perinatal death. This
is comparable to the risk for
nulliparous women in labour
The estimates of risk for adverse maternal or fetal events in VBAC are based on women receiving; continuous electronic
monitoring during their labour
29 Vaginal Birth After Caesarean Section, Uterine Rupture 165
include the risk of uterine rupture and maternal 29.4 Reasons for Litigation
morbidity” [4] A review of the literature in
2009 suggested that the rates of uterine rupture • Failure to recognise rupture/impending rupture
are similar to that of one previous section at • Failure to recognise an abnormal cardiotoco-
1.36% and comparable maternal morbidity [5]. graph (CTG)
• Failure to act on an abnormal CTG in a timely
manner
29.3 Clinical Governance Issues • Inappropriate augmentation of labour/
Induction of labour (IOL)
Uterine rupture is a trigger for a risk investigation • Failure of senior involvement in the manage-
locally and requires notification to the risk team, ment of labour for a woman requesting a VBAC
normally by a datix form. Review of the case is
for learning and feedback to the department to
ensure lessons are learned for the future. 29.5 Avoidance of Litigation
Mandatory training for midwives and obstetri-
cians includes regular CTG training which is 29.5.1 Antenatal
vital to ensure that abnormalities of the fetal heart
during labour are recognised and managed in a There should be detailed discussion and documen-
timely manner. Many units have adopted a tation in the notes with a senior obstetrician. This
“buddy approach” or “fresh eyes” approach should include the relative risks and benefits of
where a second person reviews the CTG regu- VBAC versus an elective section (see Table 29.2)
larly through labour [6] in order to improve inter- and follow the approved local guideline of the
pretation of the fetal monitoring. Trust. Ideally this plan should be made by 36
Table 29.2 RCOG Green-top guideline no 45 [4]

Appendix IV: Birth choices after caesarean delivery pathway
Likelihood of Overall Tick when
discussed
Successful VBAC (one previous caesarean delivery, no previous 3 out of 4 or 72–75%
vaginal birth)
Successful VBAC (one previous caesarean delivery, at least one Almost 9 out of 10 or up to
previous vaginal birth) 85–90%
Unsuccessful VBAC more likely in:
Induced labour, no previous vaginal delivery, body mass index (BMI) greater than 30 and previous caesarean
for labour dystocia. If all of these factors are present, successful VBAC is achieved in 40% of cases.
Likelihood of VBAC ERCS
Maternal
Uterine rupture 5 per 1000/0.5% < 2 per 10,000/< 0.02%
Blood transfusion 2 per 100/2% 1 per 100/1%
Endometritis No significant difference in risk
Serious complications in future Not applicable if Increased likelihood of placenta
pregnancies successful VBAC praevia/morbidly adherent
placenta
Maternal mortality 4 per 100,000/0.004% 13 per 100,000/0.013%
Fetal/newborn
Transient respiratory morbidity 2–3 per 100/2–3% 4–6 per 100/4–6% (risk reduced
Antepartum stillbirth beyond 3940 weeks 10 per 10,000/0.1% with corticosteroids, but there
while awaiting spontaneous labour 8 per 10,000/0.08% are concerns about potential
Hypoxic Ischaemic Encephalopathy long-term adverse effects
(HIE) Not applicable
<1 per 10,000/<0.01%)
166 K. Dent
weeks into the pregnancy, before the onset of 24 hours later with increases in the rate of infusion
labour with a plan in case labour starts before the three times in the next 3 hours up to 36 mL/h.
scheduled timings. The woman should be made Ultimately a forceps delivery was performed, fol-
aware that the risk of uterine rupture is of the order lowing a delay in the second stage, in the presence
of 0.5% (2/1000) in spontaneous labour. There of fetal bradycardia. Blood and mucus needed to
should be awareness by the obstetrician in the be removed from the claimant’s trachea before
decision making of additional risks including intubation and successful re-establishment of the
increased maternal age and induction of labour. circulation. A gaping hole was discovered in the
Some of the literature also questions the effect of a lower segment of the uterus when the Claimant’s
raised BMI [3]. Provision of an information leaflet mother was taken to theatre post-delivery, when
outlining the above information and discussion the placenta did not deliver. The claimant has cere-
points should be provided to reiterate the conver- bral palsy. The principal allegations were [1] that
sation and to indicate the choices being made. in breach of the Trust’s own guidelines, medical
induction was carried out notwithstanding that
these guidelines stipulate that there should be no
29.5.2 Intrapartum such induction in women with a previous caesar-
ean section scar and [2] that the Claimant’s mother
These labours should take place in a consultant led was not advised antenatally, or following her
labour ward with access to an emergency theatre admission to hospital, of the increased risk of uter-
and appropriate equipment. There should be senior ine rupture associated with induction of labour.
input for the management plans in labour with reg- Liability was admitted. The Trust’s guidelines on
ular obstetric review alongside continuous CTG use of prostaglandins for induction in a VBAC
monitoring in labour. Intravenous access and pre- case were inconsistent with RCOG Guidelines and
delivery FBC and Group and Save samples will it was accepted that there had been a failure to con-
reduce unnecessary delay in going to theatre for
suspected uterine dehiscence or rupture. Whilst an
epidural is not contra-indicated in labour, increas-
ing requirement for pain relief should trigger a sus- Key Points: Vaginal Birth After Caesarean
picion of uterine rupture as should a presenting part Section, Uterine Rupture
that ascends, rather than descends on vaginal • VBAC is suitable to offer in a singleton
examinations. Women should be made aware that uncomplicated pregnancy with cephalic
induction of labour or augmentation of labour in a presentation at 37 + 6 weeks with a sin-
VBAC situation carries an increased risk (2–3×) of gle previous LSCS
uterine rupture compared to a spontaneous labour • Antenatal discussion with senior
and discussed with the woman intrapartum [4]. Obstetrician in the antenatal period
• Documented discussion in the notes of
VBAC versus elective LSCS
29.6 Case Study • Labour in a Consultant led unit with
access to emergency theatre and
The claimant’s mother opted for VBAC. There equipment
was an interval of 16 months between the previous • Ensure senior Obstetric input in the
caesarean section and this delivery. Mode of deliv- management of VBAC labours
ery was discussed at 16 weeks with the consultant • Be aware of the 2–3× increase in risk of
and a maternal preference for vaginal delivery was uterine rupture in induced or augmented
noted. The Claimant attended hospital at 41 weeks VBAC labour
gestation, having noticed occasional tightenings, • Ensure there are local trust guideline for
but she was not in labour. Prostin E2 3 mg was VBAC delivery which are followed
inserted and IV Syntocinon was commenced
29 Vaginal Birth After Caesarean Section, Uterine Rupture 167
sult the claimant’s mother about the increased risk Vaginal birth after caesarean section: a cohort study
investigating factors associated with its uptake and
of uterine rupture with induction of labour in a success. BJOG. 2014;121(2):183–92.
VBAC case. The claim resolved on the basis of an 3. Ten Years of Maternity Claims – NHS Litigation
order for periodic payments with a conventional Authority. 2015. www.nhsla.com.
lump sum value of £6.1 million. 4. Royal College of Obstetricians and Gynaecologists
(RCOG). Green-top guideline No. 45. Birth after pre-
vious caesarean section. 2015.
5. Tahseen S, Griffiths M. Vaginal birth after two cae-
References sarean sections (VBAC-2) – a systematic review with
meta-analysis of success rate and adverse outcomes of
1. NHS Maternity Statistics- England 2013–2014. 2014. VBAC-2 versus VBAC-1 and repeat (third) caesarian
www.gov.uk. sections. BJOG. 2010;117:5–19.
2. Knight HE, Gurol-Urganci I, van der Meulen JH, 6. Donnelly L. A fresh eyes approach. 2012. www.rcm.
Mahmood TA, Richmond DH, Dougall A, et al. org.uk.
Sepsis in Pregnancy
30
Derek J. Tuffnell
Table 30.1 Risk factors for maternal sepsis

30.1 Background
Obesity
Impaired glucose tolerance or diabetes
Sepsis is the body’s overwhelming and life- Impaired immunity/immunosuppression medication
threatening response to infection that can lead to Anaemia
tissue damage, organ failure, and death. It is a Vaginal discharge
significant cause of maternal death. Sepsis is History of pelvic infection
defined as infection plus systemic manifestations Amniocentesis or other invasive procedure
of infection. Severe sepsis may be defined as sep- Cervical cerclage
sis plus sepsis-induced organ dysfunction or tis- Prolonged rupture of membranes
sue hypoperfusion. Septic shock is defined as the Vaginal trauma, caesarean section, wound haematoma
Retained products of conception
persistence of hypoperfusion despite adequate
Group A streptococcal infection in close contacts/
fluid replacement therapy. Severe sepsis occurs in family members
around 1 in 2000 pregnancies with septic shock Black or minority ethnic group origin
occurring in around 1 in 10,000 pregnancies. It is
an important cause of maternal mortality and
morbidity but there are also implications for the 30.2 Minimum Standards
fetus. Whilst there is clear evidence that the
prompt treatment of maternal infection can The general principles of infection control are rel-
improve maternal outcomes the evidence for the evant in all aspects of obstetric practice. This
improvement of fetal outcomes is more difficult. should include sepsis source control, source isola-
Litigation in relation to sepsis focuses upon tion, treatment with appropriate antibiotics accord-
whether the infection could have been prevented, ing to local and national guidelines and notifying
whether it was suspected or identified at an early infectious disease agencies for reportable infec-
enough point and whether the treatment support tions. It is particularly important to ensure that
and source control of infection were managed in there is appropriate hand hygiene. It is important
an appropriate way (Table 30.1). that women are informed of the need to reduce the
risk of transmission of infection, particularly with
young children when a sore throat may be a sign of
D. J. Tuffnell Group A Streptococcal infection or when there are
Department of Obstetrics and Gynaecology, outbreaks of parvovirus. Vaccination in the third
Bradford Teaching Hospitals NHS Foundation Trust, trimester of pregnancy should be offered for both
Bradford, UK influenza and whooping cough.
e-mail: derek.tuffnell@bthft.nhs.uk

https://doi.org/10.1007/978-3-319-78683-4_30
170 D. J. Tuffnell
Antibiotics are required for the following Table 30.2 The sepsis six care bundle
obstetric interventions: 1. Give oxygen to keep saturations greater than 94%
2. Take blood cultures
–– Caesarean section prior to the skin incision [1] 3. Administer antibiotics within 1 hour
–– Preterm pre-labour rupture of membranes 4. Give fluids
5. Measure serum lactate
(PPROM)—prophylaxis with erythromycin is
6. Monitor urine output
given to allow prolongation of the pregnancy
[2]. However, additional treatment should be
given where there is evidence of sepsis. There have been campaigns to try and improve
–– Third and fourth degree tears [3] the outcomes of sepsis generally but also specifi-
–– Prolonged rupture of membranes at term, the cally in pregnancy. There is now a generally rec-
current recommendation is to give antibiotics ognised package of assessment that should be
after 18 hours of labour. performed in women who present with potential
–– Group B streptococcus prevention. Currently sepsis [6] (Table 30.2). This should include the
pregnant women are not routinely screened taking of blood cultures and the prompt adminis-
or treated if the infection is detected antena- tration of antibiotics. There is good evidence that
tally. Treatment should be given in labour if delay in the administration of antibiotics has a
there is bacteriuria in the current pregnancy, detrimental effect and mortality is increased for
or a previously affected baby. There is a wide each hour delay. Antibiotics should be given
variation in practice for where women are within 1 hour of presentation. Fluids should be
found to have a positive swab in the current administered and there should be accurate mea-
pregnancy. Current recommendations are surements of basic observations but particularly
that they do not require treatment [4]. Women the urine output. Oxygen should be administered
presenting with ruptured membranes who are and the serum lactate can give good guidance as
positive for GBS should be offered immedi- to the severity of tissue hypo-perfusion in severe
ate induction. sepsis. Arterial blood gas measurements with lac-
–– Manual removal of placenta tate are an important aid to identifying the sever-
–– Retained products of conception ity of the condition and targeting treatment.
Clinicians should liaise closely with microbiolo-
(Currently there is no recommendation for gists especially when sepsis is unresponsive to
antibiotics following instrumental delivery, how- current treatment regimens. This will enable
ever the results of the ANODE trial [5] are adjustment to more appropriate antimicrobials.
awaited). The involvement of senior clinicians at an early
stage is also imperative.
30.3 Clinical Governance Issues

In most obstetric cases, it is not the treatment that
gives rise to litigation, but the failure to recognise • Failure to recognise sepsis
sepsis. Clinicians should, therefore, have a low • Failure to instigate appropriate investigation
threshold to investigate women who present with • Delayed treatment
non-specific symptoms particularly in women • Incomplete treatment
who may be more vulnerable to sepsis such as • Failure to consider urgent delivery
those with conditions, which make them immu- • Failure to isolate source of infection
nosuppressed (including pregnancy) such as • Failure to involve senior clinicians at an early
sickle cell disease or connective tissue disorders. stage
This principle applies to both antenatal and post- • Failure to utilise the multidisciplinary team
natal women. including anaesthetists, intensivists, microbi-
30 Sepsis in Pregnancy 171
ologists and infectious disease specialists at tis or pneumonia can occur in pregnancy and it
an early stage is important to involve microbiologists to ensure
• Delay in recognising failed treatment and that the antibiotics that have been prescribed are
instigating additional or alternative appropriate for this type of infection. The stan-
antimicrobials dard infection control measures should be
• Failure to transfer to HDU or critical care employed; isolate women in a single room,
setting healthcare professionals should wear protective
clothing and surgical masks and relatives should
be provided with suitable information and rele-
30.5 Avoidance of Litigation vant personal protection equipment [7, 8]. All of
these aspects of clinical care can lead to litiga-
When women present who are unwell it is impor- tion if the treatment is not provided promptly at
tant that appropriate observations are performed. an appropriately senior level.
The signs of sepsis may not be straightforward One of the most challenging areas for obstet-
such as tachycardia, high or low temperature or ric practice is the decision making around
tachypnoea. Women may present with non- women who develop a pyrexia in labour. Whilst
specific symptoms or fail to respond to treat- the general principles above of blood cultures,
ment; both are suggestive of infection. Another antibiotics and fluids are important there has to
challenge in pregnancy is that the inflammatory be a clinical decision about the risks and bene-
markers white cell count (WCC) and c-reactive fits of continuing the pregnancy. This will be
protein (CRP) are often elevated, particularly based upon the likelihood of a vaginal delivery
around the time of labour and therefore trying to within a reasonable time frame. It would take
determine a threshold for concern is difficult. It into account the gestation, parity and stage of
is for that reason that the full clinical picture has labour together with the progress of labour to
to be considered. that point. It would also be necessary to take
Sepsis is a potentially life-threatening condi- into account the nature of any fetal heart rate
tion. If women are unwell they need high abnormalities and the response of both the fetal
dependency or intensive care. It is important heart rate and the maternal condition to the ther-
that senior clinicians are involved in the man- apy that would be provided once the treatment
agement at an early stage. In addition to the has been administered. Whilst delivery by cae-
administration of antibiotics and fluids it can be sarean section will reduce the duration of labour
necessary to support the blood pressure with the addition of a surgical procedure can put the
vasopressors. woman at a greater risk of morbidity. There is
One of the key elements that is often delayed therefore a balance in terms of making that clin-
in women with sepsis is source control. In preg- ical decision. This can be a contentious area in
nancy, the source of infection is usually uterine, medico legal cases.
but not always. If the pregnancy is still ongoing Women presenting with spontaneous rupture
then delivery will assist with the treatment of of membranes can also present a challenge.
infection from both the maternal and fetal point According to current guidance these women
of view. If there is retained products then this should be offered immediate induction of labour
should be dealt with promptly. It may be neces- or expectant management up to 24 hours [9].
sary to perform definitive surgery such as hys- Unfortunately, due to continuing pressures on
terectomy if there is severe sepsis which is not many obstetric units it is not always possible to
improving with medical management. In other offer either option. Delayed induction with
cases, there may be significant wound infection SROM is also likely to increase the risk of sepsis
and appropriate drainage or debridement of the in labour and is another potential area for litiga-
wound can be important in controlling the tion especially in those women who are known
source of sepsis. Other infections such as masti- carriers of Group B streptococcus.
172 D. J. Tuffnell
30.6 Case Study

• Low threshold for investigation and
A 27-year-old lady in her second pregnancy pre- treatment
sented to the obstetric unit at 26 weeks gestation. • Use of sepsis care bundles
She complained of a raised temperature with upper • Use of modified early warning scores
respiratory congestion, cough, shivers and chills • Early involvement of multidisciplinary
and feeling generally unwell for the preceding team to include obstetric anaesthetists,
6 hours. She was assessed as having a mild viral microbiologists, infectious diseases and
infection and was discharged home and recom- critical care specialists
mended to have oral fluids and paracetamol. The • Early recourse to HDU or ICU setting
following day she returned to the obstetric unit by
ambulance. Maternal observations showed the
patient had a temperature of 38.6 degrees Celsius,
she was flushed and tachycardic with a pulse of References
120 beats per minute and blood pressure of
80/40 mmHg. On examination of the chest there 1. National Institute for clinical excellence (NICE)
Clinical guidelines CG312. Caesarean section.
were no added sounds. A diagnosis of severe sep- Published 23 Nov 2011.
sis was made. Over the next 12 hours the patient’s 2. Kenyon SL, et al. Broad-spectrum antibiotics for
clinical condition deteriorated despite antibiotic preterm, prelabour rupture of fetal membranes:
therapy and aggressive fluid resuscitation and she the ORACLE I randomised trial. The Lancet.
357(9261):979–88.
required ventilation and admission to the intensive 3. Royal College of Obstetricians and Gynaecologists
care unit. Viral swabs taken confirmed H1N1(swine (RCOG). Green-top Guideline No. 29. The manage-
flu). The patient required urgent delivery by emer- ment of third and fourth degree perineal tears. 2015.
gency caesarean section for deteriorating maternal 4. Hughes RG, Brocklehurst P, Stee r PJ, Heath P, Stenson
BM, On behalf of the Royal College of Obstetricians
condition. The baby subsequently died at 6 months and Gynaecologists. Prevent ion of early-onset neona-
post-natal. The Mother continued to have a very tal group B streptococcal disease. Green-top guideline
stormy course on the intensive care unit and subse- no. 36. BJOG. 2017;124(12):e280–305. https://doi.
quently died 6 weeks later. The post mortem con- org/10.1111/1471-0528.14821.
5. National perinatal epidemiology unit (NPEU).
firmed multi-organ failure secondary to H1NI. The ANODE: prophylactic antibiotics for the prevention
husband subsequently brought a claim against the of infection following operative delivery.
trust regarding the failure to recognise a case of 6. Dellinger RP, Levy MM, Rhodes A, et al. Surviving
viral illness at a time when there was a world-wide sepsis campaign: international guidelines for man-
agement of severe sepsis and septic shock: 2012. Crit
pandemic of swine flu. The case was won based on Care Med. 2013;41:580–637.
the medical team’s failure to assess the patient and 7. Royal College of Obstetricians and Gynaecologists
attribute her symptoms to influenza and a failure to (RCOG). Green-top guideline No.64a. Bacterial sep-
inform and administer Tamiflu. sis in pregnancy. 2012.
(RCOG). Green-top guideline No.64b. Bacterial sep-
sis following pregnancy. 2012.
Key Points: Sepsis 9. Nice clinical guideline CG70. Inducing labour.
• Every unit should have agreed protocols Published 23rd July 2008.
for antibiotic prophylaxis in agreement
with national guidelines
• Prompt identification of those women
particularly at risk
Twins
31
Mark D. Kilby and Peter J. Thomson
31.1 Background age of pregnant women has increased. All

multiple pregnancies are more common in
Twins of all types, are associated with increased women over the age of 35 years.
maternal and perinatal morbidity and mortality 3. Movement of people around the world.

[1]. Over the last 20 years, the incidence of There is some evidence that multiple preg-
‘twining’ has increased significantly, presently nancy, especially dizygous twining, is more
being 1 in 60 pregnancies in the UK [1]. This common in certain African races (i.e.
increase is associated with three main factors: Nigerian delta). Immigration and free move-
ment of peoples has increased the risk of
1. The increased use of subfertility treatment: twining by these means in the United
particularly with the use of agents that Kingdom, also.
induce supraovulation and in-vitro fertiliza-
tion. To an extent, these risks have been mit- These factors have led to an increase in the
igated by careful control of induced-ovulation prevalence of multiple pregnancy in general
and a policy of single embryo transfer. and twins, in particular over time. Although
However, internationally and indeed in the not specifically related to the management of
United Kingdom; these ‘safe guards’ have multiple pregnancy per se, the reduction of risk
been used with varying success (RCOG of a multiple pregnancy related to subfertility
Scientific Advisory Paper, 2017 [2]). treatment is an important pre-pregnancy dis-
2. Deferment of pregnancy until a later maternal cussion point. The use of supraovulation thera-
age. Again, over the last 25 years, the median pies and the reduction of number of embryos
transferred after in-vitro fertilisation (two sin-
gle or at most two) are important and have
M. D. Kilby (*) medicolegal consequences for the infertility
Academic Department, Centre for Women’s &
New Born Health, University of Birmingham, practitioner. Even the number of days of
Birmingham, UK embryo culture and morula ‘hatching’ may
Fetal Medicine Centre, Birmingham Women’s influence the risk of monochorionic pregnan-
and Children’s Foundation Trust, Birmingham, UK cies with the inherent pregnancy related risks.
e-mail: m.d.kilby@bham.ac.uk These discussions should take place with a
P. J. Thomson couple before embarking upon infertility treat-
Fetal Medicine Centre, Birmingham Women’s ment and should be prospectively and carefully
and Children’s Foundation Trust, Birmingham, UK documented.
e-mail: PETER.THOMPSON@bwnft.nhs.uk

https://doi.org/10.1007/978-3-319-78683-4_31
174 M. D. Kilby and P. J. Thomson
31.2 Minimum Standards mester combined screening for the detection of

trisomy 21, 18 and 13. The conversation regard-
The majority of twins are identified at the dating ing the detection rates of these chromosomal
ultrasound scan, usually performed after 9 weeks anomalies using this screening test and the false
of gestation. The ultrasound scan will check fetal positives should be documented [3]. A docu-
number and viability. The number of fetuses are mented conversation should take place relating to
counted and the number of amniotic sacs and pla- the complexity of high risk results in twins, the
centae associated with each fetus. In twins the effects of chorionicity on management and the
fetus with the largest crown rump length (CRL) is potential of discordant fetal results. For those
used to date the pregnancy and calculate the women presenting after this gestation a second
expected date of delivery. The most important trimester biochemical test is also available, but
aspect of the first trimester scan is to assess cho- the detection rates are lower and this should be
rionicity as this will dictate the management fully discussed. Finally, with the advent of non-
pathway for the entire pregnancy. It is mandatory invasive prenatal testing (NIPT) this presents a
that chorionicity is established and documented further screening option for women with a twin
and that an electronic copy of the ultrasound pregnancy although the pros and cons should be
images is stored. If the chorionicity is uncertain clearly discussed and documented. Currently this
then referral to a more experienced centre is option is only available in the private sector or
required. Once stratification of risk by chorionic- within the confines of on-going research trials.
ity has been performed, the intervals of antenatal The objective evidence on which to base the
care are dictated by the ultrasound scan timings timings of ultrasound scan examinations is poor.
(Fig. 31.1). However, recent data appears to confirm the
At a gestation of between 11 + 0 and 13 + 6 expert opinion set out in the professional national
weeks gestation (CRL from 45 to 84 mm) women (and international) clinical guidelines [4]. For
with twin pregnancies are also offered first tri- monochorionic twins, the ultrasound scan
Schedule of specialist antenatal clinic appointments
Type of pregnancy Minimum contacts Timing of Additional

(uncomplicated) with core appointments PLUS appointments
multidisciplinary team scans WITHOUT scans
Monochorionic 9 (including 2 with Approximately 11

diamniotic twins specialist obstetrician) weeks 0 days to 13
weeks 6 days* and
16, 18, 20, 22, 24, 28,
32 and 34 weeks
Dichorionic twins 8 (including 2 with Approximately 11 16 and 34 weeks

specialist obstetrician) weeks 0 days to 13
weeks 6 days* and
20, 24, 28, 32 and 36
weeks
* When crown–rump length measures from 45 mm to 84 mm
Fig. 31.1 Multiple pregnancy: antenatal care for twin and triplet pregnancies (CG129)
31 Twins 175
e xaminations should start from 16 weeks of ges- according to accepted risk factors. Baseline
tation and be repeated at 2 weekly intervals maternal characteristics should be recorded, par-
throughout the pregnancy. At each scan, fetal ticularly blood pressure and urinalysis. Even in
biometry should be measured (and the estimated normotensive women, the risk of developing
fetal weight recorded). In addition, the maximum pre-eclampsia is increased by four times the
vertical pool of amniotic fluid in each sac should background rate. For that reason, prophylactic
be recorded. For dichorionic twins, after the first aspirin should be recommended (75 mg daily).
trimester ultrasound scan, a 20-week anomaly Fetal anomalies may be identified at any point
scan is recommended and then ultrasound assess- in the pregnancy. A fetal anomaly may be identi-
ments at four weekly intervals. The ultrasound fied (in one or both fetuses) in up to 27% (95%
surveillance in monochorionic twins is for selec- confidence interval 15.0–42.8) of cases [8]. If
tive growth restriction (15% of monochorionic these are detected in the first trimester it is proba-
twins), twin to twin transfusions syndrome (10% ble that these are major anomalies such as anen-
of monochorionic twins) and rarer complications cephaly, body stalk anomalies or large nuchal
of spontaneous single twin demise (<5%) and translucencies. Concordance of structural defects
twin anaemia polycythaemia sequence (TAPS (both fetuses being affected) is rare (10% in
(1–2%). In dichorionic twins, ultrasound screen- dichorionic and 20% in monochorionic twin preg-
ing is predominantly for selective growth restric- nancies). Selective growth restriction (sGR) com-
tion (10% of pregnancies). plicates between 10 and 15% of all twin
The majority of twins will deliver prema- pregnancies. It is more common in monochori-
turely, either spontaneously or because of a onic twins (depending upon the definition).
pregnancy-related complication (circa 60%). In Currently, the diagnosis is made using ultrasound
those undelivered (and without complication) fetal biometry where there is a difference in esti-
national guidelines recommends delivery of mated fetal weight of greater than 20% (there has
monochorionic twins by 36 weeks and dichori- recently been a change in definition within the
onic twins by 37 weeks of pregnancy [5–7]. If UK, based upon the findings of the Irish study
this recommendation is not taken up by patients, [9]). Previous guidelines [5] use the definition of
then close fetal surveillance is required. Among a difference in estimated fetal weight of >25%.
monochorionic twins, this approach must be bal- Customised growth charts for twins are being
anced against a 1.5% risk of late in-utero death. evaluated and show signs of early promise [10]. In
both dichorionic and monochorionic twins with
SGR there should be consideration of possible
31.3 Clinical Governance Issues underlying aetiologies including aneuploidy, fetal
anomaly and fetal infection. In monochorionic
At the first trimester ultrasound examination, twins, the type and prognosis of sGR is staged by
there should be the assignment of the spatial the fetal umbilical artery Doppler velocity wave-
nomenclature of the babies to the maternal uterus form [11]. For severe sGR with absent or reversed
(for example, upper and lower, or left and right) umbilical artery Dopplers there is a risk of single
in twin pregnancies. This should be documented or double twin demise in up to 20% with at least
in the antenatal notes to ensure consistency 90% of babies decompensating and requiring
throughout pregnancy. intervention; this is usually early delivery before
Clinical governance issues should be focused 32 weeks (there is a 10% risk of neurological
around both maternal and fetal complications. injury in the larger twin). Before 26 weeks where
For the mother advice should be given in relation delivery has inherent risks of long-term morbid-
to diet and general health. There is an increased ity, consideration of selective fetal reduction
risk of fetal anaemia and full blood count esti- should be discussed with a tertiary centre.
mations should be assessed regularly. Screening Twin to twin transfusion syndrome compli-
for gestational diabetes should be performed cates 10–15% of all monochorionic twin pregnan-
cies and presents in the majority of cases prior to • Failure to treat as highest risk if chorionicity
26 weeks (98%) (most commonly between 17 and remains uncertain
22 weeks). There may be an overlap with the • Failure to highlight the pitfalls of aneuploidy
ultrasound diagnosis of sGR (~60% of the screening in twins
“donors” having sGR) but the diagnostic ultra- • Failure to discuss the issue of fetuses discor-
sound finding is discordance in liquor volume in dant for aneuploidy or structural abnormality
the amniotic sacs of the twins; the donor having a • Failure to refer to a tertiary unit when there is
maximum vertical pool (MVP) of <2 cms and the discrepant fetal growth
recipient having a MVP of at least 8 cm (before • Failure to discuss options and timing of
20 weeks) and >10 cm after 20 weeks. Such an delivery
ultrasound finding alone should prompt discus- • Failure to discuss risk of caesarean section for
sion with a fetal medicine centre and referral for the second twin
assessment and treatment. Further, assessment by
detail ultrasound can further stage severity of the
disease using intracardiac and fetoplacental arte- 31.4.2 Intrapartum
rial and venous Doppler velocimetry but they do
not alter the diagnosis or the requirement for • Monitoring the same twin’s fetal heart rate
assessment in a tertiary centre. The optimal treat- twice
ment between 16–26 weeks is fetoscopic laser • Failure to stabilise the lie of the second twin
ablation. Informed, written consent should be • Failure to determine presentation
taken and the couple informed specifically about • Failure to involve a senior clinician with
fetal loss rates (~10–15% double loss and 30–40% appropriate skills to deliver the second twin
single fetal demise), amniorhexis (~5%) and risk • Failure to anticipate post-partum
of handicap in survivors (5% each fetus). After 26 haemorrhage
weeks, treatment should be customised to the
pregnancy and may include the option of delivery.
Delivery of post-treatment fetuses (as with all 31.5 Avoidance of Litigation
complicated monochorionic twin pregnancies)
should be achieved before 36 weeks gestation. Once a diagnosis of a twin pregnancy is made all
The increased perinatal morbidity and mortal- possible attempts should be made to determine
ity for twins is also present during delivery, with chorionicity at the earliest opportunity. Referral
a higher risk of hypoxic ischaemic encephalopa- to a tertiary centre may be required. Based on
thy than in singleton pregnancies. The common- chorionicity a discussion should occur regarding
est cause of litigation is the misinterpretation of the risks of screening in twins as well as the
cardiotocographs where both twins are not moni- reduced performance of available screening tests.
tored separately. This should include a discussion of the manage-
ment of babies discordant for fetal abnormality.
Any invasive test should be conducted in a
31.4 Reasons for Litigation tertiary centre to allow accurate identification of
any fetus potentially requiring a selective reduc-
31.4.1 Antenatal tion procedure.
Patients with twins should be aware of the
• Failure to document the risks of twin preg- risks of preterm delivery and be made aware of
nancy antenatally the potential signs and symptoms, having a low
• Failure to correctly assess chorionicity in the threshold to attend for assessment.
first trimester Monochorionic twins should be assessed by
• Failure to seek a second opinion in cases ultrasound every 2 weeks looking for the pres-
where chorionicity is uncertain ence of TTTS and SGR. Any concerns should
31 Twins 177
prompt early referral to a specialist centre for gency caesarean section at 31 weeks after pre-
intervention. Dichorionic twins should be mature, pre-labour ruptured membranes and a
assessed every 4 weeks looking for SGR. A dis- course of maternal betamethasone.
cussion should occur antenatally regarding mode The ‘ex-recipient’ on neonatal cranial ultra-
of delivery and the risks and benefits of vaginal sound had localised atrophy of the right frontal
versus abdominal delivery. This should also cerebral cortex. Further investigation by MRI
include caesarean section for the second twin. confirmed focal reparative polymicrogyria.
Monochorionic twins should be offered delivery The parents alleged that once the treatment for
from 36 weeks and dichorionic twins from 37 TTTS was complete there was no further risk to
weeks. Mothers declining induction should have the babies in terms of handicap (other than the
increased monitoring. risks of prematurity). Because of clearly docu-
Vaginal delivery of twins should be con- mented consent, the case was successfully
ducted in the presence of a senior clinician with defended.
the skills for ultrasound and to conduct any
potential manoeuvres for delivery of the second
twin, including external cephalic version, inter- Key Points: Twins
nal podalic version, vaginal breech delivery and • Early assessment of chorionicity
breech extraction. These technical skills are • Documented discussion regarding
only required to be achieved by Obstetricians in screening in twins
the UK during the Advanced Labour Ward • Documented discussion regarding twins
ATSM, in the latter part of their training. Both discordant for fetal abnormality
babies should have continuous electronic fetal • Highlight the risks of pre-term delivery
monitoring. If this is not possible then consid- • Referral to a tertiary centre for twins
eration to caesarean section should be dis- discordant for fetal abnormality
cussed. There is no absolute time interval • Adherence to national guidelines
between delivery of the first and second twin as regarding ultrasound surveillance
long as CTG monitoring is normal. Following • Low threshold for fetal medicine opin-
delivery there should be anticipation of post- ion where TTTS or SGR suspected
partum haemorrhage. • Discuss timing and mode of delivery
• Senior clinician present for vaginal
delivery
31.6 Case Study • Anticipate post-partum complications
A 35-year-old multiparous women, with known

monochorionic diamniotic twins, presented for a
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ultrasound demonstrated features suggestive of 1. Kilby MD, Oepkes D. Multiple pregnancy. In:
twin to twin transfusion syndrome with Fetus A Edmonds K, editor. Dewhurst’s textbook of obstetrics
having polyhydramnios (deepest vertical pool of & gynaecology. 8th ed. Chichester: Wiley Blackwell;
2012. isbn:13 9780470654576
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2. El Toukhy T, Bhasttacharya S, Akande VA. RCOG
(<1 cm). The patient was referred to a tertiary Scientific Impact Paper (No. 22). Multiple pregnan-
centre for assessment and treatment. Within cies following assisted conception. 2017.
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cine foundation. 2004.
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4. McDonald R, Hodges R, Knight M, Teoh M, Edwards
were viable. The consent form clearly noted that A, Neil P, Wallace EM, DeKoninck P. Optimal inter-
the chance of at least one survivor was 85% and val between ultrasound scans for the detection of
the risk of neurologic morbidity was ~5% for complications in monochorionic twins. Fetal Diagn
Ther. 2017;41(3):197–201.
each fetus. The babies were delivered by emer-
5. NICE Guidance. Multiple pregnancy: antenatal care detection of congenital anomalies in twin pregnan-
for twin and triplet pregnancies. National Institute cies: population study and systematic review. Acta
of Care and Clinical Excellence Clinical guideline Obstet Gynecol Scand. 2016;95(12):1359–67.
[CG129]. Published date Sep 2011. 9. Breathnach FM, McAuliffe FM, Geary M, Daly S,
6. Kilby MD, Bricker L. Monochorionic twin preg- Higgins JR, Dornan J, Morrison JJ, Burke G, Higgins
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and Gynaecologists Green-top Guideline No. 51). Perinatal Ireland Research Consortium. Definition of
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S, Global Obstetrics Network (GONet) Collaboration. 11. Khalil A, Rodgers M, Baschat A, Bhide A, Gratacos
Prospective risk of stillbirth and neonatal complica- E, Hecher K, Kilby MD, Lewi L, Nicolaides KH,
tions in twin pregnancies: systematic review and Oepkes D, Raine-Fenning N, Reed K, Salomon L,
meta-analysis. BMJ. 2016;354:i4353. Sotiriadis A, Thilaganathan B, Ville Y. ISUOG prac-
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A. Sensitivity of first-trimester ultrasound in the
Vaginal Breech Delivery
32
Simon Grant and Emma Ferriman
32.1 Background external cephalic version (ECV) (50% success

rate) [4] and failure to diagnose breech presentation
Breech presentation complicates 3–4% of pregnan- in up to 25% of cases, vaginal breech birth will
cies at term. The incidence of breech presentation continue. In addition, maternal choice is also
in the preterm pregnancy is higher. Associations becoming a significant factor especially when
with breech presentation include uterine anoma- women consider the impact of caesarean section on
lies, congenital malformations in the fetus and their future fertility. In the NHS Resolution review
polyhydramnios. Breech presentation is higher in for litigation surrounding cerebral palsy claims
nulliiparous patients and has a significant recur- there were six claims related to breech presenta-
rence risk [1]. Following the publication of the tion; four at term and two at 34 weeks gestation. In
Term Breech Trial (TBT) in 2000 [2] there was a all six cases, delivery occurred out of hours and five
significant reduction in the number of breech were cases of undiagnosed breech in labour. Five
babies being delivered vaginally and this has con- were delivered by a specialist registrar without a
sequently led to a loss of the skills required to con- consultant present. In all six cases, there was an
duct a successful vaginal breech birth. The trial was attempt at vaginal delivery, but three were ulti-
the subject of considerable criticism particularly mately delivered by caesarean section [5].
with regard to case selection and intrapartum man-
agement. For example, in 31% of cases there was
no antenatal ultrasound assessment, in 31.9% there 32.2 Minimum Standards
was no senior obstetrician present to conduct the
delivery and in 13% of cases no obstetrician was Women presenting with a breech presentation
present at all [3]. Due to the limited success of after 37 weeks gestation should be offered an
ECV by a trained practitioner. In those women
who either decline ECV, or where ECV is contra-
S. Grant (*) indicated or where ECV is unsuccessful they
Department of Obstetrics and Gynaecology, should be counselled regarding vaginal breech
Southmead Hospital, Bristol, UK birth or elective caesarean section after 39 weeks
e-mail: Simon.Grant@nbt.nhs.uk gestation. Elective caesarean section has a small
E. Ferriman reduction in perinatal mortality compared to vag-
Department of Obstetrics and Gynaecology, Jessop inal breech birth and this is based on the avoid-
Wing, Sheffield Teaching Hospitals NHS Trust,
Sheffield, UK ance of stillbirth occurring after 39 weeks, the
e-mail: Emma.Ferriman@sth.nhs.uk avoidance of intrapartum risks and the avoidance

https://doi.org/10.1007/978-3-319-78683-4_32
180 S. Grant and E. Ferriman
of the direct risks of vaginal breech birth itself. to the umbilicus and the head. Women should be
Overall the perinatal mortality rate for elective warned that babies delivered vaginally in a breech
caesarean section after 39 weeks is 0.5/1000 presentation are more likely to have low Apgar
compared to vaginal breech birth of 2.0/1000. scores at delivery and a neonatal team should be
The chance of a successful breech delivery is present to ensure prompt resuscitation.
improved with appropriate case selection. There is limited good quality guidance for the
Contraindications will include a hyperextended preterm breech baby. For those women present-
neck, an estimated fetal weight (EFW) of greater ing in spontaneous preterm labour a routine
than 3.8 kgs, an EFW less than the 10th centile, approach of caesarean section is not recom-
footling breech presentation and any evidence of mended. The decision for mode of delivery
fetal compromise detected antenatally [1]. should be taken according to the stage of labour,
Women attending for planned vaginal breech the type of breech presentation, the wellbeing of
delivery should be delivered in a unit where there the fetus and the availability of a skilled operator.
is immediate access to caesarean section as up to In up to 14% of preterm vaginal breech deliveries
45% of women will experience labour complica- the head will become entrapped in an incom-
tions [1]. Induction of labour is not appropriate. pletely dilated cervix; in this scenario, lateral cer-
In addition, augmentation of labour is also con- vical incisions may be required to deliver the
troversial, but there may be a place to improve after-coming head. For breech presentation at the
contraction frequency for women with epidural limits of viability (22–25 + 6 weeks gestation)
anaesthesia. There is limited evidence regarding caesarean section is not usually recommended
monitoring in labour, but continuous electronic and for those women where delivery is indicated
fetal monitoring (cEFM) may lead to improved due to either fetal or maternal compromise vagi-
neonatal outcomes [6]. For women declining nal breech delivery is not appropriate.
cEFM intermittent auscultation should be per- In a twin pregnancy where the first twin is
formed as for cephalic presentation with conver- breech the standard practice is for elective cae-
sion to continuous monitoring if there are sarean section. For twin pregnancies presenting
concerns regarding fetal compromise. in labour where the first twin is breech a decision
The first stage of the delivery should be con- should be made regarding mode of delivery based
ducted as for a vaginal cephalic birth. Amniotomy on the stage of labour, the type of breech presen-
should be restricted to specific clinical indica- tation, the wellbeing of the baby and the presence
tions to reduce the risk of cord compression. of a skilled operator to conduct the delivery.
Slow progress in labour should generally be man- Breech presentation in the second twin occurs in
aged by caesarean section although there may be about 40% of twins. Following the results of the
a place for oxytocin in women with an epidural Twin Birth study the trial concluded there was no
and reduced contraction frequency. (This opinion difference in outcome for the second twin pre-
is controversial). The second stage may be man- senting in a non-cephalic presentation [7]. The
aged with a passive hour to allow descent of the two-year follow up for these babies also showed
breech within the pelvis. If the breech is not vis- that a policy of planned caesarean section con-
ible within 2 hours a caesarean section should be ferred no benefit in terms of long-term neurode-
performed as active pushing is not recommended velopmental sequelae [8].
if the breech is not visible. A skilled operator
should be present at delivery with the appropriate
skills for vaginal delivery including a “hands off” 32.3 Clinical Governance Issues
technique as fetal traction is more likely to result
in a hyper extended neck. Assisted breech deliv- Women with a diagnosed breech presentation at
ery is required if there is an interval of greater term should be managed according to a locally
than 5 min between delivery of the buttocks and agreed protocol. This may include managing
the head or greater than 3 min between delivery women in a specialist breech clinic with access
32 Vaginal Breech Delivery 181
to detailed ultrasonography to establish esti- gressing rapidly there has to be a balance of risk,
mated fetal weight, liquor and Dopplers as as attempting caesarean section when the breech
markers for fetal wellbeing, placental site, the is very low in the maternal pelvis is more likely
type of breech presentation and the attitude of to be associated with an increase in both neonatal
the fetal head. In addition, access to a clinician and maternal morbidity.
and midwife who can document any antenatal
risk factors and to accurately and impartially
discuss ECV, vaginal breech birth and elective 32.4 Reasons for Litigation
caesarean section. For those women electing to
attempt vaginal breech delivery there should be • Failure to assess relevant antenatal risk
appropriate case selection with evidence of factors
both fetal and maternal wellbeing. The use of • Failure to perform a detailed ultrasound as
an antenatal checklist may be of use to ensure part of the assessment for vaginal breech
all pre-requisites have been discussed and delivery
documented. • Poor documentation of pros and cons of
Delivery should occur within a unit with planned vaginal delivery versus planned cae-
immediate access to caesarean section and with sarean section
the presence of an experienced clinician trained • Failure to discuss the risks of caesarean sec-
in vaginal breech birth. When deliveries occur tion in labour
out of hours the experienced clinician should be • Delayed diagnosis of breech presentation in
present on site. Continuous electronic fetal moni- labour
toring should be discussed taking into account • Inadequate fetal monitoring in labour
both the woman’s wishes and the small amount • Failure to resort to caesarean section in cases
of evidence suggesting improved neonatal out- where there is either slow progress in labour
comes with continuous monitoring. or evidence of fetal compromise
Following the TBT vaginal breech delivery • Lack of senior obstetric personnel to perform
became less common and subsequently the num- a vaginal breech delivery
ber of practitioners with the relevant skills and • Failure to document higher risks of low Apgar
experience in vaginal breech birth declined. The scores and cord gases at delivery
introduction of simulation training has been • Traumatic delivery resulting in soft tissue
shown to improve the conduct of vaginal breech damage, visceral damage, long bone fracture
birth and to improve perinatal outcomes [9, 10]. and brachial plexus injury
Approved courses teaching vaginal breech deliv- • Failure to obtain prompt neonatal
ery include PROMPT (Practical Obstetric multi- resuscitation
professional training) and MOET (managing
obstetric emergencies and trauma). These courses
aim to teach senior clinicians and midwives the 32.5 Avoidance of Litigation
essential skills for successful vaginal breech
delivery. The avoidance of litigation will be focused in the
Women with an undiagnosed breech presenta- main around three areas:
tion presenting in spontaneous labour (either
term or preterm) should also be managed accord- 1. Strict selection criteria
ing to an agreed local protocol with assessment
of maternal and fetal risk factors, assessment of Women presenting at term with a breech pre-
the stage of labour, the type of vaginal breech and sentation should be counselled based on their
an accurate assessment of current fetal wellbeing. antenatal risk factors. For example, a woman
The presence of a skilled operator will also be with a previous caesarean section may opt for a
mandatory in these cases. Where labour is pro- repeat operation. In addition, the baby needs to
182 S. Grant and E. Ferriman
be properly assessed with an accurate EFW tal again, on this occasion with a five-day his-
estimation (a fetal weight greater than 3.8 kgs tory of antepartum haemorrhage and although
may be associated with a greater risk of dysto- this was initially thought to be secondary to a
cia), the type of breech presentation (flexed, cervical ectropion, examination subsequently
extended or footling), the attitude of the fetal showed her cervix to be effaced, 2 cm dilated,
head and general wellbeing of the fetus. There with bulging membranes. She progressed rap-
should be a fully documented discussion sur- idly to full dilatation over the next 3 hours and
rounding all possible options including ECV. was diagnosed with a breech presentation after
Antenatal checklists are helpful to reduce the spontaneous rupture of the membranes at an
risk of omissions. examination carried out because of fetal brady-
cardia. Initially, after assessment by the obstet-
2. Adherence to an intrapartum protocol ric registrar, pushing was encouraged, to aim for
vaginal delivery with consideration of a breech
A local protocol for the management of vagi- extraction. Subsequently, the registrar found it
nal breech delivery should be constructed with difficult to reach any part of the baby to make
adherence to the guidance when women present this manoeuvre possible and arranged transfer
in labour. Women should be delivered by caesar- to theatre for category I caesarean section. On
ean section if there is evidence of poor progress arrival in theatre, Mrs. G had progressed, with
in labour or signs of fetal compromise. the breech on the perineum and an assisted
breech delivery was performed, with the assis-
3. An experienced obstetrician in attendance tance of the consultant obstetrician.
Unfortunately, the baby was born in very poor
The presence of a skilled practitioner to facili- condition, requiring extensive resuscitation and
tate the delivery is mandatory. The prime reasons transfer to the neonatal intensive care unit
for litigation in the NHS resolution data review (NICU). Care was withdrawn at 8 days of age.
was the lack of a senior obstetrician present at The Claimant alleged breach of duty based on
delivery. the fact that the sudden bradycardia was likely
Finally, parents should be counselled regard- to have been due to a cord prolapse in that it
ing the risks of babies being born with low Apgar occurred following spontaneous rupture of
scores, and poor cord gases and should be warned membranes, the baby was in a breech presenta-
regarding fetal soft tissue and bony injuries. A tion, had a high presenting part and was pre-
suitably experienced neonatologist should also term. Furthermore, given the above there was no
be present at delivery to ensure rapid and effec- management plan for the delivery and there was
tive neonatal resuscitation. a significant delay between the diagnosis of full
dilatation with fetal bradycardia and eventual
delivery of the baby in theatre. The claim was
32.6 Case Study settled as the Defendants agreed that Mrs. G
should have been transferred to theatre for cat-
Mrs. G was a 32-year-old lady in her second egory 1 caesarean section immediately after the
pregnancy with a history of one previous mis- bradycardia when it became apparent that the
carriage. She conceived via ICSI and so was breech was high and not imminently deliver-
booked for consultant-led care. The pregnancy able. In addition, criticism also arose because
was uneventful until 27 + 4/40, when she pre- there was a lack of immediate senior supervi-
sented with decreased fetal movements, but sion for the junior registrar and no manoeuvres
ultrasound scan and CTG were both normal. At were employed to reduce cord compression as
28 + 3/40, Mrs. Godfrey presented to the hospi- should occur with a cord prolapse.
32 Vaginal Breech Delivery 183
versus planned vaginal birth for breech presen-

Key Points: Vaginal Breech Delivery tation at term: a randomised multicentre trial.
Term Breech Trial Collaborative Group. Lancet.
• Antenatal assessment of fetal and mater- 2000;356(9239):1375–83.
nal wellbeing 3. Glezerman M. Five years of the term breech trial:
• Antenatal checklist for women consid- the rise and fall of a randomized controlled trial.
ering vaginal breech delivery Am J Obstet Gynecol. 2006;194:20–5. https://doi.
org/10.1016/j.ajog.2005.08.039.
• Provide an ECV service to facilitate 4. Impey LWM, Murphy DJ, Griffiths M, Penna LK,
cephalic presentation on behalf of the Royal College of Obstetricians and
• Ultrasound assessment for suitability of Gynaecologists. External cephalic version and reduc-
vaginal breech delivery ing the incidence of term breech presentation. BJOG.
2017;124:e178–92.
• Protocol for the management of vaginal 5. Magro M. NHS resolution. Five years of cerebral
breech at term palsy claims. A thematic review of NHS Resolution
• Protocol for the management of undiag- data. 2017. https://resolution.nhs.uk/wp-content/
nosed breech in labour (term or uploads/2017/09/Five-years-of-cerebral-palsy-
claims_A-thematic-review-of-NHS-Resolution-data.
preterm) pdf
• Accurate monitoring to assess fetal 6. Goffinet F, Carayol M, Foidart JM, Alexander
wellbeing in labour S, Uzan S, Subtil D, Goffinet F, Carayol M,
• Prompt recourse to caesarean section if Foidart JM, Alexander S, Uzan S, Subtil D, et al.,
PREMODA Study Group. Is planned vaginal deliv-
poor progress in labour or concerns ery for breech presentation at term still an option?
regarding fetal wellbeing Results of an observational prospective survey
• Availability of facilities for emergency in France and Belgium. Am J Obstet Gynecol
caesarean section 2006;194:1002–11.
7. Barrett JF, Hannah ME, Hutton EK, Willan AR, Allen
• Ensure simulation training of senior AC, Armson BA, Gafni A, Joseph KS, Mason D,
obstetricians and midwives to conduct a Ohlsson A, Ross S, Sanchez JJ, Asztalos EV, Twin
vaginal breech delivery Birth Study Collaborative Group. A randomized
• Presence of a skilled obstetrician pres- trial of planned cesarean or vaginal delivery for twin
pregnancy. N Engl J Med. 2013;369(14):1295–305.
ent for vaginal breech delivery https://doi.org/10.1056/NEJMoa1214939.
• Presence of a neonatal team for resusci- 8. Asztalos EV, Hannah ME, Hutton EK, Willan AR,
tation at delivery Allen AC, Armson BA, Gafni A, Joseph KS, Ohlsson
A, Ross S, Sanchez JJ, Mangoff K, Barrett JF. Twin
Birth Study: 2-year neurodevelopmental follow-up of
the randomized trial of planned cesarean or planned
vaginal delivery for twin pregnancy. Am J Obstet
References Gynecol. 2016;214(3):371.e1–371.e19. https://doi.
org/10.1016/j.ajog.2015.12.051. Epub 2016 Jan 29
1. Impey L, Murphy D, Griffiths M, Penna L, On behalf 9. Draycott T, Sibanda T, Owen L, Akande V, Winter
of Royal College of Obstetricians and Gynaecologists C, Reading S, et al. Does training in obstetric
RCOG. Management of Breech Presentation. emergencies improve neonatal outcome? BJOG.
BJOG. 2017. http://onlinelibrary.wiley.com/ 2006;113(2):177–82.
doi/10.1111/1471-0528.14465/epdf 10. Deering S, Brown J, Jonathon H. Simulation training
2. Hannah M, Hannah W, Hewson S, Hodnett E, and resident performance of singleton vaginal breech
Saigal S, Willian A. Planned caesarean section delivery. Obstet Gynaecol. 2006;107:86–9.
Maternal Collapse in Pregnancy
33
Peter Brunskill and Emma Ferriman
33.1 Background therefore means that the true incidence of maternal

collapse lies somewhere between the two figures.
Maternal collapse is defined by the RCOG as ‘an In the SCASMM data major obstetric haemorrhage
acute’ event involving cardiorespiratory systems (MOH) remained the commonest cause of mater-
and/or the brain, resulting in a reduced or absent nal morbidity, responsible for over 80% of cases.
conscious level (and potentially death), at any stage
in pregnancy and up to 6 weeks after delivery [1].
Maternal collapse in pregnancy and in the immedi- 33.2 Minimum Standards
ate post-partum period is a potentially life-threat-
ening event with a wide range of possible causes. Not all causes of maternal collapse can be pre-
The maternal outcome primarily depends on dicted, although there may be risk factors making
prompt and effective resuscitation with the mother severe maternal morbidity more likely. For
as the priority. Maternal mortality data is accurately women with significant medical conditions these
collected via the MMBRACE-UK reporting sys- women should be cared for by a multidisciplinary
tem; Saving lives, improving mother’s care, but team and their management should include a plan
data on maternal morbidity and collapse is not rou- for delivery, whether elective or as an emergency.
tinely collected. 8.5/100,000 women died during In these high-risk patients, there may be signs
pregnancy and up to 6 weeks following delivery in and symptoms that precede the acute collapse. A
the 2012–2014 report. The 10th Scottish recurring theme in the CEMACH, CEMACE and
Confidential audit of severe maternal morbidity MMBRACE reports is substandard care where
(SCASMM) produced a morbidity rate of 7.3/1000 signs and symptoms were present and not acted
births [2]. Maternal morbidity data is further com- upon. The 2003–2005 CEMACH report recom-
plicated as not all cases of maternal morbidity are mended the introduction of an Obstetric Early
preceded by maternal collapse. In reality, this Warning Score used for all obstetric patients
requiring regular observation including those
patients being cared for in a non-obstetric setting
P. Brunskill (*) [3]. The Early Warning Score (EWS) is modified
Airedale NHS Foundation Trust, Keighley, UK to account for the normal physiological changes
e-mail: peter@brunskill.org
occurring as an adaptation to pregnancy (modi-
E. Ferriman fied early warning score (MEWS)).
Fetal and Maternal Medicine, Sheffield Teaching
Hospitals NHS Trust, Sheffield, UK Some possible causes of maternal collapse are
e-mail: Emma.Ferriman@sth.nhs.uk documented in Table 33.1. These causes may be

https://doi.org/10.1007/978-3-319-78683-4_33
186 P. Brunskill and E. Ferriman
Table 33.1 Causes of maternal collapse in pregnancy Table 33.2 Reversible causes of maternal collapse
System Cause Reversible cause Cause in pregnancy
Neurological Eclampsia 4Hs
Post epileptic seizure Hypovolaemia Haemorrhage (concealed or
Intracranial haemorrhage revealed)
Cardiac Aortic dissection Dense spinal block
Arrhythmias Septic shock
Myocardial infarction Neurogenic shock
Cardiomyopathy Hypoxia Pregnant patients become
Chest Pulmonary embolism hypoxic more quickly
Amniotic fluid embolism Cardiac events
Haemorrhage Massive obstetric haemorrhage Large vessel aneurysms
Splenic artery rupture Hypo/hyperkalaemia No increased likelihood
Hepatic rupture Hypothermia No increased likelihood
Drugs Magnesium sulphate 4Ts
Local anaesthetic Thromboembolism Amniotic fluid embolus
Illicit drugs Pulmonary embolus
Metabolic Hypoglycaemia Air embolus
Diabetic ketoacidosis Myocardial infarction
Others Sepsis Toxicity Local anaesthetic
Anaphylaxis Magnesium
Maternal trauma including road traffic Tension pneumothorax Trauma or suicide attempt
accidents and domestic violence Tamponade Trauma or suicide attempt
Vasovagal response (cardiac)
Eclampsia/ Intracranial haemorrhage
pre-eclampsia
pregnancy related or as a direct result of pre-
existing maternal disease. (Many of these causes
are discussed in the relevant chapters in the and are more difficult to ventilate and the cardio-
obstetric section of this book). Amniotic fluid vascular changes in pregnancy heighten the
embolus (AFE) remains a clinical challenge and effects of blood loss. The pregnant uterus com-
the management is supportive rather than thera- presses the inferior vena cava and the aorta form
peutic. Management should involve senior clini- 20 weeks gestation reducing cardiac output by up
cians at an early stage with active resuscitation, to 40%. This aortocaval compression will be
inotropic support and correction of coagulation relieved using left lateral tilt or manual uterine
defects. When considering a collapsed pregnant displacement. For the anaesthetist intubation is
patient there should be a structured and system- more difficult due to pregnancy weight gain,
atic consideration to the possible causes. laryngeal oedema and the enlarged breasts mak-
Collapse in a hospital environment may be ing airway access more difficult. There are also
amenable to treatment if a reversible cause is iden- the increased risks of aspiration due to relaxation
tified. The resuscitation council summarise these of the gastro-oesophageal sphincter and delayed
causes as the 4Hs and the 4Ts, but eclampsia and gastric emptying. In pregnant patients, the
pre-eclampsia should also be added for pregnant increased circulating blood volume means that
patients as documented in Table 33.2 [4]. large volumes of blood may be lost rapidly. In
The treatment of a maternal collapse should be healthy pregnant women blood loss is well toler-
based on effective and aggressive resuscitation. ated and these patients may lose up to 35% of
The physiological adaptions of pregnancy make their circulating blood volume before becoming
resuscitation more challenging and it is impera- symptomatic.
tive that obstetric, midwifery, anaesthetic and The collapsed pregnant patient should be
emergency medicine staff are familiar with the managed according to the A, B, C, D, E struc-
normal physiology of pregnancy. For example, tured approach [5]. In women in cardiac arrest
pregnant patients become hypoxic more quickly prompt initiation of chest compressions should
33 Maternal Collapse in Pregnancy 187
occur with ventilation ideally via a secured air- national courses such as MOET (management of
way with a cuffed endotracheal tube. Early obstetric emergencies and trauma) or ALSO
recourse to delivery of the fetus to aid resuscita- (advanced life support in obstetrics).
tion should occur in all pregnant patients at gesta-
tions of greater than 20 weeks. Haemorrhage
remains the commonest cause of maternal col- 33.4 Reasons for Litigation
lapse and in these women there should be a high
index of suspicion and an awareness that the typi- • Failure to appreciate risk factors for severe
cal signs and symptoms of shock will occur late. maternal disease
• Lack of antenatal planning for pregnant
women with pre-existing disease
33.3 Clinical Governance Issues • Lack of involvement of a multidisciplinary
team to facilitate planning
All pregnant women should be continually • Late recognition of the critically ill patient
assessed for the presence of risk factors for severe • Failure to escalate to senior clinicians
morbidity in pregnancy. This is particularly rele- • Late involvement of the multidisciplinary team
vant for women at risk of massive obstetric haem- • Inadequate resuscitation
orrhage and eclampsia. For those women with • Failure to empty the uterus early to aid effec-
significant risk factors a comprehensive delivery tive cardio-pulmonary resuscitation.
plan should be documented in the maternity
records and the woman’s handheld maternity
notes. This plan should include arrangements for 33.5 Avoidance of Litigation
both planned and unplanned delivery and postna-
tal management. Management plans should be For pregnant women with risk factors for severe
made within the realms of a multidisciplinary disease or with significant pre-existing maternal
team including obstetricians, anaesthetists, neo- disease these women should be managed antena-
natologists, intensivists and haematologists tally using a multi-disciplinary approach by
(where indicated). Obstetric care bundles may senior clinicians. They should be managed
assist in planning for women with placenta prae- according to an agreed and documented manage-
via and accreta [6]. The use of Modified Early ment plan with a named clinician responsible
Warning Scores (MEWS) should be employed who may be contacted in the event of an emer-
for women requiring intensive monitoring or gency or out of hours admission. There should be
women at risk of severe morbidity. a fully documented record of the relevant risk
All cases of severe maternal morbidity and factors and the possible risks to mother and baby.
maternal collapse should be reviewed by the risk Delivery options should also be discussed and
management team to ensure effective treatment documented antenatally. Unscheduled admis-
as per local and national guidance. All maternal sions should prompt early involvement of senior
deaths should be reported to MMBRACE UK. clinicians from the relevant specialties. All
All staff caring for pregnant patients should be women should have effective monitoring with the
aware of the normal physiological adaptations of minimum standard of twelve hourly in a hospital
pregnancy that make resuscitation more difficult setting [7].
and be prepared to facilitate early delivery of the For women who collapse acutely in whom the
baby to aid resuscitation in women of greater than episode is unexpected or unpredictable they
20 weeks gestation. Staff should attend annual should be managed according to the UK
training for cardiopulmonary resuscitation (CPR). Resuscitation Council guidelines: basic life sup-
In addition, simulation training in small groups port (BLS), adult advanced life support (ALS)
also enhances more effective management. Senior and automated external defibrillation (AED)
obstetric trainees may benefit from attending algorithms [8, 9] (Fig. 33.1). All clinicians and
Resuscitation algorithm
Collapsed unresponsive pregnant woman
Check airway, breathing

and circulation
Left lateral tilt
unless postnatal
or <20weeks
No breathing
No pulse
Call Resuscitation
Team 2222
Commence basic life support

CPR 30:2
Automated defibrillator
attached and shock if advised
Resuscutation team
arrives
Prepare for LSCS at 4mins

Role of obstetrician:
Decision to deliver
>20 week’s gestation
if no response to Further resuscitation as
CPR at 4 mins. required depending on response
(Deliver to improve
moternal resuscutation)
After stabilisation consider:

A) DIC development
B) Bleeding risk
C) Thrombosis risk
Fig. 33.1 Resuscitation algorithm for the pregnant patient
practitioners should be familiar with the particu- will enhance the functioning of the team in a
lar challenges of cardiopulmonary resuscitation resuscitation scenario.
in pregnant women and should be familiar with Contemporaneous documentation of the acute
possible causes of maternal collapse. Particular event is mandatory, but not always well-executed
emphasis should be paid to treatment of the making legal claims difficult to defend. The use
reversible causes that may make resuscitation of a scribe with a scribe sheet especially with
successful. All staff should have documented evi- regard to major obstetric haemorrhage will
dence of annual CPR training via the risk man- enhance documentation. For women and families
agement pathway of the department. In addition, involved in an acute maternal collapse scenario a
attendance at small group simulation training debrief by a senior clinician will help to address
33 Maternal Collapse in Pregnancy 189
any concerns regarding diagnosis and treatment was reasonable, based on her religious convic-
with follow up of traumatic events in obstetric tions and that the Defendants were aware of her
debrief clinics. Maternal collapse requiring views and had protocols in place to deal with
resuscitation should be assessed by the risk man- them. As the Defendants were responsible for a
agement process. Issues with poor practice may period of time in failing to mitigate the blood
then be addressed through a supportive learning loss and knew during that period that Mrs. D
environment for staff and direct feedback to would not accept a blood transfusion, the Judge
patients and their families provided. found in favour of the Claimant whose family
was awarded £375,000.
This case highlights the importance of early
33.6 Case Study recognition of the signs and symptoms occur-
ring prior to a maternal collapse. In particular,
M v P 2011 (Maher v Pennine Acute Trust). that a fall in blood pressure is a late feature of
Mrs. D was a Jehovah’s Witness, who major obstetric haemorrhage in a previously
declined both blood and blood products through- healthy pregnant patient. Had the signs of major
out her pregnancy and had signed an advanced haemorrhage been identified at an earlier stage,
directive. She was delivered by caesarean sec- the Claimant would have received earlier surgi-
tion but deteriorated over the subsequent 3 hours cal intervention thereby arresting the ongoing
due to haemorrhage from a rupture in the poste- bleeding. This in turn would have resulted in a
rior wall of the uterus. Mrs. D was eventually reduced blood loss that could have been man-
returned to theatre but despite surgical control aged according to the local protocol for women
of the haemorrhage died 2 days later from multi with major haemorrhage declining blood and
organ failure. blood products.
The Claimant argued that the Defendants had
failed to recognise the signs of haemorrhage—
tachycardia, pallor, poor urine output and the
relatively late sign of falling blood pressure. The
Defendants agreed that Mrs. D’s post-operative Key Points: Maternal Collapse in Pregnancy
management had been below an acceptable stan- • Identify any antenatal risk factors
dard—the Defendant’s expert described it in • Mange patients with pre-existing dis-
Court as ‘woeful’. The Defendants however ease in a specialist clinic as part of a
argued that the delay in return to theatre made no multidisciplinary approach
difference to the outcome. • Document a management plan for deliv-
In his assessment of the case the Judge consid- ery and the postnatal period for high-
ered when death from overwhelming blood loss risk patients
without replacement would have become inevi- • Ensure adequate monitoring of patients
table. He concluded that, if Mrs. D had been with a MEWS chart and escalate
returned to theatre at an appropriate time, she accordingly
would on balance have survived without the • Involve senior clinicians early
transfusion of blood products. • Ensure all staff are trained in CPR in
The Defendants also argued that even at the pregnant patients
later time of surgery, Mrs. D would not have • There should be early recourse to emp-
died if she had received blood and blood prod- tying the uterus in women beyond 20
ucts, and that her refusal therefore ‘broke the weeks gestation to aid effective
chain of causation’. The Judge however con- resuscitation
cluded that Mrs. D’s refusal of blood products
References 6. Royal College of Obstetricians and Gynaecologists

(RCOG), Royal College of Midwives (RCM) and
National patient safety agency (NPSA). Safe prac-
tice in intrapartum care project. Care bundles. 2010.
(RCOG) Green-top Guideline No. 56. Maternal col-
https://www.rcog.org.uk/globalassets/documents/
lapse in pregnancy and the puerperium. 2011. https://
guidelines/carebundlesreport.pdf
www.rcog.org.uk/globalassets/documents/guidelines/
7. National Institute for health and care excellence
gtg_56.pdf
(NICE) clinical guideline CG50. Acutely ill adults in
2. Healthcare Improvement Scotland. Scottish confidential
hospital: recognizing and responding to deterioration.
audit of severe maternal morbidity; reducing avoidable
Published 25th July 2007. https://www.nice.org.uk/
harm 10th Annual report. http://www.healthcareim-
guidance/cg50/resources/acutely-ill-adults-in-hos-
provementscotland.org/our_work/reproductive,_mater-
pital-recognising-and-responding-to-deterioration-
nal_child/programme_resources/scasmm.aspx
pdf-975500772037
3. Confidential Enquiry into Maternal and Child Health.
8. Resuscitation Council (UK). Resuscitation
Saving Mothers’ Lives: Reviewing maternal deaths to
Guidelines. 2010. http://www.resus.org.uk/pages/
make motherhood safer – 2003–2005. In: The seventh
guide.htm.
report of the confidential enquiries into maternal deaths
9. Soar J, Deakin CD, Nolan JP, Abbas G, Alfonzo A,
in the United Kingdom. London: CEMACH; 2007.
Handley AJ, et al., European Resuscitation Council.
http://www.cmace.org.uk/getattachment/927cf18a-
European Resuscitation Council Guidelines for
735a-47a0-9200-cdea103781c7/Saving-Mothers--
Resuscitation 2005. Section 7. Cardiac arrest in
Lives-2003-2005_full.aspx.
special circumstances. Resuscitation 2005;67
4. Resuscitation Council (UK). Resuscitation Guidelines.
(Suppl 1):S135–70. https://www.erc.edu/index.php/
2005. http://www.resus.org.uk/pages/guide.htm.
guidelines_download_2005/en/.
5. Managing obstetric emergencies and trauma. The
MOET course manual third edition.
Postpartum Haemorrhage
and Retained Products 34
of Conception Postnatal
Stephen O. Porter
34.1 Background twenty-five involved haemorrhage and in four

cases no central theme was identified. The total
Obstetric haemorhage is the fourth most common value of the claims identified was £3 million [4].
cause of direct maternal death in the United
Kingdom, accounting for 21 deaths per 100,000
maternities (MBRACE 2013–2015) [1] a con- 34.2 Minimum Standards
cerning increase of 7 deaths from the previous
triennium [2]. Between 1994 and 2012, postpar- Primary postpartum haemorrhage (PPH) is
tum haemorrhage accounted for between 30 and defined as the loss of 500 mL or more of blood
80% of deaths attributable to obstetric haemor- from the genital tract within 24 hours of the birth
rhage [2]. It is however, widely acknowledged of a baby. Minimum clinical standards relate to
that this small mortality rate forms the tip of a the prediction or prevention of haemorrhage, rec-
much larger morbidity ice-berg. In addressing ognition of loss and appropriate treatment.
maternal mortality and morbidity, Bewley et al.
estimated that the associated morbidity rate is up 1. Prediction/Prevention: Some of the risk fac-
to one hundred times higher [3]. Based on this tors for postpartum haemorrhage are listed in
assertion, the morbidity rate associated with the Fig. 34.2. Once identified these should be
postpartum haemorrhage in the 2012–2014 trien- documented and used to form a clear plan of
nium may have been as high as 1040 per 100,000 care.
maternities. 2. Recognition: Visual estimation of blood loss
Although morbidity following postpartum following delivery is unreliable and typically
haemorrhage is not necessarily due to clinical overestimates loss at small volumes and under-
negligence, claims for clinical negligence are estimates loss at larger volumes [5, 6].
likely to arise in the setting of morbidity Symptoms of haemorrhage often precede
(Fig. 34.1). signs. These include unexplained anxiety, a
A 10-year review of NHSLA claims identified feeling of being cold or breathlessness. It is
111 claims for postpartum haemorrhage. Eighty- therefore vital that healthcare workers pay par-
two of the cases involved retained products, ticular attention to these symptoms in women
at risk of postpartum haemorrhage. The use of
MEWS/MEOWS (Modified Early Obstetric
S. O. Porter Warning Scores) charts should be employed to
Airedale NHS Foundation Trust, Keighley, UK record the observations of all high-risk patients.
e-mail: Stephen.porter@anhst.nhs.uk

https://doi.org/10.1007/978-3-319-78683-4_34
192 S. O. Porter
3. Treatment: In the event of significant primary bleeding. It is vital that the clinician in charge
postpartum haemorrhage, the patient should appoints a scribe whose job it is to document
be resuscitated in accordance with established the personnel present and the nature and tim-
national and or local guidelines. Blood loss ing of any interventions. If possible, the scribe
should be accurately recorded, and all swabs should also note the timing of conversations
weighed to ensure accuracy. Thereafter man- with the patient and relatives particularly in
agement should be directed at the cause of relation to the consent for procedures. It is
also vital that the clinician, at the conclusion
of the case, records the events in chronologi-
NUMBER OF CLAIMS FOR POSTPARTUM
HAEMORRHAGE (111) cal order.
Haemorrhage, 25 Retained Products, 82 Other, 4 Secondary postpartum haemorrhage, defined

as excessive vaginal bleeding from 24 hours up to
6 weeks postpartum, remains a complex condi-
22% tion to manage and treat. The amount of blood
loss is not defined. Furthermore, normal post-
partum loss may continue beyond 6 weeks in
25% of women [7], especially if breast-feeding,
and the first period may be particularly heavy.
74%
These diagnostic uncertainties give rise to a lack
of consensus on how best to manage secondary
Fig. 34.1 Number of claims for postpartum haemorrhage postpartum haemorrhage. Indeed, a Cochrane
2000–2010 [4] review of the management of secondary postpar-
Risk factor The four Ts OR (95% CI)

Multiple pregnancy Tone 3.30 (1.00–10.60)16
4.70 (2.40–9.10)24
Previous PPH Tone 3.60 (1.20–10.20)16
Pre-eclampsia Thrombin 5.00 (3.00–8.50)16
2.20 (1.30–3.70)11
Fetal macrosomia Tone 2.11 (1.62–2.76)20
2.40 (1.90–2.90)24
Failure to progress in second stage Tone 3.40 (2.40–4.70)23
1.90 (1.20–2.90)11
Prolonged third stage of labour Tone 7.60 (4.20–13.50)16
2.61 (1.83–3.72)20
Retained placenta Tissue 7.83 (3.78–16.22)20
3.50 (2.10–5.80)23
6.00 (3.50–10.40)24
Placenta accreta Tissue 3.30 (1.70–6.40)23
Episiotomy Trauma 4.70 (2.60–8.40)25
2.18 (1.68–2.76)20
1.70 (1.20–2.50)24
Perineal laceration Trauma 1.40 (1.04–1.87)20
2.40 (2.00–2.80)23
Fig. 34.2 Risk factors 1.70 (1.10–2.50)24
for postpartum General anaesthesia Tone 2.90 (1.90–4.50)11
haemorrhage [15]
34 Postpartum Haemorrhage and Retained Products of Conception Postnatal 193
tum haemorrhage concluded that there was no trial cavity was found in 51% of women on day
evidence from randomised controlled trials to seven, 21% on day fourteen and 6% on day
demonstrate the efficacy of treatments for sec- twenty one. They hypothesised that either ‘an
ondary postpartum haemorrhage [8]. The most echogenic mass does not always represent
common cause of secondary post-partum haem- retained products of conception, or that prod-
orrhage is sub-involution of the uterus, either due ucts of conception are commonly retained and
to infection, retained placental tissue or both. are therefore of little clinical significance in
Investigations will include baseline blood many cases’. In another study, the authors con-
tests such as a full blood count, C reactive pro- cluded that in women with postpartum bleeding
tein, group and save, coagulation studies and a in the week following delivery, the presence of
serum bHCG. Vaginal swabs and wound swabs an echogenic mass and a uterine antero-poste-
should be undertaken. In stable patients, a rior (AP) diameter greater than the 90th centile
transvaginal ultrasound scan should be per- (approximately 25 mm) indicated the presence
formed although its interpretation may be of retained products of conception [13].
difficult. Although the study did not address ultrasonic
In the presence of significant haemorrhage, findings beyond the first postpartum week, simi-
resuscitation following local guidelines should lar findings later in the puerperium are likely to
be commenced prior to establishing a cause. In have a greater association with retained placen-
the presence of mild or moderate bleeding, or tal tissue. In the presence of on-going trouble-
once the patient has been stabilised, broad spec- some bleeding and equivocal scan findings,
trum antibiotics should form the part of the man- surgical evacuation of the uterus may be benefi-
agement of all patients with secondary cial as was demonstrated in a study in which all
post-partum haemorrhage [9]. If a conservative 72 women undergoing a uterine evacuation for
approach is adopted it is good practice to ensure secondary postpartum haemorrhage stopped
the patient has easy access to medical review bleeding despite only 36% having proven histo-
should her symptoms worsen. logical evidence of retained tissue [14].
Uterine evacuation and or hysteroscopy in The indications for uterine evacuation or hys-
women with secondary postpartum haemorrhage teroscopy in secondary postpartum haemorrhage
are not without complications and should be are:
undertaken by a senior clinician. Uterine perfora-
tion may occur in 1.5% of cases [10] and a recent (a) Significant uterine bleeding irrespective of,
review showed that intra-uterine adhesions were or in the absence of positive scan findings
present in 21.5% of women with a history of (b) Troublesome uterine bleeding with an echo-
postpartum curettage [11]. Furthermore, there genic mass and a uterine AP diameter of
may be morbidity associated with a second pro- greater than 25 mm
cedure due to the incomplete evacuation of (c) Persistent loss that has not responded to anti-
retained tissue or the need for a hysterectomy. It biotics, irrespective of scan findings.
is therefore imperative that that the woman is
fully informed of these risks and that this is care-
fully documented in the case notes. 34.3 Clinical Governance Issues
Although pelvic ultrasound is often per-
formed in women with secondary postpartum The Royal College of Obstetricians &
haemorrhage, the role of ultrasound in deter- Gynaecologists (RCOG) and the World Health
mining whether there are retained products, and Organisation (WHO) are two of several organisa-
whether surgical evacuation is needed, is not tions that that have produced robust
clear. In a study by Edwards et al. [12], in which evidence-based guidelines for the management
women with normal postpartum loss were of postpartum haemorrhage [15, 16]. These form
scanned, an echogenic mass within the endome- the basis of assessing the minimum standard of
194 S. O. Porter
care owed to patients. Guidelines by definition 34.4 Reasons for Litigation

are not mandatory. However, departure from
accepted practice may help a claimant who is The reasons for litigation following postpartum
seeking to prove negligence. haemorrhage relate to:
Organisations as well as individuals owe a
duty of care to patients. In Bull v Devon AHA • Delayed diagnosis
[17], Mrs. Bull had brought an action against • Under estimation of blood loss
Devon Health Authority on behalf of her severely • Failure to initiate active resuscitation with
handicapped son, one of twins, who had been blood and blood products
injured as a result of a delay in the registrar’s • Delayed investigation of continued postpar-
arrival while she was in labour. The system for tum bleeding
summoning an obstetrician urgently had broken • Failure to offer ultrasound examination of the
down and there was a delay of over an hour post-partum uterus
before the registrar arrived. The Court of Appeal • Failure to consider both conservative and sur-
held that the system had failed to provide an gical management
acceptable level of care. In Wilsher v Essex Area • Delayed evacuation of retained placental
Health Authority [18], a baby sustained a hypoxic tissue
brain injury because a junior doctor inserted an • Failure to follow hospital guidelines
umbilical catheter into the vein instead of the • Inadequate pre-operative counselling regard-
artery even though he checked with the registrar, ing the risks of complications for women
who made the same error. The Court of Appeal requiring surgical management
held that the standard of care should not be lower • Complications arising during a surgical proce-
for inexperienced doctors. dure (uterine perforation, ureteric injury) or
These cases suggest that an organisation can following a procedure (e.g. Asherman’s
be held directly responsible, and not just vicari- syndrome)
ously through the actions of its employees, for
the standard of care provided for its patients. In
relation to postpartum haemorrhage it is there- 34.5 Avoidance of Litigation
fore important that trusts have up to date guide-
lines and that all staff involved in the management Hospital Trusts need to ensure that easy to access,
of post-partum haemorrhage are trained to so. up-to-date, evidence-based guidelines are avail-
This can be evidenced by documented regular able within maternity departments. All staff
skills and drills, mandatory training and by ensur- working with women at risk of haemorrhage
ing that the induction of all new doctors includes should be adequately trained. There should be
training in the management of postpartum haem- evidence of regular skills and drills training
orrhage in accordance with local practice. involving all relevant staff. Trusts should ensure
All cases where blood loss is in excess of that there are clear operational policies dealing
1500 mls, requiring theatre readmission, hyster- with logistics and infrastructure, including the
ectomy or intensive care admission should be provision of appropriate equipment, theatre
reported by the appropriate risk management space, medication, and directions on major inci-
pathway. Accurate documentation remains essen- dent procedures.
tial and this may be aided by the use of prefor- The key to avoiding complaints, litigation and
matted proforma sheets. Where there is blood significant morbidity in post-partum haemor-
loss in excess of 1500 mls clinicians should rhage is:
active the major obstetric haemorrhage (MOH)
protocol to endure urgent arrival of blood and • Prediction/Prevention
blood products and senior personnel over a wide • Recognition
range of specialties. • Action
Women at high risk of post-partum haemor- ative scan findings with persistent loss that has
rhage should be identified early. They should not responded to conservative management. If
be assessed for risk factors antenatally, during a conservative approach with the use of antibi-
labour and in the immediate post-partum otics is adopted or indeed chosen by the
period. Any risks identified should be clearly woman, the clinician must ensure that the
documented along with a plan of care. This patient is reviewed either in the community or
should include as a minimum, active manage- in a Gynaecology Assessment and Treatment
ment of the third stage of labour and any other Unit (GATU). This approach allows the clini-
measures specific to the type and severity of cian to reassess the patient and be proactive in
haemorrhage thought to be most likely. adopting surgical management should conser-
Recognition of significant postpartum haem- vative measures fail.
orrhage may not be obvious if there is low Communication is vital, and the clinician
level persistent bleeding. Regular clinical must arrange timely follow-up, preferably, in a
assessments including the use of and correct quiet setting, in order to debrief the woman and
interpretation of MEWS/MEOWS charts is her partner and address any concerns they may
essential to avoid missing the ‘slow bleeder’. have.
The initial management of postpartum haem- When a woman initiates a claim after a post-
orrhage is uncontroversial and is widely avail- partum haemorrhage, a court will determine neg-
able in a number of national and international ligence based on:
guidelines [15, 16]. It is therefore essential
that the practitioner adheres to these guide- • What was said or not—Montgomery [19]
lines unless there is a very good reason not to • What was done or not—Bolam [20], England,
do so. An adverse outcome following widely Wales & NI; Hunter [21], Scotland
accepted practice is easier to defend than one • Whether harm occurred as a direct result
which arises after deviation from standard
practice. It is good practice to ensure that The standard for valid consent is high. When
every decision for a post-partum hysterectomy proposing a treatment, with its attendant risks
is discussed with at least one other senior and benefits, a clinician must consider whether
clinician. “a reasonable person in the patient’s position
In the UK, the most common source of liti- would be likely to attach significance to the
gation in relation to postpartum haemorrhage risk, or whether he is or should reasonably be
involves the management of persistent bleed- aware that the particular patient would be likely
ing with retained products [4]. Before under- to attach significance to it.” It is therefore vital
taking uterine evacuation at any time in the that when undertaking a placenta accreta cae-
puerperium, it is essential that the clinician sarean section or transferring a woman bleed-
carefully counsels the patient about the risk of ing heavily to theatre, that the clinician explains
perforation, return to theatre, hysterectomy clearly and calmly that hysterectomy is a poten-
and subsequent intra uterine adhesions. tial outcome. This is particularly important in
Surgical evacuation with antibiotic cover women of low parity in whom fertility may be
should be offered to women with secondary an important consideration. It is also vital to
post-partum bleeding/loss and scan findings of communicate this calmly and sensitively to her
a thickened endometrium (over 25 mm) and an partner.
echogenic mass. In the authors unit, endome- If the clinician’s actions are not “in accor-
trial measurements with echogenic masses are dance with a practice accepted as proper by a
not reported. All women with an echogenic responsible body”, (Bolam) or those “which no
mass in the uterine cavity of 3 cm or more are doctor of ordinary skill in that field would have
offered surgical evacuation. Surgical evacua- taken if acting with ordinary care”, (Hunter),
tion should also be offered to women with neg- then they have breached their duty of care to the
196 S. O. Porter
patient. Breach of duty may be an act of omission Mrs. H’s condition deteriorated, and she began to
or commission. If harm follows as a direct result develop disseminated intravascular coagulation.
the clinician will be found to have been negli- Mr. L reported this to the patient’s husband,
gent. The standard likely to be employed is that informing him that “there were no options” other
set by national evidence-based guidelines. than removing the uterus.
The importance of clear, comprehensive, con- It was impossible to gain informed consent
temporaneous documentation cannot be over- from the patient as a consequence of her clinical
emphasized. Illegible, incomplete documentation condition at that time. Mr. L proceeded to per-
may create an impression of a laissez-faire form a hysterectomy. Mrs. H made a satisfactory
approach to the care of the patient. Furthermore, recovery from her surgery but made a claim
as the limitation period is currently 3 years the against Mr. L for his management.
clinician may have no direct recollection of the Experts were critical of Mr. L, as he had failed
patient and so will be entirely reliant upon his to follow the hospital guidelines on the manage-
documentation. ment of postpartum haemorrhage and secondly
by not considering alternative surgical options
such as internal iliac artery ligation or ligation
34.6 Case Study of the uterine and ovarian arteries.
Furthermore, Mr. L had not documented why
Mrs. H, a 23-year-old professional photographer he had not considered less radical intervention
in her first pregnancy, was pregnant with twins. before resorting to a hysterectomy in such a
The pregnancy progressed without any complica- young woman in her first pregnancy. The case
tion, until week 36 when she went into preterm was settled out of court for a moderate sum.
labour. Mr. L was the obstetrician on duty. As the In this case, reported in the January 2013 edi-
first twin was a breech presentation, an emer- tion of the MPS journal [22], one could argue (as
gency caesarean section was performed under the author would) that Mr. L quickly concluded
spinal anaesthetic and both twins were delivered that the cause of the bleeding was surgical and
in good condition. therefore, returned the patient to theatre for an
Soon after the procedure, whilst still in the EUA. Deviation from the hospital guideline
recovery room, Mrs. H began bleeding steadily which in this case may have been appropriate at
vaginally and became hypotensive. She was the time, was not documented. There was also no
resuscitated with intravenous fluids. Mr. L admin- consultation with a consultant colleague. The
istered oxytocin with little effect, followed by issue of consent in these cases is fraught with dif-
insertion of misoprostol per rectum. ficulty but needs to be obtained in as sensitive
He did not follow hospital protocol for post- and compassionate manner as possible. It is not
partum haemorrhage which advised the adminis- clear whether the Obstetrician considered and
tration of ergometrine and carboprost if the discounted internal iliac or uterine artery liga-
bleeding continued despite the use of oxytocin. tion—it was not documented.
As the bleeding continued, Mr. L decided to take Documentation is crucial, particularly if treat-
Mrs. H to theatre for an examination under gen- ment departs from local or national guidelines. It
eral anaesthesia to identify the source of bleed- is also good practice to gain the support of a col-
ing. In the meantime, resuscitation continued league when performing a post-partum emer-
with blood products. gency hysterectomy.
During laparotomy, the uterus was found to be The importance of post-partum debriefing
atonic, but there was no rupture or evidence of any (which may be several appointments with the
retained products of conception. Unfortunately, woman and her partner) is vital.
blood loss in obstetrics: how accurate and consistent

Key Points: Postpartum Haemorrhage and are health-care professionals? Arch Gynecol Obstet.
2010;281:207–13.
RPOC Postnatal
6. Chua S, Ho LM, Vanaja K, Nordstrom L, Roy AC,
• Identify women at high risk for postpar- Arulkumaran S. Validation of a laboratory method
tum haemorrhage and document man- of measuring postpartum blood loss. Gynecol Obstet
agement plan. Investig. 1998;46:31–3.
7. Neill A, Thornton S. Secondary postpartum haemor-
• Ensure that delivery suites have the per- rhage. J Obstet Gynaecol. 2002;22:119–22.
sonnel, equipment and infrastructure to 8. Alexander J, Thomas PW, Sanghera J. Treatments
manage postpartum haemorrhage for secondary postpartum haemorrhage (review).
• Adhere to guidelines for major primary Cochrane Database Syst Rev. 2008;1
9. Groom KM, Jacobson TZ. The management of sec-
postpartum haemorrhage unless there is ondary postpartum haemorrhage.
a logical reason not to do so. 10. Pather S, Ford M, Reid R, Sykes P. Postpartum

• Ensure consent for surgical procedures curettage: an audit of 200 cases. Aust N Z J Obstet
is thorough and valid Gynaecol. 2005;45:368–71.
11. Deans R, Abbott J. Review of intrauterine adhesions.
• Ensure that documentation is contempo- J Minim Invasive Gynecol. 2010;17(5):555–69. Epub
raneous and meticulous 2010 Jul 24
• If secondary postpartum haemorrhage is 12. Edwards A, Ellwood DA. Ultrasonographic evalu-

managed conservatively, ensure that ation of the postpartum uterus. Ultrasound Obstet
Gynecol. 2000;16:640–3.
follow-up arrangements are made with 13. Mulic-Lutvica A, Axelsson O. Ultrasound finding
the woman of an echogenic mass in women with secondary
• Ensure that the woman and her partner postpartum hemorrhage is associated with retained
are offered at least one opportunity to be placental tissue. Ultrasound Obstet Gynecol.
2006;28:312–9.
debriefed following a postpartum haem- 14. King PA, Duthie SJ, Dong ZG, Ma HK. Secondary
orrhage in a quiet interruption free postpartum haemorrhage. Aust N Z J Obstet Gynaecol.
environment. 1989;29:394–8.
15. Mavrides E, Allard S, Chandraharan E, Collins

P, Green L, Hunt BJ, Riris S, Thomson AJ, on
behalf of the Royal College of Obstetricians and
Gynaecologists. Prevention and management of post-
References partum haemorrhage. BJOG. 2016;124:e106–49.
16. WHO recommendations for the prevention and treat-
1. MBRRACE-UK (2012–2014) – Saving lives, improv- ment of postpartum haemorrhage. World Health
ing mothers’ care. 2016. Organization. 2012.
2. MBRRACE-UK (2009–2012) – Saving lives, improv- 17. Bull v. Devon Area Health Authority [1993] 4 Med
ing mothers’ care. 2014. LR 117 (CA).
3. Waterstone M, Bewley S, Wolfe C. Incidence and 18. Wisher v. Essex AHA [1986] 3 All ER 801 (HL).
predictors of severe obstetric morbidity: case control 19. Montgomery v Lanarkshire Health Board [2015]

study. BMJ. 2001;322(7294):1089–93. discussion UKSC 11.
1093-1084 20. Bolam v Friern Hospital Management Committee

4. Maternity Claims – Information Sheet Postpartum [1957] 1 WLR 582.
Haemorrhage. Ten years of maternity claims – NHS 21. Hunter v Hanley 1955 SLT 213.
Litigation Authority. 2012;113–4. 22. Ignoring the guidelines. Medical Protection Journal. 1
5. Yoong W, Karavolos S, Damodaram M, et al. Observer Jan 2013.
accuracy and reproducibility of visual estimation of
Perineal Trauma and Episiotomy
35
Dharmesh S. Kapoor and Abdul H. Sultan
35.1 Background Posterior perineal tears have been reclassified

by Sultan (Fig. 35.1) [2–4] in which third and
All clinicians should be trained in accurately fourth degree tears are collectively referred to as
diagnosing and classifying perineal trauma. Per OASIs (Obstetric Anal Sphincter Injuries). These
rectal examination should be an integral part of are dealt with in the chapter on OASI.
post-partum perineal evaluation to exclude a third Rectal button-hole tears are outside this clas-
or fourth degree tear. Competency based assess- sification, but can also occur and predispose
ments should be mandatory for all clinicians per- women to rectovaginal fistula.
forming perineal repairs. Episiotomy should be
considered for operative vaginal delivery and
35.1.1 First Degree Perineal Tears
when clinically indicated in normal deliveries. A
60 degree angled mediolateral episiotomy at
These are diagnosed when only the perineal skin
crowning is the recommended technique.
is disrupted. While traditional midwifery practice
Perineal trauma affects 80% of pregnant
has been to leave them unsutured, it is recom-
women with nearly 50% requiring suturing. The
mended to suture 1st degree tears when there is
term is inclusive of injuries in the anterior and
bleeding, or when the tear is extensive. NICE [3]
posterior perineal compartments. Anterior trauma
recommends, “Advise the woman that in the case
includes injuries to the urethra, clitoris, and peri-
of first-degree trauma, the wound should be
urethral region. In addition, labial tears can occur.
sutured in order to improve healing, unless the
In the UK, perineal trauma was the fourth high-
skin edges are well opposed”.
est reason for obstetric medico-legal claims in
obstetrics over a ten-year period accounting for
8.7% of claims [1]. Thirty one million pounds were 35.1.2 Second Degree Perineal Tears
paid out for 441 claims made for perineal trauma.
These are diagnosed when the skin and perineal
muscles are disrupted. Studies have shown that
leaving 2nd degree tears unsutured can lead to
gaping wounds [3].
D. S. Kapoor
Royal Bournemouth Hospital, Dorset, UK NICE advises the following:
“Advise the woman that in the case of second-
A. H. Sultan (*)
Croydon University Hospital, Croydon, Surrey, UK degree trauma, the muscle should be sutured in
e-mail: abdulsultan@nhs.net order to improve healing.

https://doi.org/10.1007/978-3-319-78683-4_35
200 D. S. Kapoor and A. H. Sultan
Fig. 35.1 The Sultan First-degree tear: Injury to perineal skin and/or vaginal mucosa.
classification of perineal
trauma [2–4] Second-degree tear: Injury to perineum involving perineal muscles but not involving the
anal sphincter.
Third-degree tear: Injury to perineum involving the anal sphincter complex:
Grade 3a tear: Less than 50% of external anal sphincter (EAS) thickness torn.
Grade 3b tear: More than 50% of EAS thickness torn.
Grade 3c tear: Both EAS and internal anal sphincter (IAS) torn.
Fourth-degree tear: Injury to perineum involving the sphincter complex (EAS and IAS)
and anorectal mucosa.
If the skin is opposed after suturing of the sutured episiotomy angles of 40–60 degrees are
muscle in second-degree trauma, there is no need more important that the incision angles of 45–60
to suture it.” degrees [3].
The Royal College of Midwives also cautions
against leaving such trauma unsutured [4].
and Clinical Governance
35.1.3 Episiotomy Issues
An episiotomy is an incision performed to The explicit aim of an episiotomy is believed to

enlarge the vaginal outlet to facilitate delivery be to prevent OASIs that may occur otherwise.
of the baby. Only mediolateral episiotomies Common indications for episiotomy include sus-
are performed in the UK [3, 4] and Europe pected fetal distress, to prevent severe perineal
(some also perform lateral episiotomies) while tears when they are deemed imminent, a rigid/
median (midline) episiotomies are prevalent in inelastic perineum, prolonged second stage and
the USA. when there is need to enlarge the vaginal opening
Previously the concept of mediolateral episi- during operative vaginal deliveries.
otomy was one that was angled away from the A key question arises about which patient sub-
midline, and consequentially, the anal sphincter groups are at high risk for OASIs, and where an
muscle complex. However, there were no univer- episiotomy may logically be expected to be ben-
sally agreed definitions. Various authors recom- eficial in reducing the risk of OASIs.
mended episiotomies at 40–60 degrees and the The RCOG [3], NICE [4] and the NHS
technique recommended to cut from the posterior Litigation Authority report [1] acknowledge the
fourchette towards the ischial tuberosity of the literature showing a protective effect for medio-
woman in the lithotomy position [3, 4]. lateral episiotomies in operative vaginal
Recently, it has become known that an episi- deliveries.
otomy cut at 40 degrees results in a sutured angle NICE states, “Perform an episiotomy if there
of 22 degrees, and episiotomies cut at 60 degrees is a clinical need, such as instrumental birth or
resulted in sutured angles of 45 degrees [5–8]. It suspected fetal compromise”.
was also found that the suture angle of the episi- The RCOG Green-Top Guideline states, “there
otomy at 45 degrees resulted in a 20-fold OASIs is evidence that a mediolateral episiotomy should
reduction compared to a sutured episiotomy be performed with instrumental deliveries as it
angle of 25 degrees [9, 10]. The RCOG guidance appears to have a protective effect on OASIs.”
recommends a 60 degree angled episiotomy at Whilst there are other high risk groups identi-
the time of crowning and stresses the difference fied for OASIs such as Asian ethnicity, nullipar-
between the incision angle and the sutured episi- ity, shoulder dystocia, occipito-posterior position
otomy angle. The guidance also asserts that and birth weight > 4 kg, there are no large
35 Perineal Trauma and Episiotomy 201
randomised studies showing that a prophylactic competence in repairing perineal trauma, this
episiotomy is beneficial in reducing OASIs. should become mandatory for all obstetricians
There are no validated scoring systems that indi- and midwives.
vidualise the risk for a patient either.

35.2.1 Perineal Repair Techniques
Within a secondary review conducted by the
It is recommended both by the RCOG [3] and National Health Service Litigation Authority, the
RCM [11] that a rectal examination should be important reasons for litigation included
performed before and after suturing the perineal
tear or episiotomy. –– Grade and experience of the accoucheur who
NICE [3] recommends the following: sutured the laceration and conducted the
follow-up
• If the skin does require suturing, use a contin- –– Failure to consider a caesarean section
uous subcuticular technique. –– Failure to perform or extend the episiotomy
• Undertake perineal repair using a continuous –– Failure to diagnose the true extent and classi-
non-locked suturing technique for the vaginal fication of the injury including
wall and muscle layer. –– Failure to perform a proper rectal examination
• Use an absorbable synthetic suture material to –– Inadequacy of the repair, or failure to repair in
suture the perineum. the first instance were also reported as
• Offer rectal non-steroidal anti-inflammatory allegations.
drugs routinely after perineal repair of first-
and second-degree trauma provided these Failure to diagnose or classify the tear accu-
drugs are not contra-indicated. rately was claimed in 59% of deliveries per-
formed by midwives, and 66% of deliveries
The RCM [4] also endorses that the continu- performed by doctors. In both groups, 87% of
ous suturing method of suturing vagina, perineum the claims were confirmed as OASIS that had
and skin with an absorbable Polygalactin suture been under classified as first or second degree
is preferred to suturing the muscles with inter- tears.
rupted stitches and skin with transcutaneous
stitches.
35.4 Avoidance of Litigation
35.2.2 Training and Good Practice The above data highlights the importance of hos-
pitals providing time and resources to staff for
All doctors and midwives who care for women attending training courses in perineal trauma
during labour and delivery can repair perineal detection and repair [1].
birth trauma, provided that in addition to having The RCOG [3] and NICE [4] state that all
attended training sessions in assessment and women having a vaginal delivery are at risk for
repair they have been certified to be competent. OASI, and that a digital rectal examination prior
NICE recommends, “All relevant healthcare to commencing repair should be performed to
professionals should attend training in perineal/ assess the damage.
genital assessment and repair, and ensure that The RCOG also specifies that an appropriately
they maintain these skills [4].” trained clinician or a trainee under supervision
Although specialist registrars are required to should repair OASI [3], and it would be reason-
complete OSATS (Objective Structured able to assume that the same principles should
Assessment of Technical Skills) as a measure of apply for other grades of perineal trauma.
Systematic assessment of genital trauma Medico-legally, the RCOG guidance would be

should include [2–4]: considered more reflective of current practice and
therefore adherence to the NICE guidance and
–– Further explanation of what the healthcare not the RCOG guideline would not exonerate a
professional plans to do and why practitioner if OASIs occurred [12].
–– Confirmation by the woman that effective In 2013, the High Court awarded £1.6 million
local or regional analgesia is in place in damages to a woman where breach of duty of
–– Visual assessment of the extent of perineal care included failure to perform an episiotomy
trauma to include the structures involved, the adequately angled away from the anal sphincters.
apex of the injury and assessment of bleeding Therefore, it is vital to appreciate that a mediolat-
–– A rectal examination to assess whether there eral episiotomy sutured angle needs to be more
has been any damage to the external or inter- than 30 degrees away from the midline to prevent
nal anal sphincter if there is any suspicion that OASIs. The episiotomy also needs to be of ade-
the perineal muscles are damaged. quate length and depth to prevent additional tear-
ing. In accordance with NHSLA and RCOG
The woman should usually be in the lithotomy recommendations, a pictorial representation/pho-
position to allow adequate visual assessment of tograph of the sutured episiotomy scar would be
the degree of the trauma and for the repair itself. regarded as good practice in contentious cases.
This position should only be maintained for as It is in the normal deliveries that the role of
long as is necessary for the systematic assess- episiotomy remains debated. A large English
ment and repair. The systematic assessment and cohort of more than 1.2 million births and a sys-
its results should be fully documented, preferably tematic review have both found mediolateral epi-
pictorially. siotomy to be protective in first normal vaginal
The RCOG [3] states that failure to diagnose births, reducing OASIs by 67% [13, 14].
OASIS may be considered substandard care and The recent revision of episiotomy in the
be regarded as negligent. The NHSLA report [1] Cochrane review [2017] [15] has been retitled
endorses the RCOG point of view. It goes further ‘selective versus routine episiotomy’. Ironically,
to state that all women should be advised to the ranges in both selective (mean = 32%,
attend a post-natal check at 6–8 weeks after range = 8–59%) and routine (mean = 83%,
delivery and should be asked about their stitches range = 51–100%) groups overlapped, and there
and perineum. Women should be advised to was heterogeneity in trial criteria for selective
report symptoms of faecal incontinence. episiotomies. However, they did report reduced
The average settlement time by NHSLA is OASIs with selective episiotomies. It should be
4.3 years from the incident, but 8.5 years for borne in mind that none of the studies included in
more complex cases. Hence, it is important to this review measured the angle of the episiotomy.
consider this while planning financial reserve It has been shown that very few episiotomies
allocations for future liabilities. The erstwhile achieve a suture angle of 40 degrees [16]. If epi-
CNST maternity standards included perineal siotomies were being given inaccurately, there
trauma courses for all levels of certification. would be more OASIs expected in the routine
NICE (2015) [4] guidance did not revise the episiotomy group.
original section (2007) [4] concerned with episi- While such data are important in assessing the
otomy and therefore continues to mention an epi- overall benefit of a procedure, it is the application
siotomy incision angle of 45–60 degrees. of this knowledge to the individual patient that is
However there is now evidence that cutting episi- relevant from the medico-legal standpoint. The
otomies at 45 degree angles resulted in sutured decision to perform an episiotomy or not is based
episiotomy angles of 22 degrees, that puts women on the accoucheur’s clinical experience and
at a 20 times higher OASI risk, than if the sutured judgement and quite often it is a last minute deci-
episiotomy angle was around 45 degrees. sion. While most clinicians would consider an
35 Perineal Trauma and Episiotomy 203
episiotomy if it can expedite delivery in fetal dis- An endo-anal ultrasound scan confirmed
tress, it is the other indications where there are that the tear in the external anal sphincter was
subjective differences in perception. For exam- not present at the anal verge and was “occult”.
ple, if there has been a prolonged second stage This confirmed the findings of the specialist
with the head at the perineum for a length of registrar and the tear was not clinically
time, a rigid perineum could be the cause. An epi- detectable.
siotomy might be considered in such a situation. With good quality notes and independent radi-
The dilemma arises when the perineum begins ology, the claim was withdrawn and the Trust’s
to tear. The accoucheur has to judge whether it legal costs met. “However, since the publication
will result in a small first/second degree tear, or by Andrews et al. [17], for all intents and pur-
extend to an OASI. The decision cannot be criti- poses, occult injuries of the external sphincter do
cised in retrospect, as routine episiotomy in nor- not exist and therefore such cases would no lon-
mal deliveries is not recommended by RCOG/ ger be defensible.
NICE. It would, however, be worthwhile consid-
ering other proven and recommended interven-
tions such as manual perineal protection and
warm perineal compresses. Failure to employ Key Points: Perineal Trauma and Episiotomy
(and document) any measures to reduce OASIs –– Perineal trauma is the fourth highest rea-
could be viewed with concern. son for medicolegal claims in obstetrics.
Under English law, the testimony of the expert –– It can lead to long-term problems of
witness will remain paramount in informing the sexual dysfunction and dyspareunia
Court. However, any clinician who has failed to even without OASIS.
adhere to national guidelines and does not have a –– Episiotomies that are too acute (less
reasonable explanation for his/her actions will be than 30 degrees suture angle) or too
inviting the court to uphold the allegations of wide (more than 60 degrees suture
negligence [12]. Hence it is recommended that angle) have higher incidence of OASIS
clinicians consider episiotomy during operative –– Perineal trauma should be appropriately
vaginal delivery, and perform episiotomies at 60 classified. A drawing or pictorial repre-
degrees away from the midline when clinically sentation is desirable.
indicated. –– Trusts should provide adequate training
in detection and repair of perineal
trauma.
35.5 Case Study –– Per rectal examination must be per-
formed before and after suturing
A patient’s delivery was being managed by a –– Episiotomy must be performed at 60
senior registrar, under the supervision of the con- degree angle to the midline at crowning.
sultant obstetrician. It was completed using –– Episiotomy should be considered in
Keilland’s forceps after three tractions. The med- operative vaginal deliveries especially
ical records were detailed. A second degree tear forceps.
was sutured and a first degree tear was also noted.
No third degree tear was noted nor an extension
to the episiotomy. This was said to be a straight-
forward delivery. Conflicts of Interest DS Kapoor is a co-inventor of the
EPISCISSORS-60 episiotomy scissors. He is a share-
The claimant developed disabling faecal holder of MEDINVENT LTD, the company that owns the
incontinence as a result of a third degree tear. She commercial rights to the scissors.
was unable to work. Her claim was valued in the AH Sultan-none.
region of £500,000.
References 9. Eogan M, Daly L, O’Connell PR, O’Herlihy C. Does

the angle of episiotomy affect the incidence of anal
sphincter injury? BJOG. 2006;113:190–4.
1. Ten Years of Maternity Claims: An Analysis of NHS
10. Stedenfeldt M, Pirhonen J, Blix E, Wilsqaard T, Vonen
Litigation Authority Data. ISBN: 978–0–9565019-2-
B, Qian P. Episiotomy characteristics and risks for
9. http://www.nhsla.com/safety/Documents/Ten%20
obstetric anal sphincter injury: a case-control study.
Years%20of%20Maternity%20Claims%20-%20
BJOG. 2012;119:724–30.
An%20Analysis%20of%20the%20NHS%20LA%20
11. Evidence Based Guidelines for Midwifery-Led Care
Data%20-%20October%202012.pdf.
in Labour ©The Royal College of Midwives 2012.
2. Sultan AH, Thakar R, Fenner D. Perineal and anal
12. Sultan AH, Ritchie A, Mooney G. Obstetric anal

sphincter trauma. London: Springer; 2007. p. 13–32.
sphincter injuries: Review of recent medico-legal
3. RCOG Greentop guideline 29: the management of
aspects. Clinical Risk. 2016;0(0):1–4. https://doi.
third and fourth-degree perineal tears: RCOG June
org/10.1177/1356262216676131:.
2015, www.rcog.org.uk.
13. Gurol-Urganci I, Cromwell D, Edozien L, Mahmood
4. Intrapartum care. National Institute of Health and
T, Adams E, Richmond D, Templeton A, van der
Care Excellence (2014), [CG190]. London: www.
Meulen J. Third- and fourth-degree perineal tears
nice.org.uk/guidance/cg190.
among primiparous women in England between
5. Kalis V, Landsmanova J, Bednarova B, Karbanova J,
2000 and 2012: time trends and risk factors. BJOG.
Laine K, Rokyta Z. Evaluation of the incision angle of
2013;120:1516–25.
mediolateral episiotomy at 60 degrees. Int J Gynecol
14. Verghese TS, Champaneria R, Kapoor DS, Latthe
Obstet. 2011;112:220–4.
PM. Obstetric anal sphincter injuries after episiotomy:
6. El-Din AS, Kamal MM, Amin MA. Comparison
systematic review and meta-analysis. Int Urogynecol J.
between two incision angles of mediolateral episiot-
2016;27(10):1459–67. https://doi.org/10.1007/s00192-
omy in primiparous women: a randomised controlled
016-2956-1. Epub 2016 Feb 19.
trial. J Obstet Gynaecol Res. 2014;40:1877–82.
15. Jiang H, Qian X, Carroli G, Garner P. Selective versus
7. Freeman RM, Hollands H, Barron L, Kapoor
routine use of episiotomy for vaginal birth. Cochrane
DS. Cutting a Mediolateral Episiotomy at the Correct
Database Syst Rev. 2017;(2):CD000081.
Angle: Evaluation of a new device: The Episcissors-60.
16. Andrews V, Thakar R, Sultan AH, Jones PW. Are
Med Devices (Auckl). 2014;7:23–8. https://doi.
mediolateral episiotomies actually mediolateral?
org/10.2147/MDER.S60056.eCollection2014.
BJOG. 2005;112(8):1156.
8. Sawant G, Kumar D. Randomized trial comparing
17. Andrews V, Thakar R, Sultan AH, Jones PW. Occult
episiotomies with Braun-Stadler episiotomy scissors
anal sphincter injuries—myth or reality? BJOG.
and EPISCISSORS-60(®). Med Devices (Auckl).
2006;113:195–200.
2015;8:251–4. https://doi.org/10.2147/MDER.S83360.
eCollection2015.
Part IV
General Gynaecology
Swati Jha and Janesh Gupta
Abdominal Hysterectomy
36
Thomas Keith Cunningham and Kevin Phillips

Hysterectomy is one of the most common surgi-
cal procedures for managing benign gynaecolog- NICE have recently issued guidance that hyster-
ical disease such as, abnormal uterine bleeding, ectomy should not be performed as a first line
fibroid uterus, and prolapse, with reportedly 30% treatment for heavy menstrual bleeding (HMB).
of women in the US by the age of 60 undergoing Hysterectomy should only be considered when
the procedure [1]. Up until the 1990s the vast other medical treatments have failed (NICE
majority of hysterectomies were performed either CG44) [3]. This includes a trial of levonorgestrel-
vaginally or abdominally and this may have var- releasing intrauterine system, for at least
ied from region to region depending on the train- 12 months, transexamic acid or non-steroidal
ing undertaken. The advances in laparoscopic anti-inflammatory drugs (NSAIDs) or combined
surgery have allowed hysterectomies to be per- oral contraceptive pills or norestesterone daily
formed totally laparoscopically or laparoscopi- from days 5 to 25 of the menstrual cycle in women
cally assisted with the uterus being removed with no or small <3 cm fibroids. For those women
vaginally. Gynae-oncologists now offer laparo- with fibroids greater than 3 cm GnRH analogues
scopic hysterectomies for certain stages of endo- can be offered. Use of Ulipristal acetate will
metrial cancer (NICE IPG 356) [2]. depend on the guidance issued following review,
as it was temporarily stopped in February 2018.
T. K. Cunningham · K. Phillips (*)

Department of Obstetrics and Gynaecology, Hull and
East Yorkshire Hospitals NHS Trust, Hull, UK
e-mail: Keith.Cunningham@hey.nhs.uk;
Kevin.Phillips@hey.nhs.uk

https://doi.org/10.1007/978-3-319-78683-4_36
208 T. K. Cunningham and K. Phillips
Endometrial ablation can be offered when osis. Previous medical and surgical history,
medical management has failed to control the comorbidities, previous management of their
women’s symptoms and the bleeding is still hav- condition, and the women’s preference must be
ing an effect on their quality of life and fertility is taken into consideration. The patient must be
not an issue, or as a first line if the women is fully made aware of the various surgical techniques,
counselled of the risks and benefits of the which include:
procedure.
Women can undergo numerous medical and • Total abdominal hysterectomy
less invasive surgical procedures that can be per- • Vaginal hysterectomy
formed in the outpatient department rather than • Laparoscopically assisted vaginal
undergoing major abdominal surgery. At this hysterectomy
point hysterectomy should only be considered • Total laparoscopic hysterectomy
when:
Selecting what type of hysterectomy to per-
• The above treatments have failed or are form will be based on a number of factors, these
unsuccessful include the surgical proficiency of the surgeon,
• The women wishes amenorrhea the woman’s characteristics (previous surgery,
• The women no longer wishes to retain her BMI, parity) and clinical evidence. These are all
uterus and thus her fertility important factors when consenting a patient for
• A fully informed women requests it surgery as these will directly effect the risks of
surgery and the short/long-term morbidity of the
Hysterectomies are thus being offered less woman.
frequently as a result of the introduction of NICE states the surgeon must assess each
these uterus-preserving treatments. This has a patient individually and consider several factors
direct effect on the skills of the gynaecological including:
surgeons of the future. Thus not all gynecolo-
gists will be able to perform a hysterectomy • Uterine size
independently. In fact the RCOG offer • Presence and size of uterine fibroids
Advanced Training Skills Modules (ATSM) • Mobility and descent of the uterus
titled Benign abdominal surgery: open and lap- • Size and shape of the vagina
aroscopic, to develop skills to perform routine • History of previous surgery
gynaecological procedures and the advanced • Presence of any other gynaecological condi-
laparoscopic ATSM to train for more advanced tions or disease
laparoscopic surgery including laparoscopic
myomectomies and total laparoscopic hysterec- The woman must also be made aware why
tomies. This demonstrates that modern training certain surgical approaches are not appropriate
is also adapting to the change in practice and for them and if the woman chooses an option not
only those gynaecologists trained to a specific available at that unit they must be offered referral
level will be allowed to perform these proce- to an appropriately trained surgeon.
dures independently.
Women considering a hysterectomy must be
informed of the risks and benefits of surgical and 36.3 Reasons for Litigation
medical management of their condition whether
that is due to HMB, pressure symptoms second- The reasons for litigation following a hysterec-
ary to fibroids, or pain associated with adenomy- tomy are related to
36 Abdominal Hysterectomy 209
• Preoperative counselling and choices hysterectomy and bowel injuries in vaginal hys-
provided terectomy. Makinen et al. [6] then published a ten
• Preoperative investigation year follow up and noted that the overall compli-
• Consent and discussion of complications cation rates fell significantly for laparoscopic
• Training of the surgeon hysterectomy over the 10 year period demon-
• Complications arising during or after the sur- strating the benefits of surgical experience.
gery and failing to recognise and deal with To reduce complications follow appropriate
them at the time of surgery structured surgical technique including safe port
• Negligently causing or contributing to known entry at laparoscopy. Women must be counselled
risks of the surgery, including bladder, ure- regarding the risks of the laparoscopic entry tech-
teric, bowel, vaginal vault granulation and nique [7] (RCOG Green-top No.49) [8]. These
post operative infections include injury to the bowel, urinary tract and major
• Unnecessary or improper surgery vessels. The difficulty in that bowel injury may not
be immediately recognised and patients usually
present after discharge from hospital. Following
36.4 Avoidance of Litigation open or laparoscopic entry the importance of good
exposure of the operative field, including full
As with any consultation, the patient must have examination of the pelvis and associated structures
undergone the necessary preoperative assessment should be undertaken to plan the surgical approach.
and the appropriate investigations arranged such The most common cause of litigation following
as an USS or MRI for fibroid uterus or endome- a hysterectomy is a ureteric injury and the failure
trial biopsy to exclude pathology. At this point to recognise these injuries frequently results in a
the patient can be counselled and offered medical successful claim [9]. Ureteric injury remains a
and/or surgical treatments for their condition, but major concern regarding laparoscopic hysterec-
the consequences and risks of having no treat- tomy. A large meta-analysis of 47 studies by Aarts
ment must also be explained (RCOG CGA6) [4]. et al. [1] was underpowered to detect any clinically
If surgery is required the surgeon should discuss significant increase in bladder and ureter injuries
the options available, with an explanation of the as separate entities for a laparoscopic approach to
risks and complications and supply a patient total abdominal hysterectomy, however when
information sheet and offer the patient thinking these two entities were pooled they detected a sig-
time if they require it. nificant increase in urinary tract injuries for lapa-
NICE recommend that all surgeons undertak- roscopic injury versus abdominal hysterectomy.
ing hysterectomy should demonstrate compe- The most common sites of ureteric injury
tence in both their consultation and technical are [10].
skills during training and in subsequent practice
(NICE CG44) [3]. Those surgeons undertaking • Lateral to the uterine vessels
training should be assessed by trainers through a • Uterovesicle junction adjacent to the cardinal
structured process as per the RCOG ATSM pro- ligaments
cess or alternative systems in place. Makinen • The base of the infundibulopelvic ligaments
et al. [5] prospectively reported on the surgical as the ureters cross the pelvic brim at the ovar-
learning curve of 10,110 hysterectomies for ian fossa
benign disease (5875 abdominal, 1801 vaginal • At the level of the uterosacral ligament
and 2434 laparoscopic). The surgeons experience
significantly correlated inversely with the occur- The appropriate use of urology if required for
rence of urinary tract injuries in laparoscopic assistance in visualising ureters or inserting ureteric
210 T. K. Cunningham and K. Phillips
stents in those women with complex anatomy for with decreased venous return associated with
example distorted by fibroids, adhesions or endo- pneumoperitoneum [14].
metriosis. With caesarean section rates on the rise, Laparoscopic procedures rely on the use of
this can increase the risk of both bladder and bowel electrocautery which result in a large proportion
injuries at hysterectomy by any approach as the of both ureteric and bowel injuries. It is impera-
bladder is adherent to the uterus and also the risk of tive that throughout both laparoscopic and abdom-
bowel adhesions. inal surgery always visualise the electro-cautery
Damage to the bowel is another common vis- device and to remember that the tip of the instru-
ceral injury associated with hysterectomy. Aarts ment may remain hot even after the power has
et al. [1] found bowel injury more likely to occur been turned off after use. These injuries are often
in abdominal hysterectomy. The risk of adhesion not detected at the time of surgery and usually the
related-bowel obstruction was investigated by patient will represent with abdominal pain.
Al-Sunaidi and Tulandi [11] in 326 women admit-
ted for small bowel obstruction. Once malignancy
was excluded, of the 135 remaining cases 50.4% 36.5 Case Study
were related to gynaecological surgery, most
commonly total abdominal surgery with no cases In the case of Hooper vs. Young [1995] C.L.Y.
following laparoscopic hysterectomy. 1717, the claimant underwent a routine abdomi-
It would now be routine for patients to receive nal hysterectomy and had a left ureteric injury. it
prophylactic antibiotics following a hysterec- was felt that unintended kinking of the ureter was
tomy, irrespective of the route. A recent Cochrane caused by the proximity of a suture, and was
review [12] shows a significant reduction of post- negligent.
operative infections with antibiotic use. There is In the court of appeal (Hooper vs. Young
no clear consensus on dose regimen or route [1998] Lloyds Rep Med 61), this judgement of
though it would be usual to give intravenous negligence was reversed based on evidence given
broad spectrum coverage intraoperatively. by experts. The claimant and defendant experts
All patients must be counselled and risk unanimously agreed that if a ureter was obstructed
assessed regarding VTE prevention. Appropriate during a hysterectomy by an encircling suture or
measures taken to reduce an intraoperative the application of a clamp, then substandard sur-
VTE, for example intermittent pneumatic com- gery had been performed. However, if the ureter
pression devices. If complications arise it is had been kinked by a suture, then liability was at
necessary to reassess the VTE status of the issue. They concluded that the ureteric kinking
patient postoperatively. Barber et al. [13] stud- arose by a non-negligent cause. The four methods
ied VTE events on a database of 44,167 sub- by which the ureter might be damaged are a mis-
jects undergoing hysterectomy for benign placed encircling stitch, a misplaced clamp, kink-
disease. 12,733 underwent total abdominal hys- ing of the ureter by a stitch placed near the suture
terectomy, 22,559 underwent laparoscopic hys- and use of diathermy.
terectomy and 8857 underwent vaginal The Appeal Court Judges accepted the evi-
hysterectomy. Women who underwent a total dence of the patient’s urologist that he had found
abdominal hysterectomy had a 3-fold increase a lot of fibrosis around the ureter that could not
in the risk of VTE compared to minimally inva- have been predicted. This judgement demon-
sive surgery (laparoscopic and vaginal). This strates that each case must be considered on its
increase persisted even after for controlling for own merits and there may be a non-negligent
BMI, smoking, age, diabetes and hypertension. explanation for ureteric damage if it is probable
However prolonged operating times with lapa- that the mechanism of ureteric damage is kinking
roscopic surgery can increase the risk of VTE and not direct trauma.
36 Abdominal Hysterectomy 211
assisted vaginal hysterectomy) for endometrial can-

cer. 2010 Interventional procedures guidance 356.
Key Points: Abdominal Hysterectomy
3. NICE Heavy menstrual bleeding: assessment and
• Patients must be assessed and all forms management. Clinical guideline [CG44] Published
of medical treatment must be discussed date: January 2007.
and offered to the patient. 4. Royal College of Obstetricians and Gynaecologists.
Obtaining Valid Consent. London: RCOG; 2008.
• Thorough preoperative counselling and http://www.rcog.org.uk/files/rcog-corp/CGA6-
patient choice. 15072010.pdf
• The procedure whether open or laparo- 5. Mäkinen J, Johansson J, Tomás C, Tomás E, Heinonen
scopic must be undertaken by an appro- PK, Laatikainen T, et al. Morbidity of 10 110 hys-
terectomies by type of approach. Hum Reprod.
priately trained surgeon who is aware of 2001;16(7):1473–8.
the surgical risks and complications. 6. Mäkinen J, Brummer T, Jalkanen J, Heikkinen AM,
• Good surgical technique will allow Fraser J, Tomás E, et al. Ten years of progress-improved
prompt recognition of complications hysterectomy outcomes in Finland 1996-2006: a longi-
tudinal observation study. BMJ Open. 2013;3(10)
and their management. 7. Ahmad G, Gent D, Henderson D, O’Flynn H,
• Safe laparoscopic entry technique and Phillips K, Watson A. Laparoscopic entry tech-
exclude visceral injury after primary niques. Cochrane Database of Systematic Reviews
trocar insertion. 2015, Issue 8. Art. No.: CD006583. DOI: https://doi.
org/10.1002/14651858.CD006583.pub4
• Have in insight to know when necessary 8. Sutton CJG and Phillips K. Preventing Entry-Related
to convert laparoscopic procedure to Gynaecological Laparoscopic Injuries. RCOG Green-
open procedure in the event of top Guideline No.49. 2008.
complications. 9. Jha SD, Rowland ST. Litigation in gynaecology.
Obstet Gynaecol. 2014;16:51–7.
• Appropriate follow up of patients. 10. Jha S, Coomarasamy A, Chan KK. Ureteric injury
in obstetric and gynaecological surgery. Obstet
Those patients that present with delayed Gynaecol. 2004;6:203–8.
complications are managed appropriately 11.
Al-Sunaidi M, Tulandi T. Adhesion-Related
Bowel Obstruction After Hysterectomy for Benign
with necessary clinical governance proce- Conditions. Obstet Gynecol. 2006;108:1162–6.
dures undertaken. 12. Ayeleke R, Mourad S, Marjoribanks J, Calis KA,

Jordan V. Antibiotic prophylaxis for elective hyster-
ectomy. Cochrane Database of Systematic Reviews
2017, Issue 6. Art. No.: CD004637. DOI: https://doi.
org/10.1002/14651858.CD004637.pub2
References 13. Barber EL, Neubauer NL, Gossett DR. Risk of venous
thromboembolism in abdominal versus minimally
1. Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry invasive hysterectomy for benign conditions. Am J
R, Mol BW, et al. Surgical approach to hysterectomy Obstet Gynecol. 2015;212:609.e1–7.
for benign gynaecological disease. Cochrane Database 14. Nguyen NT, Cronan M, Braley S, Rivers R, Wolfe
of Systematic Reviews 2015, Issue 8. Art. No.: BM. Duplex ultrasound assessment of femoral venous
CD003677. DOI: https://doi.org/10.1002/14651858. flow during laparoscopic and open gastric bypass.
CD003677.pub5 Surg Endosc. 2003;17(2):285–90.
2. NICE. Laparoscopic hysterectomy (including lapa-
roscopic total hysterectomy and laparoscopically
Diagnostic and Operative
Laparoscopy 37
Andrew Baxter
37.1 Background their symptoms. The consent process should be car-

ried out in accordance with the judgment in the case
Laparoscopic complications are one of the main of Montgomery v Lanarkshire Health Board, which
sources of medical litigation in the UK, with inci- consolidated the pre-existing GMC guidance on
dents of visceral injury from ‘blind’ insertion of consent: “Consent: Patients and Doctors Making
the primary trocar making up a large share of Decisions Together”, 2008. It is now mandated to
claims. It worth bearing in mind that the thresh- discuss and to document all conservative, medical
old for litigation can be low in diagnostic proce- and surgical options available to the patient. If sur-
dures, as women generally are suffering from gery is chosen, the pros and cons of laparoscopic
benign conditions and the decision for surgery versus open surgery should be discussed.
can therefore be based on a delicate balance of It is important to clarify and document any
quality of life and risk. ‘Minimal access’ surgery potential limitations to the operative part of the
also suggests small incisions with a fast recovery, planned procedure. The patient themselves may
leaving patient expectations to be high. place restrictions on the type of surgery under-
taken, but the clinician should make it clear
where their limits lie and whether, depending on
37.2 Minimal Standards the surgical findings, a further laparoscopy might
and Clinical Governance be required under a more specialist surgeon.
Issues Specific risks of a diagnostic laparoscopy are
detailed in the RCOG Green top guideline No.49:
37.2.1 Pre-operative Counseling “preventing entry-related gynaecological laparo-
scopic injuries” [1]. The quoted incidences of lapa-
As with any procedure the decision to opt for sur- roscopic complication rates vary considerably
gery should only be taken after a comprehensive between reports and the experience of the surgeon.
discussion of the risks and benefits of the operation, They also increase significantly in obese patients
allowing the patient to weigh up such risks against and those with other pathologies. The RCOG
Consent advice on diagnostic laparoscopy states that
women should be informed of the following risks:
A. Baxter
Department of Obstetrics and Gynaecology, Jessop • Serious risks (injury to bowel, bladder or
Sheffield, UK major blood vessel requiring immediate lapa-
e-mail: tedbaxter@btinternet.com rotomy): 2 in 1000 cases

https://doi.org/10.1007/978-3-319-78683-4_37
214 A. Baxter
• Failure to gain entry to abdominal cavity geon should use a proven one that they find most
• Death in 3–8 women in every 100,000 successful and comfortable [2].
• Blood transfusion
37.2.3.2 Site of Primary Port
The frequent more minor risks are bruising, In most cases the ideal location for the primary
infection, dehiscence of the port sites and port is at the base of the umbilicus, where the
shoulder- tip pain. Women should also be abdominal wall is thinnest and the abdominal lay-
informed that they may require a laparotomy, ers tend to be closely attached. However, when
blood transfusion or repair of visceral damage. the chances of intra-abdominal adhesions are
Women undergoing a diagnostic laparoscopy increased, insertion in the left upper quadrant, or
should be advised that the chance of negative Palmer’s point, is advised. In women with a mid-
laparoscopy is up 50%. This may be reassuring or line scar the incidence of adhesions underneath
useful in planning future treatment, but it is may be up to 50%; in such cases it is inappropri-
important to set realistic expectations on the out- ate to insert a primary port in the umbilicus.
come of surgery.
It is good practice to record all written patient 37.2.3.3 Gas Pressure
information leaflets given to the patient If a closed technique is used the gas pressure
pre-operatively. should be increased to 20–25 mmHg before
insertion of the primary port to reduce the risk of
major vascular injury by the trocar.
37.2.2 Surgical Training
37.2.3.4 Secondary Port Insertion
It is essential that any surgeon undertaking a lap- This should be performed under direct vision
aroscopy has received the requisite training or is ensuring that the inferior epigastric vessels are
adequately supervised, is familiar with the equip- avoided. In most patients this artery with its veins
ment and has suitable assistance. Independent are readily visible on the underside of the abdom-
performance of a diagnostic laparoscopy should inal wall. However, in obese patient identification
be within the remit of any trainee in obstetrics in may not be so easy. As these vessels are in most
gynaecology who has completed RCOG core cases located 6 cm or less from the midline,
training. Operative laparoscopy would generally inserting secondary ports in a perpendicular fash-
require, as a minimum, completion of the RCOG ion lateral to that distance will generally avoid
advanced training module in benign gynaecol- this vascular injury. A surgeon should have a
ogy, or equivalent. clear plan for the management of an injury to the
inferior epigastric vessels. Options for treatment
are suturing with a port-closure device or large
37.2.3 Operative Technique curved needle, tamponade with a urinary catheter
balloon or direct suturing after extension of the
37.2.3.1 Primary Port Insertion abdominal wall incision.
Gynaecologists have tended to prefer the closed
Veress needle technique for primary port inser- 37.2.3.5 Port-closure
tion, although increasingly direct access optical A port-site hernia can occur in any location and
ports are being used. General surgeons have gen- with any size trocar. However, the risk only
erally favoured the open Hasson technique. There becomes significant with secondary ports larger
is no strong evidence to indicate which method is than 8 mm and the sheath of all secondary ports
safest, but whichever technique is used the sur- >8 mm should be sutured. Umbilical primary port
37 Diagnostic and Operative Laparoscopy 215
sites often do not require closure of the sheath, A surgeon should ensure that they are adequately
although each case should be assessed individually. trained for the procedures they are undertaking.
However, in very slim patients, consideration The surgeon should rigidly adhere to the same
should be given to closure of the sheath of all ports. criteria for diagnostic laparoscopy in both private
and NHS practices. A lack of indication for sur-
37.2.3.6 Post-operative Care gery could leave a surgeon open to litigation
Any patient who has undergone laparoscopic sur- should a recognized complication arise in an oth-
gery should improve steadily in the days following erwise competently performed procedure.
surgery. Patients should be informed therefore to The primary port should be inserted in a standard
contact the hospital directly if they develop technique. If a complication should arise in a case
increasing abdominal pain, a pyrexia or become when a non-standard technique is used, the onus
systemically unwell. Any patient presenting in the would be on the surgeon to demonstrate that their
post-operative phase with the above features method was based on sound surgical concepts.
should be assumed to have a visceral injury until Secondary ports should be inserted under
proven otherwise. The white cell count and direct vision. Visceral injury during this part of
C-reactive protein levels should be monitored and the procedure would be hard to defend.
if there is any concern over a perforation, a CT Close the rectus sheath in all port sites greater
scan should be performed. Clearly if bowel or vas- than 8 mm.
cular damage has occurred a laparotomy should be A high index of suspicion should be maintained
undertaken, but in more borderline cases a diag- for any patient presenting with potential signs of
nostic laparoscopy can be performed. visceral or vascular damage. Appropriate investiga-
tions should be undertaken early and if necessary
repeatedly. Should a complication occur, an appro-
37.3 Reasons for Litigation priate specialist colleague should be asked to attend
promptly; a substandard repair of any trauma would
Litigation may arise from the following only compound the potential adverse outcome and
in turn, the risk of a successful litigation.
• Failure to warn of the risks including laparot- Any complication should be discussed fully
omy and visceral injury and frankly with the patient at the time and then
• Failure to adhere to the Guidance of preven- again in clinic a few weeks later.
tion on entry related injuries A surgeon should maintain a prospective
• Intra-operative visceral damage (bowel, blad- record of their surgical practice along with their
der or blood vessels) complication rate.
• Failure to diagnose visceral damage at the
time of surgery
• Failure to close ports adequately 37.5 Case Study
Greenall v ST Helens & Knowsley Hospitals

37.4 Avoidance of Litigation NHS Trust (2009)
During a diagnostic laparoscopy the claimant
Pre-operative counseling should be thorough and suffered a vascular injury to her aorta with the for-
comprehensive allowing the patient time to con- mation of a large haematoma. It was identified
sider all treatment options and whether the risks during surgery when her blood pressure fell sig-
of surgery are justified in relation to the potential nificantly and as a result an emergency laparotomy
benefits. was performed. A vascular surgeon was called
216 A. Baxter
from a neighbouring hospital and they detected a

perforation on the right side of the claimant’s • Primary and secondary ports should be
aorta, above the right common iliac artery. This inserted using sound, proven
was caused by a failure to insufflate the abdomen techniques
sufficiently during the laparoscopy. The perfora- • A high index of suspicion for visceral
tion was subsequently closed. The claimant spent injury should be maintained should a
several weeks in hospital and suffered extreme patient become unwell post-operatively
pain and immobility during the recovery. She
required assistance in her day to day activities and Clear and thorough note-keeping on
suffered occlusion of her right common iliac need- pre-operative discussions, the procedure
ing several angioplasties. itself, as well as a prospective log of opera-
Liability was admitted by the Trust and an out tion numbers and any complications will
of court settlement for £40,000 made. facilitate the defence of any claim.
Learning points include the need to adhere to
basic principles during abdominal entry for a lapa-
roscopy. Mere detection of an injury is not a guar-
antee against litigation if adequate precautions to References
prevent it from happening have not been taken.
1. Green-top guideline 49. Preventing entry-related gyn-
aecological laparoscopic injuries. London: RCOG;
2008.
Key Points: Diagnostic and Operative 2. Ahmad G, Duffy JMN, Phillips K, Watson
Laparoscopy A. Laparoscopic entry techniques (protocol).
• Fully informed consent in line with Cochrane Database Syst Rev. 2007;3:CD006583.
https://doi.org/10.1002/14651858.CD006583.
Montgomery and the GMC
• A clinician should not attempt proce-
dures without adequate training
Diagnostic and Operative
Hysteroscopy 38
Ertan Saridogan
38.1 Background copy [1]. The BSGE, in association with the

European Society for Gynaecological Endoscopy
Modern hysteroscopy for the diagnosis and treat- (ESGE) published guidelines on the management
ment of intrauterine disorders has been an inte- of fluid distension media for operative hysteros-
gral part of clinical practice since the second part copy [2]. The National Institute for Health and
of the twentieth century after the development of Care Excellence (NICE) has guidelines on the
cold light fiberoptics. With the development of management of women with heavy menstrual
hysteroscopic resectoscopes, minihysteroscopes, bleeding [3] and evidence based recommenda-
endometrial ablation techniques and hystero- tions on hysteroscopic metroplasty [4, 5], sterili-
scopic morcellators, it has been possible to treat sation [6] and morcellation [7].
many gynaecological conditions arising from the Initial assessment of the patient should include
uterine cavity in an ambulatory or outpatient set- a history and clinical examination if appropriate.
ting. There are now a wide range of indications Alternatives to hysteroscopy for diagnosis and
for diagnostic and operative hysteroscopy treatment should be considered. Alternatives to
(Table 38.1). Diagnostic and therapeutic hystero- diagnostic hysteroscopy include pelvic ultra-
scopic procedures may be carried out in the out- sound examination with or without endometrial
patient setting or in operating theatres under biopsy and saline instillation sonography, but
anaesthesia or sedation. quite often these are used together as comple-
mentary investigations. Alternatives of operative
hysteroscopy depend on the indication but may
38.2 Minimum Standards include no treatment, medical/hormonal treat-
and Clinical Governance ment, Mirena IUS, abdominal (laparoscopic or
Issues open) myomectomy, hysterectomy, uterine artery
embolisation and laparoscopic sterilisation as
The Royal College of Obstetricians and well as other hormonal and non-hormonal con-
Gynaecologists (RCOG) and the British Society traceptives. The views of the patient and her
for Gynaecological Endoscopy (BSGE) provided background clinical circumstances (co-
best practice guidelines for outpatient hysteros- morbidities) should be taken into account and a
method that is likely to deliver her expectations
with an acceptable safety profile should be agreed
E. Saridogan
University College London Hospital, London, UK upon. If the patient chooses a method that is not
e-mail: ertan.saridogan@uclh.nhs.uk available in the unit to which they have presented,

https://doi.org/10.1007/978-3-319-78683-4_38
218 E. Saridogan
Table 38.1 Indications for diagnostic and operative Complications can be grouped as intraopera-
hysteroscopy
tive, early or late postoperative events.
Diagnostic hysteroscopy Operative hysteroscopy Intraoperative complications of diagnostic hyster-
Abnormal uterine bleeding Endometrial/ oscopy include cervical laceration, uterine perfo-
• Heavy and irregular Endocervical polyps
periods Submucosal fibroids ration, bleeding and failed procedure. As long as
• Postmenopausal Endometrial ablation/ they are managed appropriately, these complica-
bleeding resection tions are unlikely to cause severe morbidity.
• Intermenstrual bleeding Metroplasty for Intraoperative complications following oper-
• Hypomenorrrhoea mullerian anomalies
Infertility Intrauterine adhesions ative hysteroscopy include cervical laceration,
• Filling defects in the Hysteroscopic uterine perforation, bleeding, visceral injury
uterine cavity (polyp, sterilisation for and fluid overload. Some of these complications
submucosal fibroid, contraception or can be severe and may lead to severe morbidity
intrauterine adhesions) occlusion of
• Abnormal (thin or thick) hydrosalpinges and even mortality, especially when there is
endometrium Persistent retained bowel perforation. Infection is an early postop-
Congenital uterine anomalies products of conception erative complication and intrauterine adhesion
formation which may lead to hypo- or amenor-
they should be given the option of being referred rhoea and infertility as a late postoperative
to another unit where the method is available. complication.
The clinician who carries out the procedure
should have appropriate training or should be
under supervision of an accredited person. In the 38.4 Avoidance of Litigation
United Kingdom training structure, diagnostic
hysteroscopy and endometrial polyp removal are Preoperative counselling and consent process
covered in the core curriculum, however sur- should not only cover the possible success and
geons carrying out operative hysteroscopic pro- failure rates of the procedure, but also include a
cedures should have received specialised training detailed description of possible complications.
for the relevant procedure such as the ‘Advanced The procedure should be expected to meet the
Training Skills Module Benign Gynaecological patient’s expectations and the patient should be
Surgery: Hysteroscopy’. Gynaecologists who involved in the decision making process, having
completed their training prior to 2007 had a dif- been informed of the alternatives. Provision of
ferent accreditation structure. There are also patient information leaflets would be useful.
accreditation programmes for outpatient hyster- Clinicians performing the procedure should
oscopy for nurses and general practitioners. have appropriate training and/or accreditation as
explained earlier and an adequate annual case
load.
38.3 Reasons for Litigation Measures should be taken to reduce risk of
complications. Risk factors which increase risk
Litigation related to diagnostic hysteroscopy is of complications should be identified. For exam-
less common, however the clinicians should be ple, presence of intrauterine adhesions, history of
aware that there is a campaign against outpatient previous caesarean section (particularly those
hysteroscopy due to pain or lack of pain control. with scar defect or niche) and extreme antever-
Litigation related to operative hysteroscopy is sion or retroversion with reduced mobility would
however more likely for a number of reasons: increase risk of uterine perforation. Determining
the position of the uterus before dilatation of the
• Preoperative assessment and counselling cervix, use of ultrasound guidance and preopera-
• Consent and discussion of complications tive cervical priming may help reduce the risk of
• Recognition of complications perforation during cervical dilatation. Fluid over-
• Management of complications load is more likely to develop in the presence of
38 Diagnostic and Operative Hysteroscopy 219
large uterine cavity, low mean arterial pressure, When fluid overload is diagnosed the proce-
high distension medium pressure and during pro- dure should be terminated, a urinary catheter
cedures that require deep myometrial penetra- should be inserted, strict fluid input-output moni-
tion. The intrauterine pressure should be kept as toring and measurement of serum electrolytes
low as possible to maintain adequate distension should be implemented.
of the cavity to reduce the risk of fluid overload.
Hypotonic media that is used for monopolar
resection systems such as glycine are more likely 38.5 Case Study
to cause electrolyte imbalance and its subsequent
complications, hence consideration should be A 37 year-old woman with a history of infertil-
given to bipolar resection systems and isotonic ity was found to have a ‘filling defect’ in the
distension media. Fluid input and output should uterine cavity during fertility investigations and
be monitored throughout the operative hysteros- she was referred to a gynaecologist for further
copy procedures and the procedure should be ter- investigation and treatment. After an initial
minated when the recommended fluid deficit is consultation a hysteroscopy and resection pro-
reached. Fluid balance should be recorded in the cedure was performed. At surgery the gynaeco-
operation records and it is advisable to use a sep- logist was unsure whether the filling defect was
arate fluid monitoring sheet. Preoperative antibi- due to a submucosal fibroid or intrauterine
otic prophylaxis should be given to women who adhesions, this area was resected. The gynaeco-
have higher risk of infection, for example to those logist noted abdominal distension at the end of
with tubal disease or hydrosalpinx. the procedure and suspected that the uterus
A very important aspect of avoiding litigation might have been perforated. A laparoscopy was
is recognition and appropriate management of performed and a small fundal perforation was
complications when they occur. Perforation site found. Three litres of glycine solution was aspi-
may be directly visible or intraperitoneal struc- rated from the peritoneal cavity and the perfo-
tures may be seen, confirming perforation. It ration site was cauterised for haemostasis. No
should be suspected when there is sudden loss of other visceral injury was detected. The patient
cavity distension or unexplained inability to dis- was kept in overnight for observations. Her
tend the cavity. Midline and fundal perforations, postoperative serum electrolyte analysis
particularly with blunt instruments, are unlikely showed a sodium level of 125 mmol/L. She
to cause excessive bleeding or injuries to other remained stable overnight and was discharged
structures. Cervical and lateral wall perforations, home the following morning with no further
particularly with large and sharp instruments can follow up arrangements.
cause troublesome bleeding and retroperitoneal The medicolegal expert was critical of the fol-
haematomas. Perforations during activation of lowing points:
the electrode of the resectoscope can cause sharp
or thermal injury to other viscera and blood ves- • The gynaecologist was not able to differenti-
sels. In this situation, the procedure should be ate between a submucosal fibroid and intra-
terminated and consideration should be given to uterine adhesions,
a laparoscopy or laparotomy. If expectant man- • Uterine perforation was not recognised during
agement is chosen, the patient should be admit- the procedure until abdominal distension was
ted for observation for possible intraabdominal noticed,
bleeding or visceral injury. The patient should be • No fluid balance monitoring was carried out
advised to report signs of delayed visceral injury or recorded during the hysteroscopy
such as worsening abdominal pain, fever, feeling procedure,
unwell, nausea and vomiting when she is dis- • There was no evidence of fluid input-output
charged home. monitoring postoperatively,
220 E. Saridogan
• The sodium levels were not checked again

before discharge, • Good documentation of the procedure,
• There was no follow up arrangement or evi- monitoring of fluid balance and man-
dence of the patient being asked to report agement of complications is of para-
signs of delayed visceral injury. mount importance.
The case was settled for a moderate sum.
References
1. RCOG. Best Practice in Outpatient Hysteroscopy.
Key Points: Diagnostic and Operative Green-top Guideline No. 59, 2011, https://www.rcog.
Hysteroscopy org.uk/en/guidelines-research-services/guidelines/
• Appropriate preoperative assessment gtg59/.
2. Umranikar S, Clark TJ, Saridogan E, Miligkos D,
and counselling should include a discus-
Arambage K, Torbe E, et al. BSGE/ESGE guideline
sion to establish the views of the patient on management of fluid distension media in operative
and her comorbidities. A method that is hysteroscopy. Gynecol Surg. 2016;13:289–303.
likely to deliver the patient’s expecta- 3. NICE. Heavy menstrual bleeding: assessment and
management. August 2016, https://www.nice.org.uk/
tions with an acceptable safety profile
guidance/cg44.
should be agreed upon. 4. NICE. Hysteroscopic metroplasty of a uterine septum
• The procedure should be performed by for primary infertility-guidance. https://www.nice.
an accredited/trained surgeon. org.uk/guidance/ipg509.
5. NICE. Hysteroscopic metroplasty of a uterine septum
• Risk factors for complications should be
for recurrent miscarriage-guidance. https://www.nice.
determined preoperatively and mea- org.uk/guidance/ipg510.
sures should be taken to reduce risks. 6. Hysteroscopic sterilisation by tubal cannulation
• Complications should be recognised and placement of intrafallopian implants-guidance.
https://www.nice.org.uk/guidance/ipg315.
when they occur and should be managed
7. Hysteroscopic morcellation of uterine leiomyomas
appropriately. (fibroids)-interventional procedures guidance. https://
www.nice.org.uk/guidance/ipg522.
Endometriosis
39
Alfred Cutner
39.1 Background • Deep infiltrative disease

• Non-pelvic disease
Endometriosis is a condition where endometrial
type tissue lies outside the uterus. This can be Deep infiltrative disease can be anterior and
asymptomatic but may cause fertility issues, invade the bladder. Where it is on the side wall it
painful periods, pain on intercourse, pain open- may result in ureteric involvement. Posterior dis-
ing bowels and bladder pain. Progression may ease involves the uterosacral ligaments and may
result in chronic pain that is outside the menstrual cause pain on intercourse. Where the recto-
cycle. Endometriosis affecting the adnexa may vaginal septum is involved then there may be
result in loss of tubal function and hydrosalpin- pain opening the bowels and rarely bowel
ges and it may also reduce ovarian reserve. Where obstruction. Deep disease may extend laterally
the endometriosis affects the ovary, it may result and involve the ureters. Endometriosis may be
in an abdominal mass and the patient can present found at distant sites to the pelvis. Typical areas
due to pressure symptoms. Progression of severe are the appendix and the diaphragm. The latter
disease may result in haematuria, rectal bleeding may result in cyclical shoulder pain.
and occasionally bowel obstruction. On rare Endometriosis classically presents in nullipa-
occasions, patients may develop a loss of renal rous women in their 30s. However, it should not
function. This is normally a silent loss and is not be discounted in women who have had children
preceded by renal angle tenderness. especially if there was a degree of subfertility. In
Endometriosis is often classified according to addition, it may be found in adolescents and
the revised American fertility scoring system hence the possibility should not be disregarded.
(AFS). However, this largely relates to fertility and
does not correlate with the other pain symptoms.
Surgically endometriosis is better classified as: 39.2 Minimum Standards
• Superficial where there are peritoneal patches Issues
• Adnexal disease involving the tubes and
ovaries Treatment for endometriosis related symptoms
may be reassurance or simple pain relief where the
symptoms are mild. Medical treatment consists of
A. Cutner
University College Hospital, London, UK hormone manipulation. This may be the combined
e-mail: acutner@mac.com contraceptive pill (normally taken continuously

https://doi.org/10.1007/978-3-319-78683-4_39
222 A. Cutner
for at least 3 months without a break) or progesto- discussed as well as the requirement to excise
gen therapy. It may take the form of high dose pro- endometriosis at the same time.
gesterone for 6 months, the mini-pill or the Mirena
contraceptive device. Danazol and other drugs in
this class are now rarely used. The alternative 39.3 Reasons for Litigation
option is down regulation with LHRH analogues
to make the woman menopausal. Use of this with- Litigation will normally result following one of
out add-back hormone replacement therapy is the list below:
licensed to a maximum of 6 months.
Surgical treatment is normally carried out • Complications of long-term LHRH analogues
laparoscopically and can entail ablation or exci- (used off license)
sion of lesions and releasing adhesions in • Silent loss of a kidney due to delayed
severe disease and excising nodules of disease. treatment
Under-treatment will result in early recurrence. • Suffering pain long-term without treatment
Over-treatment will increase the possibility of being offered
complications and may in the case of the ova- • Loss of ovarian reserve from surgery
ries, reduce the ovarian reserve. Where the • Inadequate treatment resulting in progression
tubes are found to be blocked and dilated this and a complication of subsequent surgery
will have a negative effect on IVF outcomes • Lack of appropriate treatment due to non-
and they may require removal as part of the sur- expert care
gical treatment. • Intra-operative damage to a ureter or the bowel
Excision of rectovaginal disease where there • Undiagnosed ureteric or bowel injury
is extensive dissection required, may result in • Development of ureteric stricture
post-operative voiding difficulties. This can be • Development of bowel leak or fistula
short term or long term. Monitoring of bladder • Inappropriate treatment for the patient’s cur-
function post-operatively is essential to prevent rent requirements
bladder over distension with its sequelae. Shaving
of the bowel rather than bowel resection is pre-
ferred as a low bowel resection has the risk of 39.4 Avoidance of Litigation
developing anterior resection syndrome and
swapping pain for severe bowel dysfunction. When a patient with symptoms of endometriosis
The overall risks of excision of recto-vagi- presents it is important that they are seen by a
nal disease is of the order of 10% and major gynaecologist with an interest in the care of
risks include a secondary leak from the bowel, women with this condition. This is part of the
development of a fistula, bowel injury, ureteric organisation of services as laid out in the recent
injury and developing a ureteric stricture. All NICE guidance on the management of endome-
patients need to be made aware that the pain triosis [1]. An ultrasound should be carried out
may remain and endometriosis may recur. and it is recommended that this should be a vagi-
Apart from these risks all the other risks of nal scan (unless contra-indicated). An MRI may
laparoscopic surgery are as in general laparo- be considered as an alternative. A trial of medical
scopic surgery but the risk of laparotomy or treatment would be advised except where the
vascular injury are increased as are the risks of patient presents with fertility issues or where on
thromboembolism due to the extent of surgery examination and/or investigations suggest severe
that may be required. disease. Long-term medical treatment or reassur-
Endometriosis may be associated with adeno- ance without referral to a specialist centre will
myosis and some patients will opt for hysterec- result in a patient suffering from pain and can be
tomy. In this situation, the ovaries need to be a cause of complaint. Such care is not normally
39 Endometriosis 223
the main indication for litigation but often an tion where a complication arises. The possibility
aggravating factor in any claim. of requiring an elective ileostomy or colostomy
Lack of an examination and appropriate inves- must be fully discussed. The issue of bowel prep-
tigations in women with severe disease may result aration remains contentious but local guidelines
in long-term medical treatment. By the time the should be adopted.
patient presents to a specialist centre, she may Specific areas that result in litigation are
have lost renal function in one kidney. In women delayed recognition of a ureteric injury or a
with a large rectovaginal nodule, a renal scan delayed bowel leak or fistula. Use of ureteric
should be done as a screen to exclude ureteric stents would reduce the chance of missing a ure-
involvement. Severe disease requiring extensive teric injury but failure to use them would not be
surgery due to long-term lack of appreciation of considered a breach of duty. At the end of any
the condition can be another cause of litigation. procedure requiring excision of recto-vaginal
Women with severe disease require referral to endometriosis, a sigmoidoscopy should be car-
a specialist centre with a multidisciplinary set-up ried out to perform an air test and document
for the surgical care of these women. All the bowel integrity. In the past gynaecologists used a
options must be clearly documented. Patients 50 ml syringe but this is not adequate to test for a
require treatment by appropriate surgeons with leak. Energy sources used to cut out tissue may
the correct level of expertise and careful postop- result in heat spread and typically the patient will
erative observation. This is highlighted in the present at 5 to 10 days due to a avascular necro-
recent NICE guidance on endometriosis and is sis. If a patient becomes unwell after major endo-
integral within British Society for Gynaecological metriosis surgery it is mandatory to perform a CT
endoscopy (BSGE) endometriosis centres crite- to exclude a leak and it is advisable to enlist the
ria [1]. Pre-operative counselling and investiga- help of a colorectal colleague to exclude a bowel
tions needs to exclude absolute indications for cause. Delayed recognition will lead to severe
surgery such as ureteric or bowel stricture. morbidity and indeed mortality and delay in
Assuming this is not the case, it is important to diagnosis is a common cause for litigation.
determine whether fertility or pain is the primary The digital recording of an operation will iden-
indication. Removal of recto-vaginal disease in a tify appropriate technique and may prevent litiga-
relatively asymptomatic woman who requires tion when it can be demonstrated that the bowel or
IVF would be breach of duty. Litigation would ureter injury was not due to poor surgical tech-
result if there was a complication or loss of ovar- nique. However, it must be appreciated that retro-
ian function from the surgery carried out. spective viewing of an operation may also
Where excision surgery is to be considered, incriminate a surgeon and demonstrate a breach of
two stage surgery should be contemplated to duty. Without a digital record, the surgical report
enable full counselling about the pros and cons of would be relied upon and also the demonstration
radical excision and the risks of any surgery to be of the surgeon having the required experience.
performed. It also enables the use of pre-operative Post-operative care must include a measurement
down regulation to reduce vascularity and the of bladder residual after the catheter is removed to
size of the lesions. Where surgery results in an ensure that the patient will not develop over-dis-
inadvertent bowel or ureter injury but carried out tension resulting in long term voiding problems.
by a surgeon without specific expertise, this may
give rise to litigation. The requirements for mul-
tidisciplinary surgery in centres of excellence for 39.5 Case Study
severe cases is identified by the BSGE and the
recent NICE guideline. Joint surgery with a [2013] EWHC 4744 (QB)
colorectal surgeon where there is significant The claimant underwent a laparoscopic exci-
bowel involvement will reduce the risk of litiga- sion of a rectovaginal nodule in 2009. Monopolar
224 A. Cutner
scissors were used for the excision via an operat-

ing laparoscope. The claimant was discharged Key Points: Endometriosis
the following day. She re-presented 6 days later • Do not delay referral for symptoms that
in severe pain. She had a laparotomy to repair a fail to respond to medical treatment
2 cm hole in the rectum and a loop colostomy • Refer to an appropriate unit
was carried out. • Severe disease should be operated on in
The whole operation had been recorded. The an appropriate multidisciplinary set up
claim was that the rectal probe was not used • Operate according to patients current
appropriately and that diathermy had been clinical requirements and fully discuss
applied directly to the bowel wall. These were all the implications of extensive surgery
both rejected. It was accepted that the injury • Check for renal obstruction in severe
occurred due to delayed necrosis due to heat disease
caused by diathermy at the time of the initial • Discuss ovarian reserve at time of surgery
operation. It was accepted that there is no stan- • Treat endometriosis at the time of
dard as to how a rectal probe should be used and hysterectomy
the direct application of diathermy to the bowel • Do not delay investigating post-operate
wall was not proven. In addition, the court deter- patients who become unwell
mined that inadvertent heat damage to the tissue
is a recognised complication of this type of
surgery.
This case demonstrates that injury can occur
Reference
during surgery for severe endometriosis and is a
recognised complication and does not necessarily 1. NICE guideline [NG73]: Endometriosis: diagnosis
indicate a breach of duty. and management 2017.
Ectopic Pregnancy and Miscarriage
40
Andrew Farkas
40.1 Background not only with significant physical morbidity such

as haemorrhage and sepsis, but also with psycho-
An ectopic pregnancy is the occurrence of a preg- logical sequelae.
nancy in a location other than the body of the
uterus, usually in the fallopian tube. The inci-
dence of ectopic pregnancy is around 11 per 1000 40.2 Minimal Standards
pregnancies. It usually presents at between 6 and and Clinical Governance
8 weeks gestation, usually with vaginal bleeding Issues
and lower abdominal pain but sometimes as an
acute abdomen with haemoperitoneum following The National Institute of Clinical excellence (NICE)
rupture of the fallopian tube. guidance highlights the importance of an early
Risk factors for ectopic pregnancy include a his- pregnancy assessment service (EPAS) [2]. It should
tory of pelvic infection, pelvic surgery and, in par- be a dedicated service provided by healthcare pro-
ticular, tubal surgery and IVF. It remains an important fessionals competent in diagnosing and caring for
cause of maternal death, with six maternal deaths women with pain and/or bleeding in early preg-
reported between 2006 and 2008 [1]. It is important nancy. It should offer ultrasound and assessment of
to avoid delay in the diagnosis of an ectopic preg- serum human chorionic gonadotrophin (hCG) lev-
nancy to minimise the risk of rupture. Medical man- els. hCG is the hormone measured when perform-
agement with methotrexate has to some extent ing a pregnancy test. Systems should be in place to
replaced surgical management by removal of the fal- enable women referred to their local EPAS to attend
lopian tube (salpingectomy), so altering patients’ within 24 h if the clinical situation warrants it.
expectations of diagnosis and treatment. Although The combination of a positive pregnancy test,
most known cases are treated medically or surgi- vaginal bleeding and abdominal pain should raise
cally, spontaneous resolution may also occur. the suspicion of an ectopic pregnancy. A ruptured
Miscarriage occurs in 10–20% of clinical ectopic pregnancy should be treated as an acute
pregnancies. A miscarriage may be associated surgical emergency.
The diagnosis of either a miscarriage or an ecto-
pic pregnancy is usually made on the basis of inves-
A. Farkas tigations rather than clinical findings. Pelvic
Department of Obstetrics and Gynaecology,
examination is not usually performed in the setting
Jessop Wing, Sheffield Teaching Hospitals NHS Trust,
Sheffield, UK of an EPAS. Key to diagnosis is the use of transvagi-
e-mail: Andrew.Farkas@sth.nhs.uk nal ultrasound scanning (TVS). Ultrasound scan-

https://doi.org/10.1007/978-3-319-78683-4_40
226 A. Farkas
ning is increasingly used to identify an ectopic an intrauterine pregnancy, breast-feeding, and

pregnancy as well as an intrauterine gestation and abnormal liver function.
transvaginal scanning is the tool of choice. A tubal It is not always possible to make a firm diag-
ectopic is diagnosed by the identification of an nosis of either a viable intrauterine pregnancy or
adnexal mass that moves separate to the ovary. There ectopic pregnancy, leading to the term ‘preg-
is no specific endometrial appearance of an ectopic. nancy of unknown location (PUL)’. Expectant
The presence of fluid inside the uterus can give the management is an option for PUL in clinically
appearances of a pseudosac and should be distin- stable women and those with an ultrasound diag-
guished from an early intrauterine pregnancy. The nosis of ectopic pregnancy and a decreasing
presence of free fluid in the abdomen is a common hCG, initially <1500iu/L.
finding, but not diagnostic of an ectopic. When pres-
ent in excessive amounts it may suggest a rupture.
The Royal College of Obstetricians and 40.3 Reasons for Litigation
Gynaecologists (RCOG) have identified ultrasound
criteria for the diagnosis of cervical, cornual/intersti- The main reasons for litigation in cases of ectopic
tial, abdominal, heterotopic and caesarean scar preg- pregnancy are related to delay in making the
nancy [1]. An intrauterine pregnancy is diagnosed on diagnosis, leading to:
the basis of the size of the gestational sac and the
crown rump length (CRL) of the fetal pole. To make –– Failure to diagnose the ectopic
the diagnosis of a viable intrauterine pregnancy, the –– Failure to counsel regarding the various
gestation sac should be ≥25 mm with a CRL ≥ 7 mm. treatments
The absence of an intrauterine pregnancy in con- –– Rupture of the ectopic pregnancy
junction with hCG estimations often leads to the –– Laparotomy
diagnosis of an ectopic pregnancy. hCG is produced –– Salpingectomy
by the rapidly proliferating trophoblastic tissue in –– Complications related to the surgical
early pregnancy. The discriminatory zone is the treatment
hCG level at which it is assumed all viable intrauter- –– Loss of opportunity for medical treatment
ine pregnancies will be visualised by transvaginal with methotrexate
ultrasound. This level is usually 1000–1500 iu/L, –– Inadequate monitoring in cases managed
depending on local guidelines. An increase in serum conservative
hCG concentration > 63% from the baseline level –– Loss and perceived loss of fertility
after 48 h suggests the likelihood of a developing
intrauterine pregnancy, although the possibility of Reasons for litigation in respect of miscar-
an ectopic pregnancy still cannot be excluded. riage include:
NICE recommends that methotrexate should
be the first line management for women who are –– The failure to make the diagnosis of miscar-
able to return for follow-up and who have: riage accurately on ultrasound scanning
–– Failure to offer various options for treatment
–– No significant pain –– Complications of surgical management of
–– An unruptured ectopic pregnancy with a mass miscarriage, including haemorrhage and uter-
smaller than 35 mm with no visible heartbeat ine perforation
–– A serum hCG between 1500 and 5000 iu/L –– Retained products of conception
(below 5000 iu/L is the usual cut off used in
practice)
–– No intrauterine pregnancy (as confirmed on 40.4 Avoidance of Litigation
ultrasound scan)
The diagnosis of pregnancy should be consid-
Important contraindications to methotrexate ered in all women of reproductive age. Menstrual
include haemodynamic instability, presence of age cannot be relied upon to exclude a preg-
40 Ectopic Pregnancy and Miscarriage 227
nancy. A urine pregnancy test is extremely sen- management is associated with improved repro-
sitive and will usually give a positive result ductive outcomes compared with radical surgery,
(hCG 20 iu/L) the day after the menstrual period i.e. salpingectomy. In this group, conservative
was expected. surgery (salpingotomy) is associated with a
Women should be offered a range of man- higher rate of subsequent intrauterine pregnancy
agement options for a confirmed miscarriage. than salpingectomy [3].
These include expectant management, which Clinicians undertaking ultrasound for the
is recommended by NICE as a first line man- diagnosis of early pregnancy problems must have
agement, medical management and surgical received appropriate training. There should be
management. departmental protocols in place to identify which
In cases of suspected miscarriage, particularly structures are to be examined and what measure-
when symptoms have included pain as well as ments need to be taken. The written report from
bleeding, it must be ensured that a urine preg- the scan is an important legal document and
nancy test is negative two weeks following pre- should be issued in all cases. Surgical manage-
sentation. When undertaking abortions at early ment of ectopic pregnancy requires appropriate
gestations adequate precautions need to be taken training. In particular, laparoscopic surgery
to avoid missing an ectopic pregnancy. This is dis- requires appropriate equipment and trained the-
cussed in more detail in the chapter on abortion. atre and surgical staff.
Patients should be informed that methotrexate
is recommended as first line management in
women with a small unruptured ectopic preg- 40.5 Case Studies
nancy. It is not always effective and subsequent
surgical treatment may be required. There is also Although it is often possible to demonstrate
a small risk of rupture. breach of duty in respect of the management of
Methotrexate should never be given at the first ectopic pregnancy, very few cases come before
visit unless the diagnosis of an ectopic pregnancy the courts. This is because such claims are usu-
is absolutely clear and a viable intrauterine preg- ally of relatively low value and causation is either
nancy has been excluded. not present or limited. The cases described below
Although 90% of ectopic pregnancies are illustrate some of the issues which may arise in
tubal, the possibility of an ectopic pregnancy in litigation.
another location should be considered. These Case 1
include the ovary, interstitial (uterine) portion of Mrs. AB was aged 31 when she presented to the
the fallopian tube (Cornual ectopic), caesarean EPAS with a history of vaginal bleeding. She was
section scar and abdominal pregnancies. discharged three days later following a fall in hCG
The majority of tubal ectopic pregnancies are levels from 240 to 120 iu/L. Further follow-up was
managed surgically. Laparoscopy is preferable to not arranged. She presented four weeks later with
laparotomy in terms of speed of recovery, abdominal pain and vaginal bleeding. An ectopic
although there is no difference in terms of subse- pregnancy was identified. She underwent laparo-
quent successful pregnancy benefits between scopic salpingectomy. The claim was settled on
laparoscopy and laparotomy. The RCOG guid- the basis of the failure to adhere to the unit proto-
ance [1] states that in the absence of a history of col of checking that a urine pregnancy test became
sub-fertility or tubal pathology, women should be negative two weeks following initial discharge.
advised that there is no difference in the rate of Case 2
fertility, the risk of future tubal ectopic pregnancy Mrs. CD had a history of anxiety and depres-
or tubal patency rates between the different meth- sion. She attended the EPAS with a history of
ods of management. abdominal pain and vaginal bleeding. hCG was
Women with a previous history of sub-fertility 4200 iu/L. Ultrasound scan showed the absence
should be advised that treatment of their tubal of an intrauterine gestation. She was reviewed
ectopic pregnancy with expectant or medical two days later, when the hCG had risen to
228 A. Farkas
7300 iu/L. Continued monitoring was advised.

She presented a further three days later with a • A laparoscopic approach is preferable to
ruptured ectopic pregnancy and a laparotomy open surgery for ectopic pregnancy
and salpingo-oophorectomy was required. • There is no difference in fertility rate
It is likely that earlier intervention would following different treatments for ecto-
still have required a salpingo-oophorectomy. pic pregnancy in women with no previ-
However, a laparoscopic approach would have ous history of sub-fertility
been possible. Psychological stress would have
been reduced.
Key Points : Ectopic Pregnancy and References

Miscarriage
• Suspect a pregnancy in all women of 1. RCOG (Royal College of Obstetricians &
Gynaecologists) Diagnosis and management of
reproductive age ectopic pregnancy Green-top Guideline No. 21
• Confirm an intrauterine pregnancy by 2016.
ultrasound 2. NICE (National Institute of Clinical Excellence)
• Methotrexate is first line management in Ectopic pregnancy and miscarriage: Diagnosis and
initial management CG 154 2012.
a small, unruptured ectopic pregnancy 3. Becker S, et al. Optimal treatment for patients with
in a clinically stable patient ectopic pregnancy and a history of fertility—reducing
factors. Arch Gynaecol Obstet. 2011;283:41–5.
Ovarian Surgery
41
Swati Jha and Ian Currie
41.1 Background Surgery on the ovary for whatever reason

requires specific counselling due to the pivotal
The ovaries lie within the ovarian fossa, which is importance of these organs on a womans repro-
bound by important structures such as the external ductive capability, whether this be for infertility
iliac, obliterated umbilical artery and the ureter. At treatment such as ovarian drilling, or the removal
birth a female has approximately one to two million of ovarian cyst/ovary for endometriosis.
eggs but only 300–400 of these will ever mature and An oophorectomy may be performed either
be released for purposes of fertilisation. From alone or in combination with another procedure
puberty till the menopause the ovaries produce a usually a hysterectomy or a salpingectomy.
range of hormones including oestrogen and proges- Oophorectomy is performed in a range of medical
terone. They also produce other hormones including conditions including ovarian tumours benign and
testosterone and androstenedione in lesser amounts. cancerous, endometriosis, ovarian torsion, ovar-
In post-reproductive life, however the female hor- ian/tubo-ovarian abscess and pelvic inflammatory
mone production from the ovary terminates as this disease. It may also performed prophylactically in
is linked to the menstrual cycle. Thus, the androgens women with a family or personal history of breast
that are produced take on a greater siginificance as or ovarian cancer who are at a higher than average
they are converted to oestrogen elsewhere. risk. Ovarian surgery can be performed through
Ovarian surgery may be performed as part of one of several routes including the open abdomi-
nal or laparoscopic route. The specific complica-
1 . Infertility treatment (ovarian drilling)
tions of laparoscopic surgery will not be discussed
2. Removal of part of ovary (benign conditions)
in this chapter as they are discussed elsewhere.
3. Removal of total ovary with:
Cyst (benign or malignant)
Another procedure (hysterectomy)
Prevention of ovarian cancer
Issues
S. Jha (*)
Department of Obstetrics and Gynaecology, Jessop Wing,
As with any surgical procedure adequate preop-
Sheffield Teaching Hospitals NHS Trust, Sheffield, UK
e-mail: Swati.Jha@sth.nhs.uk erative counselling is imperative and should be in
line with the GMC guidance and Montgomery
I. Currie
Buckinghamshire Healthcare NHS Trust, Aylesbury, UK ruling on consent. In particular, the options a
e-mail: iancurrie1964@mac.com woman has to consider must be understood by

https://doi.org/10.1007/978-3-319-78683-4_41
230 S. Jha and I. Currie
her and its impact on reproduction must be need to be informed that this may affect their
clearly documented. Special considerations that ovarian reserve and this has a link to reduced IVF
may arise might include when someone is con- capacity, even though pregnancy rates were
sidering oophorectomy whilst still being nullipa- found to be the same as women with both ovaries
rous or a women who specifically states that they [4]. Clear explanation of why the clinician is
never want children. Careful counselling, docu- resorting to oophorectomy rather than possible
mentation of their reflection and understanding cystectomy needs to be documented. This is par-
as well as second opinion are all best practice ticularly true when there is torsion or a large
points to consider. It is not appropriate to think benign tumor on one ovary which will necessitate
that a clinician is protected from breach of duty the removal of the entire ovary. Ovarian torsion
just because information is given to the patient deserves a special mention in that practice has
and received. Recognition of the impact of ovar- been moving to more conservative intraoperative
ian function, or rather the lack of, is given high treatment with attempts being made to salvage
priority by the courts. the ovary. Clear operative notes are essential giv-
When surgery may impact on ovarian reserve ing reasons as to the course of action taken.
this needs to be discussed with the patient. Clear Several benign tumours of the ovary can also
concise bullet points in the medical notes are be bilateral. In women presenting with such
always helpful in later scrutiny of a woman’s tumours when childbearing is not complete, a
decision making process. cystectomy should be performed in preference to
Ovarian drilling is sometimes offered to an oophorectomy where possible. As this cannot
women with polycystic ovarian disease to induce always be predicted in advance, especially when
mono-ovulatory cycles when they have failed ini- the tumor is large, patients should be warned of
tial medical treatment. As well as documentation the risk of developing the tumor on the contralat-
of complications it is also important that not only eral ovary. Approximate recurrence risks should
is the correct treatment suggested but that it sits be given preoperatively with further clarification
correctly in the treatment algorithm for the con- once histology is received. Dermoids are the
dition being treated. Over zealous and prompt commonest benign tumor of the reproductive age
recourse to surgery may be criticized thereafter, group and are bilateral 20% of the time. Even if a
particularly if it is within private practice. For contralateral dermoid is not present at the time of
example, ovarian drilling should not be offered as a surgery there is a 25% risk of developing another
first line treatment as there is no evidence of supe- dermoid on the opposite side. This figure may
riority over more conservative treatments [1, 2]. lead to an older patient opting for bilateral oopho-
When it is performed monopolar electrocautery rectomy. Benign serous cystadenomas and muci-
(diathermy) or laser can be used giving compara- nous cystadenomas can also be bilateral in up to
ble results. Normally, three to eight diathermy 25 and 10% respectively.
punctures are performed in each ovary using Ultrasound confirmation of whether an ovar-
600–800 J energy for each puncture, and this ian tumor is benign or malignant can be difficult
leads to further normal ovulation in 74% of the and where there is doubt patients should be ade-
cases in the next 3–6 months. However, patients quately warned of this as a cystectomy in this
should be informed about the risk of reduction in scenario with a subsequent diagnosis of malig-
ovarian reserve and premature ovarian failure nancy may warrant further surgery.
when undergoing this procedure though the Where malignancy is suspected referral to an
impact of this is not substantiated in meta- oncologist should be considered and usual cancer
analysis [3]. Harming ovarian function in a pathways should be followed. The clinician
patient who is trying to conceive very often leads should be aware of the available grading systems
to litigation. for suspected malignancy as they are a useful
When women who have not completed child- adjunct to conservative management. When a
bearing require a unilateral oophorectomy they patient is expressing a desire to avoid surgery and
41 Ovarian Surgery 231
have conservative management, the clinician be informed of this in the postoperative period.
should document as to whether he/she is in agree- Adequate care to positively identifying and
ment with this. thereby avoiding injury to the ureters should be
In women undergoing a prophylactic oopho- taken in this scenario due to its close proximity to
rectomy without an underlying risk factor at the the ovary. The usual precautions as discussed in
time of a hysterectomy, the benefits of removal the chapter on Laparotomy and Laparoscopy
and prevention of ovarian cancer has to be should be taken. Failure to recognise and discuss
weighed up against the risks of removal and a full when surgery may not be straightforward and
discussion with the patient regarding this should routine is frequently met with regret for the clini-
take place. In premenopausal women this cian as the complication is seen in the light of a
includes the sudden onset of menopausal symp- low risk procedure. Potential bowel adhesions
toms and the possible need for HRT. Studies have from diseases such as endometriosis or infection,
shown that compared with ovarian conservation, distortion of anatomy from pathology or previous
bilateral oophorectomy at the time of hysterec- surgery must not be overlooked or understated. A
tomy for benign disease is associated with a patient may have chosen a more conservative
decreased risk of breast and ovarian cancer but an approach in hindsight.
increased risk of all-cause mortality, fatal and
nonfatal coronary heart disease, and lung cancer.
In no analysis or age group was oophorectomy 41.3 Reasons for Litigation
associated with increased survival [5].
In women with familial cancer syndromes • Failure to counsel women of the reproductive
such as hereditary breast and ovarian cancer syn- impact of reduced ovarian reserve when oper-
drome (BRCA1 and BRCA2) and Lynch syn- ating on/removing an ovary.
drome due to an increased risk of developing • Failure to inform women of the risk of devel-
ovarian cancer, prophylactic removal of their oping a tumor on the remaining ovary when
ovaries and fallopian tubes at age 35–40 years performing a unilateral oophorectomy.
after childbearing is complete is commonly • Failure to warn of menopausal symptoms fol-
recommended.
Risk reducing salpingo- lowing bilateral oophorectomy.
oophorectomy (RRSO) has been shown to • Failure to warn of advantages of retaining the
significantly impact on woman’s psychological ovaries (cardio-protection/libido).
and sexual well-being, with women wishing they • Removal of the wrong ovary.
had received more information about this prior to • Removal without consent.
undergoing surgery [6]. The most commonly • Incorrect diagnosis (Diagnosis of a benign
reported sexual symptoms experienced are vagi- tumor being made instead of a malignancy, a
nal dryness and reduced libido. Preoperative fibroma can mimic a fibroid).
counselling should include discussion of these • Failure to adequately refer to an oncologist
sequelae and the limitations of menopausal hor- where malignancy is suspected.
mone therapy in managing symptoms of surgical • Persistence of an ovarian remnant.
menopause. Linking with genetic counsellors, • Visceral injury occurring during removal.
oncologists are a useful addition to the decision
making process.
During surgery complications can arise usu- 41.4 Avoidance of Litigation
ally related to distorted anatomy, and the early
involvement of a colorectal or urological surgeon As discussed, adequate informed consent and a
is advised. When an oophorectomy was planned detailed discussion of the advantages and disad-
for benign indications but risks causing injury to vantages of an oophorectomy or a cystectomy
adjacent viscera, it is not substandard to leave an depending on the indication for surgery should
ovarian remnant behind, but the patient needs to take place. Giving time to make appropriate
232 S. Jha and I. Currie
d ecisions is always helpful as well as documenta- When there is difficulty removing the ovary in
tion in medical notes regarding the level of under- its entirety, the reasons for this should be clearly
standing, citing specific examples is useful. documented in the notes and explained to the
At surgery, precautions should be taken in patient. This is especially true in cases of endo-
entering the abdomen to gain access to the ova- metriosis, tumours and when removing residual
ries irrespective of the route of entry. These are ovaries because of adhesions. When an oopho-
discussed in detail in the chapter on laparotomy rectomy is being performed for benign indica-
and laparoscopy. Where bowel adhesions are tions it is not substandard care to fail to remove it
anticipated in advance of the surgery, a bowel if the risks associated with removal outweigh the
surgeon should be available especially when an risk of injury to adjacent viscera including the
oophorectomy is being performed for known bowel and urinary tract. In these situations the
endometriosis. When advanced stage disease is reasons for incomplete excision should be docu-
already suspected consideration should have mented and explained to the patient. This can
taken place preoperatively with respect to tertiary sometimes be difficult to confirm and it is worth
centre referral. When bowel involvement is con- checking the histology to establish if complete
sidered to be significant preoperative referral and removal has been achieved.
discussion with a bowel surgeon should be con-
sidered. It is inappropriate to be suddenly calling
for a general surgeon suddenly when the clinical 41.5 Case Study
picture suggested high risk of bowel involve-
ment. When there are concerns about visceral Case 1. Ms. G’s ultrasound scan demonstrated a
injury, the decision to proceed to a laparotomy mass on her left ovary and the consultant, recom-
should be made to rule this out particularly when mended laparoscopy to investigate this mass to
there are intra-abdominal adhesions. rule out malignancy and remove it if necessary.
When performing ovarian drilling the settings Ms. G was peri-menopausal and had a history of
should be documented in the operative notes and endometriosis and adhesions which had been
greater than 7–8 holes should be discouraged [7]. noted during a laparoscopy a few years earlier.
When operating on women with benign During laparoscopy multiple bowel adhesions
tumours, wherever possible a cystectomy should were noted completing encasing the ovary and to
be performed especially when this can be bilat- the anterior abdominal wall. Diathermy was used
eral, however if an oophorectomy is required the to dissect the ovary which was found to be
reasons for this should be documented. When healthy. The operative notes stated “the possibil-
there is doubt about the nature of the tumour and ity of a thermal injury and leak remains”.
conservative treatment is agreed on, the patient Unfortunately there was a bowel perforation
should be warned of the need for further surgery which presented a few days after surgery requir-
if the tumour is subsequently found to be malig- ing several further surgeries. The perforation had
nant on histology. The risks of spillage should occurred to the ileum at the ovarian adhesion site.
also be discussed in this context of uncertainty. An allegation of negligence was made on the
Occasionally an oophorectomy is required grounds that had a laparotomy been performed
due to surgical difficulty where it was not antici- the risk of bowel perforation would have been
pated. This is usually when performing a difficult reduced and would have been more likely to be
hysterectomy and every attempt should be made detected at the time of surgery. The expert gynae-
to conserve one ovary if the patient has not con- cologist supported this view saying that ‘the
sented to an oophorectomy. Clear documentation manipulations required to free dense adhesions
of the reasons for the unplanned oophorectomy through the laparoscope are difficult, and the risk
should be made and this should be discussed with of thermal injury to the bowel in these circum-
the patient immediately postoperatively. stances is high. The patient would have been
41 Ovarian Surgery 233
better served by abandoning the laparoscopic

attempts to free the adhesions and proceeding to and ovarian cancer risk or at the time of
open laparotomy, where the adhesions could routine hysterectomy) should be
have been dealt with much more easily and informed of the pros and cons of ovarian
safely.’ An out of court settlement was made. removal.
Learning points include early conversion to • Adequate counselling of the operative
open surgery when the view is obscured, there is risks depending on the route of
uncontrolled bleeding, the equipment isn’t ade- surgery.
quate for the job in hand (or fails), or the opera- • Involvement of other specialists when a
tion is taking too long. The reasons for doing so complication is identified.
should then be fully documented. • Low threshold for Conversion to a lapa-
Case 2. Mrs. SD underwent a TAH and BSO rotomy when complications arise/in the
for severe grade 4 endometriosis. The theatre notes presence of adhesions.
at the time document clearly that the procedure • In difficult cases, check histology con-
was difficult and access to the ovaries limited by firms complete removal of ovaries so
multiple bowel adhesions. The patient made an that the patient can be informed of the
uneventful recovery and as she was premeno- possibility of an ovarian remnant.
pausal was commenced on HRT. She presented
with non-specific symptoms of bloating and gas-
trointestinal symptoms for several years and was
treated for IBS as her uterus and ovaries had been References
removed. After 2 years of treatment an ultrasound
scan demonstrated a mass in the left adnexae. 1. Farquhar C, Rishworth JR, Brown J, Nelen WL,

Marjoribanks J. Assisted reproductive technology: an
When she was referred back to her gynaecologist, overview of Cochrane Reviews. Cochrane Database
the histology from the initial specimen was Syst Rev. 2015;7:CD010537.
reviewed and this stated that the left ovary had not 2. Farquhar C, Marjoribanks J, Brown J, et al.

been identified at the time of histology. She under- Management of ovarian stimulation for IVF: narra-
tive review of evidence provided for World Health
went further surgery for this and a borderline ovar- Organization guidance. Reprod Biomed Online. 2017;
ian tumor was confirmed. It was alleged that it had 35(1):3–16.
been negligent to leave behind an ovarian remnant 3. Amer SA, Shamy TTE, James C, Yosef AH, Mohamed
and this led to the development of the borderline AA. The impact of laparoscopic ovarian drill-
ing on AMH and ovarian reserve: a meta-analysis.
tumor. The expert stated that leaving behind an Reproduction. 2017;154(1):R13–21.
ovarian remnant was not negligent but failing to 4. Younis JS, Naoum I, Salem N, Perlitz Y, Izhaki I. The
inform the patient of this was and led to a delay in impact of unilateral oophorectomy on ovarian reserve
the diagnosis. An out of court settlement was in assisted reproduction: a systematic review and meta-
analysis. BJOG. 2017.
made. Learning points include cross checking the 5. Parker WH, Broder MS, Chang E, et al. Ovarian con-
histology where anatomy is distorted. servation at the time of hysterectomy and long-term
health outcomes in the nurses' health study. Obstet
Gynecol. 2009;113(5):1027–37.
Key Points: Ovarian Surgery 6. Tucker PE, Cohen PA. Review article: sexuality and
• Women in the reproductive age group risk-reducing salpingo-oophorectomy. Int J Gynecol
Cancer. 2017;27(4):847–52.
undergoing ovarian surgery should be 7. Amer SA, Li TC, Cooke ID. Laparoscopic ovarian
adequately counselled of the risks of diathermy in women with polycystic ovarian syn-
reduced ovarian reserve. drome: a retrospective study on the influence of the
• Women undergoing a prophylactic amount of energy used on the outcome. Hum Reprod.
2002;17(4):1046–51.
oophorectomy (for underlying BRCA
Laparotomy
42
James Campbell

The Oxford English Dictionary defines Issues
Laparotomy as a surgical incision into the
abdominal cavity for diagnosis or in preparation The Royal College of Surgeons (RCS) have
for major surgery. A laparotomy may be explor- issued guidance for emergency and elective sur-
atory and diagnostic or targeted and therapeutic. gical care and surgical standards for unscheduled
A diagnostic laparotomy may of course become a surgical care [1]. The GMC have issued guide-
therapeutic procedure. A laparotomy may also be lines on good standards of medical and surgical
performed after a diagnostic laparoscopy or fol- practice [2].
lowing a complication at laparoscopic surgery. A detailed clinical history, examination and
With more procedures being carried out using targeted investigations should be performed.
laparoscopic surgical techniques and the increasing Information from the patient’s relatives and GP
use of good diagnostic imaging, the need for diag- should be sought if the patient is unable to com-
nostic laparotomy has reduced. However it is still an municate and lacks capacity. Dementia assess-
important surgery for acute life threatening gynae- ment for elderly patients should be considered.
cological conditions (e.g. collapsed unstable patient An appropriate translator for non-English speak-
with haemoperitoneum, pelvic trauma, peritonitis) ers should be sought. Ideally this should not be a
and where a laparoscopic approach would be too relative. Pre-operative imaging (ultrasound,
hazardous or contra-indicated for anaesthetic rea- MRI, CT) can be extremely helpful when assess-
sons or lack of operator experience. ing the patient’s condition and surgical approach
Elective laparotomy would be considered for to treatment. There may be no time to complete
patients with significant pelvic adhesions from these investigations in an emergency situation. A
chronic infection, advanced endometriosis, can- differential diagnosis should be made and a plan
cer and complex mixed pathologies involving the for what might be anticipated in theatre.
bowel, renal tract and retroperitoneum. Scheduled Expectant and medical management options
surgical care permits involvement of colleagues and interventional radiology might be considered
with appropriate experience. before thoughts are given to surgery. The type of
surgery, laparotomy versus laparoscopy, and
J. Campbell scheduling acute versus elective should be con-
Department of Obstetrics and Gynaecology, Leeds sidered. Peri-operative care is important to opti-
Teaching Hospitals NHS Trust, Leeds, UK
e-mail: drjamescampbell@hotmail.com
mise the chance of having a successful surgical

https://doi.org/10.1007/978-3-319-78683-4_42
236 J. Campbell
episode and uncomplicated recovery. Enhanced Consent should include a discussion about the
recovery programmes have been introduced for diagnosis, aims of surgery, alternative procedures
gynaecological operations [3, 4]. and surgical complications, their management,
An anaesthetic opinion when a patient has success and prognosis and the clinicians involved.
complex co-morbidities is valuable. Operations The possibility of pregnancy and fertility status
are carried out under general and regional anaes- should be appreciated. A preoperative pregnancy
thesia with some anaesthetists choosing a com- test would be recommended. The patient may be
bined approach. Advice from a Multi-Disciplinary unaware of pregnancy and enquiries should be
team may be sought before the procedure. made about the last menstrual period, menstrual
Surgical colleagues may be called upon for cycle and contraception. The impact of delaying
advice and help in undifferentiated cases and in surgery on the patient’s health should be consid-
anticipation of an exploratory laparotomy. ered and the sequelae from laparotomy. Caution
Only gynaecologists who have received is advised when dealing with cancer patients;
appropriate training in open surgical procedures some may not want to know the seriousness of
should undertake a laparotomy. They must be their condition.
competent in opening and closing the abdominal Patients should be made aware of the different
wall and recognising pelvic anatomy particularly types of surgical incision. The three main
the structures on the pelvic sidewall. A senior approaches are:
colleague should supervise a gynaecologist with
less experience and be involved with the care of • Pfannenstiel incision
the patient where the risk of complication and • Midline incision
mortality is high. Gynaecologists should be • Paramedian incision
encouraged to keep a record of their cases and
outcomes for audit and clinical governance Midline incisions may extend above the umbi-
meetings. licus and the incision may skirt around the umbi-
Patients requiring a therapeutic laparotomy licus or pass through it. The choice of incision
(e.g. multiple myomectomy, open abdominal and surgical approach should be explained and
hysterectomy) should be informed of the bene- the patient’s wishes considered. Some patients
fits and risks of surgery and the alternatives may object to having a midline incision for cos-
available (e.g. radiological intervention and metic reasons. Some may have abdominal scars
pharmacology therapies) and a surgical already and prefer the gynaecologist to operate
approach should consider the patient’s likely through the same scar.
pathology, medical and surgical history, co- A “mini-laparotomy” may be performed to
morbidities and treatment preferences. The help remove an ovarian cyst or fibroid or apply
patient is entitled to choose which treatment to sterilisation clips.
undergo. Patients having elective surgery will have a
Surgical advice depends on the suspected con- pre-operative assessment usually by a nurse
dition, the nature of the treatment and the con- practitioner [3]. The patient’s pre-operative
cerns of the patient. condition should be optimised (e.g. anaemia
The gynaecologist should make sure a patient should be corrected, periods postponed,
knows the material risks of the operation and fibroids reduced in size, weight loss if obese,
alternatives and the risks associated with those stop smoking, tightening glycaemic control,
alternatives. treat hypertension and chest conditions,
Consent is usually signed in advance of the MRSA negative, bridging therapy for antico-
surgery and confirmed on admission. Valid con- agulants). Local guidelines should be fol-
sent from conscious patients in emergency situa- lowed. Pre-operative preparation of the bowel
tions is challenging and the doctor’s duty of care using enemas and laxatives is thought to be
is to ensure decisions taken about her manage- unnecessary for many cases. If bowel surgery
ment are in her best interests [5]. is anticipated information about de-functioning
42 Laparotomy 237
and stomas ought to be given by a surgeon and 42.3 Reasons for Litigation

stoma practitioner. Allergy to latex and iodine
should be noted and theatre informed. The The reasons for litigation following a laparotomy
emergency patient should also have their pre- are related to:
operative condition optimised. This may
involve a period of fasting, intravenous fluid • Consent, advice and discussion of
replacement, antibiotics, correction of anae- complications.
mia and clotting and electrolyte and glucose • Competency of surgeon/failure to consult
imbalance and normalising blood pressure and colleagues.
urine output. Thromboembolism (VTE) risk • Intra-operative and post-operative complica-
assessment should be performed taking into tions—immediate and delayed/failure to rec-
account the current and future risk of haemor- ognise complications and inappropriate
rhage. An anaesthetic opinion prior to surgery management.
should be sought and consideration given to • Pre-procedure investigation and care.
the postoperative care bundle which might • Post-surgical care and recovery.
include high dependency care. This is impor- • Surgical complications associated with laparot-
tant with unplanned emergency returns to omy include—haemorrhage, return to theatre,
theatre. urine retention, bladder/ureteric/bowel/vessel
Patients declining recommended treatment and nerve injuries, post-operative ileus, Ogilvie
should be offered a second opinion. syndrome, sepsis, abdominal wall collection
A number of specialists may be required in (haematoma, abscess, seroma, infection), necro-
theatre particularly when the diagnosis is uncer- tising fasciitis, dehiscence, incisional/ventral
tain or complex pathology involving the bowel hernia, adhesive intestinal obstruction, entero-
and renal tract is predicted. Good team working cutaneous fistula, sterility, adhesions.
is essential and communication with pathology
services including haematology and transfusion. Patients may also complain of altered sensa-
The WHO surgical safety checklist must be tion around the scar, hypertrophic and unsightly
completed before starting the operation and the scars, a bulge/roll of loose skin above the
use of the checklist should be entered into the Pfannenstiel incision, awareness of suture mate-
clinical notes or electronic record. rial/knots below the skin.
Gynaecologists should ensure their operative Complications can arise with drains, suprapu-
notes are clear and accurate, comprehensive and bic catheters, stomas.
contemporaneous and follow the standards expected NHS England Patient Safety Domain published a
for good surgical practice [1]. Handover to col- revised never events policy and framework on
leagues should be appropriate and any important 27/3/15. Serious incidents still occur in the operating
information mentioned in the theatre case debrief. theatre environment. “Never Events” meet all the
Pain management should be highlighted and plans following criteria—are preventable, have the poten-
for any immediate drain and catheter care. tial to cause serious patient harm or death, have
Communication with patients and relatives occurred in the past and occurrence of the Never
following surgery is important. The GP should Event is easily recognised and clearly defined.
receive a summary of the surgical episode. Relevant to laparotomy were:
Advice about enhanced recovery and VTE pro-
phylaxis should be mentioned. Patients should • Wrong site surgery—an operation performed
receive feedback about the operation and be on the wrong patient or wrong site.
offered an appropriate follow up appointment. • Retained foreign object post-procedure.
Discharge advice should include information • Unintentional transfusion of ABO incompati-
about accessing care if there were to be a compli- ble blood components.
cation. Risk of ectopic pregnancy should be men- • Misplaced nasogastric tube in the respiratory
tioned in appropriate cases. tract.
238 J. Campbell
42.4 Avoidance of Litigation gists are trained and able to operate on and with
the adjacent viscera. Case selection and delega-
There should be in-depth pre-operative planning tion is important. In an emergency situation, the
with realistic and appropriate surgical aims. The gynaecologist might have no alternative but to
reason for performing an exploratory laparotomy perform an unfamiliar operative procedure if
should be discussed and the fact that a therapeu- there is no other option to ensure the patient’s
tic procedure may be performed under the same best interests and safety. There may not be a more
anaesthetic. Patient’s wishes should be consid- experienced colleague available to help. Accurate
ered, particularly her desire for fertility and ovar- note keeping describing the episode is especially
ian and cervical conservation. Laparotomy important.
should be mentioned as a possible additional sur- In emergency cases, there should be prompt
gery to patients having a laparoscopic procedure, attendance and timeliness of surgery. Team work-
either diagnostic or therapeutic. Conversion to a ing is essential when dealing with undifferenti-
laparotomy might be required to deal with more ated emergency patients in the casualty
extensive pathology than was anticipated or a department. Appropriate delegation of surgical
surgical complication or as part of the planned cases is important and a senior doctor should
treatment (e.g. to remove a solid ovarian tumour). review admissions at high risk of complications
Elective laparotomy may be carried out under a and mortality.
regional or general anaesthetic. Patients should An anaesthetic review prior to theatre should
attend for a pre-operative assessment screen and have taken place. The choice of anaesthetic and
appropriate patient information sources should use of local nerve blocks for postoperative anal-
have been disclosed and the explanation for sur- gesia should be discussed. The use of rectal anal-
gical treatment with clear aims, risks, complica- gesia should be mentioned and any objections
tions, benefits and alternative treatments recorded in the notes.
documented. The concept of enhanced recovery The WHO Surgical Safety Checklist must be
should be mentioned [3, 4]. completed before the start of the operation.
Consent for a laparotomy should be valid and An indwelling urinary catheter should be
the provision of information is essential. A signa- inserted to empty the bladder and reduce the
ture on the consent form is not proof of valid con- chance of injury when opening the lower perito-
sent. In the case of written consent make sure you neum. Antiseptic solution should be applied to
record discussions within the patient’s health the vaginal tissues and pooling avoided. A naso-
record and confirm the patient still wishes to go gastric tube might be required to decompress the
ahead with surgery answering any further ques- stomach if there are anaesthetic concerns about
tions where necessary. Adequate time for reflec- aspiration or as part of the management of bowel
tion should be given. A copy of the consent form obstruction. The patient may be positioned
should be given to the patient. Any changes to the supine or in a flat “Lloyd-Davies” position to
consent form thereafter should be initialled and improve access to the deeper pelvis when rectal
dated by both the patient and the doctor [5]. surgery might be anticipated. Positioning and
The choice of incision should be discussed. A support is important to reduce the likelihood of
final decision may not be made until after a pel- compression injuries to the common peroneal
vic examination in theatre. This should be made nerves from stirrups and straining of the lower
clear to the patient. back. The arms are either placed by each side or
The gynaecologist should be competent per- abducted at right angles to the body avoiding
forming the procedure and be carrying out this hyperextension. The diathermy plate should be
surgery on a regular basis. Senior support should applied properly to a dry surface. Any superficial
be considered and opinions sought from other bruises should be noted. The operating table
specialities if additional non-gynaecological sur- should allow for intraoperative radiology should
gery is thought likely. Gynaecological oncolo- that be required.
42 Laparotomy 239
A laparotomy is undertaken either through a cyst, ectopic pregnancy, trauma, retrograde men-
low transverse incision or midline incision in struation and non-gynaecological causes.
most cases. Bleeding after surgery can occur with the use of
An infra-umbilical midline incision is usually non-steroidal anti-inflammatory drugs and low
performed. The initial size of incision will be molecular weight heparin. Careful inspection of
dependent on the anticipated diagnosis and the the pelvis is required to identify the source of
incision can always be extended if required. A bleeding and appropriate action taken. Pressure is
scalpel or cutting diathermy is used to incise the applied to the source. Good exposure is obtained
skin and cut through the subcutaneous fat. The before controlling measures are put in place. Soft
rectus abdominis muscles are split in the mid- tissue clamps can be applied initially. Insertion of
line taking care not to disturb the inferior epigas- sutures and ligatures in a blind fashion should be
tric vessels. The preperitoneal fat is divided and avoided if at all possible. On occasion damage to
the peritoneum identified. The peritoneal layer is adjacent structures from efforts made to stop
breached with digital dissection or opened with bleeding can happen. Circumstances will dictate
scissors. The peritoneum is grasped with two what action is acceptable and the surgical misad-
forceps and opened after checking for the pres- venture can be understandable.
ence of bowel and omentum. A second laparot- Multiple sources of arterial and venous bleed-
omy may be more challenging because of ing in the pelvis can be a difficult challenge and
scarring and adhesions to the abdominal wall. hot compression packs left in the pelvis for a few
Care must be taken to avoid electro-cautery inju- minutes can be helpful. Haemostatic agents can
ries to the skin and inadvertent contact with also be used and intravenous tranexamic acid.
bowel and bladder when cauterising vessels or If bowel pathology is diagnosed—a perfora-
cutting tissues. tion and spillage of contents, obstruction, volvu-
Care must be taken not to damage the bowel lus, torsion, infarction, tumour, inflammation
and omentum if they are adherent to the anterior (appendicitis, diverticulitis), dense adhesions,
abdominal wall. It is prudent to explore the mar- burn—a bowel surgeon must be requested.
gins of the incision digitally before carefully Thermal spread from electrosurgical devices
positioning a retractor so as not to trap loops of should be appreciated.
small bowel and omentum before stretching the The management of chronic pelvic inflamma-
wound. Care should be taken to avoid muscle tory disease, tubo-ovarian abscesses, advanced
tears and bleeding. Compression of the lateral endometriosis and malignancy should be done
pelvic vessels and nerves should be avoided by with the help and advice of experienced col-
the use of appropriately sized blades. Care must leagues. A urologist should be asked to help if
be taken in very thin patients. ureterolysis or stenting of a ureter or bladder
New non-metallic retractors are less likely to repair is required.
cause these problems (e.g. Alexis wound Laparotomy should be adequately covered
retractor). with prophylactic antibiotics. Co-amoxiclav
An initial systematic exploration of the perito- should be avoided in penicillin sensitive patients.
neal cavity is performed and a plan formulated. At the conclusion of the operation, all packs
The patient is placed in a Trendelenburg position and swabs should be removed. The scrub practi-
with adequate support to stop sliding and the tioner completes a count of instruments, needles
bowel and its mesentery lifted and packed out of and swabs before the peritoneum is closed and
the pelvis. Packing is done carefully to avoid again before the skin is closed. There should be
tears in the mesentery. An adhesiolysis might be no count discrepancy. Information about swabs
required and mobilisation of the sigmoid colon to and instruments (e.g. ureteric stents) intention-
improve exposure. ally retained after the procedure has finished
Haemoperitoneum can be associated with rup- should be clearly recorded in the patient’s notes
ture of a physiological and pathological ovarian with a plan for removal at a later date.
240 J. Campbell
Different techniques may be used to close the accompany the patient to the ward. Abbreviations
incision. A single layer mass closure is popular open to misinterpretation should be avoided.
for vertical incisions. Closing the wound in lay- Notes of the laparotomy should include—date
ers can also be considered and is the method of and time, names of the gynaecology team and
choice for Pfannenstiel incisions. A continuous anaesthetist, operation performed, incision and
suture using an absorbable suture material or operative diagnosis and findings, complications
delayed absorbable suture material is usually and extra procedures required, specimens
used. There is a difference in opinion as to removed, details of closure technique and antici-
whether closure of the peritoneum is necessary or pated blood loss, postoperative care instructions
not. It is important to ensure that the bowel and and signature.
omentum are not caught when suturing the sheath A formal handover of the patient should occur.
and peritoneum. Care must be taken at the lower Postoperatively, patients should receive appro-
limit of the mid-line incision not to catch the priate fluid and nutritional support and pain relief
bladder. The skin is closed using clips or a [4]. VTE prophylaxis should be considered.
delayed subcutaneous absorbable suture or non- Physiotherapy support and advice about wound
absorbable interrupted sutures. Local anaesthetic care should be given. Bladder care guidelines
may be injected into and around the wound or should be followed and help to address constipa-
given via catheters. This is unnecessary with an tion. Enhanced recovery programme should be
epidural anaesthetic. The placement of a drain in encouraged. Patients should be told the diagnosis
the rectus sheath or pelvis is dependent on the and treatment undertaken. If a complication
circumstances. A drain might be placed to reduce occurred an explanation should be offered and
the risk of haematoma or abscess formation. apologies and careful follow up. Patients should
Careful insertion is required to avoid injuries to be offered a post-operative review usually
abdominal wall vessels and intraperitoneal con- 6–8 weeks after discharge, but this is not always
tents. Drain entrapment can be a problem if it is necessary.
brought out of the Pfannenstiel incision and inad- Audits should be performed looking at the
vertently caught in the rectus sheath closure. It is outcomes of surgical treatment and complica-
wise to check the drain slides before closing the tions related to elective and emergency laparot-
skin and anchoring the drain to the skin. omy and any readmissions within 30 days.
Appropriate wound dressings should be used. A
note should be made of any loss in the drain and
urine volume and colour. Frank blood with no 42.5 Case Study
urine in the catheter should alert to the risk of
bladder injury and re-exploration of the pelvis. A 47-year-old woman underwent a laparotomy
Good communication with the relatives is for a cholecystectomy. She was referred to a phy-
encouraged if there are intraoperative complica- sician eight years later for abdominal pain and
tions and the surgery is difficult and not going to hepatic enlargement. Antibiotics failed to resolve
plan. A message from theatre to the ward staff symptoms and a diagnosis of hepatic carcinoma
and relatives can be helpful. was made but as the patient remained well was
The operation should be recorded and any revised to a chronic hepatic abscess. Chest X-rays
pathology specimens labelled correctly. A case showed elevation of the right hemi-diaphragm,
debrief should occur with all staff. The operative pleural reaction at the right costophrenic angle
notes must be clear and preferably typed and and elevation and thickening of the horizontal
42 Laparotomy 241
ssure. An opacity below the right hemi-dia-

fi
phragm was overlooked. Over the next 12 years Key Points: Laparotomy
until approximately 20 years after the cholecys- • Adequate perioperative care and coun-
tectomy the patient received ongoing regular selling, valid consent and material risks
treatment from the specialist and her GP. At discussed and patient choice.
68 years of age she consulted a new doctor about • Procedure performed by competent
her continuing abdominal pain and discomfort. gynaecologist following standards for
Barium meal demonstrated two calcified masses surgical care.
and an enlarged liver which were confirmed on a • Good surgical technique, timely control
CT scan. At laparotomy two large abscesses in of haemorrhage and involvement of sur-
the subphrenic space above the liver were found. geons for non-gynaecological pathology.
In one of these abscesses besides pus, a large sur- • Appropriate use of WHO surgery safety
gical swab was found with calcification of the checklist.
wall. Following this the patient made an uncom- • Appropriate use of antibiotics and VTE
plicated recovery and liability for the retained prophylaxis.
swab was admitted by the hospital. The patient • Appropriate operation note.
received £27,000 in compensation. • Adequate follow up of patients.
Gossypiboma or textiloma is referred to as a • Immediate and delayed complications
surgical gauze or towel inadvertently retained should be appropriately managed and
inside the body following surgery. Though this is recorded.
a rare medical error it is completely preventable
and in the doctrine of res ipsa loquitur will
always be viewed as surgical negligence.
Learning points include References
• Surgical counts before during and at the end of 1. RCS (Royal College of Surgeons). Emergency

Surgery—Standards for Unscheduled Surgical Care;
surgery are an essential error minimisation 2011.
technique, but are not infallible. 2. GMC (General Medical Council). Good medical prac-
• Symptoms may not present initially, and com- tice; 2013.
plications may present after a great delay 3. Nelson G, Altman AD, et al. Guidelines for pre- and
intra-operative care in gynaecologic/oncology sur-
sometimes even decades. gery: Enhanced Recovery After Surgery (ERAS)
• Presentation may be with infection, abscess or Society recommendations – Part 1. Gynecol Oncol.
adhesion formation with consequent obstruc- 2016;140(2):313–22.
tion, as well as fistula formation and migration. 4. Nelson G, Altman AD, et al. Guidelines for post-
operative care in gynaecologic/oncology sur-
• Suspicion of retention of surgical materials gery: Enhanced Recovery After Surgery (ERAS)
warrants the use of plain radiographs to detect Society recommendations –Part II. Gynecol Oncol.
intact radio-opaque materials in the first 2016;140(2):323–32.
instance but inevitably result in further sur- 5. Treharne A, Beattie B. Consent in clinical practice.
Obstet Gynecol. 2015;17:251–5.
gery for removal.
Urological Injuries
43
Christopher R. Chapple
43.1 Background Ureteric proximity to the female genital tract

also puts it at risk of injuries during pelvic sur-
Urinary tract injury is reported in approximately gery. Most published studies quote a range or
1% of women who undergo pelvic surgery [1]. ureteric injury rates of laparoscopic gynecologi-
The urinary tract is at risk of injury particu- cal surgery from <1 to 2% [3]. However, there is
larly during laparoscopic gynecological surgery, a significant range in the literature, with rates
either due to the entry process (for example, dur- being as low as 0.06% and as high as 21% [5, 6].
ing suprapubic port insertion) or as a conse- It is estimated that approximately 250,000
quence of its close relationship with the operative women undergo laparoscopic surgery in the UK
field (for example, during hysterectomy). In each year; the majority are without problems,
more complex situations, the bladder can also be but it can be assumed that approximately 250
at risk because of its direct involvement in the serious complications occur every year.
disease process (for example, utero-vesical Observing the ureter for peristalsis is often
endometriotic nodules). The reported incidence used to identify the ureter, but it is not a valid test
varies greatly. Injury rates range from 0.02 to for ureteral integrity. In a prospective study in
8.3% [2]. This places bladder injury at the top of which women undergoing total abdominal hys-
the list of viscera which can be damaged in the terectomy were evaluated with intraoperative
context of laparoscopic pelvic surgery [3]. cystoscopy, peristalsis was present in five of six
Dissection of the bladder from the cervix, the women with ureteral injury [7]. Full evaluation of
introduction of the Veress needle/trocar are com- a ureter may require further dissection of the ure-
mon incidences when injury may occur to the ter, if the ureter has not been fully isolated.
urinary tract. Certain procedures such as laparo- Whether to perform this ureteral dissection ini-
scopic assisted vaginal hysterectomy appear to tially or defer dissection and evaluate the urinary
be associated with a higher frequency of bladder tract integrity at a later time during surgery (e.g.,
injury compared with other procedures [4]. with cystoscopy) is based upon the surgeon’s
preference and skills.
As a general rule, symptoms coincide with the
location and type of injury. A combination of
obstruction or the sequelae of a laceration in the
C. R. Chapple
urinary tract may present with a combination of
Department of Urology, Sheffield Teaching Hospitals
NHS Trust, Sheffield, UK signs and symptoms. It is also important to realise
e-mail: c.r.chapple@sheffield.ac.uk that more than one area may be involved and a

https://doi.org/10.1007/978-3-319-78683-4_43
244 C. R. Chapple
classical example is where a vesicovaginal fistula 43.2.1 Intraoperative

is identified but there is no imaging of the upper
tracts and a concomitant ureterovaginal fistula is When there is a finding suggestive of injury, intra-
missed. Whilst a ureteral or bladder defect with operative evaluation is essential. If a defect can be
leakage of urine into the peritoneal cavity will seen grossly after a laceration or transection to a
present with abdominal pain and as a conse- ureter or the bladder, then an appropriately skilled
quence of obstruction to the upper tract, also with individual should be called to the operating theatre.
flank pain, the clinical symptoms may be mis- If injury is suspected (a telltale indication of this
leading. If there are any atypical signs then imag- being the presence of haematuria) then a cystos-
ing of the upper tracts initially with ultrasound is copy is mandatory. If a ureteric injury is suspected,
essential. Certainly on some occasions cases of then this can be clearly delineated by a cystoscopy
complete ureteric obstruction may present with and passage of a guide wire, with or without an
minimal symptoms and signs other than of mild appropriate ureteric catheter passed up the ureter
sepsis or non-specific discomfort. which is thought to be potentially affected.
If there is a direct injury to the bladder (cys-
totomy) then direct closure to this can be carried
43.2 Minimum Standards out as long as it is not close to the ureter. If this is
and Clinical Governance suspected then a cystoscopy and insertion of a
Issues guide wire or stent is appropriate, potentially
involving a urological surgeon to assist.
The best management is prevention with clear If a clamp is identified in close proximity to
delineation of anatomy to identify important the ureter, or a suture or staple, then a ureteric
structures such as the ureters, bladder and ure- injury should always be excluded by passage of a
thra. Whether it is open or laparoscopic, the sur- guide wire and/or stent up the ureter.
geon should be experienced, not only in Bladder injuries are more likely to be diag-
appropriate anatomical dissection but also man- nosed during visual inspection than ureteric inju-
agement of adhesions. Particular account should ries. In a prospective study of 839 women who
be taken of any previous abdominal scar and underwent hysterectomy, visual inspection
adhesions relating to the urinary tract suspected detected 9/24 bladder injuries (38%) versus 1/15
when mobilizing tissues to gain access to the ureteric injuries (7%) [8].
gynecological organs. If a surgeon is not fully The use of intravesical or intravenous dye to
experienced in a new technique then they should colour the urine can be advised. The intravesical
be adequately trained and/or supervised. dye which is commonly used is methylene blue and
Surgeons should be familiar with the equip- intravenously carmine 2.5 mL of 0.8% solution,
ment, instrumentation and energy sources that which can be administered by the anesthetist. It is
are being used. Surgeons undertaking any sur- not recommended that methylene blue should be
gery should ensure that the nursing staff and given intravenously because a cumulative dose
surgical assistants are appropriately trained for greater than 7 mg/kg can result in methemoglobin-
the roles that they will undertake during the emia in susceptible individuals. If a urologist is
procedure. called to the scene, then they can also use other
Full informed consent is essential, and should techniques such as ureteroscopy to inspect a ureter.
outline all of the major complications and minor
complications. It is important that women should
be aware of the risks of significant morbidity and 43.2.2 Postoperative
mortality association with any surgical proce-
dure. Issues of consent have been outlined in pre- Postoperative recognition of injury is a signifi-
vious chapters. cant precursor to litigation. In a series of 20 uri-
nary tract injuries in women after pelvic surgery,
43 Urological Injuries 245
the main time to diagnose this was 5.6 days between these in the context of a delayed onset of
(range 0–14 days) [9]. manifestation of the injury. Likewise, discussions
Precursor symptoms are: relating to complete or partial damage to the ure-
ter rely heavily on surmise.
• Unilateral or bilateral flank pain
• Haematuria
• Oliguria 43.3 Reasons for Litigation
• Anuria
• Abdominal pain or distension • Inadequate preoperative discussion and coun-
• Nausea with or without vomiting selling, and failure to document adequate
• Ileus consent.
• Fever • Lack of surgical experience.
• Poor surgical technique, usually resulting
The manifestations of fistulation of the uri- from lack of training or inadequate senior
nary tract are very variable in nature and may supervision.
take from days to weeks to present. If pathology • Inappropriate surgical approaches, such as
is suspected, then a thorough clinical examina- laparoscopic approaches in a heavily scarred
tion is essential. Routine biochemistry and a full abdomen, or failure to convert from laparos-
blood count, and examination of any drained copy to open surgery.
fluid can also be helpful in identifying the pres- • Failure to adequately examine the abdomen at
ence of urine. Standard imaging of the upper the time of suspected injury and/or failure to call
tracts whether by intravenous urography, CT upon a senior colleague in the same specialty or
scanning or MRI are mandatory, optimally after an alternative specialty such as urology.
discussion with a radiological colleague to iden- • Difficulty managing peri-operative bleeding,
tify the best modality. In particular a cystogram is leading to inappropriate placement of clamps
useful along with a subsequent cystoscopy. and sutures, with potential occlusion of struc-
If ureteric injury is suspected, then in addition tures such as the ureter or injuries to the blood
cystoscopy and insertion of a ureteral stent can be supply to the ureter or bladder.
considered. If complete obstruction of the ureter • Inappropriate early management of a patient
is felt to be the case, then insertion of a nephros- with suspected complications.
tomy tube as an emergency is appropriate, with • Failure to recognize the likelihood of a urinary
the antegrade passage of a stent performed by a tract injury and to evaluate appropriately, for
radiologist. example in a patient with incontinence of urine
If any injury is identified within the first occurring de novo after hysterectomy, the fail-
2–3 weeks whether it is a bladder injury with a ure to recognize the potential for there being a
fistula for instance or a ureteric injury and a stent fistula; an alternative scenario would be failure
cannot be passed, then early intervention can cer- to investigate a non-specific symptom such as
tainly be contemplated and conducted by an expe- flank pain or persistent pyrexia with subse-
rienced surgeon who is familiar with all of the quent recognition of a ureteric injury.
techniques available, as this will obviate the need
for a prolonged period of management, because
beyond 3 weeks, most reconstructive surgeons 43.4 Avoiding Litigation
who deal with urinary tract injury will advise
leaving tissues to heal for a period of 3 months. 1. Careful preoperative preparation and consent;
A common discussion in medico legal circles taking a careful history of previous surgical
relates to whether ureteric injury has occurred as intervention; informing the patient about any
a consequence of a thermal injury, a clamp, or a potential complications and how these would
suture. It is usually not possible to differentiate be managed; devoting time to counsel the
246 C. R. Chapple
patient and answering any questions that they action was taken. The haematuria persisted on the
may have; discussing all alternatives to the ward for 48 h and then settled. The catheter was
proposed treatment strategy; documenting all removed after 72 h. Three weeks later, the patient
potential complications relating to both mor- contacted the clinician’s secretary to state that she
bidity and mortality. was experiencing marked frequency and urgency,
2. Careful surgical technique and recognition of and had been diagnosed as having a urinary tract
situations where a urinary tract injury may infection. She was advised antibiotic therapy. She
have occurred. Calling on a senior colleague re-contacted the department two weeks later (five
or colleague from another specialty such as a weeks postoperatively) to say that she had a per-
urologist, to reassess the situation should be sistent urinary tract infection and persistent symp-
considered. toms. She was advised that she would be seen in
3. Appropriate recognition, investigation and
clinic as previously arranged, and was seen at
early management of any urinary tract injury. seven weeks postoperatively. She was reviewed
It is important that the patient should be fully by the Staff Grade doctor in the department, who
informed of what may have occurred, how this reassured her that such a situation was not uncom-
will be evaluated and dealt with. Failure to mon, and she was advised that she would be seen
involve the patient in the process and explain in a further three months. Her symptoms persisted
to them exactly what is going on is more likely and she was referred to a urologist who carried
to lead on to litigation. out a cystoscopy and identified the presence of
4. Early intervention, whenever an injury is sus- polypropylene mesh which had been used for the
pected, may allow early resolution of the sacrocolpopexy, lying at the dome of the bladder.
problem. Litigations is more likely to occur if Comment: The presence of marked haematu-
the patient has to live with the complication ria was a strong indication for carrying out a cys-
for some months prior to final resolution of toscopy at the end of the procedure. It is likely
the problem. that this would have demonstrated an abrasion at
5. Preventing unnecessary deterioration in renal the dome of the bladder and early intervention
tract function, for example early intervention would have saved the subsequent course of
will prevent loss of renal function if there is a events. When this lady presented with persistent
ureteric obstruction. Appropriate use of anti- symptoms for the second time, then certainly ear-
biotics and management of infection are also lier investigation would have been appropriate,
essential to prevent unnecessary damage to either when she called the department on the sec-
the urinary tract. ond occasion or when she was seen in clinic.
6. When there is an unsuspected lesion such as
urethral diverticulum during prolapse or sling
surgery a urologist/urogynaecologist should 43.5.2 Case Study #2: Obstetric
be involved in the management of this situa- Surgery
tion. If this is not managed optimally then a
complication and subsequent litigation are A 44-year-old lady who had a previous normal
more likely to occur. vaginal delivery underwent an emergency caesar-
ean section following which she was troubled by
persistent abdominal discomfort. A week after the
43.5 Case Study surgery, having been discharged after 48 h, she got
in contact to say that she had a purulent discharge
43.5.1 Case Study #1: Laparoscopic per vaginum which was intermittent in nature, and
Surgery passage of the discharge relieved her discomfort.
The discharge was not continuous and at times it
A 34-year-old woman underwent a laparoscopic was clear in nature. She was reassured and told
sacrocolpopexy. The surgeon felt the procedure that this should settle. When she re-presented for
was uneventful, but marked haematuria was noted review at a post-natal visit at one month, the symp-
by the assistant at the end of the procedure. No toms were persisting and on examination there
43 Urological Injuries 247
was noted to be a clear discharge in the vagina, but

the history was that the discharge was not continu- Key Points: Urological Injuries
ous. She was reassured. Her symptoms persisted • Counsel and consent patients, and docu-
and six weeks later her general practitioner wrote ment it appropriately.
to the department stating that she was still experi- • Document the potential for injury of the
encing intermittent discharge and abdominal dis- urinary tract, whether it be ureter, blad-
comfort, which was usually relieved by the der or urethra.
discharge. A cystoscopy was arranged which • Early intraoperative discovery of an
showed no intravesical abnormality. No imaging injury and seeking advice of either a
of the upper tracts was carried out and it was not senior colleague or urologist may
until four months later following this that she was well allow for early resolution of the
referred to the urology department where imaging problem and avoid subsequent
of the upper tracts was performed and a uretero- litigation.
uterine fistula was identified. • In cases where there is significant bleed-
Comment: Early imaging of the upper tracts ing then careful reappraisal of the
may well have identified this as contrast would situation either peroperatively or post-
have been seen passing into the uterine cavity. operatively, and appropriate imaging are
essential. If any possibility of urinary
tract injury may have occurred, then
43.5.3 Case Study #3: Radical Surgery document this to allow potential early
intervention as necessary.
A 44-year old lady underwent a radical hysterec- • Whenever in doubt, utilize cystoscopy
tomy for an early stage endometrial cancer. She to exclude an intravesical injury. If a
noticed when she returned home that she was ureteric injury is thought to even be pos-
experiencing persistent urinary discharge per sible, then coupled with a cystoscopy,
vaginam. She contacted her gynecologist who passage of a guide wire or ureteric cath-
told her that it was very common to get some uri- eter up the ureter is an easy way of
nary leakage after radical surgery such as this for excluding pathology. Appropriate use of
up to 18 months. Her symptoms persisted and she dye as noted above can identify urinary
was using 8–10 pads per day. Her general practi- tract leakage.
tioner referred her back to the hospital at a month • Having a low index of suspicion for the
and she was again reassured. Eventually at three possibility of a urinary tract injury hav-
months following surgery a locum surgeon in the ing occurred with and arranging an
department who was reviewing her arranged for ultrasound of the upper tracts, will usu-
her to have a cystogram, which showed the pres- ally identify the possibility of obstruc-
ence of a vesico-vaginal fistula. This was noted to tion to a kidney or show the presence of
be small, approximately 4 mm in diameter a fluid collection, which may then
according to the imaging, and she was told that prompt further investigation.
this might well heal. Her symptoms persisted and • The presence of incontinence occurring
she contacted her local Citizens Advice Bureau de novo should always lead on to early
who suggested she contact the hospital com- investigation.
plaints group. A review of her case led on to her
being referred to another centre where tertiary
work was carried out. Imaging of her upper tract
showed the presence of both a vesicovaginal and References
ureterovaginal fistula.
1. Gilmour DT, Das S, Flowerdew G. Rates of uri-

Comment: The case demonstrates a failure to nary tract injury from gynecologic surgery and the
act on the patients symptoms, a subsequent fail- role of intraoperative cystoscopy. Obstet Gynecol.
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ef?an=00006250-200606000-00024.
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4. Johnson N, Barlow D, Lethaby A, Tavender E, Curr 8. Ibeanu OA, Chesson RR, Echols KT, Nieves M,
L, Garry R. Methods of hysterectomy: systematic Busangu F, Nolan TE. Urinary tract injury during
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tomy (LASH), a retrospective study of 1,584 cases A. Evaluation and treatment of iatrogenic ureteral injuries
regarding intra- and perioperative complications. during obstetric and gynecologic operations for nonma-
Arch Gynecol Obstet. 2012;285(5):1391–6. http:// lignant conditions. J Am Coll Surg. 1994;178(2):144–8.
link.springer.com/10.1007/s00404-011-2170-9. http://www.ncbi.nlm.nih.gov/pubmed/8173724.
6. De Cicco C, Schonman R, Craessaerts M, Van
Cleynenbreugel B, Ussia A, Koninckx PR, et al.
Bowel Injury
44
Janesh K. Gupta and Tariq Ismail
44.1 Background tively (no deaths) but when injury was unrecog-
nised at the time of surgery and when the diagnosis
As of 2009, 20% of 600,000 hysterectomies per- was delayed (41% of cases), this resulted in a mor-
formed in the United States were done laparo- tality rate of 1 in 31. Eighty percent of bowel inju-
scopically [1] and approximately 250,000 women ries were managed by laparotomy.
undergo laparoscopic surgery in the UK each Bowel injury can also occur from other gynae-
year. The advantages of laparoscopy over lapa- cological procedures such as dilatation and curet-
rotomy have been well established and include tage (D&C), open abdominal hysterectomy and
less post-operative pain, shorter hospital stays hysteroscopic procedures. The incidence of bowel
and reduced blood loss [2, 3]. injuries is 1:333 in hysterectomy [5]. Usually the
Laparoscopic related complications involving sigmoid colon and rectum is at risk in women
the bowel usually occur during initial abdominal with a history of endometriosis, malignancy, pel-
access, trocar placement, dissection of adhesions or vic inflammatory disease or diverticulitis.
the use of electrosurgery. Complications are more For the purposes of this chapter we shall dis-
litigious when it is associated with gynaecological cuss pertinent issues between gynaecological
laparoscopic surgery rather than by laparotomy. laparoscopy and bowel injury and also cover
A recent meta-analysis [4] indicated that there methods to identify the mechanism of injury
were 604 bowel injuries reported following depending on the timescales of presentation in
474,063 gynaecological laparoscopies, giving an the post-operative period.
incidence of 1:769. Bowel injury rate varied from
1:3333 for sterilisation to 1:256 for hysterectomy.
The small bowel was the most frequently injured 44.2 M
inimal Standards and Clinical
(47%). Fifty-five percent of bowel injuries Governance Issues
occurred during Veress needle or trocar placement.
Most bowel injuries were recognised intra-opera- 44.2.1 Open Laparotomy
J. K. Gupta (*)
See chapter on laparotomy.
Birmingham, UK
e-mail: j.k.gupta@bham.ac.uk 44.2.2 Safe Laparoscopic Entry
T. Ismail
University Hospital Birmingham, Birmingham, UK In gynaecological practice, the closed method
e-mail: tariq.ismail@uhb.nhs.uk for port entry is commonly used, using a Veress

https://doi.org/10.1007/978-3-319-78683-4_44
250 J. K. Gupta and T. Ismail
needle. Initially blind trocar insertion of the pri- 44.4.2 Laparoscopic Surgery
mary port through the umbilicus is followed by
direct vision insertion of lateral trocars. The There are several national and international spe-
direct trocar entry has also been used in gynaeco- cialist Society guidelines that can be summarised
logical practice. There is evidence to suggest that as specific steps for safe laparoscopic entry [6–9].
this technique is associated with a lower risk of
vascular injury and failed entry compared to 1. Patient should be lying flat with an empty
closed entry techniques [6]. bladder.
Alternative entry techniques should be used 2. Veress needle should be checked for spring
such as Palmer’s Point or open Hasson for and gas patency. This should be indicated on
patients with previous abdominal surgery, obe- the insufflator as 0 mm Hg pressure and a flow
sity, extremely thin patients and those with rate of between 1.7 and 2.3 L/min, depending
known abdominal adhesions. upon the calibre of the Veress needle. This can
The open Hasson technique may be consid- only be checked after allowing the insufflator
ered an alternative to the closed technique. to run for at least 20 s.
Although it is associated with a reduced rate of 3. A 10 mm vertical intra-umbilical incision

failed abdominal injury, there is no significant starting in the umbilical pit, extending
difference in the risk of vascular or visceral injury caudally.
rates [6]. 4. Insertion of Veress needle at the level of the
deep umbilical pit 90° to the skin in a con-
trolled manner and not inserting the needle
44.3 Reasons for Litigation more than 20 mm. The Veress needle should
not be excessively moved after insertion to
• Failure to adequately select patients. avoid any injury to be extended to become a
• Failure to adhere to the principles of safe lapa- large complex tear.
roscopic entry as recommended by National 5. Initial intra-abdominal pressure should be

Bodies (see below). negative. During insufflation a pressure of
• Failure to detect bowel injury at the time of <8 mm Hg pressure with a high flow rate indi-
surgery. cates correct Veress placement.
• Failure to detect bowel injury in the early 6. The insufflator should be set to 25 mm Hg
postoperative period. pressure which allows maximum safe distance
• Failure to convert to a laparotomy when bowel between abdominal wall and underlying
injury suspected. abdominal contents. This abdominal pressure
• Failure to call a bowel surgeon when bowel also achieves a tympanic splinting effect of
injury suspected/occurs. the abdominal wall and does not compromise
• Attempting repair of bowel injury in the inferior vena caval compression.
absence of adequate case load as a 7. Insertion of trocars should not be uncon-

gynaecologist. trolled. Primary trocar insertion should be in a
controlled two-handed screwing manner, ver-
tically at 90° to the skin. Further advancement
44.4 Avoidance of Litigation should not be beyond the tip of the trocar
through the abdominal wall.
44.4.1 Open Laparotomy 8. Initial 360° laparoscopic check for intra-

abdominal visceral or vascular injury should
See chapter on laparotomy. be performed.
44 Bowel Injury 251
Fig. 44.1 Timeline for

post-operative Principles of post-operative care
complications Timelines for indicating possible causes
1˚ haemorrhage 1˚ Infection 2˚ Infection

tachycardia Wound Wound
normotensive Pelvis Pelvis
hypotension Chest Chest
Urine Urine
0 24h 5 7 10 14
Thrombosis days
Thrombosis
DVT/PE DVT/PE
Pyrexia > 38˚C
Direct Injury Indirect Injury
Usually UTI
Visceral Avascular necrosis
perforation e.g. Visceral performation
bowel, bladder, e.g. peritonitis,
ureters vesicovaginal or
ureteric fistula
9. Insertion of secondary trocars under direct

care should be followed [10], which can indicate
vision should be in a two-handed controlled a mechanism of injury, and are summarised in
manner at 90° to the skin, avoiding inferior Fig. 44.1.
epigastric vessels. Following the insertion of
trocars, the intra-abdominal pressure should
be reduced to a working pressure of between 44.5 Case Study
12 and 15 mmHg pressure.
A 32-year-old woman with a BMI of 24 was
Concise, clear and comprehensive documen- requesting laparoscopic sterilisation procedure
tation of the surgical technique is important fol- after completing her family with three normal
lowing the principles for safe laparoscopic entry. vaginal deliveries. She had no previous abdomi-
Recognition of intra-abdominal injury and resort- nal surgery. A 3-L carbon dioxide insufflation
ing to laparotomy reduces the risks of litigation. was carried out through a two port procedure and
Laparoscopic repair should not be performed a Filshie clip sterilisation of the fallopian tubes
without first seeking help and involving trained was carried out. Three days later she was admit-
surgeons. In the systematic review only 8% of ted with pain and abdominal distension.
injuries were managed laparoscopically [4]. It is Laparotomy confirmed rectal injury requiring a
believed that Veress needles injuries can be Hartman’s procedure.
observed expectantly but only six cases in In an uncomplicated case, if there had been
46 years of literature have followed this approach good surgical techniques, the likelihood of lapa-
[4]. Patients returning with atypical symptoms roscopically related bowel injury is highly
should be investigated thoroughly for intra- unlikely. If there are no alternative pausible non
abdominal injury to avoid a delay in diagnosis, negligent explanations for a complication, then
which is a common reason for morbidity, mortal- the defendant is likely to be liable and follows
ity and litigation. Principles for post-operative the principles of res ipsa loquitir (“the thing
252 J. K. Gupta and T. Ismail
speaks for itself”) [11]. Although the defendant’s to hysterectomy for benign gynaecological disease.
Cochrane Database Syst Rev. 2015;(8):CD003677.
view point is that a bowel injury is a recognised https://doi.org/10.1002/14651858.CD003677.pub5.
complication of laparoscopy, the occurrence is 3. Gupta J. Vaginal hysterectomy is the best mini-
therefore not proof of negligence per se. mal access method for hysterectomy. Evid Based
However, if there are no risk factors and the sur- Med. 2015;20(6):210. https://doi.org/10.1136/
ebmed-2015-110300.
geon follows safe laparoscopic entry techniques, 4. Llarena NC, Shah AB, Milad MP. Bowel injury in
as detailed above, then the risk of injury is highly gynecologic laparoscopy: a systematic review. Obstet
improbable. Gynecol. 2015;125:1407–17.
5. Kafy S, Huang JY, Al-Sunaidi M, Wiener D,
Tulandi T. Audit of morbidity and mortality rates
of 1792 hysterectomies. J Minim Invasive Gynecol.
Key Points: Bowel Injury 2006;13(1):55–9.
• The overall incidence of bowel injury 6. Ahmad G, Gent D, Henderson D, O'Flynn H,
Phillips K, Watson A. Laparoscopic entry techniques.
in gynaecological laparoscopies is Cochrane Database Syst Rev. 2015;(8):CD006583.
1:769 but increases with surgical https://doi.org/10.1002/14651858.CD006583.pub4.
complexity. 7. Djokovic D, Gupta J, Thomas V, Maher P, Ternamian
• Laparoscopic hysterectomy bowel A, Vilos G, Loddo A, Reich H, Downes E, Rachman
IA, Clevin L, Abrao MS, Keckstein G, Stark M,
injury rate is 1:256. van Herendael B. Principles of safe laparoscopic
• Delayed diagnosis is associated with entry. Eur J Obstet Gynecol Reprod Biol. 2016. pii:
mortality rate of 1:31. S0301–2115(16)30138–5. https://doi.org/10.1016/j.
• Following ten surgical steps can aid safe ejogrb.2016.03.040.
8. Varma R, Gupta JK. Laparoscopic entry techniques:
laparoscopic entry. clinical guideline, national survey, and medicolegal
• Alternative methods for entry include ramifications. Surg Endosc. 2008;22:2686–97.
open Hasson and direct trocar entry. 9. Royal College of Obstetricians and Gynaecologists.
Preventing entry related gynaecological laparoscopic
injuries, Green Top Guideline No 49; 2008.
10. Gupta JK, Soeters R, Ndhluni A. Chapter 43:

References Postoperative care. In: Coomarasamy A, Shafi M,
Willy Davila G, Chan KK, editors. Gynecologic and
Obstetric Surgery – Challenges and Management
1. Cohen SL, Vitonis AF, Einarsson JI. Updated hys-
Options (GOSMO). Hoboken: Wiley Blackwell;
terectomy surveillance: factors associated with
2016. p. 131–2. ISBN: 97-804-706-576-14.
minimally invasive hysterectomy, a cross-sectional
11. Driscoll V. Bowel injury during laparoscopic steriliza-
analysis. JSLS. 2014;18. pii: e2014.00096.
tion – Vanessa Palmer v Cardiff & Vale NHS Trust.
2. Aarts JWM, Nieboer TE, Johnson N, Tavender E,
The AvMA Med Legal J. 2004;10(3):109–11.
Garry R, Mol BWJ, Kluivers KB. Surgical approach
Vascular Injury
45
Jonathan D. Beard
45.1 Background were reported to the National Patient Insurance

Association following 70,607 laparoscopic pro-
A survey of all hospitals in Sweden undertaking cedures [2]. The rate of major vascular complica-
gynaecological surgery and a review of the litera- tions was 0.1/1000. In the Netherlands, the results
ture found that the frequency per 10,000 opera- of a prospective multi-centre study of 72 hospi-
tions were: 0.93 after laparoscopy, 0.76 after tals found 145 complications from 25,764 lapa-
laparotomy, and 0.33 after major vaginal surgery roscopies [3]. There were two fatalities and 84
[1]. It seems counter-intuitive that laparoscopic women required a laparotomy to deal with the
procedures, which are often diagnostic, are asso- complications. There were 27 cases of vascular
ciated with a higher risk of vascular injury than injury (1.05/1000), and 57% of the injuries were
open procedures, and is explained by the fact that attributed to laparoscopic entry. Women with a
the majority of laparoscopic injuries are entry- previous laparotomy were also found to be at par-
related. Another reason is that retroperitoneal ticular risk.
vascular injuries are more easily missed. A large
section of this chapter therefore deals with entry-
related laparoscopic injuries. 45.2 Minimum Standards
In the Swedish survey, laparoscopic injuries and Clinical Governance
affected the iliac arteries more often and most Issues
were simply treated by arterial suture without
complications. Injuries during laparotomy were The RCOG ‘Standards for Gynaecology Care’ [4]
most frequently venous and accompanied by states that “Valid consent must be taken prior to
more severe bleeding. In one case the external any operative procedure” and that “Gynaecologists
iliac vein was ligated, with immediate postopera- who perform elective surgery should be able to
tive swelling, and in another case the external demonstrate their competency at the procedures
iliac artery was ligated, after which the patient they perform. This will be by continuous personal
developed postoperative ischemia. audit of the number of different procedures and
Similar rates of vascular injury have been log of outcomes, any complications, readmis-
reported from Finland where 256 complications sions, return to theatre and complaints. This
information is required for consultant appraisal”.
J. D. Beard
Documentation of vascular injury as a possi-
Sheffield Teaching Hospitals NHS Trust,
Sheffield, UK ble complication on the consent form is no
e-mail: j.d.beard@btinternet.com defence if the procedure is performed

https://doi.org/10.1007/978-3-319-78683-4_45
254 J. D. Beard
i ncompetently or the vascular injury poorly man- The RCOG Green Top Guideline number 49
aged. If the procedure has a particularly high risk on ‘Preventing entry-related gynaecological lap-
of vascular injury, then the surgeon also needs to aroscopic injuries’ states [7]:
ensure that adequate vascular cover, or assis- “Women must be informed of the risks and poten-
tance, is in place. tial complications associated with laparoscopy.
The Standards also state that “There must be a This should include discussion of the risks of the
locally agreed protocol for the thromboprophy- entry technique used: specifically, injury to the
bowel, urinary tract and major blood vessels, and
laxis and antibiotic prophylaxis to women under- later complications associated with the entry
going surgery.” ports: specifically, hernia formation. Surgeons
This protocol needs to follow NICE Guidance must be aware of the increased risks in women who
[5] in terms of timing, dosage and duration, are obese or significantly underweight and in those
with previous midline abdominal incisions, perito-
depending on the risk factors. A particular prob- nitis or inflammatory bowel disease. These factors
lem with pelvic surgery is that DVT may com- should be included in patient counselling where
mence in the iliac veins, rather than in the leg appropriate”.
veins. Therefore, duplex ultrasonography to
exclude DVT must include the iliac veins, and if During Laparoscopic surgery an intra-
not visualised, an MR venogram should be con- abdominal pressure of 20–25 mmHg should be
sidered [6]. used for gas insufflation before inserting the pri-
No surgeon should undertake a new procedure mary trocar. It is necessary to achieve a pressure
without adequate training and supervision. This of 20–25 mmHg before inserting the trocar, as
applies to consultants as well as trainees. this results in increased splinting and allows the
Surgeons also need to ensure an adequate trocar to be more easily inserted through the lay-
procedure- specific caseload to maintain their ers of the abdominal wall. The increased size of
competence. All surgeons should be able to pro- the ‘gas bubble’ and this splinting effect has been
vide patients with details of their caseload and shown to be associated with a lower risk of major
complication rates. These standards should also vessel injury. If a constant force of 3 kg is applied
apply to trainees who perform procedures unsu- to the abdominal wall at the umbilicus to an
pervised. Such trainees must be able to demon- abdominal cavity insufflated to a pressure of
strate their experience from a logbook and 10 mmHg, the depth under the ‘indented’ umbili-
competence from workplace-based assessments, cus is only 0.6 cm. When the same force is
and a procedure should ideally be signed off as an applied to an abdomen distended to 25 mmHg,
‘Entrustable Professional Activity’ by their the depth increases to 5.6 cm (range 4–8 cm). The
Educational Supervisor, as now recommended by mean volume of CO2 required to reach this pres-
the GMC. sure was 6 L [8]. No adverse effect on circulation
The Standards also state that “If surgery is or respiratory function was observed as long as
being performed in a satellite unit, there must be the patient is lying flat, but In the Trendeleburg
a defined pathway for the anaesthetist and sur- position, it is advisable to reduce the distension
geon to call for additional help of a colleague pressure to 12–15 mmHg once the insertion of
and a transfer pathway to the nearest emergency the trocars is complete. This reduces the risk of
gynaecological inpatient hospital. In the event of lower limb venous/arterial insufficiency and
a complication and where relevant, facilities to makes ventilation easier.
convert to abdominal surgery must be available. The primary trocar should be inserted in a
A rapid access ambulance and transfer team controlled manner at 90° to the skin, through the
must be available if a higher level of care is incision at the thinnest part of the abdominal
required postoperatively. Wherever the surgery is wall, in the base of the umbilicus. Insertion
being conducted, there must be a clear pathway should be stopped immediately the trocar is
to call for assistance from a general, gastrointes- inside the abdominal cavity. Once the laparo-
tinal, vascular or urological surgeon if complica- scope has been introduced through the primary
tions occur”. cannula, it should be rotated through 360° to
45 Vascular Injury 255
check visually for any adherent bowel or bowel/ opinion should be obtained before closure (see
vascular damage. case report 2).
Secondary ports must be inserted under direct If the hole is large, or the gynaecologist/ assis-
vision perpendicular to the skin, while maintain- tant inexperienced, then pressure should be re-
ing the pneumoperitoneum at 20–25 mmHg. applied and help from a vascular surgeon
During insertion of secondary ports, the inferior requested. If there is no vascular available on-
epigastric vessels should be visualized laparo- site, then help should be summoned from the
scopically to ensure the entry point is away from nearest major vascular unit. The commonest
the vessels. cause of adverse sequalae from vascular injury is
Secondary ports must be removed under direct due to a failure to ask for help at an early stage.
vision to ensure that any haemorrhage can be
observed and treated, if present. Before placing
the lateral ports, it is essential that the inferior 45.3 Reasons for Litigation
epigastric vessels are visualised from within the
peritoneal cavity by the laparoscope and that the The commonest reasons for litigation following
entry point of the port is away from these vessels. arterial injury relate to:
The inferior epigastric arteries and veins can be
visualised just lateral to the lateral umbilical liga- 1. Inadequate preoperative discussion/documen-
ments (the obliterated hypogastric arteries) in all tation of complications prior to obtaining
but the most obese patient. In the woman who is consent.
obese, the incision should be made well lateral to 2. Lack of appropriate thromboprophylaxis or
the edge of the rectus sheath, taking care to avoid failure to diagnose postoperative DVT.
injury to the vessels on the pelvic side wall. 3. Poor surgical technique, lack of training and
Many vascular injuries to arteries and veins inadequate senior supervision.
are relatively minor, and many will stop with the 4. Inadequate facilities to convert to laparotomy
application of sustained pressure for 5 min or so. or delay in transfer of a patient with a signifi-
This is preferable to repeated attempts at electro- cant vascular injury to a major vascular centre
coagulation, as this is likely to make any vascular for treatment.
injury worse. If the area continues to ooze, then 5. Failure to document/investigate peripheral

further compression should be applied after arterial disease and/or absent femoral pulses
application of an absorbable haemostat or throm- prior to surgery.
bin sealant. Once the bleeding has stopped, the 6. Poor surgical technique, particularly regard-
area should be re-inspected prior to closure to ing laparoscopic entry procedures.
ensure that it remains dry. 7. Failure to recognise, or take seriously, peri-
Continued bleeding from a minor ‘unimport- operative bleeding, leg swelling or ischaemia.
ant’ vessel such as the epigastric artery is best 8. Inadequate treatment of a vascular complica-
dealt with by over-sewing the area with 2/0 Vicryl tion and/or failing to ask for help from a vas-
or similar. cular surgeon.
If a small hole can be easily identified in an
‘important’ vessel such as the iliac artery or vein,
then it is reasonable for a gynaecologist with 45.4 Avoiding Litigation
experience of dealing with such a complication,
to attempt repair with a 4/0 or 5/0 Prolene suture. 45.4.1 Preoperative Preparation
This requires a good assistant to keep the area and Consent
clear of blood with well-directed suction. The
sutures should be placed in line with the longitu- All patients undergoing gynaecological surgery
dinal axis of the vessel to reduce the risk of nar- should be asked about a history of deep venous
rowing. Any narrowing of the iliac vein or artery thrombosis (DVT) and peripheral arterial disease
risks peri-operative thrombosis, and a vascular (PAD). A history of DVT is important as it will
256 J. D. Beard
influence the thromboprophylaxis regime. A his- on to prevent deterioration in the patient’s

tory of PAD is important because leg ischaemia condition.
due to aortoiliac arterial disease may be made Postoperatively, if there has been a vascular
worse by open pelvic or vaginal surgery, and the injury during surgery, then both legs should be
presence of PAD increases the Waterlow score checked for foot pulses, sensation, movement,
regarding the prevention of pressure sores [9]. pain and swelling. Foot pulses should be equal—
if they are weaker on the affected side then
arrange for urgent Doppler studies and notify the
45.4.2 Avoiding Entry-Related vascular surgeon immediately. Any loss of sensa-
Vascular Injuries tion or power represents a vascular surgical emer-
gency, especially if foot pulses are weak or
The most effective way to reduce complications absent. Swelling of the leg may indicate occlu-
of laparoscopic entry is to optimise insertion of sion of the iliac vein, or a compartment syndrome
the primary trocar and cannula, although there is due to reperfusion injury after a prolonged lapa-
controversy as to the safest technique for achiev- roscopic procedure, especially if painful. In sum-
ing this. Gynaecologists have tended to favour mary, any postoperative limb symptoms must be
the closed or ‘Veress’ needle entry technique, taken seriously.
whereby the abdominal cavity is insufflated with
carbon dioxide gas before introduction of the pri-
mary trocar and cannula. The Royal College of 45.5 Case Study
Surgeons of England recommends that the open
or ‘Hasson’ approach be used in all circum- 45.5.1 Case Study 1 (Laparoscopic
stances. This latter method uses a small incision Surgery)
to enter the peritoneal cavity under direct vision.
The two techniques are well described in an arti- A woman with four children underwent day-
cle published by the Society of Obstetricians and case laparoscopic sterilisation after being coun-
Gynaecologist of Canada [10]. selled about the alternatives. Consent included
A meta-analysis of systematic review and two the risk of bleeding, blood transfusion, repair of
randomized trials found a higher risk of bowel any damage and laparotomy, and was obtained
injury associated with open access but the risk of by the locum consultant surgeon. A Veress nee-
vascular injury was too small for any difference dle was used to create the pneumoperitonem.
to be observed [11]. The use of a direct trocar After application of clips to both fallopian tubes,
entry technique appeared to have some benefit in significant bleeding was noted from the retro-
prevention of vascular injury though the quality peritoneum. A laparotomy was performed to
of data was poor [11]. Therefore, what really allow pressure to be applied to the area of bleed-
matters is strict adherence to an accepted tech- ing and the on-call vascular surgeon summoned.
nique (see case report 1). The vascular surgeon arrived without delay and
repaired a small laceration in the left common
iliac vein without much difficulty. She made an
45.4.3 Managing Vascular Injuries uneventful recovery, although a blood transfu-
sion was required (estimated blood loss
Minor vascular injuries should be dealt with by 2000 mL).
application of pressure or over sewing of vessels. The situation was explained to the patient and
Electrocoagulation should be used with caution her family by the surgeon before her discharge,
and repeated electrocautery avoided to prevent and at a subsequent meeting with the Clinical
worsening of the vascular injury. Once major Director. Despite adequate consent regarding the
vascular injury has been identified, assistance risk of such a complication and the lack of any
from a vascular surgeon should be sought early adverse complications, apart from the l aparotomy
45 Vascular Injury 257
scar, the patient successfully sued. The damages Despite a patent bypass graft, the claimant
were not large but the costs were high, because was left with a post-thrombotic limb due to per-
the case went to court. In court, it was not possi- sistent occlusion of the iliac vein and a femoral
ble for the experts to determine whether the nerve injury cause by the bypass graft surgery.
injury had been caused by the Veress needle or The case was settled for a large sum on the
trocar, but the case was lost because the surgeon basis that although very experienced, the con-
admitted that the Veress needle had been inserted sultant gynaecologist had undertaken an inap-
too far after hearing the double-click and that propriate and inadequate vascular repair. On
insufficient CO2 had been insufflated to ensure the balance of probability, calling for help from
sufficient intra-abdominal pressure before inser- a Vascular Surgeon, would have resulted in suc-
tion of the primary trocar. cessful repair of the iliac vein (and artery), thus
avoiding the crossover graft, femoral nerve
injury, second laparotomy and post-thrombotic
45.5.2 Case Report 2 (Open Surgery) syndrome.
A senior consultant oncological gynaecologist

performed a radical hysterectomy with pelvic
and iliac lymphadenectomy for invasive cervi-
cal carcinoma. During the procedure, the right Key Points: Vascular Injury
external iliac vein was torn during the extra- • Laparoscopic procedures have a higher
peritoneal dissection of the pelvic lymph nodes. risk of vascular injury than open gynae-
Before the vein could be repaired, it was neces- cological surgery, mainly due to entry-
sary for the surgeon to mobilise and sling the related injuries to the iliac or inferior
external iliac artery to allow adequate access to epigastric vessels.
the vein, so that it could be clamped above and • Documentation of vascular injury on a
below the tear before it was repaired with a 2/0 consent form is no defence if the proce-
absorbable suture. On completion of the repair, dure has been performed incompetently,
the repaired segment was narrowed, but it did or the injury poorly managed.
not seem to be occluded. The iliac artery was • Documentation of a history of a previ-
also narrowed, which the surgeon attributed to ous DVT or PAD, and further investiga-
arterial spasm caused by mobilization of the tion/management if present, is vital
artery. before any major gynaecological
In recovery, the surgeon noted that the right procedure.
leg pulses were weaker than the left and there- • Failure of adequate thromboprophy-
fore contacted the on-call Vascular Surgeon. laxis, or investigation of postoperative
The Vascular Surgeon measured the Doppler leg swelling, is indefensible.
Ankle Brachial Pressure Index, which was only • Creation of a pneumoperitoneum and
0.6 (normal greater than 1.0). A subsequent trochar insertion/removal must be by an
duplex ultrasound scan reported occlusion of approved technique.
both the right external iliac artery and vein. • Units without on-site 24-h vascular
Attempted arterial embolectomy via the femo- cover must ensure that adequate arrange-
ral artery in the groin failed to restore inflow ment are in place, in case vascular injury
and therefore a femoro-femoral crossover graft occurs.
was performed. Therapeutic anticoagulation • If a vascular injury cannot be simply
was instigated to prevent extension of the DVT, treated, then apply pressure and call for
but this resulted in pelvic bleeding which advice/help from the nearest on-call
required a second laparotomy and further blood vascular surgeon.
transfusion.
258 J. D. Beard
References imal leg vein thrombosis in asymptomatic high-risk

patients. Am Coll Phys. 1992;117:735–8.
7. Royal College of Obstetricians and Gynaecologists.
1. Bergqvist D, Bergqvist A. Vascular injuries durin
Green-top Guideline No. 49. Preventing entry-related
gynecologic surgery. Acta Obstet Gynecol Scand.
gynaecological laparoscopic injuries. RCOG London;
1987;66:19–23.
2008.
2. Harkki-Siren P, Kurki T. A nationwide analysis of laparo-
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scopic complications. Obstet Gynecol. 1997;89:108–12.
gas is required for initial insufflation at laparoscopy?
3. Jansen FW, Kapiteyn K, Trimbos-Kemper T, Hermens
Gynaecol Endosc. 1999;8:369–74.
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9. Royal College of Nursing Clinical Practice Guidelines.
spective multi-centre observational study. Br J Obstet
Pressure ulcer risk assessment and prevention. RCN
Gynaecol. 1997;104:595–600.
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10. Society of Obstetricians and Gynaecologist of Canada
Standards for Gynaecology Care. Providing quality
Clinical Practice Guideline. Laparoscopic entry: a
care for women. RCOG London; 2016.
review of techniques, technologies and complications.
5. National Institute for Health and Care Excellence
JOGC. 2007;193:433–47.
Clinical Guideline 92. Venous thromboembolism:
11.
Ahmad G, Duffy JMN, Phillips K, Watson
reducing the risk for patients in hospital; 2010. nice.
A. Laparoscopic entry techniques (protocol).
org.uk/guidance/cg92.
Cochrane Database Syst Rev 2007; (3): CD006583.
6. Davidson BL, Elliott CG, Lensing WA. Low accuracy
https://doi.org/10.1002/14651858.CD006583.
of colour Doppler ultrasound in the detection of prox-
Part V
Urogynaecology
Swati Jha
Vaginal Repair and Concurrent
Prolapse and Continence Surgery 46
Philip Toozs-Hobson
46.1 Background that surgeons should collect their data and in the
UK that would equate to using the BSUG data-
With an aging population the prevalence of pel- base [1] or equivalent. One such equivalent is the
vic organ prolapse and urinary incontinence is IUGA database [2] yet both of these are volun-
increasing and with it the need for corrective sur- tary and not funded or supported as mandatory;
gery. Advances in anaesthetic techniques and the as such both lack strength in that cases may not
wider adoption of spinal anaesthetics mean that be sequential. However the BSUG database now
more patients may potentially be offered surgery. has over 115,000 registered cases and some data
The complexity of surgery is also increasing as is being extracted to inform on a large dataset.
patients have higher demands, are more likely to In accordance with the principles of
have had previous pelvic surgery (including Montgomery all risks, benefits and alternatives
Caesarean section) and have more co-morbidities. for pelvic surgery should be discussed. In terms
Identifying women who would be suitable for of recent evidence for treatment of prolapse, the
concurrent prolapse and continence surgery is POPPY study has outlined the role of
imperative to reducing morbidity and dissatisfac- Physiotherapy as a primary treatment [3] and
tion with the procedure. should now be discussed as an option prior to fur-
ther management. However prolapse surgery is
more complex in terms of the options and to a
46.2 Minimum Standards degree surgeons leaning as to what is advised.
and Clinical Governance Emphasis, from as “little as possible” surgery to
Issues the “best objective result” maximum can be
patient or surgeon driven. Some surgeons will be
Incontinence surgery and prolapse surgery should keen to emphasize on “level 1 support” and
only be carried out by surgeons who practice this favour vault procedures wherever possible, in
regularly and should have either subspecialty some circumstances as the basis of any other
training or advanced training skills module repair, to reduce the risk of further surgery; oth-
(ATSM) in Urogynaecology if UK trained. The ers will look to repair the defect on its own to
RCOG, BSUG and NICE recommendation is reduce the risk of complications. Data supporting
either approach are lacking. Identifying patients
P. Toozs-Hobson
with pain conditions (including dyspareunia) pre
Birmingham, UK operatively may be particularly important in
e-mail: PHILIP.TOOZS-HOBSON@bwnft.nhs.uk predicating outcomes and providing realistic

https://doi.org/10.1007/978-3-319-78683-4_46
262 P. Toozs-Hobson
expectations of what to expect postoperatively. In ment separate to consent of their active participa-
the author’s practice the use of the ePAQ question in understanding the risks and benefits [7].
tionnaire [4] has been extremely helpful in iden- With the later in mind, best practice would be
tifying patients with significant pain problems to identify the patient’s most bothersome symp-
pre-operatively and suggesting that pain was toms before proceeding to surgery. It is useful to
pre-existing. list patient related outcome measures, e.g. what
When considering concurrent prolapse and would you like to be able to do after the surgery?
incontinence surgery, appropriate investigation to This must be both realistic and specific. These
identify voiding dysfunction, post void residuals, can be used as the basis of the anticipated bene-
urgency symptoms with underlying detrusor fits of surgery.
over-activity should be undertaken preopera- Alternatives to surgery must include physio-
tively. This will usually be by urodynamic inves- therapy, pessaries and the range of operations
tigations. Though urodynamics has not been which may be considered, acknowledging when
shown to alter outcomes following continence and where this may require referral to another
surgery alone [5], most urogynaecologists would unit/clinician. Where suggesting multiple proce-
not perform concurrent surgery without it. It is dures (including continence procedures) the
also likely, in the current environment where tape increased risk of side effects (e.g. pain or voiding
and mesh surgery has been an area of medicole- difficulties) should be mentioned.
gal interest, that the process of Urodynamics and If an injury does occur then one should involve
reporting is likely to come under increasing med- colleagues early and make sure that the patient
icolegal scrutiny. has early recourse to review and details of how to
Increasingly consent is becoming a longer be seen. An apology should be given, which is
event, starting with imparting information, allow- not an admission of negligence and an offer to be
ing patients to reflect, potentially reviewing cases seen by a colleague made.
in a MDT, giving an “appropriate” patient infor- Complications should be handled in accor-
mation leaflet, ideally discussing surgeon specific dance with the trust governance procedures and
outcomes/complications. Risks should include recorded on their database (as national figures are
general risks such bleeding, infection, DVT and only right if the data included inclusive).
PE. There should then be more specific risks such Audits should be undertaken for monitoring
as visceral injury, scarring, pain, dyspareunia, outcomes of surgical treatment and complica-
recurrence and failure to achieve satisfactory tions related to surgery. This can be achieved by
result. When performing concurrent surgery it is submitting their outcomes to national registries
important to give patients the option of having the such as those held by the British Society of
two procedures separately and for patients choos- Urogynaecology (BSUG) and international
ing to have them done together highlighting Urogynaecology association (IUGA).
• Increased risk of voiding dysfunction.

• Difficulty identifying which of the two opera- 46.3 Reasons for Litigation
tions has caused a complication particularly in
relation to voiding problems. The reasons for litigation following vaginal sur-
• Increased overall complications when per- gery and concurrent prolapse and incontinence
forming both surgeries together. surgery are related to:
• Potential resolution of incontinence symp-
toms with prolapse surgery alone thereby • Preoperative counselling/ choices provided.
negating the need for continence surgery. • Failure to offer a two stage procedure.
• Failure to highlight added risks of concurrent
In England the new NHSE leaflets on prolapse surgery.
[6] and tape surgery should be used, which • Preoperative investigation.
require the patients to give written acknowledge- • Consent and discussion of complications.
46 Vaginal Repair and Concurrent Prolapse and Continence Surgery 263
• Training of surgeon. the patient should be made during surgery.

• Complications during/arising from the proce- Complications during surgery are not themselves
dure especially visceral injury and problems a reflection of negligence and where they are
with intercourse. recognised and repaired immediately the impact
• Failure to involve a urologist or bowel surgeon of any injury is often minimised. If there is any
when a complication has arisen. concern about visceral injury then a cystoscopy
• Failure to adequately manage/comply with should be considered and advice from appropri-
guidelines for high residuals following ate colleagues sought. If performed the presence
removal of the catheter. of ureteric jets should be noted. The application
• Failure to follow-up. of instillagel over the bladder base is a simple
and quick way which may aid visualisation of
the ureteric jets now that intravenous methylene
46.4 Avoidance of Litigation blue has been discouraged. Intravenous diuretics
can be administered and where the skills are
Appropriate preoperative assessment and coun- available ureteric catheterisation performed.
selling of the patient followed by adequate inves- Ureteric catheterisation is quoted as having a 1%
tigation and the offer of conservative and/or risk of ureteric injury; this figure is based on a
medical treatment should form the basis of man- large series of operative ureteric procedures
agement of all patients presenting with prolapse. including stone removal. Some would advise the
When performing concurrent prolapse and conti- availability of imaging if ureteric catheterisation
nence surgery urodynamic investigations would is to be considered, but this remains contentious
be considered good practice. The use of vali- and the use of an image intensifier has not been
dated questionnaires and PROM’s ensure that shown to reduce this risk. Likewise a rectal
the surgeon is addressing the relevant problems examination can be performed if there are con-
for the patient. If the prolapse is part of a larger cerns about a rectal injury.
issue then the express objectives of prophylaxis Early involvement of an Urologist or a
should be outlined. If surgery is needed, patients Colorectal Surgeon should be considered when a
should be given the range of options and alterna- complication has been identified to allow optimal
tives, appropriate patient information leaflets management of the complication. Attention and
and an explanation of the risk and complications. confirmation of haemostasis with an estimated
Sources include NHS leaflets, the BSUG and the blood loss is mandatory. The use of vasoconstric-
IUGA websites. One suggestion has been that tion agents during surgery generally will reduce
patients should request surgery rather than con- loss, but confirming haemostasis is important as
sent, the emphasis being they chose when they these agents may wear off, clot may be dislodged
are adequately informed and certainly allowing a or other agents (NSAID’s or anticoagulants) may
period of reflection, documenting patient ques- subsequently lead to bleeding.
tions are important. Writing directly to the Post operatively the patients should be
patient covering the above points copying to the reviewed and an assessment of post-void residu-
GP also ensures that adequate discussion has als made. This is especially vital if concurrent
taken place. surgery has been performed. If symptoms are dis-
Clinicians performing the procedures should proportionate to the surgery then serious consid-
have adequate training and an adequate case load. eration to a complication should be documented.
Where clinicians are unable to offer patient’s the In particular pain is associated with a h aematoma,
procedure of their choice they should be referred haematuria with a bladder injury and rectal bleed-
elsewhere. ing with a rectal injury. Early recognition pre-
The procedure should be undertaken with due vents further unnecessary interventions (e.g.
diligence to avoidance of bladder, ureter, ure- blood transfusion or further pain) and early return
thral and bowel injury as well as vaginal mucosa to theatre, or active decision to manage conserva-
in the sulci. Attention to adequate positioning of tively should be documented.
264 P. Toozs-Hobson
46.5 Case Study

Key Points: Vaginal Repair and Concurrent
Mrs. SD had long standing problems with Prolapse and Continence Surgery
stress urinary incontinence. At 52 she pre- • Adequate assessment and offer of con-
sented with prolapse symptoms both of the servative treatment. Appropriate investi-
anterior and posterior vaginal wall. She was gation where indicated. Adequate
consented for a vaginal wall repair and was preoperative counselling [PILs] and
adequately counselled of all the risks of this patient choice.
surgery. She was offered the option of a con- • Use standardised instruments e.g. QoL
current procedure for her urinary incontinence questionnaires and PROM’s pre
but given very little information on what this operatively.
would entail and was referred for Urodynamics • Procedure undertaken by adequately
preceding her surgery. The Urodynamics was trained surgeons who audit and monitor
performed by another clinician as the treating outcomes and complications.
clinician was not trained to undertake the tests. • Good surgical technique with prompt
A diagnosis of urodynamic stress incontinence recognition of complications and their
was made. The clinician performing the UDS management.
identified that the patient had no understanding • If there is concern perform a check cystos-
of what the continence component of the sur- copy/rectal examination during procedure.
gery would involve and advised the treating • Record estimated blood loss.
clinician to discuss this with the patient prior • Appropriate use of antibiotics.
to proceeding to concurrent surgery for both • Recognise (and document) where the
prolapse and incontinence. This discussion did patients post-operative course is differ-
not take place and the patient was not given the ent to what would normally be expected.
choice of having a two stage procedure. She • Adequate follow up of patients.
went on to develop voiding problems and it
was felt this was related to the repair hence
nothing was done in the immediate postopera-
tive period. The patient accepted this but References
returned a year later with ongoing problems.
1. BSUG; 2017. https://nww.bsug.nhs.uk/bsug/. Ref
The midurethral sling had started to extrude Type: Generic.
into the vagina and was cut to alleviate her 2. IUGA. 2017. http://www.iuga.org/. Ref Type: Generic.
voiding problems. The claimant alleged that 3. Hagen S, Stark D, Glazener C, et al. Individualised pel-
vic floor muscle training in women with pelvic organ
there had been a breach in failing to adequately prolapse (POPPY): a multicentre randomised con-
consent her for a synthetic sling and its inher- trolled trial. Lancet. 2014;383(9919):796–806.
ent risks, failure to offer her a two stage proce- 4. Radley SC, Jones GL, Tanguy EA, Stevens VG,

dure and warn her of the increased risk of Nelson C, Mathers NJ. Computer interviewing in
urogynaecology: concept, development and psycho-
voiding problems with concurrent surgery. She metric testing of an electronic pelvic floor assessment
also alleged that had she been informed there questionnaire in primary and secondary care. BJOG.
was a small possibility that her incontinence 2006;113(2):231–8.
may improve after surgery she would not have 5. NICE IPG 566. Single-incision short sling mesh inser-
tion for stress urinary incontinence in women; 2016.
opted to have the two performed together. An Ref Type: Generic.
out of court settlement was made. 6. NHS england; 2017. https://www.england.nhs.uk/pub-
The case highlights the importance of treating lication/surgical-procedures-for-treatment-of-pelvic-
the patients main presenting complaint, ade- organ-prolapse-in-women/. Ref Type: Generic.
7. NHS england; 2017. https://www.england.nhs.uk/wp-
quately consenting patients undergoing concur- content/uploads/2017/11/stress-urinary-incontinence-
rent surgery as well as giving them the option of mesh-tapes-leaflet-v24.pdf. Ref Type: Generic.
undergoing a two stage procedure.
Midurethral Synthetic Slings
47
Swati Jha
47.1 Background before invasive investigations. This includes life-

style interventions such as weight reduction
Midurethral slings have revolutionised the man- [those with a BMI > 30] and reduction of Caffeine
agement of stress urinary incontinence and has intake. Pelvic floor muscle exercises and behav-
replaced Colposuspension as the leading surgical ioural therapy in the form of bladder retraining
procedure for this condition. With 17 year data should be offered to all patients. Conservative
available, they are well established in routine treatment may also include a trial of anticholiner-
clinical care [1]. When obtaining consent and gics which are usually used in the treatment of
performing these procedures it is important to OAB.
bear in mind some of the problems which have Investigation in the form of urodynamics
been described and are unique to synthetic slings. should be considered in those who have symp-
toms of overactive bladder, previous surgery or
voiding dysfunction. In a select group of women
47.2 Minimum Standards where the diagnosis is of pure Stress urinary
and Clinical Governance incontinence (SUI) based on a detailed clinical
Issues history, 3 day diary, office investigations such as
uroflowmetry and examination, Urodynamics
The National Institute of Clinical Excellence may not be necessary.
(NICE) have issued guidance when performing Consideration of the child-bearing wishes
mid-urethral slings [2]. Assessment of symptoms should be made when counselling women con-
with a detailed history should be undertaken. sidering surgery. Surgery should ideally be
Quality of life questionnaires and frequency vol- delayed till childbearing is complete or patients
ume charts can be useful aids in initial patient should be informed of the risks of recurrence if
assessment. Patients should be offered conserva- they pursue further pregnancies.
tive treatment as one of the options for the man- Duloxetine should not be offered routinely but
agement of urinary incontinence before surgery. may be offered as second-line therapy if women
Conservative treatments should be commenced prefer pharmacological to surgical treatment or
are not suitable for surgical treatment. If dulox-
S. Jha etine is prescribed, women should be counselled
Department of Obstetrics and Gynaecology, Jessop about its adverse effects.
Wing, Sheffield Teaching Hospitals NHS Trust, Surgery for SUI should be undertaken only by
Sheffield, UK surgeons who have received appropriate training
e-mail: Swati.Jha@sth.nhs.uk

https://doi.org/10.1007/978-3-319-78683-4_47
266 S. Jha
in the management of urinary incontinence and in the treatment of stress urinary incontinence
associated disorders or who work within an MDT and pelvic organ prolapse in women [3] went a
with this training, and who regularly carry out stage further and recommended that when sur-
this surgery. Only surgeons who carry out a suf- gery involving polypropylene or other synthetic
ficient case load to maintain their skills should mesh tape is contemplated, a retropubic approach
undertake this surgery. An annual workload of at is recommended.
least 20 cases is recommended. Surgeons should In October 2016 NICE published interven-
maintain an audit of their outcomes. tional procedures guidance on single-incision
Patients considering surgery for stress urinary short sling mesh insertion for SUI in women
incontinence should be informed of the benefits (IPG566) [4]. This stated that, given the current
and risks of surgical and non-surgical options and evidence, the procedure should not be used unless
should be reviewed at an MDT to consider the there are special arrangements in place for clini-
woman’s preference, past management, comor- cal governance, consent and audit or research.
bidities and treatment options. Patient Decision Patients should be offered a follow up appoint-
Aids (PDA) may assist the consent process allow- ment within 6 months to exclude extrusion/
ing patients to identify their own values and com- erosion.
pare the various procedures before deciding
which procedure is most appropriate for them.
When offering surgery patients should be 47.3 Reasons for Litigation
made aware of the various surgical approaches
which include: The reasons for litigation following a mid-
urethral synthetic sling are related to:
• Synthetic mid-urethral tape
• Open colposuspension • Preoperative counselling/choices provided.
• Autologous rectus fascial sling • Preoperative investigation.
• Urethral Bulking agents • Consent and discussion of complications.
• Training of surgeon.
If the patient chooses an option not available in • Complications during/arising from the
the unit to which they have presented, they should procedure.
be offered referral to an alternative surgeon/unit. • [Bladder, urethral, ureteric, nerve, rectal or
When using synthetic slings, devices for blood vessel injury, fistula formation, voiding
which there is current high quality evidence of dysfunction and self-catheterisation, retropu-
efficacy and safety should be used. Some criteria bic haematoma, groin pain for trans-obturator
that these devices should fulfil include: tapes, need for a laparotomy, sexual dysfunc-
tion, failure, recurrence].
• Use of a device that surgeons have been • Failure to follow-up.
trained to use. • Mesh Erosion/Extrusion.
• Use a device manufactured from type 1 mac-
roporous polypropylene tape.
• Consider using a tape coloured for high visi- 47.4 Avoidance of Litigation
bility, for ease of insertion and revision.
Appropriate preoperative assessment and coun-
When women are offered a procedure involv- selling of the patient followed by adequate inves-
ing the obturator approach, they need to be tigation and the offer of conservative and/or
informed of the lack of long term outcome data. medical treatment should form the basis of man-
The Scottish Independent review of the use, agement of all patients presenting with urinary
safety and efficacy of transvaginal mesh implants incontinence. If surgery is needed, patients should
47 Midurethral Synthetic Slings 267
be given the range of options and alternatives, pubic tapes and in the inferolateral position [five
adequate patient information leaflets and an and seven o clock position] with trans-obturator
explanation of the risk and complications. tapes. If bladder injury is noted the needle is
Clinicians performing the procedures should removed and the tape reinserted. Recognition of
have adequate training and an adequate case load excessive bleeding and attention to tape adjust-
[NICE have historically recommended 20 cases ment free of tension is necessary. The procedure
per annum]. Where clinicians are unable to offer should be adequately covered with antibiotic
patient’s the procedure of their choice they should prophylaxis.
be referred elsewhere. If an Obturator tape is Postoperatively all patients should have post-
offered, the lack of long term data, increased risk void residuals checked on two occasions before
of groin pain and problems associated with com- discharge to ensure they are voiding normally.
plete removal of the tape should be discussed. In This should be checked in accordance with local
should also be born in mind that the Scottish guidelines. In patients who fail to void at all
Independent review made a recommendation for within 24 h, consideration should be given to
a retropubic tape in preference to an obturator so loosening of the tape, and this can be undertaken
going forwards this should be the preferred syn- up-to 7 days after the procedure. For patients
thetic sling of choice. where residuals remain high this should be
The procedure should be undertaken with due observed closely to ensure this is improving.
diligence to avoidance of bladder, ureter, urethral Provided patients are voiding in excess of 50% of
and bowel injury as well as vaginal mucosa in the their bladder volume this usually resolves over
sulci. Attention to adequate positioning of the the next few days. Postoperatively all patients
patient should be made during surgery. This should be offered a follow-up appointment in
should be the lithotomy position [avoiding more outpatients at 3 to 6 months to rule out mesh
than 70° flexion] for retropubic tapes and hyper extrusion.
flexed position of the hips over the abdomen for Patients presenting at a later date with prob-
trans-obturator tapes. lems such as voiding dysfunction or problems
For retropubic midurethral slings, adequate of mesh extrusion or erosion should be referred
retropubic and suburethral infiltration followed to centres where there is a sufficient caseload
by dissection should be undertaken. Three inci- and dealt with by clinicians who have experi-
sions are made, two 1 cm wide incision at the ence of dealing with these complications. All
upper rim of the pubic bone, each 2–4 cm lateral complications of erosion/extrusion related with
to the midline and a vaginal midline incision the mesh should be reported to the MHRA.
approximately 1.5 cm wide starting 0.5 cm from Patients who present with recurrence of stress
the urethral meatus. Careful blunt paraurethral urinary incontinence should also be managed in
dissection between the vaginal mucosa and pubo- centres which have the expertise to offer differ-
cervical fascia in undertaken. The tape is passed ent treatment options and are recognised cen-
starting at the suburethral incision along the dis- tres commissioned for purposes of recurrent
sected paraurethral space and emerging at the incontinence.
skin incision. Audits should be undertaken for monitoring out-
Trans-obturator tapes requires dissection comes of surgical treatment and complications
more laterally and skin incisions are in the groins related to surgery. This can be achieved by submit-
with the position depending on the device being ting their outcomes to national registries such as
used. those held by the British Society of Urogynaecology
Cystoscopy should be undertaken in all cases (BSUG), British Association of Urological Surgeons
of both retropubic and trans-obturator synthetic Section of Female and Reconstructive Urology
tapes. This should be with a 70° scope to avoid (BAUS-SFRU) or the International Urogynaecology
missing a bladder injury near the dome for retro- Association (IUGA).
268 S. Jha
47.5 Case Study

Key Points: Midurethral Synthetic Slings
McGinty v Pipe [2012] EWHC 506 (QB) • Adequate assessment and offer of con-
(QBD): M (Claimant), a 46 year old under- servative treatment. Appropriate investi-
went a TVT operation in July 2006. During gation where indicated. Adequate
surgery, the main artery in her left leg was preoperative counselling [PILs] and
damaged, leading to serious injury and perma- patient choice.
nent disability. P (Defendant) admitted liabil- • Procedure undertaken by adequately
ity. M had previously been fit and active but trained surgeons who audit and monitor
discomfort, restricted mobility and fatigue outcomes and complications.
were now a part of her daily life. She was left • Good surgical technique with prompt
with scarring and suffered a moderately severe recognition of complications and their
depressive illness. management. Adequate positioning and
M sought damages for pain, suffering and check cystoscopy of patients during pro-
loss of amenity, past and future loss of earn- cedure. Appropriate use of antibiotics.
ings, past and future care costs, and the cost of • Post-void residuals checked before dis-
orthotics, upgrades to holidays as a result of charge and high residuals adequately
her needing more leg room on flights, travel dealt with.
including an automatic car, increased heating, • Adequate follow up of patients.
DIY and gardening, therapies and housing • Patients presenting with delayed com-
adaptations. plications should be adequately man-
The court assessed damages as a result of a aged and reported.
surgeon’s admitted negligence during surgery.
The total award of damages was the sum of
£365,260.
For pain, suffering and loss of amenity References
(PSLA): M was awarded £52,500.
1. Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer
Special damages included £6000 for past C. Seventeen years’ follow-up of the tension-free vag-
loss of earnings; £51,375 for two-and-a-half inal tape procedure for female stress urinary inconti-
years’ net loss of her pre-accident earning nence. Int Urogynecol J. 2013;24(8):1265–9.
2. NICE CG171. The Management of Urinary
potential; £101,154 for care and seven hours of Incontinence in Women; 2013. Ref Type: Generic.
paid assistance per week for the rest of her life; 3. The Scottish independent review of the use, safety and
£31,360 for upgrades and priority boarding efficacy of transvaginal mesh implants in the treat-
during travel; M was also awarded costs of DIY ment of stress urinary incontinence and pelvic organ
prolapse in women, final report; 2017. Ref Type:
and gardening, increased heating, travel and the Generic.
provision of an automatic car, therapies includ- 4. NICE IPG 566. Single-incision short sling mesh
ing podiatry and ultrasound tests, and housing insertion for stress urinary incontinence in women;
adaptations. 2016. Ref Type: Generic.
Colposuspension and Autologous
Fascial Sling 48
Andrew Farkas
48.1 Background cumstances the choice between these two proce-

dures generally rests with surgical preference and
Colposuspension is a surgical procedure to treat training. Colposuspension tends to be favoured
stress urinary incontinence (SUI). Through a by gynaecologists and fascial slings by urolo-
suprapubic transverse incision, the paravaginal gists, but there is overlap.
fascia is attached to the ipsilateral iliopectineal
ligament of the pubic bone. The procedure may
also be performed laparoscopically. An autolo- 48.2 Minimum Standards
gous fascial sling involves the use of the patient’s and Clinical Governance Issues
own fascial tissue, usually from the anterior
abdominal wall but sometimes from the thigh, to NICE guidance [1] highlighted the importance of
form a sling supporting the urethra. assessment of symptoms with a detailed history,
Until the early 2000s, colposuspension was quality of life (QoL) questionnaires and fre-
regarded as a gold standard surgical treatment for quency volume charts. Conservative measures
SUI. TVT and other synthetic mid-urethral tape are considered in the chapter on synthetic mid-
procedures became increasingly popular because urethral slings.
they could be performed as day case procedures Surgery should only be considered following
with low immediate surgical morbidity. In recent the failure of conservative measures, particularly
years, concern about mesh complications has led pelvic floor physiotherapy. In recent years, prac-
to a re-evaluation of alternatives to synthetic mid- tice has moved from undertaking urodynamic
urethral tapes, including colposuspension and investigations in all cases of planned surgery.
fascial slings. They should still be performed in cases other
Sling surgery carries a slightly higher risk of than pure SUI, which include patients with symp-
voiding dysfunction than colposuspension, toms of overactive bladder such as frequency,
though these problems are usually short or urgency, and urge incontinence, previous surgery
medium term. Other than in certain specific cir- and voiding dysfunction. Urodynamics should
however be considered in all cases of recurrent
incontinence following failed surgery.
A. Farkas Patients considering surgery for stress urinary
Department of Obstetrics and Gynaecology, incontinence should be informed of the benefits
Sheffield, UK and risks of surgical and non-surgical options.
e-mail: Andrew.Farkas@sth.nhs.uk They should be reviewed at an MDT meeting to

https://doi.org/10.1007/978-3-319-78683-4_48
270 A. Farkas
consider patient preference, past management, –– Failure to identify suture material within
comorbidities and treatment options. Surgical the bladder
options include: –– Ureteric injury
• Longer term problems:
• Urethral bulking agents –– Urinary voiding problems
• Synthetic mid urethral tapes –– Prolapse, particularly of the posterior vagi-
• Open/laparoscopic colposuspension nal compartment
• Autologous fascial sling –– Recurrent stress incontinence
–– Stitch complications when using perma-
Women should be given comprehensive infor- nent suture i.e. stitch migration into the
mation about planned procedures. Examples bladder or stone formation
include patient information leaflets on colposus-
pension or autologous fascial slings produced by
the British Society of Urogynaecology [2] and the 48.4 Avoidance of Litigation
British Association of Urological Surgeons [3]
which are available from their website. Decision There should be adequate evidence of stress
making and the consent process may be facilitated incontinence and its effect on a woman’s quality
by the use of shared decision making tools. of life. This evidence may be adduced from the
There are issues around the number of proce- clinical history, examination findings and urody-
dures performed by an individual surgeon. It is namic investigations.
recommended that only surgeons who carry out a Women should be offered conservative man-
sufficient case load to maintain their skills should agement in the first instance, particularly pelvic
undertake surgery for urinary incontinence in floor physiotherapy [1]. Some women refuse
women. An annual workload of at least 20 cases of pelvic floor physiotherapy and in others the
each primary procedure for SUI is recommended extent of SUI is so severe that proceeding
[1]. With increasing use of conservative measures directly to surgery is reasonable. A range of sur-
and a wider variety of surgical procedures, it may gical alternatives should be discussed with the
not be possible to meet this standard. patient and appropriately documented in the
Surgeons who undertake incontinence surgery medical records. Preferably, decision making
should maintain careful audit data so that their should be made taking account of patient choice
outcomes contribute to the national registries such and within the context of an MDT discussion.
as those held by BSUG and BAUS Section for Surgery should be performed by an adequately
Female Reconstructive Urology (BAUS–SFRU). trained surgeon who undertakes a reasonable
number of procedures for urinary incontinence.
As a routine, colposuspension should be per-
48.3 Reasons for Litigation formed as an open procedure. Only an experi-
enced laparoscopic surgeon working in the MDT
The main reasons for litigation in cases of colpo- with expertise in the assessment and treatment of
suspension and fascial sling include: urinary incontinence should perform the proce-
dure laparoscopically [4].
• Lack of conservative management before pro- It is important when obtaining patient consent
ceeding with surgery. for a colposuspension or fascial sling to explain
• Failure to counsel women about the various alter- the likelihood of success, which is around 70% at
natives and warn of risks and complications. 10 years [4], and potential complications. In par-
• Operating for inappropriate indications, i.e. ticular, are the risks of urinary tract trauma, uri-
overactive bladder. nary voiding problems and symptoms of
• Operative complications: overactive bladder. Such an explanation is consid-
–– Bleeding erably assisted by evidence of the patient having
–– Bladder injury being supplied with a patient information leaflet.
48 Colposuspension and Autologous Fascial Sling 271
Operative complications may arise. The bladder Court of Appeal (Northern Ireland)
may be injured when reflecting it medially, particu- Reported 2013
larly in cases of previous surgery. This does not H had undergone an operation for urinary
represent substandard technique. The ureter may incontinence [colposuspension]. The surgeon
be kinked following dissection and elevation of the used sutures to elevate the neck of the bladder.
paravaginal fascia. In the author’s opinion, kinking Afterwards she complained of severe back ache,
does not represent a breach of duty whereas encir- and a second operation was necessary to remove
clement of the ureter by a suture is substandard. the suture on one side, as one of the ureters had
At open surgery, the use of an absorbable suture kinked. The judge accepted the evidence of the
such as PDS or vicryl is preferred, although some surgeons who had been involved in the first and
surgeons do use non-absorbable suture material. It second operations that the stitches had not been
is, however, more common practice to use a non- inserted in the wrong place and that elevation of
absorbable suture at laparoscopic colposuspension. the bladder might have resulted in kinking of the
Practice varies in respect of intra-operative cystos- ureter through lack of elasticity following an ear-
copy. Many gynaecologists do not undertake rou- lier hysterectomy.
tine intra-operative cystoscopy at colposuspension The appeal was dismissed.
but this should be considered if there are any con-
cerns with urinary tract injury. Stone formation in
the bladder may occur around the suture, whether it Key Points: Colposuspension and
was originally in the bladder or eroded into the Autologous Fascial Sling
bladder at a later date. Such a complication is • Both colposuspension and autologous
highly unlikely when absorbable sutures are used. fascial slings are appropriate alterna-
Voiding problems occur frequently, particu- tives to a synthetic mesh sling.
larly in the short term, following these proce- • Adequate counselling and discussion of
dures. Post-void residuals should be checked, the procedure, alternatives, risks and
usually using a portable ultrasound machine on complications.
the ward. There should be a low index of suspi- • Preoperatively:
cion for urinary voiding problems following –– Appropriate assessment of symp-
such surgery. Although these problems are usu- toms and bladder function.
ally short-term, it is crucial that they are man- –– Adequate conservative measures
aged appropriately with catheter drainage. This have been tried.
may be with a suprapubic or urethral catheter or –– Appropriate counselling and patient
through intermittent self-catheterisation (ISC). information given.
SUI is associated with weakness of the pelvic • Operatively:
floor and urogenital prolapse. Prolapse, particularly –– The procedure is performed by an
of the posterior vaginal compartment, may occur appropriately trained surgeon.
following colposuspension. The failure of the pro- –– Absorbable suture material is used
cedure may lead patients to consider litigation. for open colposuspension.
However, success is not guaranteed and recurrent –– Adequate precautions are taken to
SUI is a recognised complication. For avoidance of ensure the bladder has not been
legal action it is important that patients are pre- breached, particularly if non-
warned of these problems including failure, recur- absorbable sutures are used.
rence and development of prolapse in the long term. • Postoperatively:
–– There is awareness of the risk of uri-
nary voiding problems.
48.5 Case Study –– Assessment of voiding function so
that these are adequately dealt
Haughey v Newry and Mourne Health and Social with.
Care Trust
272 A. Farkas
References 3. Autologous vaginal tape for stress incontinence, infor-

mation for patients. British Association of Urological
1. Alcalay M, Monga A, Stanton SL. Burch colposuspen- Surgeons, Leaflet 16/145.
sion: a 10-20 year follow up. Br J Obstet Gynaecol. 4. NICE (National Institute Clinical Excellence). Urinary
1995;102:740–74. incontinence in women, CG171; 2013.
2. Colposuspension for stress incontinence, patient informa-
tion leaflet BSUG (British Society of Urogynaecology).
Vaginal Mesh Surgery
49
Mark Slack
49.1 Background dures, transvaginal operations for prolapse using

mesh were also developed and promoted by
Vaginal surgery involving the use of mesh either device companies as an improvement over stan-
for the management of stress urinary inconti- dard procedures. Unfortunately, many of these
nence (SUI) or pelvic organ prolapse (POP) has procedures were introduced and promoted with-
gained much prominence and attracted an enor- out any supporting data or documentation.
mous amount of attention regarding potential liti- In 2008, following an escalation in complica-
gation in recent years. This chapter deals with the tions reported to the Manufacturer and User Facility
use of vaginal mesh for POP. Device Experience (MAUDE) Database, the US
The use of mesh first came to prominence in Food and Drug Administration (FDA) issued a
the late 1990s with the introduction of the Tension notification to warn the public about possible nega-
Free Vaginal Tape (TVT®) which was marketed tive outcomes from vaginal mesh surgery. These
for the management of Stress Urinary included vaginal mesh erosion (exposure, extru-
Incontinence (SUI). The TVT was subject to sion or protrusion), pain (including painful sexual
extensive scientific evaluation, and was com- intercourse known as dyspareunia), infection, uri-
pared against the standard of treatment (the nary problems, bleeding, and organ perforation.
Burch colposuspension) in the context of a large There were also reports of recurrent prolapse,
randomized controlled trial [1]. Two year data neuro-muscular problems, vaginal scarring/shrink-
from this trial has been presented showing the age and emotional problems. Many of the Medical
TVT to be as effective as the colposuspension, Device Reports (MDRs) cited the need for addi-
and to be associated with a low complication rate tional intervention, including medical or surgical
[2]. The introduction of TVT as treatment for treatment and hospitalization.
SUI was followed by a wave of very similar alter- In the UK there are still a number of operations
native procedures for SUI, as well as the intro- carried out that utilise mesh for both the treatment
duction of multiple operations for the treatment of urinary incontinence and POP. Despite calls by
of POP. Alongside the use of mesh in SUI proce- patient groups and politicians for these to be
banned the official position remains that many are
safe and should continue to be used. Both the
Scottish Government group and the English Mesh
M. Slack
Oversight Group Report concluded that mesh
Addenbrooke’s Hospital, University of Cambridge
Teaching Hospital Trust, Cambridge, UK midurethral slings are equally effective as colpo-
e-mail: markslack@me.com suspension but that the use of transvaginal mesh

https://doi.org/10.1007/978-3-319-78683-4_49
274 M. Slack
for POP should not be used for primary repair and the outcome of these operations. Ideally outcomes
should only be considered in complex cases in should be added to an external database such as the
particular after failed primary surgery [3, 4]. BSUG database or included in the hospitals regular
Following publication of the results of the audit of complications and outcomes. Adverse out-
PROSPECT study [5], in December 2017 NICE comes related to the mesh should always be
issued guidance on the use of vaginal mesh for reported to the MHRA. Surgeons must be able to
anterior and posterior vaginal wall prolapse demonstrate they have a sufficient case load.
(NICE IPG 599) [6] which recommends that these The surgeon must be able to demonstrate that
devices only be used in a research setting. This they are practising according to the accepted stan-
was due to the absence of evidence of long term dards of care and that they follow an evidence-
efficiency. The PROSPECT trial demonstrated based approach. This is a rapidly evolving field,
that the augmentation of a vaginal repair with and surgeons have a personal responsibility to
mesh or graft material did not improve women’s ensure their own practice is in line with current
outcomes in terms of effectiveness, quality of life, professional standards of care. Only implants
adverse effects, or any other outcome in the short with an appropriate CE mark or FDA clearance
term, but more than one in ten women had a mesh should be used. Any products without such
complication. Increasing recognition of compli- approval should only be used with the appropriate
cations has resulted in a significant decline is use ethics approval or in the context of a clinical trial.
of vaginal mesh for POP in recent years. All cases being considered for surgery must
be discussed in an MDT.

and Clinical Governance 49.3 Reasons for Litigation
Issues
Potential reasons for litigation include:
Appropriate selection of patients remains the cor-
nerstone of correct practice when considering these • Inadequate counselling.
procedures as treatment options. It is also essential • Failure to offer conservative therapy ahead of
that patients have been informed of all the available surgery.
options including conservative and surgical • Failure to make the patient aware of all the
approaches. Ideally all patients should have had a options, risks of the specific procedure and com-
trial of conservative therapy ahead of surgery. plications including the need for further surgery.
When surgery is agreed it is important to • Poor documentation of the process of counsel-
ensure that the patients have been informed of all ling and the decision making process.
the surgical options available and had the oppor- • Inadequate patient information leaflets.
tunity to discuss these with the surgeon. It must be • Failure to audit practice.
demonstrated that the patient has had the opportu- • Suboptimal surgical outcomes.
nity to reflect on the advice and been given an
opportunity to make their own decision. The con-
sent process must be meticulous, and involve 49.4 Avoidance of Litigation
clear evidence of dialogue between the patient
and her doctor. Risks specific to the use of the Any surgeon using vaginal mesh based products
vaginal mesh operation must be discussed along- needs to be aware of the controversy surrounding
side risks that are relevant to that specific patient, these operations and to keep up to date with the
in line with the Montgomery standard of consent. national and specialist guidelines on the subject.
An up to date consent form must be completed They also have a responsibility to ensure that their
which gives a clear indication that the pros and patients are also aware of the issues and are fully
cons of the operation have been discussed. advised of the alternatives, their risks and benefits,
The surgeon and hospital must be able to pro- and potential outcomes as well as limited evidence
duce evidence that systems are in place to monitor of added efficiency compared to native tissue repair.
49 Vaginal Mesh Surgery 275
49.4.1 Current Understanding It remains to be said that patients presenting with

anterior and posterior repair, in the absence of any
A number of publications exploring the contro- apical defect, are increasingly uncommon. Surgeons
versies surrounding mesh have been produced by seeing this group of patients must be properly
health bodies in recent months. The first was the trained and dealing with an appropriate case load.
Scientific Committee on Emerging and newly They should have evidence of good training and be
identified Health Risks (SCENIHR) opinion on able to show evidence of robust governance.
the safety of surgical meshes used in urogyneco- Surgeons undertaking this work should ensure
logical surgery [7]. In addition there have been meticulous documentation of the discussions at
reports by NHS England [4], the Scottish consultation and be able to demonstrate that they
Government [3] and the Cochrane group [8]. have given the patient the necessary information
There have also been other authoritative publica- on the available options both surgical and non-
tions on the same subject in the peer reviewed surgical. The outcomes of surgical cases should
literature [9, 10]. be captured on an appropriate database such as
The conclusion of all these bodies is that mesh the British Society of Urogynaecology (BSUG)
procedures for anterior and posterior compart- database. Their unit must have an audit process
ment prolapse cannot be recommended for pri- that allows scrutiny of the surgical results. The
mary repair. surgeon must also be able to produce evidence of
Given the very high failure rate of primary pro- ongoing professional development.
lapse surgery it is conceivable that surgeons may Finally, any patients being offered surgery
want to consider transvaginal mesh augmentation must be informed of all the options available
for a select group of failed surgery patients who including those of doing nothing and those not
are likely to experience suboptimal native tissue offered in the local hospital. The hospital needs
repair and who have a contraindication to abdomi- to be willing to refer patients to centres that can
nal surgery. Normally the next step for failed pri- undertake the surgery that the patient chooses.
mary surgery would be consideration of an
abdominal (open, laparoscopic or robotic) sacro-
colpopexy with a concomitant anterior and poste- 49.5 Case Study
rior repair or a transvaginal sacrospinous
colpopexy with simultaneous natural tissue repair. Mrs. A, a 60 year old patient, was referred to hospi-
Some patients may have a contraindication to tal with a history of incontinence and vulval sore-
abdominal surgery or have a vaginal length too ness. A diagnosis of Lichen Sclerosus was made by
short for a sacrospinous fixation. In this very small the Gynaecology Vulva clinic. She had previously
group of patients consideration can be given to a undergone a hysterectomy for menorrhagia. She
mesh based transvaginal operation. This should was then referred to general gynaecology for an
only be considered in situations where very strict opinion on her bladder and the physical finding of
governance and guidelines are in place. Ideally a rectocele. At that clinic she was noted to be com-
this would only be done in specialist centres by plaining of symptoms of overactive bladder (OAB)
surgeons considered to be reconstructive experts and a small rectocele was diagnosed. Urodynamics
with significant experience in repeat surgery. were organised which demonstrated marked detru-
There will also likely to be developments in sor over activity. She was started on anticholiner-
mesh technology delivering new and improved gics. She had no response to two different
mesh designs. As the failure rates for primary anticholinergic medications and was then offered a
vaginal surgery continues to be high surgeons, in transvaginal mesh repair by Mr. B. He suggested
an attempt to improve outcomes, will try these that this would reduce the vulval irritation, correct
new technologies. In the light of the current con- the bladder symptoms and reduce the bulge. She
troversy it would seem prudent that any new tech- was warned that this could be complicated by
nologies are introduced under trial circumstances “haemorrhage, infection, injury to rectum and a
with the necessary ethical framework and under 1–3% risk of mesh erosion”. A month later she
Good Practice Guidelines (GCP) conditions. underwent a CE marked transvaginal mesh kit (For
276 M. Slack
posterior and apical prolapse) repair by Mr. B.

Postoperatively the patient continued to c omplain that a repeat natural tissue repair is
of problems with OAB. She also developed vaginal contraindicated and where there is no
bleeding and was noted to have a mesh extrusion. value in resorting to an abdominal
The mesh was excised under anaesthetic. As her procedure.
symptoms were worsening her GP referred her to • Procedure only to be undertaken after
another gynaecologist in the same hospital. A fur- discussion in a formal MDT.
ther mesh extrusion was noted and the patient then • Cystoscopy of patients at end of proce-
referred to a tertiary referral hospital for further dure to ensure good ureteric function.
management. Despite excision of the mesh the • Adequate follow up of patients.
patient continues to suffer with severe OAB and is • Patients presenting with delayed com-
continuously troubled by the symptoms of Lichen plications should be adequately man-
Sclerosus. As a result of this case Mr. B was aged and reported.
referred to the Medical Director. It transpired that
the trust had banned all vaginal mesh procedures
following the FDA warning of 2008. The trust had
agreed that any patients being considered for a
mesh procedure should be referred to the adjacent
References
teaching hospital for an opinion. The Medical 1. Ward K, Hilton P. Prospective multicenter randomised
Director was of the opinion that Mr. B had acted trial of tension-free vaginal tape and colposuspension
outside of his area of expertise and had operated as primary treatment for stress incontinence. BMJ.
outside of the governance framework that the trust 2002;325:67.
2. Ward K, Hilton P. A prospective multicentre ran-
had mandated. The Medical Director was also con- domized trial of tension-free vaginal tape and
cerned that the patient had had major surgery for colposuspension for primary urodynamic stress
prolapse when in fact her dominant symptoms incontinence: two-year follow-up. Am J Obstet
were due to Lichen Sclerosus and OAB. Gynecol. 2004;190:324–31.
3. http://www.gov.scot/Publications/2017/03/3336.
Disciplinary procedures were started against Mr. B 4. h t t p s : / / w w w. e n g l a n d . n h s . u k / w p - c o n t e n t /
who subsequently resigned from the trust. He was uploads/2017/07/mesh-oversight-group-report.pdf.
also referred to the General Medical Council 5. Glazener CM, Breeman S, Elders A, et al. Mesh,
(GMC) for unprofessional behaviour. The trust graft, or standard repair for women having primary
transvaginal anterior or posterior compartment pro-
made an undisclosed out of court settlement to the lapse surgery: two parallel-group, multicentre, ran-
patient. domised, controlled trials (PROSPECT). Lancet
2017;389:381–92.
6. https://www.nice.org.uk/guidance/ipg599.
7. https://ec.europa.eu/health/sites/health/files/scien-
Key Points: Vaginal Mesh Surgery tific_committees/emerging/docs/scenihr_o_049.pdf.
• Adequate assessment and offer of con- 8. h t t p : / / w w w . c o c h r a n e . o r g / C D 0 1 2 0 7 9 /
servative treatment. Appropriate investi- MENSTR_transvaginal.
gation where indicated. Adequate 9. Morling JR, McAllister DA, Agur W, Fischbacher
CM, et al. Adverse events after first, single, mesh
preoperative counselling [PILs] and and non-mesh surgical procedures for stress urinary
patient choice. incontinence and pelvic organ prolapse in Scotland,
• Procedure only to be undertaken under- 1997-2016: a population-based cohort study. Lancet.
taken by adequately trained surgeons 2017;389(10069):629–40. https://doi.org/10.1016/
S0140-6736(16)32572-7.
who audit and monitor outcomes and 10. CMA G, et al. Mesh, graft, or standard repair for
complications. women having primary transvaginal anterior or pos-
• Procedure only to be undertaken as a terior compartment prolapse surgery: two parallel-
secondary procedure when it is judged group, multicenter, randomized, controlled trials
(PROSPECT). Lancet. 389(10067):381–92.
Vaginal Hysterectomy
50
Swati Jha and Linda Cardozo
50.1 Background • Clinical indication for salpingo-oopherectomy

i.e. need for concurrent abdominal proce-
Pelvic floor disorders are common in women of all dures, which can often be overcome using a
ages with a 12% lifetime risk of needing prolapse or laparoscopically assisted approach.
continence surgery between the ages of 20 and 80
[1]. A vaginal hysterectomy and pelvic floor repair The procedure can be performed under
remains the commonest operation performed for regional or general anaesthetic, and is usually
uterine prolapse [2] in the UK. The vaginal route suitable even for women with comorbidities and
has been shown to be the safest and most cost-effec- in the frail elderly.
tive for hysterectomy, and even in the absence of
prolapse is the first-line approach whenever possi-
ble as demonstrated by a Cochrane review [3]. 50.2 M
In women with prolapse there are relative con- Clinical Governance Issues
traindications and caution should be exercised in
the following situations when considering a vagi- Surgeons appropriately trained in pelvic floor
nal hysterectomy: procedures should undertake this surgery. They
should have an adequate case load, and should
• Enlarged uterus (greater than 16–18 week audit the outcomes of their surgery and complica-
size). tions. This can be done through the use of
• Immobile uterus. National databases such as the British Society of
• Adnexal disease eg severe endometriosis or Urogynaecology (BSUG) database.
adhesions. Adequate alternatives including doing nothing
where the prolapse is above the introitus (vaginal
opening), Pelvic floor exercise therapy and the
use of vaginal pessaries should be discussed. The
S. Jha (*) surgical alternatives including uterine conserving
Department of Obstetrics and Gynaecology, options should be discussed and where facilities
for performing these are not available the patient
Sheffield, UK
e-mail: Swati.Jha@sth.nhs.uk should be given the option of referral to another
unit able to offer alternatives.
L. Cardozo
King’s College Hospital, London, UK It is routine practice to give patients prophylac-
e-mail: linda@lindacardozo.co.uk tic antibiotics within 1 h of commencing surgery,

https://doi.org/10.1007/978-3-319-78683-4_50
278 S. Jha and L. Cardozo
usually given intraoperatively. Thromboprophylaxis required and a variety of methods needed to

is also routine and it is good practice to introduce deliver the specimen including uterine bisec-
an indwelling catheter. tion, morcellation and intramyometrial coring.
The patient is placed in the lithotomy position Before closure of the peritoneal cavity the
and may need head down tilt to allow adequate pedicles are checked to secure complete haemo-
exposure. The buttocks should be positioned over stasis. To prevent enterocele formation and sub-
the end of the table. Stirrups or leg supports which sequent vaginal vault prolapse, either a McCalls
protect the vulnerable neurologic, vascular and Culdoplasty (obliterating the cul-de-sac, plicat-
bony points of the lower extremities should be ing the uterosacral-cardinal complex, and elevat-
used e.g. (Allen Stirrups) and hyperflexion of the ing any redundant posterior vaginal apex) or a
thighs avoided as this can cause femoral neuropa- Moschcowitz repair (closing the cul-de-sac and
thy. If using Candy cane stirrups adequate pad- bringing the uterosacral-cardinal complex
ding should be used at potential pressure points. together in the midline) is recommended. The
Once anaesthetised an examination is per- vaginal epithelium is reapproximated vertically
formed to assess the degree of prolapse the size of or horizontally with either continuous or inter-
the uterus and any undetected adnexal pathology. rupted sutures. If the sutured vaginal vault
Some surgeons prefer an indwelling catheter from descends into the introitus during closure a sacro-
the start, others insert one at the end of the surgery spinous ligament fixation can be undertaken.
preferring to empty the bladder with an in/out If a concurrent vaginal repair is to be per-
catheter or not at all when starting the procedure. formed, this can be completed before or more
Some surgeons use vasoconstrictor agents commonly after the hysterectomy.
with or without local anaesthetic injected into
the cervical, paracervical and sub epithelial tis-
sues to identify tissue planes and reduce bleed- 50.3 Reasons for Litigation
ing but these are not mandatory. The vaginal
incision is aimed at opening the peritoneum The common reasons for litigation following a
both anteriorly and posteriorly. This is achieved vaginal hysterectomy are:
by circumscribing the cervix followed by a
combination of sharp and blunt dissection. The • Wrong diagnosis and/or unnecessary or
advantage of opening the peritoneum anteriorly improper procedure.
before clamping the uterosacral ligaments is • Failure to adequately counsel and consent the
that the ureters are deflected when the bladder is patient.
mobilised upwards from the operative field. If • Failure to offer alternatives.
however this is not feasible then after opening • Visceral injury
the posterior cul de sac to access the peritoneal –– Ureteric
cavity, the uterosacral are identified and clamped –– Bladder
perpendicular to the uterine axis incorporating –– Bowel
the lower portion of the cardinal ligaments. • Bleeding.
When clamping the uterine vessels, the anterior • Shortening of the vagina.
and posterior leaves of the visceral peritoneum • Sexual dysfunction.
should be included. The final pedicle incorpo- • Negligently causing or contributing to any of
rating the round ligaments and fallopian tubes, the above risks.
once clamped and cut will usually allow deliv- • Failing to get the patient’s permission before
ery of the specimen. Where the uterus is performing new procedures, except in emer-
enlarged, more than three pedicles may be gency situations.
50 Vaginal Hysterectomy 279
Surgery for pelvic organ prolapse (POP) these injuries be diagnosed with certainty intraop-
addresses bother related to quality of life. As POP eratively. Failure to diagnose a visceral injury is a
is rarely dangerous, it is necessary to establish common cause of litigation. Resorting to a cystos-
what the patients expectation are from outcomes copy if there is suspicion of urinary tract injury is
from surgery. Whereas surgery addresses the advisable. The actual repair of a cystotomy
bulge it does not necessarily improve urinary or depends on the size and location of the injury as
bowel problems and is unlikely to improve sexual well as the expertise of the surgeon. Where a
function. It may even exacerbate stress urinary bowel injury is suspected, this must be ruled out
incontinence (occult incontinence) and the with certainty and will sometimes require addi-
patients must be forewarned of this. It is important tional surgery (Laparoscopy/laparotomy). Early
to avoid performing prophylactic surgery concur- involvement of the urologist or colorectal surgeon
rently such as a mid-urethral sling or posterior is advisable in the case of a visceral injury.
repair. Patient satisfaction has been shown to be An important function of the vagina is for sex-
directly linked to the patient’s self-described pre- ual intercourse. Therefore if there is a good ana-
operative goals and dissatisfaction to unprepared- tomical repair but the patient suffers postoperative
ness for surgery, perception of routine dyspareunia there can be significant dissatisfac-
postoperative events as complications (eg. need tion following the surgery. Although the risk of
for a Foleys catheter after the initial post-opera- this is not great after vaginal hysterectomy and
tive period) and development of new symptoms. native tissue repair, it is important to identify pre-
existing or predisposition to pain such as fibro-
myalgia, pre-existing dyspareunia, chronic pain
50.4 Avoidance of Litigation syndrome or bladder pain syndrome. Pain can be
caused due to the creation of vaginal constriction
Once a diagnosis of uterine prolapse has been rings, vaginal shortening due to excision of
made it is important to emphasise to patients that excess vaginal mucosa, nerve entrapment, plica-
this is not usually a dangerous condition hence tion of the levator muscles or from fibrosis scar-
surgery can usually be timed to suit patient con- ring or inflammation. During excision of vaginal
venience rather than being urgent surgery. epithelium digital assessment should be per-
Alternatives to surgery as well as the various sur- formed to avoid excessive trimming of skin.
gical options should be discussed including their Urogenital atrophy in postmenopausal women
risks and benefits. Success of individual proce- should be identified and treated with low dose
dures should be discussed. The possible compli- local oestrogen therapy as this may contribute to
cations associated with each operation should be postoperative dyspareunia.
explained and patient’s expectations from sur- Where a complication occurs intraoperatively
gery explored. a detailed explanation including the conse-
Surgery should be undertaken by surgeons quences of the complication if any should be
with appropriate training and adequate case made to the patient postoperatively.
load. Where the expertise is not available for For the majority of women vaginal hysterec-
the procedure of choice the patient should be tomy with or without pelvic floor repair is a safe
referred to another specialist with appropriate and straightforward procedure with good out-
expertise. comes. However, as with any surgery complica-
Visceral injury may be caused by surgical dis- tions can occur due to unexpected findings at the
section, injury during clamping of pedicles or time of surgery, poor surgical technique or just bad
thermal injury from cautery, however, irrespective luck. In order to avoid litigation every effort must
of the mechanism of injury it is axiomatic that be made to correct any problems which do occur
280 S. Jha and L. Cardozo
promptly and efficiently using clinicians with the hysterectomy and vaginal repair for uterine
appropriate skills. Apologies to the patient and her prolapse.’
relatives and an explanation of what went wrong Significant intra-abdominal bleeding must be
will help to avoid later complaints. the number one differential diagnosis of sus-
tained postoperative hypotension, in the absence
of other differential diagnoses such as sepsis,
50.5 Case Study anaphylaxis and myocardial depression.
Sustained clinical indicators of hypovolaemia
Mrs. T, a 36-year-old mother of two young chil- must not be ignored in a postoperative patient.
dren, attended as an inpatient for an elective vagi-
nal hysterectomy and repair of prolapse. She was
fit and well. The procedure was complicated by a Key Points: Vaginal Hysterectomy
significant bleed and in recovery she was noted to • Appropriate explanation to the patient of
be pale and agitated, complaining of abdominal the various treatment options including
pain. She returned to the ward just under an hour doing nothing and other conservative
after surgery, but nursing staff called the anaes- options such as pelvic floor physiother-
thetic registrar, an hour later as she had become apy and the use of vaginal pessaries.
unwell, pale and hypotensive with a borderline bra- • Exploration of the patients problems in
dycardia (BP 100/60 mmHg, pulse 52 bpm). She the various domains of pelvic floor
was prescribed 40% oxygen and 500 mL of colloid function including urinary, bowel and
fluid over an hour. An attempt to take venous blood sexual function in addition to vaginal
failed and it was noted that the patient’s vital signs prolapse symptoms.
were unchanged but her veins were collapsed. • Adequate counselling regarding the
Mrs. T was given one unit of whole blood over risks and benefits of surgery.
the next hour and a further unit of blood was to be • Surgery undertaken by appropriately
transfused over the following four hours. trained surgeons with adequate case
Although she was reviewed several times and load.
persistent hypotension noted no action was taken. • Good surgical technique.
Two hours after the blood transfusion had • Post-operative explanation of proce-
been started, Mrs. T had a BP of 95/55 mmHg dures undertaken.
and a heart rate of 52 bpm. A urinary output of • Identification of visceral injury and its
100 mL since surgery was recorded. It was finally management.
decided to return Mrs. T to the recovery room to
put her on a monitor and insert a CVP line. Before
this could be done, however, the patient collapsed References
and stopped breathing. A vaginal examination
revealed no haematoma or other abnormality, and 1. Fialkow MF, Newton KM, Lentz GM, Weiss

a chest X-ray was reported as normal. Fresh fro- NS. Lifetime risk of surgical management for pelvic
zen plasma was instituted but during the transfu- organ prolapse or urinary incontinence. Int Urogynecol
J Pelvic Floor Dysfunct. 2008;19(3):437–40.
sion Mrs. T had a fit, developed bradycardia and 2. Jha S, Cutner A, Moran P. The UK National Prolapse
cardiac arrest. She did not respond to attempts to Survey: 10 years on. Int Urogynecol J. 2017.
resuscitate her. 3. Aarts JW, Nieboer TE, Johnson N, et al. Surgical

At autopsy, the cause of death was given as approach to hysterectomy for benign gynaeco-
logical disease. Cochrane Database Syst Rev.
‘haemorrhagic shock due to an intra-abdominal 2015;8:CD003677.
haemorrhage from pelvic operative site following
Laparoscopic Prolapse Surgery
51
Simon Jackson
51.1 Background but significant morbidity associated with these

has meant that they have been abandoned by
Our ever ageing population has meant that pelvic many urogynaecologists. There have been thou-
organ prolapse has become a common problem, sands of transvaginal mesh lawsuits filed against
with an overall 19% lifetime operation risk [1]. medical device companies and many of these
The traditional vaginal surgical approach of man- have now been recalled or withdrawn from the
aging prolapse has a reoperation rate ranging market.
between 17 and 29% [2–4]. Over the last decade Repairing weak native tissue has a high risk of
there has been an increase in the amount of syn- failure; there is consequently a continued need for
thetic mesh being used in order to try and prevent mesh implant in selected cases. The problems
this recurrence. A wide range of laparoscopic encountered with transvaginal mesh implant have
procedures have been described in the literature necessitated a move towards abdominal implant sur-
but by far the most commonly performed proce- gery. Type 1 macroporous polypropylene abdomi-
dures are laparoscopic sacrohysteropexy and nal mesh implants have been used successfully over
laparoscopic sacrocolpopexy. Both have evi- the last 10–15 years for both laparoscopic sacrohys-
dence to support their safe use [5, 6] It is impor- teropexy and laparoscopic sacrocolpopexy [7].
tant to consider some of the problems specific to Vaginal mesh erosion rates are significantly lower
this type of surgery. than with transvaginal mesh kits.
The use of prosthetic mesh materials was
introduced to augment inherent tissue weakness,
reduce prolapse recurrence rates and maintain 51.2 Minimum Standards
normal vaginal function. Both biological and and Clinical Governance
synthetic mesh grafts are available but it is the Issues
polypropylene implant in the form of transvagi-
nal mesh kits which have been scrutinised by Urogenital prolapse assessment should include a
media coverage in the past few years. Mesh kits detailed account of clinical symptomatology.
such as Prolift®, Apogee®, Avaulta® and Perigee® Asymptomatic or non-bothersome prolapse, fre-
appeared to have good objective success rates, quently detected coincidentally during gynaeco-
logical examination, does not require treatment.
There are no specific investigations required for
S. Jackson
John Radcliffe Hospital, Oxford, UK urogenital prolapse. Urodynamics are not neces-
e-mail: Simon.Jackson@ouh.nhs.uk sary as part of prolapse assessment.

https://doi.org/10.1007/978-3-319-78683-4_51
282 S. Jackson
Management of prolapse should be individu- that patients are given all the alternative options
alised in order to relieve prolapse symptoms, that they would reasonably wish to consider. The
restore function and improve quality of life. A previous ‘Bolam test’ has been superseded by
systematic approach to management include the Montgomery in issues of consent. The General
following as a minimum: medical Council is clear about providing patient-
centred care when taking consent [9]. Patients
1 . Is treatment necessary? should be counselled in depth and should be pro-
2. What conservative measures can be used? vided with all the necessary information, aided
3. What are the surgical options—vaginal surgery by the use of patient information leaflets to allow
versus a laparoscopic abdominal approach? them to make an informed decision. Despite
4. What are the advantages and disadvantages of being an onerous task, concise evidence that this
each? has been adhered to should be documented.
With respect to laparoscopic urogynaecology
A common cause of litigation is the omission The National Institute of Health and Clinical
of this discussion [8]. Excellence (NICE) provide guidance for both
Lifestyle changes such as weight loss, directed sacrocolpopexy and hysteropexy, and have
pelvic floor muscle training, and the reduction of recently being updated (NICE IPG 583 and 584)
heavy weight lifting should be part of the recom- [5, 6]. NICE supports this type of apical prolapse
mendation to all patients. Conservative treatment surgery on the understanding that surgeons are
options such as ring pessaries may be considered adequately trained, work within multi-disciplinary
in the very frail and elderly, in those whose fami- teams and appropriate consent has been taken.
lies are incomplete or those who wish to avoid Audit and compliance with clinical governance is
surgical intervention. also mandated. Opinions with regards to the use of
There is no available guidance to direct clini- mesh in urogynaecology have also been published
cians as to the best surgical approach. Many fac- by the RCOG and various European societies
tors have an impact when deciding which including the Scientific Committee on Emerging
approach is ideal for each individual patient. and Newly Identified Health Risks (SCENIHR).
In women who have not completed their fami- The risks documented on the consent form
lies, surgery should preferably be recommended and explanation to the patient should include
once accouchement is complete. Women who general risks of surgery (infection, haemorrhage,
have not completed their families and who opt for thrombosis, anaesthetic risks) but also the more
sacrohysteropexy should be informed that deliv- specific risks associated with these procedures,
ery will need to be by caesarean section if the which are:
hysteropexy technique involves the mesh com-
pletely encircling the cervix. Data in relation to • Visceral damage (bladder, bowel, ureter, ves-
pregnancy is minimal. sels, nerves)
If considering laparoscopic surgery, patients • Pain/neurological damage
must be suitable for general anaesthetic, pneumo- • Prolapse recurrence
peritoneum and Trendelenburg positioning. • Mesh extrusion/erosion
When counselling women for prolapse sur- • Infection in or around mesh (Discitis, vaginal
gery it is important to offer all the appropriate infection)
surgical and non-surgical options available, to • Bladder and bowel dysfunction
discuss the benefits and risks of each procedure, • Sexual dysfunction
provide the appropriate patient information leaf-
lets and finally obtain informed consent. Laparoscopic surgical treatment of prolapse
The law on informed consent has changed fol- should be performed by surgeons who have had
lowing the ruling in the case Montgomery vs training and experience in the field and who are
Lanarkshire Health Board. It is now necessary part of a multidisciplinary team. An adequate sur-
for doctors to ensure that patients are aware of gical workload of each procedure in a year should
any risks involved in a proposed treatment and be necessary in order to maintain the appropriate
51 Laparoscopic Prolapse Surgery 283
skills, although there is no recommended num- • Substandard surgery

ber. Referral to an appropriate surgeon should be –– Inadequate surgical training.
made if the patient chooses a procedure which –– Complications during/arising from the pro-
cannot be offered locally. cedure (injury to bladder, bowel, ureters
At present UK training in these procedures are blood vessels, nerves, fistula formation,
only mandated within the RCOG accredited sexual dysfunction, bowel obstruction, vag-
Urogynaecology subspecialty training program. inal discharge, prolapse recurrence, back
The Urogynaecology and Vaginal Surgery pain, osteomyelitis, need for laparotomy).
Advanced Training Skills Module (ATSM) does –– Mesh and polyester suture complications
not train surgeons to perform this surgery but is (erosion/shrinkage/rejection).
available as an optional training module. • Failure to recognise complications and man-
It may be necessary to develop a certification age them proactively.
system for gynaecologists who wish to offer
these procedures but who have completed their
training prior to the onset of ATSM/Subspecialty 51.4 Avoidance of Litigation
training. Consultants with a special interest in
Urogynaecology who would like to learn to per- Laparoscopic entry associated injuries and failure
form these procedures may be able to affiliate to recognise these are a major cause of litigation
themselves with experts in the field to attend reg- [10]. Various entry techniques and technologies
ular training sessions. have been introduced over the years to try and
As with all surgical procedures it is good prac- eliminate this risk, but there is no evidence to sup-
tice to maintain a log of surgical cases and audit port one single technique over another.
the results of these and any associated complica-
tions. All data relating to these procedures should 1. Appropriate knowledge of anatomy and the
be captured in the national British Society of technology in use is the cornerstone to safe
Urogynaecology (BSUG) database. access.
2. Palmer’s point entry may be more appropriate
in those with midline incisions.
51.3 Reasons for Litigation 3. On entry it is important to have good optics at
all times.
• Counselling 4. Skilled assistants with knowledge of the pro-
–– Inadequate preoperative counselling and cedure are vital; this surgery cannot be safely
not providing all available choices. performed by an individual operator.
–– Failure to follow appropriate national & 5. A 360° survey should be made initially and
international guidance. bowel injury should be excluded especially
• Consent in the area where the first trocar is inserted.
–– for Sacrocolpopexy clinicians should ensure Following this it is necessary to identify the
patients understand there is a risk of vaginal anatomical landmarks and also anatomical
vault prolapse happening again and of seri- anomalies (e.g. Adhesions, endometriosis,
ous mesh complications including mesh ero- pelvic kidneys, abnormally low bifurcation
sion into the vagina and neighbouring viscera of the aorta and vena cava on the sacrum etc.)
which would require further surgery. 6. Ensure the bladder is empty and secondary
–– for Sacrohysteropexy patients should be ports are placed above the bladder dome in
informed of the risk of recurrence of uter- order to avoid inadvertent bladder injury.
ine prolapse and potentially serious com- 7. Injury to the inferior epigastric vessels can
plications including erosion into the be avoided by lateral port placement.
bladder and the need for further surgery. Identifying the vessels by trans illumination
In all cases clear written patient information is good practice but where this is not possi-
leaflets should be given and the use of the NICE ble, knowledge of the pelvic anatomical
information for the public is recommended. landmarks is essential.
284 S. Jackson
8. The mesh is anchored to the sacral promon- possible it is best to keep the implant away from
tory either by sutures or titanium fixation the site of vaginal incision as subsequent erosion
devices. Knowledge of the sacral promontory rates at this site will be elevated, presumably to a
and the surrounding landmarks is crucial. level seen with transvaginal mesh implant.
Inability to clearly visualise the anterior longi- If bowel is inadvertently opened a surgeon
tudinal ligament due to low vascular bifurca- must be called to effect repair. Mesh implant
tion or adipose deposition is an indication to must be abandoned as the surgical field is no lon-
abandon the procedure. ger sterile.
9. When using electro surgery the whole of the Non-dissolvable polyester sutures (e.g.
active part of the instrument should be kept in Ethibond, Ethicon Inc., Somerville, NJ, USA or
view to avoid injury to surrounding structures. Prolene) may be used to secure the mesh to the pos-
The tips of electrosurgical instruments remain terior or anterior aspect of the uterus during a sacro-
hot after use and should not be used to subse- hysteropexy and has been used to suture the vagina/
quently manipulate organs. vaginal vault during a sacrocolpopexy, though most
It is important not to operate outside your com- clinicians would use a dissolvable (polydioxanone
fort zone and to have a backup plan in place or PDS) suture when attaching mesh to the vagina.
should the original procedure not be possi- Late complications can arise from non-dissolvable
ble. New consultants are most vulnerable sutures including erosion, chronic granulomas, and
and should always be prepared to approach chronic infection leading to abnormal vaginal dis-
senior more experienced colleagues for help. charge and pain. When suturing to the vagina, dis-
The type of mesh chosen for laparoscopic pro- solvable alternatives must be considered to avoid
lapse surgery varies depending on whether mesh long-term complications.
is applied directly to the vagina/vault or around Previously it was not thought necessary to
the uterus. It is important to use implants which peritonealise abdominal mesh [11] but we now
have characteristics to ensure both compliance know exposed mesh leads to subsequent compli-
and strength. Various techniques have been cations such as bowel adhesions and bowel
described for each: obstruction. The entire length of the mesh must
Hysteropexy: the mesh may be sutured to the be peritonealised. Care must be taken when peri-
posterior aspect of the uterus, or may be trans- tonealising along the pelvic side wall, to identify
fixed around the cervix. the ureter so as not to include this in peritoneali-
Sacrocolpopexy: the extent of dissection is sation or cause kinking.
dependent on the type of prolapse, vaginal com- Patients having laparoscopic surgery should be
pliance and length. Where the mesh is applied to fit for earlier discharge compared to patients hav-
the vagina is dependent on which compartment ing laparotomy. Patients not making an appropri-
requires support. ate recovery should be monitored closely and any
Often, with sacrocolpopexy, the vault is deterioration in their condition should trigger
scarred from previous surgery. Inadvertent injury timely and appropriate management. If there is
to the bladder or opening the vagina may occur. any suspicion of sepsis from bowel or urinary tract
If cystotomy occurs this may be repaired by a injury prompt investigation (Imaging or diagnostic
suitably experienced Urogynaecologist. If this laparoscopy as appropriate) is mandatory.
experience is not available a Urological colleague Discitis from sacral promontory fixation is
must be called. Once the bladder has been extremely rare but the neurological sequelae can
repaired it would be the authors practice to com- be devastating. If there is any suspicion of discitis
plete surgery, proceeding with mesh implant. prompt investigation by MRI is essential. All mesh
However, intravesical mesh erosion risk will be complications should be reported to the MHRA.
increased and this practice may be criticised by Mortality from sepsis is extremely high and
some medicolegal experts. any suspicion of this must be managed
If the vagina is inadvertently opened it must be proactively (e.g. CT scan, MRI, repeat laparos-
repaired before proceeding with mesh implant. If copy etc.)
51 Laparoscopic Prolapse Surgery 285
51.5 Case Study

• Surgeons who do not recognise their
A 50 year old underwent a laparoscopic sacro- limitations and fail to abandon surgery
hysteropexy in 2012. The mesh was completely or call for assistance are at high risk of
peritonealised and the procedure was docu- litigation. New consultants are particu-
mented as uncomplicated. Sixteen months after larly vulnerable.
her procedure she developed small bowel • Any post-surgery complications must
obstruction secondary to bowel torsion around be managed proactively. Always assume
non-peritonised exposed abdominal mesh. 15 cm the worst case scenario!
of gangrenous bowel was resected.
It is probable the suture used for peritonealisa-
tion came undone during the post-operative
period, the patient claimed negligent surgery. References
The claimant’s medical expert did not consider
surgery was performed negligently; sutures can 1. Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime
risk of undergoing surgery for pelvic organ prolapse.
come undone and there is published literature to Obstet Gynecol. 2010;116(5):1096–100.
support non peritonealisation of abdominal mesh. 2. Ma D, Gregory WT, Boyles SH, Smith V, Edwards
However, the clinician had not discussed conser- SR, Clark AL. Reoperation 10 years after surgically
vative and alternative surgical options. There was no managed pelvic organ prolapse and urinary inconti-
nence. Am J Obstet Gynecol. 2008;198:555.e1–5.
documented discussion that hysteropexy was a new 3. Al O, Smith VJ, Bergstrom JO, Colling JC, Clark
procedure and alternative options such as vaginal AL. Epidemiology of surgically managed pelvic
hysterectomy were available. There was no evidence organ prolapse and urinary incontinence. Obstet
that mesh implant, and potential complications, Gynecol. 1997;89(4):501–6.
4. Ismail S, Duckett J, Rizk D, et al. Recurrent pelvic
were discussed. Counselling did not comply with organ prolapse: international Urogynaecological
Montgomery 2015 and the hysteropexy national research and development committee opinion. Int
guidelines (NICE) were not followed. Urogynecol J. 2016;27:1619–32.
Consequently the patient was able to claim 5. https://www.nice.org.uk/guidance/ipg583.
6. https://www.nice.org.uk/guidance/ipg584.
causation; had she been aware of mesh risk, she 7. Leron E, Stanton SL. Sacrohysteropexy with syn-
stated she would have chosen vaginal hysterec- thetic mesh for the management of uterovaginal pro-
tomy, and all subsequent mesh complications lapse. BJOG. 2001;108(6):629–33.
would have been avoided. 8. Montgomery v Lanarkshire Health Board; 2015.
9. General Medical Counsel. Good medical Practice
The case succeeded, not because of substan- and Consent: patients and doctors making decisions
dard surgery, but because of substandard coun- together; 2008.
selling and consent. 10. Vilos GA. Laparoscopic bowel injuries: forty litigated
gynaecological cases in Canada. J Obstet Gynaecol
Can. 2002;24:224–30.
11. Elneil S, Cutner AS, Remy M, et al. Abdominal sacro-
colpopexy for vault prolapse without burial of mesh: a
Key Points: Laparoscopic Prolapse Surgery case series. BJOG. 2005;112(4):486–9.
• Patients have the right to know all treat-
ment options (Montgomery 2015).
• All risks must be discussed when mesh
implant surgery is being offered.
• Only surgeons with appropriate training
should perform laparoscopic Urogynae
cology, and they must audit outcomes and
report complications (BSUG and MHRA).
Acute Urinary Retention
52
Mark Slack
52.1 Background and second stage of labour, and that voiding

should be documented within six hours of deliv-
Acute urinary retention is a common conse- ery. A urinary catheter should be inserted for 24 h
quence of gynaecological surgery, regional after repair of perineal trauma to prevent urinary
anaesthesia and childbirth. When unrecognised it retention. If urine has not been passed within 6 h
can result in acute prolonged bladder overdisten- after the birth, efforts to assist urination should be
sion leading to irreversible bladder damage with advised, such as taking a warm bath or shower.
long-term voiding dysfunction. Prevention, early When these measures are not successful, urgent
recognition and timely intervention are essential action to evaluate bladder volume and catheteri-
to prevent significant life-long lower urinary tract sation is advised.
symptoms and litigation. Most units will have local guidelines on blad-
der care after gynaecological surgery, regional
anaesthesia and childbirth. Guidelines should
52.2 Minimum Standards cover the prevention, recognition and manage-
and Clinical Governance ment of acute urinary retention. However these
Issues patients often require a highly individualised
approach. Therefore guidelines must be supple-
Acute bladder overdistension occurs when the mented by robust training programs for medical,
bladder is filled to greater than 120% of normal nursing and midwifery staff, together with 24-h
bladder capacity [1], which is typically greater access to clinical expertise should problems arise.
than 400–600 mL. At the time of writing there are Junior staff must be encouraged to ask for advice
no published National Guidelines specifically ded- if there is any uncertainty in decision-making.
icated to the prevention and management of acute
urinary retention in Obstetrics and Gynaecology.
NICE guidance on intrapartum [2] and post- 52.3 Reasons for Litigation
natal care [3] advises that the frequency of pass-
ing urine should be documented during the first Potential reasons for litigation include:
• Failure to implement routine post-operative /

M. Slack
delivery bladder monitoring.
Addenbrooke’s Hospital, Univ. of Cambridge
Teaching Hospital Trust, Cambridge, UK • Failure to consider acute urinary retention as a
e-mail: markslack@me.com cause of bladder symptoms.

https://doi.org/10.1007/978-3-319-78683-4_52
288 M. Slack
• Failure to place an indwelling catheter after an indwelling catheter placed into their bladder, left
episode of acute urinary retention. on free-drainage. Significant risk factors include
• Early removal of catheter after an episode of age over 50 years, regional anaesthesia, pro-
prolonged bladder over distension, with inad- longed surgery (greater than two hours), inconti-
equate assessment of ongoing voiding nence or radical pelvic surgery, prolonged labour,
function. perineal pain, and vaginal packing.
Patients with persistent voiding dysfunction

require prompt referral to specialist urogynaecol- 52.4.2 Trial Without Catheter
ogy or urology services for further investigations
and longer-term management. The indwelling catheter should be removed as
early as possible to minimise the risk of urinary
tract infection. However, the timing of removal
52.4 Avoidance of Litigation must be balanced against the presence of risk fac-
tors, and clinical judgement is required to evalu-
All healthcare professionals caring for women at ate the appropriate timing for each individual
risk of acute urinary retention should be aware of case.
the importance of prevention, recognition and Clear protocols should be in place for trial
urgent treatment of this condition. without catheter, including how to access exper-
tise if problems arise. A typical protocol will
involve removing the catheter and instructing the
52.4.1 Risk Factors and Prevention patient to wait to pass urine until she either has a
strong urge to void, or until four hours have
All women undergoing gynaecological surgery, passed, whichever is sooner. She is given clear
or after childbirth, should be considered to be at instructions to void into a measuring collection
risk for acute urinary retention, even in the device and to inform the nursing staff when she
absence of specific risk factors. The operating had done so. The residual volume of urine in the
surgeon, obstetrician or midwife should docu- bladder is recorded immediately (within 15 min),
ment clear bladder care instructions in the either by bladder ultrasound scanning, or by
patient’s medical records, and ensure that this is clean catheterisation. Definitions of success vary,
clearly communicated to the nursing staff caring but it is usually defined by a post-void residual
for them. volume of less than 100 mL, or the ability to void
Women without an indwelling catheter must greater than two thirds of the total bladder vol-
be monitored carefully to ensure that they pass an ume (which is the sum of the voided and residual
adequate volume of urine within 4–6 h of surgery volume). This should be carried out successively
or delivery, and that this is documented clearly in twice. The trial is deemed successful if they pass
the medical records. Ideally the volume of urine the second trial, and there is no need for further
passed should be also be measured and recorded. intervention or assessment. Patients who are
If there is any suspicion of retention, the woman completely unable to void, or who fail the first
requires further evaluation with a post-void blad- test with a large residual volume (typically
der scan or intermittent clean catheterisation. An 400 mL or more), should be re-catheterised
indwelling catheter should be placed if there is a immediately. All patients who fail the second test
significant post-void residual volume of urine will require re-catheterisation.
within the bladder (400 mL or more), to prevent Women who fail their trial without catheter
overdistension injury. can be managed with either an indwelling blad-
Women with significant risk factors for acute der catheter, or clean intermittent self-
urinary retention should have a prophylactic catheterisation. A repeat trial without catheter
52 Acute Urinary Retention 289
should be planned on an individual basis and retained urine. Accurate documentation of vol-
exacerbating factors, such as analgesics or con- umes and measurements are essential in case of
stipation, should be addressed where possible. future litigation.
The patient can be discharged from hospital for When retention presents with a total inability to
outpatient management unless there are addi- void, abdominal pain and a painful palpable blad-
tional medical or social issues that necessitate der, recognition is simple and usually leads to
inpatient care. prompt intervention. However, clinicians must
Clean intermittent self catheterisation (CISC) have a high index of suspicion for patients with
is preferred over indwelling catheterisation for more subtle clinical presentations. Retention may
women who can master the technique, as it is be relatively silent, without significant abdominal
associated with fewer complications and lower discomfort, particularly with the use of regional
rates of infection. Women should be advised to anaesthesia and analgesics. Focusing on the voided
continue catheterisation until their post void volume alone may miss retention. Other signs may
residual volumes are consistently less than one include increasing frequency of micturition, with
third of the total voided volume. Women who are diminishing voided volumes and incontinent epi-
unable to manage intermittent catheterisation sodes of overflow. The elderly may present with
should have a follow-up trial without catheter. acute delirium. When retention is suspected, blad-
der volume should be assessed urgently with blad-
der scanning or catheterization.
52.4.3 Acute Urinary Retention If the volume exceeds 400 mL, the catheter
should be left in place, especially for women with
The implementation of regular post-operative or prolonged and large volume urinary retention.
post-delivery bladder monitoring should prevent Recovery of bladder function will depend on
acute bladder overdistension. However, acute whether irreversible damage has occurred.
urinary retention is a medical emergency and Women should be followed up to ensure that
timely recognition and management is essential voiding returns to normal, or referred to special-
to prevent long term bladder damage. Bladder ist services if there is any evidence of persistent
overdistension results in reduced bladder blood voiding dysfunction.
flow from high intra-vesicular pressure, with
progressive bladder wall ischaemia, and associ-
ated nerve and muscle damage. An indwelling 52.5 Case Study
catheter must be inserted immediately to drain
the bladder. Recovery will depend on the degree Post-Partum Urinary Retention [4]
of damage the bladder has sustained during the Mrs. A was transferred to the postnatal ward after
episode of overdistension. Larger volumes, espe- the birth of her baby. She had not yet passed
cially if greater than 1000 mL, and prolonged urine, and began to experience low back pain.
duration, are associated with an increased risk of The midwife advised her to practice pelvic floor
long-term bladder damage. Whenever an exercises. Mrs. A was struggling to pass urine
indwelling catheter is placed for acute retention and experienced two episodes of urinary inconti-
of urine, the total volume of urine in the catheter nence. A catheter was placed and removed 24 h
must be measured and documented clearly at later. On removal of the catheter she again failed
30 min post-catheterisation. Premature measure- to pass urine and was re-catheterised. The
ment will result in a potential under-estimate the physiotherapist advised her to use a flip-flow

total volume of urine within the bladder, as there valve to retrain her bladder, and she was dis-
will have been insufficient time for the retained charged home. She returned 10 days later to have
urine to drain. Conversely, delaying the mea- the catheter removed. Post-voiding residual vol-
surement will result in an overestimate of umes were not measured, and she was discharged.
290 M. Slack
She continued to have ongoing problems, and a

month later she was unable to pass urine. She was • Acute urinary retention should be
left with permanent neurological damage to her treated as a medical emergency with
bladder. Mrs. A was awarded £42,500 in an out- swift intervention to reduce the risk of
of-court settlement for the failure to identify and bladder overdistension injury and long-
manage her urinary retention following the birth term voiding dysfunction.
of her baby. • Whenever an indwelling catheter is
placed for acute retention of urine, the
total volume of urine in the catheter
Key Points: Acute Urinary Retention must be clearly documented at 30 min.
• In the absence of National Guidelines, • Women who experience acute bladder
local units should establish clear proto- overdistension should be referred to
cols for the prevention and management specialist services for ongoing assess-
of acute urinary retention in women ment and management.
undergoing gynaecological surgery,
childbirth and regional anaesthesia.
• Guidelines should be supplemented by
References
adequate training for doctors, nurses
and midwives, and 24-h access to clini- 1. Madersbacher H, Cardozo L, Chapple C, Abrams P,
cal expertise for advice. Toozs-Hobson P, Young JS, et al. What are the causes
• Fastidious attention to detail and docu- and consequences of bladder overdistension? ICI-RS
mentation of voided and residual vol- 2011. Neurourol Urodyn. 2012;31(3):317–21.
2. NICE. Intrapartum care for healthy women and babies
umes should be standard practice for [CG190]; 2017.
all women at risk of acute urinary 3. NICE. Postnatal care up to 8 weeks after birth [CG37];
retention. 2015.
• A high index of suspicion is essential to 4. IrwinMitchell. Figure figure compensation sum secured
for woman suffering from urinary retention; 2017.
detect urinary retention in women with http://www.irwinmitchell.com/client-stories/2013/
minimal or atypical symptoms. november/five-figure-compensation-for-woman-suf-
fering-from-urinary-retention.
Obstetric Anal Sphincter Injury
[OASI] 53
Swati Jha and Abdul Sultan
53.1 Background risks missing an OASI. Even in women who have

an intact perineum there may be a button hole
The incidence of OASI varies but in the UK it is tear between the rectum and vagina which may
reported to occur in 2.9% of women undergoing be missed without a rectal examination. Failure
vaginal delivery (6% during first vaginal deliv- to recognise these buttonhole tears can be associ-
ery) [1] and is a serious maternal complication ated with a rectovaginal fistula. OASI cannot be
following childbirth. The classification of differ- excluded without a proper rectal examination.
ent types of OASI is given in the chapter on The technique of examination and accurate clas-
Perineal Trauma. Unfortunately not all risk fac- sification has been described [3].
tors for OASI are modifiable and therefore not If there is doubt about the grade of the external
entirely preventable. It is now established that if a sphincter tear it is advisable to classify it to a
sphincter defect is seen on anal ultrasound in higher degree Eg. 3b instead of 3a [4]. Although
woman after the first delivery, the most likely rea- it is good practice to suture the tear soon after it
son is that OASI was missed at delivery [2]. has occurred, a delay for reasons such as lack of
surgical expertise or theatre capacity does not
appear to affect functional outcomes [5].
53.2 Minimum Standards The patient should be informed of the tear and its
and Clinical Governance potential implications for future bowel function as
Issues well as future pregnancies. Repair of these tears
should be undertaken after proper consent in the
Following a vaginal delivery all women should operating theatre with good lighting, under aseptic
undergo a meticulous vaginal and rectal exami- conditions with adequate anaesthesia and assistants.
nation by the trained accoucheur (as described in Intra-operative intravenous antibiotics should be
the Chapter on Perineal Trauma). Failure to do so commenced and in keeping with the local protocol
the antibiotics can be continued orally. Stool soften-
S. Jha (*) ing agents such as Lactulose should be prescribed
Department of Obstetrics and Gynaecology, post-operatively to ensure a loose consistency of the
Jessop Wing, Sheffield Teaching Hospitals NHS Trust, stools to avoid constipation and bowel impaction.
Sheffield, UK All obstetricians undertaking OASI repair
should be adequately trained in the repair of
A. Sultan OASI. Formal training in anal sphincter repair
Croydon University Hospital, London, UK
e-mail: abdulsultan@nhs.net techniques is recommended as an essential

https://doi.org/10.1007/978-3-319-78683-4_53
292 S. Jha and A. Sultan
c omponent of obstetric training by attending for- regional block or general anaesthesia. Repair of
mal hands-on workshops and undergoing individual components of the IAS and EAS
Objective Structured Assessment of Technical should be with either monofilament sutures such
Skill (OSATS). Obstetricians should also famil- as Poydiaxonone [PDS] 3–0 or Polyglactin
iarise themselves with their local departmental [Vicryl] 2–0. The IAS should be repaired using
guidelines on the management of these tears. end-to-end interrupted mattress sutures. The EAS
All patients who suffer an OASI should be should be repaired using the same technique but
adequately followed up by an Obstetrician/ an overlap technique can be used only if there is
Gynaecologist or specialist nurse/midwife with full thickness EAS tear or greater. A Cochrane
expertise in this area, and women with ongoing review demonstrated no difference in outcomes
problems or symptoms of incontinence or pain between an end-to-end and an overlap repair
should be appropriately investigated. Where although it identified that compared to an end-to-
facilities are available this should be in a desig- end repair an overlap repair is associated with a
nated Perineal Trauma clinic. lower incidence of urgency symptoms and a
Women who suffer an OASI, may do so after lower anal incontinence score [8]. The procedure
a prolonged labour and/or traumatic delivery and should be adequately covered with antibiotics
patients often associate the two. General dissatis- which should be commenced intra-operatively
faction with the way their labour was managed and continued post-operatively depending on
accounts for the reason why many seek compen- local protocols. Post-operative laxatives should
sation and this can be avoided by communicating be used to prevent wound dehiscence. Women
with patients and allowing them an opportunity should be offered physiotherapy as it may be
to go through events leading up to the OASI. This beneficial.
can be in the setting of a “Birth Afterthoughts All women should be offered postoperative
Clinic” or a debrief with a senior clinician who follow up and referred on where they have on-
can address any unresolved issues. going problems. If facilities are available, fol-
Most Obstetric units will have guidance in low-up of women with OASIs should be in a
place for the management of OASI, and clini- dedicated perineal clinic with access to endo-
cians should familiarise themselves with local anal ultrasonography and anal manometry as
guidelines. Where such guidance does not exist this can aid decision making regarding future
the RCOG [4] and the ACOG [6] have issued delivery [4].
guidance which should be followed. A small number of women may require refer-
Identification of risk factors antenatally is not ral to a colorectal surgeon for consideration of
usually an indication for elective caesarean sec- secondary sphincter repair. It is important to rec-
tion. For the prevention of OASI, it is advisable ognise that concordance of digital examination
to perform an episiotomy when performing a and endoanal scan when assessing the anal
forceps delivery and with a Ventouse where sphincter is poor.
appropriate [4, 7]. Where an episiotomy is indi- Women who have suffered an OASI in a previ-
cated, the mediolateral technique is used in the ous pregnancy should be counselled regarding
UK ensuring a 60 degree angle at perineal dis- the mode of delivery by a senior obstetrician and
tension (See Chapter on Perineal trauma and this should be clearly documented in the notes.
episiotomy). Women should be informed that following future
When describing OASI, the RCOG recog- pregnancies there is a risk of worsening of symp-
nised international classification should be used toms with subsequent vaginal delivery. They
[3, 4]. The internal anal sphincter [IAS], external should therefore be given the choice of a vaginal
anal sphincter [EAS] and anorectal mucosa delivery or a caesarean section, and adequately
should be identified and their integrity com- counselled of the risks of a caesarean delivery
mented on. Repair should be performed in the too. In a future vaginal delivery there is no proven
operating theatre with few exceptions and role for prophylactic episiotomy unless clinically
patients adequately anaesthetised with either a indicated. If the woman is symptomatic or shows
53 Obstetric Anal Sphincter Injury [OASI] 293
abnormal anorectal manometric or endoanal Once diagnosed, suturing should be under-

ultrasonographic features, she should be coun- taken in theatres with appropriate lighting and
selled regarding the option of elective caesarean adequate anaesthesia. Aseptic techniques should
birth. be adopted with antibiotic prophylaxis, use of
Units should undertake rolling audits of the appropriate sutures, appropriate techniques and
incidence of OASI to ensure these are compara- assistants. Antibiotics should be used to cover the
ble to National standards and local/National patients intra-operatively and post-operatively
guidelines are being adhered to. (depending of local protocols) together with stool
softeners.
All obstetricians undertaking repair of OASI
53.3 Reasons for Litigation should be adequately trained or supervised to do
so.
The reasons for litigation following OASI include All patients who suffer an OASI should be fol-
lowed up after delivery and assessed for out-
–– Failure to diagnose an OASI or a rectal muco- comes following the repair. Patients who are
sal tear [single most common reason for suc- symptomatic or have evidence of deficiency of
cessful litigation]. the anal sphincter should be refereed for anal
–– Failure to perform a proper rectal examination ultrasound and manometry. They may need refer-
before and after the repair of a perineal lacera- ral to either a Urogynaecologist or a colorectal
tion or episiotomy. surgeon for further management if they have
–– Delay in suturing. ongoing faecal urgency or incontinence.
–– Non performance of episiotomy where clini- In future pregnancies, all women should have
cally indicated. a choice regarding the mode of delivery and
–– Lack of communication regarding the diagno- advised in favour of a caesarean section if they
sis and implications of the tear. are symptomatic or have a defect in the anal
–– Formation of a fistula. sphincter on anal endosonography. Recommended
–– Failure to repair in theatres. criteria have been published [4]. They should
–– Failure to cover with antibiotics and also be informed of the risk of deterioration in
laxatives. anal sphincter function following a vaginal
–– Faecal incontinence. delivery.
–– Inadequate training of the surgeon. In keeping with the principles of good clinical
–– No follow up. practice the anatomical structures involved,
–– Pain following repair and scar tissue forma- method of repair and suture materials used should
tion causing dyspareunia. be clearly documented and the woman informed
of the nature of the injury.

53.5 Case Study
Appropriate management of the second stage
requires adherence to guidelines to prevent OASI 53.5.1 Davison vs. Leitch 2013;
where possible with interventions such as episi- EWHC 3092; QB
otomy. It is not routine to offer elective caesarean
to women who suffer OASI as risk factors are dif- Mrs. Sarah Davison delivered her first child on
ficult to predict until after the incident. All clini- the 7th December 2008 whilst under the care of
cians managing women in labour should be the defendant. During the course of her delivery
trained in the identification of OASI and where both her external and internal anal sphincter were
there is doubt, a senior review should be sought. damaged but no proper examination was carried
Accurate identification and classification is the out and there was no clear documentation of the
first step to prevention of litigation. severity of tear which remained undetected.
294 S. Jha and A. Sultan
There was no treatment with antibiotics and the

discharge letter stated that a small midline episi- appropriate sutures under appropriate
otomy had been performed which had been anaesthesia and antibiotic cover.
repaired with Vicryl. • Repair undertaken by adequately trained
Due to ongoing problems she was reviewed surgeons.
by the colorectal surgeon who following investi- • Adequate follow up of patients to identify
gation with endoanal sonography identified adverse outcomes and complications.
unequivocal evidence of a structural internal • Patients presenting with a fistula should be
and external sphincter defect and an associated managed by a colorectal surgeon and will
functional deficit. Despite surgery she was left probably need a defunctioning colostomy.
with significant ongoing symptoms with obvi- • Mode of delivery in future pregnancies
ous impact on her mental as well as physical is based on patient choice, symptoms
health. and endoanal ultrasound and manometry
The High court Judge identified the breach of [where available].
duty which included failure to comply with
National Guidelines [4, 7], failure to perform an
episiotomy which was adequately angled away
from the anal sphincter, a failure to diagnose the References
injury, inadequate postoperative care and a fail-
ure to inform the patient and her GP about the 1. Thiagamoorthy G, Johnson A, Thakar R, Sultan
AH. National survey of perineal trauma and its sub-
condition. sequent management in the United Kingdom. Int
Mrs. Davison was 32 at the time of her deliv- Urogynecol J. 2014;25(12):1621–7. https://doi.
ery and had a highly successful banking career in org/10.1007/s00192-014-2406-x.
the City. The issues at trial related largely to 2. Andrews V, Thakar R, Sultan AH, Jones PW. Occult
anal sphincter injuries – myth or reality? BJOG.
quantum consequent on the injury suffered dur- 2006;113:195–200.
ing childbirth. She was awarded £1.6 million in 3. Sultan AH, Thakar R, Fenner D. Perineal and anal
damages. sphincter trauma. London: Springer; 2007.
4. RCOG. The management of third and fourth degree
perineal tears. Green Top Guideline No 29; 2015.
5. Nordenstam J, Mellgren A, Altman D, Lopez A,
Key Points: OASI Johansson C, Anzen B, et al. Immediate or delayed
• Adequate identification of the grade of repair of obstetric anal sphincter tears-a randomised
tear. controlled trial. BJOG. 2008;115(7):857–65.
6. h t t p s : / / j o u r n a l s . l w w. c o m / g r e e n j o u r n a l /
• Appropriate explanation to the patient. Abstract/2016/07000/Practice_Bulletin_No__165___
Debrief of the delivery and the factors Prevention_and.46.aspx.
contributing to the tear as well as its 7. Intrapartum Care for healthy women and their babies.
implications for future bowel function NICE (National Institute for Health and Clinical
Excellence). CG190; 2014. www.org.uk/guidance/
and pregnancies. cg190.
• Repair in theatres with adequate light- 8. Fernando RJ, Sultan AH, Kettle C, Thakar R. Methods
ing, good surgical technique with use of of repair for obstetric anal sphincter injury. Cochrane
Database Syst Rev. 2013;12:CD002866. https://doi.
org/10.1002/14651858.CD002866.pub3.
Part VI
Infertility, Subfertility and the Menopause
Swati Jha and Raj Mathur
Fertility Testing and Treatment
Decisions 54
Ying Cheong and Rachel Broadley
54.1 Background Male

• Semen analysis (SA)—WHO reference values
For many people, the wish to have a family is a
natural desire and the prospect of childlessness Semen volume: ≥1.5 mL
can bring significant heartache. pH: ≥7.2
The definition of subfertility by NICE is the Sperm concentration: ≥15 million spermatozoa per mL
“inability to conceive after 1 year of unprotected Total sperm number: ≥39 million spermatozoa per
vaginal sexual intercourse, in the absence of any ejaculate
Total motility (percentage of progressive motility and
known cause of infertility” (NICE 2013). non-progressive motility): ≥40% motile or ≥32% with
However, fertility is not a binary state. In addi- progressive motility
tion to clinical knowledge and acumen, the man- Vitality: ≥58% live spermatozoa
agement of people experiencing subfertility Sperm morphology (percentage of normal forms): ≥4%
requires careful dialogue to reassure and manage
expectations. In the context of shared decision- • Sperm antibody screening (not recommended).
making, clear and comprehensive information • Repeat SA if first test is abnormal (3 month
pertinent to the individual’s circumstance is enor- gap between tests recommended).
mously helpful to avoid misunderstanding that
could lead to complaint or litigation. Female
• Post coital test not recommended.
54.2 M
inimum Standards and • Ovarian reserve testing
Use age as an initial indicator
Total antral follicle (AFC) ≤4 = low response;
To guide practice, NICE has recommended mini- >16 = high response
mum standards relating to fertility investigations: Anti-Müllerian hormone (AMH) ≤5.4 pmol/L = low
response; ≥25.0 = pmol/L high response
Y. Cheong (*) Follicle-stimulating hormone (FSH) >8.9 IU/L = low
University of Southampton, Princess Anne Hospital, response; <4 IU/L = a high response
Southampton, UK
e-mail: y.cheong@soton.ac.uk • Luteal phase progesterone for ovulation
R. Broadley status.
Southampton NHS Treatment Centre, Royal South • Prolactin, thyroid function test, endometrial
Hants, Southampton, UK biopsy should not be routinely performed.
e-mail: rachel.broadley@careuk.com

https://doi.org/10.1007/978-3-319-78683-4_54
298 Y. Cheong and R. Broadley
• Women without history of fertility-related could leave themselves open to complaints, liti-
comorbidities should be offered tubal assess- gation and accusations of negligence by recom-
ment, with the remained being offered a lapa- mending such courses of investigation outside of
roscopy and dye test. the clinical trial arena [1].
• Rubella, chlamydia status should be It is the clinician’s duty to ensure that all
determined. investigations are accurately interpreted.
Notwithstanding the impact on the patient, an
error in the interpretation leading to potential or
54.3 Reasons for Litigation actual harm, could bring question as to the clini-
cian’s ability to practice and could indeed be
1 . Missed or misinterpretation of investigations. deemed a breach in the clinician’s duty of care or
2. Delay in investigations and diagnosis. medical negligence.
3. Miscommunication of investigation results
Many fertility clinics are now privately owned.
and diagnosis. It is not uncommon for patients to visit several
4. Miscommunication pre- and post-operatively. fertility centres and undergomultiple investiga-
tions at each. It is the clinician’s responsibility to
ensure that they have access to previous test
54.4 Avoidance of Litigation results. If the results of a critical investigation are
not available to the treating clinician, they may
The NICE definition of subfertility as failure to need to be repeated, or reports requested from
conceive after 12 months offers a valid starting elsewhere. If the investigation results are abnor-
point for investigations relating to fertility. mal, it is the responsibility of the current manag-
However, in cases where there is a known condi- ing clinician to initiate further investigations and/
tion affecting fertility (e.g., endometriosis) or or intervention prior to commencing fertility
factors in the history point to an obvious potential treatment.
cause (e.g., irregular menstrual cycles, previous If the patient requires further advice from
testicular surgery), investigation should com- another specialty (e.g. genetics, haematological
mence without delay. Delaying investigation and/ advice for anti-coagulation) it is the clinician’s
or referral in such situations may be negligent, duty to ensure that the patient seeks this advice
and may lead to a reduction in the chance of con- prior to the commencement of treatment. Failing
ception owing to passage of time. to do so, resulting in actual or potential harm to
Up to one third of couples who undergo fertil- the patient could be deemed negligent.
ity investigation will have ‘normal’ investigation For a multitude of reasons, there may be sig-
outcomes. This diagnosis is termed unexplained nificant delays in initiating appropriate investiga-
subfertility. After investigation or the inability to tions and reaching a diagnosis. Much of the
conceive, to be informed that ‘nothing wrong can frustration patients experience is further fuelled
be found’ can be distressing and difficult to com- by the inconsistent guidance on the age limit
prehend. It is also challenging for a clinician not acceptable for IVF funding set by national guide-
to be able to provide an adequate answer for the lines e.g. NICE and commissioners e.g. Clinical
disappointed patient who is desperate to con- Commissioning Groups (CCGs) in the UK. Be it
ceive. This clinical conundrum has, over the organisational, administrative or clinically
years, led the fertility industry to offer a large related, a significant delay in the patient’s treat-
panel of tests, some quite expensive, but without ment pathway ultimately can impact on fertility
a sufficient evidence-base for improving out- prognosis, and the cost associated with potential
comes. Patients are in a position of vulnerability negligence claim.
and will frequently defer to the specialist’s rec- Clarity is key to the avoidance of complaints
ommendations. Even with transparent discussion and litigation. Taking the time to ensure under-
as to the lack of scientific evidence, a clinician standing and encouraging questions to avoid
54 Fertility Testing and Treatment Decisions 299
ambiguity and misinterpretation is enormously field. As a result, the claimant suffered multiple
valuable. cycles of failed IVF.
Informed consent is mandatory and must be The case was settled out of court, for an undis-
carefully documented and supplemented by writ- closed moderate amount.
ten patient information provided in a timely man-
ner before an intervention. Fundamentally,
performing an operation without a patient’s Key Points: Fertility Testing and Treatment
explicit consent (applying the principles of the Decisions
Mental Capacity Act where relevant) could leave • Specialist multidisciplinary teams should
a clinician open to criminal charges as well as manage patients with subfertility requir-
jeopardizing medical registration. ing treatment at the tertiary level; initial
If, during the course of a procedure, it was investigations are performed as per NICE
necessary to deviate from the pre-operative plan Guidance in the community and second-
to avoid serious patient harm, a full discussion ary care where appropriate.
must be held with the patient (after full recovery • Discussions, investigations and man-
from sedation/anaesthesia) and carefully docu- agement must be tailored to the patient’s
mented. The clinician should note they should individual circumstances and be guided
only perform the least invasive intervention to by up-to-date evidence-based practice.
prevent serious harm or death. Any further man- • Taking the time to understand and real-
agement should be completed at a later stage istically manage expectations of patients
after detailed discussion with the patient. In addi- with subfertility, right from the initial
tion, the Duty of Candour is a statutory obliga- appointment, is crucial for patient satis-
tion on all healthcare providers. faction, even in the absence of ulti-
mately achieving a pregnancy.
• Clear communication of investigations
54.5 Case Study results, their implications on the indi-
vidual patient’s fertility; seek to ensure
The claimant had a history of ruptured appendici- clear understanding and supplement
tis in her teens. At age 38, she was referred the with written information wherever
fertility specialist for a 2 year history of subfertil- possible.
ity. Prior to her referral, she had a laparoscopy in • Explain the implications and impact of
another hospital, by a different surgeon, which treatment (surgical or medical) on fertil-
revealed a large left hydrosalpinx that was ity prior to embarking on treatment.
drained. She did not qualify for NHS funded IVF • Audit and monitor appointment referral
cycle, and was referred to Mr. X privately for IVF to treatment time; unnecessary delays
treatment. During the consultation, the signifi- can have major implications for treat-
cance of hydrosalpinx removal was not clarified, ment prognosis and availability of
and the claimant subsequently underwent two funding.
cycles of self-funded fresh IVF cycles and one
frozen embryo transfer with no success.
The claimant sought a second opinion else-
where, underwent a laparoscopic right salpingec- Reference
tomy and since had a successful IVF pregnancy
at age 40. 1. Fertility problems: assessment and treatment. NICE
It was alleged that Mr. X’s failed to provide Clinical guidelines CG156; 2013.
the correct advice prior to the IVF treatment, and
as such, his standard of care fell below what was
expected of a reasonable clinician in the same
Assisted Conception
55
Raj Mathur
55.1 Background assisted conception are performed annually in

the UK.
It is estimated that one in six couples who try for Certain specific features of assisted concep-
a baby will fail to conceive despite 12 months of tion practice in the UK are relevant to under-
regular sexual intercourse. Couples without an standing medicolegal risk management in this
obvious cause of subfertility retain a reasonable area. Many clinics are entirely privately-owned
likelihood of conception in the second 12 months and most provide treatment to both state-funded
of trying, but thereafter the likelihood of sponta- and privately-funded patients. In a competitive
neous conception is low. Treatment of subfertility market, advertising and social media are used to
may involve measures directed to a detectable enhance provider profiles. Patients often compare
cause, such as ovulation induction in anovulatory ‘success rates’ between clinics. Whilst the
women with polycystic ovary syndrome or sur- Human Fertilisation and Embryology Authority
gery for endometriosis. However, if these mea- (HFEA) provides validated and complete figures
sures do not succeed, or if no cause is obvious, on its public website, this data is usually at least
then assisted conception is an important option to a year or more out of date (because of the length
allow couples to attain parenthood [1]. of time from treatment to birth). As a result,
Assisted conception refers to techniques patients may rely on figures from clinic websites,
where gametes (eggs or sperm) and/or embryos which are published prior to full validation and
are manipulated outside the body. Broadly speak- may not reflect accurately the likelihood of a suc-
ing, these are Intra-Uterine Insemination (IUI), cessful outcome.
In-vitro Fertilization (IVF) and Intra-cytoplasmic The field of assisted conception is dynamic
Sperm Injection (ICSI). Additional measures and female fertility specifically is highly age-
may include the use of donor gametes or embryos dependent. Hence, there is a temptation to bring
and genetic screening of gametes or embryos into clinical practice techniques that may not
prior to therapeutic use. Over 60,000 cycles of have completed the usual process of scientific
testing and randomised evaluation. When the
patient is considering paying for treatment that
R. Mathur
has a scant evidence base, the need to counsel the
Manchester University NHS Foundation Trust,
Manchester, UK patient appropriately and maintain adequate doc-
umentation is obvious.
University of Manchester, Saint Mary’s Hospital,
Manchester, UK A further significant feature of UK practice is
e-mail: rmathur@nhs.net that assisted conception clinics are often

https://doi.org/10.1007/978-3-319-78683-4_55
302 R. Mathur
free-standing enterprises not linked to an acute may result in a clinic losing, or suffering restric-
hospital. Hence, patients who develop complications to, its license to provide assisted concep-
tions of treatment may require further manage- tion treatment.
ment in centres other than the clinic that carried Although the HFEA defines standards, the
out their fertility treatment. regulator has steered clear of writing detailed
clinical guidelines, preferring instead to work
in collaboration with the National Institute of
55.2 Minimum Standards Health and Clinical Excellence (NICE), the
and Clinical Governance Royal College of Obstetricians and
Issues Gynaecologists (RCOG) and specialist profes-
sional bodies such as the British Fertility Society
Assisted conception is probably the most (BFS) and Association of Clinical Embryologists
closely regulated branch of medicine in the (ACE).
UK, falling under the purview of the Human
Fertilisation and Embryology Act 1990,
amended in 2008. All UK clinics are subject to 55.3 Reasons for Litigation
regulation by the HFEA, an ‘arms-length’ gov-
ernment body. The HFEA licenses and inspects • Inadequate evaluation of the couple/individual
clinics, sets standards for clinical practice and prior to starting assisted conception, ‘missing’
research and provides authoritative informa- a potentially significant finding in history or
tion to patients and public. The HFEA pub- investigation—for instance uterine septum or
lishes a Code of Practice, which is an invaluable submucous fibroid.
resource for staff working in assisted concep- • Delayed provision of assisted conception
tion. Every clinic is mandated to have a Person leading to reduced likelihood of success due
Responsible (PR), who “should have enough to increased female age.
understanding of the scientific, medical, legal, • Advising couples to have assisted conception
social, ethical and other aspects of the centre’s when a less invasive option would have pro-
work to be able to supervise its activities prop- vided a reasonable likelihood of success, e.g.
erly”, besides possessing integrity, and mana- ovulation induction, lifestyle modification.
gerial authority and capability. It is not • Inadequate counselling prior to treatment
mandatory that the person should be a clini- about the risks and implications of
cian. The PR carries significant legal responsi- treatment.
bilities for the work of the clinic, although they • Failure to complete valid consent forms for
are not expected to be able to personally pro- legal parenthood prior to start of donor gamete
vide every aspect of care. Broadly speaking, treatment.
the PR must ensure that the functioning of the • Complications of treatment—Ovarian
clinic at all times is compliant with the regula- Hyperstimulation Syndrome where available
tions of the HFEA. preventative measures were not advised,
The Code of Practice lays out specific stan- severe pelvic infection following egg
dards on patient investigation and information collection.
to be provided prior to treatment. Further stan- • Complications relating to adjuvant treatment
dards cover procuring, processing, storage, for which the evidence base is poor, e.g.
import and export of gametes, screening and immunosuppressive treatment for recurrent
compensation for donors, egg sharing arrange- implantation failure.
ments, surrogacy, traceability and premises and • Laboratory error resulting in ‘mis-match’ of
facilities. Clinics are inspected against these gametes or embryos and use of ‘wrong’ gam-
standards and a serious breach of standards etes or embryos in treatment.
55 Assisted Conception 303
55.4 Avoidance of Litigation ‘natural killer’ cells are not supported by the evi-
dence base as it currently stands. Nonetheless,
The PR of an assisted conception clinic must dis- several clinics and competent clinicians prescribe
charge his duties in accordance with the HFEA these in their practice. In order to defend against
Code of Practice. The duties of a PR are so broad litigation in the event of a complication from
as to seem daunting, particularly in an NHS set- such treatment, one possible argument could be
ting where management may not be aware of the that there is a divergence of opinion amongst
implications of a breach of the Code. It is impor- experts and basic science studies indicate a role
tant for the PR in NHS clinics to have adequate for immunologic modification in reproductive
time in their job plan, along with the confidence success. Demonstrating thorough and adequately-
of senior management and the ability to raise documented patient counselling would be
concerns when issues arise. In private clinics, the helpful.
PR must be conscious of the potential conflict Clinicians practicing in assisted conception
between their statutory role in ensuring compli- often receive patients who have had their initial
ance with regulation, and commercial impera- investigations, and even treatment, elsewhere. In
tives. ‘Success’ rates advertised to the public such a situation, it is important to have first-hand
should be presented according to HFEA guide- communication from the referring clinician about
lines, ensuring accuracy and completeness. the results of investigations, operative findings and
Clinical practice that is in keeping with the treatment provided. In the absence of clear infor-
Code is likely to be sufficient for the purpose of mation, it is reasonable to advise further investiga-
avoiding regulatory sanction and certain types of tion. For instance, if it is not clear whether a
litigation. For instance, following the specific submucous fibroid or uterine septum has been
provisions in regard to consent for legal parent- resected completely, a hysteroscopy should be
hood may pre-empt the possibility of litigation in offered before assisted conception is started.
cases of donor gamete treatment where the rela- OHSS is recognised to be the most significant
tionship breaks down following successful short-term complication of assisted conception
treatment. [2]. The BFS has published guidelines on the pre-
However, the Code is not sufficiently compre- vention of OHSS and every clinic should include
hensive as to provide a defence against several prevention of OHSS within its protocols [3]. In
types of patient complaints and litigation. the prevention of litigation, it is important to doc-
Clinicians must follow the principles of good ument adequate patient counseling and the use of
medical practice, be familiar with the evidence preventative measures such as GnRH antagonist
base and ensure adequate patient counselling and protocol, agonist trigger or cryopreservation of
documentation to minimise the risk of litigation. all embryos depending on the clinical situation.
Specific clinical guidance from the RCOG, BFS The management of OHSS presents specific
and other professional bodies covers most aspects risks where the clinic and the acute hospital are
of clinical practice in assisted conception. UK separate [4]. Good communication and joint pro-
clinicians who base their practice on such guid- tocols between the clinic and the acute hospital
ance could legitimately claim to deliver care at a are recommended. The HFEA requires clinics to
reasonable level of competence. Where practice report all cases of severe or critical OHSS who
diverges from guidelines, for instance in repro- are admitted to hospital and this requires efficient
ductive immune testing and treatment, patients communication and adherence to agreed classifi-
should be clearly informed that this is the case cation schemes. In the UK, the classification sys-
and be made aware of the risks and potential ben- tem used by the RCOG and accepted by the
efits of treatment. In the example of reproductive HFEA should be used.
immunology, professional body guidance is clear The BFS [3] and RCOG [2] have both pub-
that tests and treatments aimed at uterine or blood lished guidance on management of OHSS, and
304 R. Mathur
clinics should ensure that their protocols are cur- stimulation with FSH in a long protocol down-
rent and available to staff at all times. There are regulated cycle resulted in a good ovarian
problems both with under- and over-diagnosis of response. At egg collection, a large endometri-
OHSS, as affected women are often assessed as oma was found to lie between the puncture site
emergencies by junior staff with little experience and a number of ovarian follicles. The endome-
of assisted conception. In the author’s experi- trioma was drained and follicles aspirated.
ence, non-specialist clinicians are sometimes Antibiotics were not provided. When SL pre-
quick to label women presenting with abdominal sented for embryo transfer she was in pain and
pain after fertility treatment as suffering from felt unwell with tachycardia. Further assessment
OHSS. This carries the risk of missing serious was not carried out and embryo transfer was per-
pathology, occasionally with tragic consequences formed. Later that day, SL presented as an emer-
(see Case 2). It should be kept in mind that severe gency with pelvic infection. Over a period of
abdominal pain, pyrexia and peritonism are not several weeks, she had severe pelvic sepsis, cul-
features of OHSS and an alternative diagnosis minating in laparotomy and unilateral salpingo-
should be sought if these are noted, or if features oophorectomy. The patient alleged that antibiotics
of severe OHSS such as ascites and haemocon- should have been provided at egg collection and
centration are absent. Diagnoses that have been the embryo transfer should not have been carried
wrongly attributed to OHSS include Group B out without a full evaluation of her severe symp-
Strep pelvic sepsis following IUI, ovarian torsion toms, which were not to be expected three days
and appendicitis. after egg collection. A significant out of court
Clinicians should keep in mind that infective settlement was agreed.
complications following egg retrieval, although
uncommon, are more often seen in women with Case 2
endometriosis or pelvic inflammatory disease. If KH presented to the Emergency Department
pelvic sepsis occurs, it is a reasonable defence to the day after IUI, having undergone monofol-
say that an endometrioma had to be traversed in licular ovulation induction, with severe pain
order to access follicles that were otherwise inac- and tachycardia. The hospital did not have an
cessible. Provision of prophylactic antibiotics in on-site gynaecology service and she was dis-
such cases would also constitute a reasonable pre- charged with analgesia. She re-presented 3 days
caution, even though there are no trials on the later on a Friday afternoon with severe pain,
benefit of this measure and severe infection can pyrexia and abdominal tenderness and was sent
still occur in cases of endometriosis despite anti- by blue-light ambulance to the gynaecology
biotic administration at egg retrieval. Importantly, unit of a neighbouring hospital. Here she was
if a patient presents with significant abdominal diagnosed with severe OHSS (despite having
pain at embryo transfer, she should be assessed had only one pre-ovulatory follicle) and started
clinically rather than automatically proceeding to on the ‘OHSS protocol’. She remained unwell
transfer. In a number of cases, patients were likely with severe pain requiring morphine, tachycar-
ill at the time of transfer but this was not take seri- dia and raised white cell count. Some 72 h after
ously by clinicians focused on the task at hand. admission, she collapsed and a diagnosis of
septicaemic shock became apparent. Sadly,
despite intensive care, she passed away a few
55.5 Case Study days later. Her survivors alleged that the diag-
nosis of pelvic infection was missed and a mis-
Case 1 diagnosis of OHSS made which led to her not
SL was known to suffer from severe endometrio- receiving antibiotics for several days, by which
sis and had been trying to conceive for several time it was too late for survival. A substantial
years before being referred for IVF. Ovarian settlement was agreed.
55 Assisted Conception 305
Key Points: Assisted Conception • Clinics should maintain good communi-

• Assisted conception in the UK is subject cation and shared protocols for manag-
to statutory regulation by the HFEA, ing OHSS with acute hospitals in their
which publishes a Code of Practice. catchment area, guarding against both
Adherence to the Code is likely to be under- and over-diagnosis of OHSS.
sufficient to avoid regulatory penalties, • Women presenting with significant
but may not be sufficient to prevent abdominal pain at embryo transfer
litigation. should be assessed fully prior to decid-
• Individuals and couples considering ing whether to proceed with transfer.
assisted conception should be fully
informed and consented, including con-
sents for legal parenthood, prior to start-
ing treatment. References
• Assessment should be carried out
before treatment to rule out any cor- 1. Fertility problems: assessment and treatment. NICE
rectable potentially significant Clinical guidelines CG156; 2013.
abnormalities. 2. The management of Ovarian Hyperstimulation
Syndrome. RCOG Green-top Guideline no. 5; 2016.
• OHSSS should be recognised as an 3. Tan B, Mathur R. Management of ovarian hyperstimu-
important and often unpredictable com- lation syndrome. Produced on behalf of the BFS Policy
plication for which explicit patient and Practice Committee. Hum Fertil. 2013;16(3):151–9.
information is necessary. Preventative 4. Gebril A, Hamoda H, Mathur R. Outpatient manage-
ment of severe ovarian hyperstimulation syndrome: a
measures should be provided in high systematic review and a review of existing guidelines.
risk cases. Human Fertility. 2017. https://doi.org/10.1080/14647
273.2017.1331048.
Gamete Donation and Surrogacy
56
Sharon Pettle and Hannah Markham
56.1 Background Clinic staff must be aware of the full statutory

provisions and guidance, and the strict rules gov-
The medico-legal landscape is broad and complex. erning consent forms which must be signed before
This chapter will focus on the implications of treatment begins. They must be familiar with docu-
incorrect management of the consent process in ments and able to inform prospective parents of
third party reproduction, comment on surrogacy, these matters and their importance. Directions
and on the use of foreign clinics. Thinking prospec- given by the HFEA, in accordance with its’ statu-
tively is a measure of prudent professional conduct tory powers, have at all times required that consent
for clinicians, enhances the treatment of the patients required under sections 37(1) and 44(1) “must” be
and demonstrates care for the children created. recorded on specified forms. From April 3rd 2017
new consent documents will apply to married cou-
ples and those in civil-partnerships. Forms WP and
56.2 Minimum Standards PP [critical sections relating to birth registration are
and Clinical Governance summarised below] will continue for unmarried
Issues heterosexual couples and non-civil partnered same
sex couples. This change will mean that staff must
The creation, storage and implantation of human be particularly vigilant as to which forms are used
embryos is controlled by the Human Fertilisation and if a couple change status during the treatment
and Embryology Act 1990, amended by the com- process, new forms will need to be completed.
plex provisions of Part 1 of the Human Fertilisation
and Embryology Act 2008. The question of who is,
or are, the parent(s) in law of a child created using 56.2.1 Form WP: ‘Your Consent
donated gametes is covered in Part 2, s33-47 of to Your Partner Being
the 2008 Act. All UK clinics are subject to regula- the Legal Parent’
tion by the Human Fertilisation and Embryology
Authority [HFEA]. The first two sections provide the names and
birth dates of the woman receiving treatment and
S. Pettle her partner. The third entitled ‘Your consent’
University College London, London, UK
e-mail: DrSharonPettle@popsiiiicle.com requires that the patient consents to their named
partner being the legal parent of any child result-
H. Markham (*)
Family Law Bar Association, London, UK ing from the treatment. The patient signs that
e-mail: hmarkham@36family.co.uk they have been given information about the

https://doi.org/10.1007/978-3-319-78683-4_56
308 S. Pettle and H. Markham
options set out in the form and have had an oppor- stating that she consents to her male partner being
tunity to have counselling, and that they under- regarded as the father and the partner has given
stand the implications of giving consent, and the written notice consenting to being regarded as the
consequences of withdrawing it. father, or where the mother has given to the clinic
written notice stating that she consents to her
female partner being regarded as the second
56.2.2 Form PP: ‘Your Consent female parent and the partner has given written
to Being the Legal Parent’ notice consenting to being regarded as the second
female parent, and that such consent has not been
This requires two names and birth dates [identical to withdrawn.
the above]. The section entitled ‘Your consent’ The Handbook clarifies in the following para-
requires that the person signing consents to being the graph that:
legal parent of any child born as a result of his/her 3: It is not necessary routinely to see copies
partner’s treatment. The next critical section for the of the consent notices in order to confirm that
purposes of birth registration is a declaration that, the necessary consent had been given and/or
before completing the form, s/he was given informa- that treatment was carried out by a licensed per-
tion about the options and an opportunity to have son/clinic in the United Kingdom. However, if
counselling, and is aware of the implications and there is doubt as to the accuracy of information
consequences of giving, or withdrawing, consent. given by an informant in these respects or there
is any conflict between the parents as to the
facts, copies of their consent notices should be
56.2.3 Registration of Births requested in order to establish the correct par-
enthood before registering. Copies of consent
The Registrar General issues instructions and notices should be readily available from infor-
guidance to General Register Office staff [1]. mants if needed as UK clinics automatically
One chapter covers the registration of births fol- give copies to their patients at the time of giving
lowing assisted conception. At present the rele- consent.”
vant paragraphs are B2A.1(iii), 2 and 3. The accuracy of record keeping is absolute.
Para B2A.1: “The Human Fertilisation and Whether clinics have followed the correct prac-
Embryology Act 2008 provides the following tice and procedure has been scrutinised in cases
parenthood definitions regarding who is the placed before The President of the Family
father or second female parent (i.e. the mother’s Division of England and Wales commonly
female partner) of a child born to a woman as a known as the ‘alphabet’ cases, in which several
result of the placing in her of an embryo or of parents lost their rights to register their child as
sperm and eggs or her artificial insemination. their lawful child due to procedural errors at the
And later …. clinic. The Handbook requires updating follow-
(iii): where a woman received fertility treating the lead judgment of The President known as
ment from a licensed person in the United Re A [2].
Kingdom and no husband is to be regarded as the
father … or no spouse or civil partner is to be
regarded as the second female parent …, the man 56.2.4 If an Error Occurs
with whom the mother has a parenthood agree-
ment (see B2A.2) is regarded as the father”. If an error occurs or is found by any member of
In this context: clinic staff, the Person Responsible and/or
2: The Parenthood agreement means where Clinical Director should be contacted as a matter
the mother has given to the clinic written notice of urgency. If necessary, legal advice should be
56 Gamete Donation and Surrogacy 309
sought as to the appropriate action[s] to take. the forms prior to the commencement of the
Patients should be informed about this and treatment.
efforts made to rectify this and/or to manage the • Lack of understanding of consent.
consequences. • Errors in record keeping.
• Lack of counselling for couples prior to
treatment.
56.2.5 Surrogacy
Surrogacy arrangements are defined in s54 of the 56.4 Avoidance of Litigation

2008 Act which sets out the law regarding paren-
tal orders. Hearings in the Family Courts have It is a possibility that recommendations to use
argued the ‘parental’ rights of intending parents, a foreign clinic could result in such claims.
and those of the woman the law regards as the Arrangements between clinics [more or less
legal mother. Existing surrogacy legislation was formalized] are known to exist and travelling
debated in the House of Lords [3] and is under abroad is suggested for cost reasons; greater
review including the rights of single people as the accessibility of donated gametes [particularly
President of the Family Division declared that the eggs and embryos]; and for donor anonymity.
current HFEA provisions in relation to single There are potential pitfalls as many prospec-
people are incompatible with Human Rights Law tive parents assume that the regulations are
and Adoption legislation. The Department of identical in a clinic linked with one in UK, and
Health is developing best practice guidelines for do not fully understand the ramifications of
surrogates, professionals and intended parents treatment abroad. They express surprise at pro-
but these have not yet been published. posed multiple embryo transfer, the paucity of
Family Judges repeatedly identify difficulties non-identifying information about donors, do
arising when there is a breakdown in the relation- not appreciate that donors are not registered
ship between a surrogate and commissioning par- through the HFEA and do not have the option
ents but the law currently gives no guidance to to re-register as identifiable. Donor gametes
those involved, save for reference to the Children may be suggested with little time for consider-
Act 1989. ation and no counselling being offered.
Psychological assessment of commissioning Furthermore, the consent documentation out-
parents, potential surrogates and of the relation- lined above is not in place raising the potential
ship between them is rarely undertaken and regu- for difficulties at birth registration. Some par-
lations do not promote counselling in these ents feel unprepared, and struggle to help their
circumstances. Currently the HFEA does not children deal with anonymity when other chil-
suggest any special preparation is required when dren of a similar age have more information
using surrogacy and it should be noted that and express their feelings about meeting donors
‘implications counselling’ for those using in the future [4].
donated gametes is still only optional. Reviews of research exploring the impact fer-
tility treatment conclude that many couples expe-
rience a negative impact on their partnership,
56.3 Reasons for Litigation emotional distress, depression and high stress
levels [5, 6]. Issues of blame may exacerbate the
• Failure of clinics to adhere to the statutory distress [7] and in lower/middle income countries
guidance within the HFEA. and some cultures, infertility increases the risk of
• Failure of clinics to provide correct advice and domestic violence [8]. However well people pres-
direction in the signing of and completion of ent in the consulting room, patients represent a
310 S. Pettle and H. Markham
potentially vulnerable group whose capacity to declared one of the child’s two legal parents, los-
think through the ramifications and implications ing her right to legal parentage. This has dramatic
may be compromised. consequences for the mother and the child.
It may be advisable for a UK clinic recom- Subsequently, an audit required by the HFEA
mending a linked clinic abroad to offer or provide revealed that 51 clinics (46%) discovered “anom-
counselling, and/or to provide written details of alies” in their records relating to consent forms:
the differences, and likely expectations and out- being absent; incorrectly completed (unsigned,
comes if this option is pursued, so that prospec- incomplete, completed by the wrong person or
tive parents are fully informed. Clinics need to having missing pages); or, completed/dated after
help patients understand the wider issues involved the treatment had begun; and in many instances,
and have executed their duty of care to people there was no evidence that an offer of counselling
who are psychologically vulnerable. had been made. Over 75 legal cases were identi-
Additionally: fied in which legal parenthood had been affected
by the failure to follow procedures. Adherence is
• Clinics can ameliorate reasons for litigation essential as this allows intended parents [male or
through internal training from either external female] to be parents in law and register their
or internal lawyers specialist in this area. child as their legitimate and lawful child. The
• Creation of a role within the clinic of a person HFEA 2017-2020 Strategy [9] cites as Objective
trained in record keeping and understanding 1 in ‘fewer non-compliances and incidents in
of the current law and any subsequent changes, clinics’.
who is responsible for helping the Person The subsequent run of the aforementioned
Responsible disseminate information and ‘alphabet cases’ heard by the President of the
audit relevant processes. Family Division highlighted the failings of a
• Regular audits of record keeping and consent number of clinics and necessitated some careful
will also identify any potential pitfalls. These review of the formulation of the consent forms to
are required by the HFEA as part of its inspec- preserve parenthood for a number of parents. It
tion regime for clinics. also led to several claims against the clinics who
• Recommendation to the prospective parents to met the cost of the litigation and settled claims
access counselling and or legal advice prior to out of court.
treatment in cases of surrogacy or where the Some Judgements are in the public domain
legal parenthood of any resulting children is albeit in anonymized form: one concerned a sur-
unclear. An example would be the use of rogate who had such resentment towards the bio-
donor embryos by a single woman. logical commissioning parents that she refused
consent to the making of a parental order yet she
agreed that the children should be brought up by
56.5 Case Study them [10]. The outcome was to adjourn the appli-
cation making a Child Arrangement Orders
In 2013 a Judgement Justice Cobb—AB v CD which gave them Parental Responsibility. In
and the Z Fertility Clinic [2013] EWHC 1418 another case where no agency was involved [11],
(Fam), [2013] 2 FLR 1357 named serious short- the behavior of parties during the pregnancy [a
comings in a clinic due to failure to adhere to the homosexual couple and the surrogate] was con-
regulations: including the way forms were com- sidered relevant in deciding with whom the child
pleted, signed, and whether counselling had been should reside and who was best placed to meet
offered. This led to a mother who had been the child’s emotional needs.
56 Gamete Donation and Surrogacy 311
3 FCR 555: (2015) 146 BMLR 123: [2015] Fam Law

1333.
Key Points: Gamete Donation and Surrogacy
3. House of Lords debate on surrogacy—December 19th
• Adherence to the statutory guidance in 2016.
the HFEA as laid out in the Code of 4. Pettle S. Groups for donor conceived children. A step
Practice. forward … into the unknown. J Fertil Counselling
Assoc [Spring]. 2014:20–5.
• Ongoing training and understanding of 5. Luk BH, Loke AY. A review of supportive interven-
the laws relating to consent and parent- tions targeting individuals or couples undergoing
hood within the HFEA. infertility treatment: directions for the development of
• Ensuring forms WP & PP are the correct interventions. J Sex Marital Ther. 2016;42(6):515–33.
6. Rockliff HE, Lightman SL, Rhidian E, Buchanan H,
up to date versions. Gordon U, Vedhara K. A systematic review of psycho-
• Training and understanding of record social factors associated with emotional adjustment in
keeping and form filling prior to in vitro fertilization patients. Hum Reprod Update.
treatment. 2014;20(4):594–613.
7. Peloquin K, Brassard A, Arpin V, Sabourin S, Wright
• Provision of adequate support to pro- J. Whose fault is it? Blame predicting psychological
spective parents prior to treatment via adjustment and couple satisfaction in couples seek-
counselling and access to legal advice if ing fertility treatment. J Psychosom Obstet Gynaecol.
required. 2018;39(1):64–72.
8. Stellar C, Garcia-Moreno C, Temmerman M, van
der Poel S. A systematic review and narrative report
of the relationship between infertility, subfertil-
ity, and intimate partner violence. Gynaecol Obstet.
References 2016;133(1):3–8.
9. h t t p : / / i f q t e s t i n g . b l o b . c o r e . w i n d o w s . n e t /
1. Handbook for Registration Officers published by umbraco-website/1346/hfea_strategy-2017_aw.pdf.
HMGOV.uk. 10. (1) C (2) D v (1) E (2) F (3 & 4) A & B (By their
2. RE A & 7 ORS (Human Fertilisation & Embryology Guardian) [2016] EWHC 2643 (Fam).
Act 2008) (2015) LTL 14/9/2015: [2016] 1 WLR 11. Re: Z [ACHILD] sub nom (1) A (2) B v (1) X (2) Z [A
1325: [2016]. 1 All ER 273: [2017] 1 FLR 366: [2015] CHILD BY HIS GUARDIAN] 2016.
Termination of Pregnancy
(Abortion) 57
Swati Jha and Lesley Regan
57.1 Background Since 2012 the average number of abortions

performed in the UK has remained relatively
Abortion is the spontaneous or induced termination constant at 185,000 per annum. In 2016 [4],
of pregnancy. For the purposes of this chapter, abor- abortion rates for women between 15 and
tion is used to refer to induced termination of preg- 44 years of age were 16.0 per 1000 and the under
nancy. Abortion in England, Scotland and Wales is 16 year rate was 1.7 per 1000. The abortion rate
regulated by the Abortion Act 1967 [1]. However, was highest for women at the age of 22. Most
the Scotland Act 2016 [2] now allows the Scottish abortions are carried out at under 13 weeks
Parliament to legislate on abortion law. The Abortion (92%). Of the abortions performed in 2016, 2%
Act 1967 has never extended to Northern Ireland, were performed because of the risk of the child
where abortion continues to be regulated by provi- being born with serious handicap (Criteria E of
sions in criminal law and is illegal other than in very the TOP act).
specific circumstances [3]. All abortions other than In a legal setting where sterile facilities are avail-
those performed as an emergency require approval able, abortion is a safe procedure for which major
by two registered medical practitioners and must be complications and mortality are rare at all gesta-
performed in facilities registered for this purpose. tions. However, when performed in an unsafe envi-
Ninety-eight per cent of abortions were funded by ronment abortion can lead to chronic disability.
the NHS. Of these, over two thirds (68%) took place Various methods are used to terminate a preg-
in the independent sector under NHS contract, as nancy and depends on the gestation and individ-
was the case in 2015 (68%) [4]. Abortions over ual preferences. These include medical and
24 weeks can only take place in an NHS hospital [1]. surgical approaches. Medical abortions accounted
for 62% of the total abortions in 2016. This is
S. Jha (*) higher than in 2015 (55%) and more than double
Department of Obstetrics and Gynaecology, Jessop the proportion in 2006 (30%).
Sheffield, UK
L. Regan 57.2 M
Department of Obstetrics and Gynaecology, Imperial
College Healthcare NHS Trust, St Mary’s Hospital,
London, UK
Women requesting an abortion should be given
Royal College of Obstetricians and Gynaecologists,
London, UK written, objective, evidence-guided information
e-mail: l.regan@imperial.ac.uk to allow them to make an informed choice and

https://doi.org/10.1007/978-3-319-78683-4_57
314 S. Jha and L. Regan
decision-making support about their pregnancy 5% with medical). This may be a surgical inter-
options [5]. Women should be informed of the vention following a medical or re-evacuation fol-
methods of abortion available and the character- lowing a surgical management.
istics of both methods. The complications, seque- Women should be reassured that there is no
lea of abortion and the risks of the medical versus association between abortion and subsequent ecto-
the surgical method should be highlighted. The pic pregnancy, placenta praevia, infertility, breast
need for severe bleeding requiring transfusion cancer or psychological problems. They should
(1 in 1000 rising to 4 in 1000 when gestation is have a pre-procedure blood test including assess-
>20 weeks), risk of uterine perforation and cervi- ment of Rhesus status and haemoglobin levels. It
cal trauma should be mentioned. When a serious is also good practice to investigate for STI but this
complication arises the need for further treatment should not delay the abortion. Alternatively antibi-
(laparoscopy, laparotomy blood transfusion and otic prophylaxis should be given. Before a woman
hysterectomy) should also be discussed. is discharged, future contraception should have
Abortion on grounds relating to the physical been discussed with each woman and contracep-
or mental health of the woman or of any existing tive supplies should have been offered.
children can be performed within the law at ges- For pregnancy less than 14 weeks a surgical or
tations up to 24 weeks. At all gestations up to medical abortion is a feasible option. Surgical
this limit, abortion can be performed using either methods involve the use of vacuum aspiration
surgical or medical methods; however, different using either a suction cannula or forceps if
abortion techniques are appropriate at different required. Oxytoxics are not recommended.
gestations. It should be highlighted that a par- Where abortion is undertaken at less than 7 weeks
ticular method may be more suitable for some it is good practice to inspect the aspirated tissue
women. In severely obese women, women with to confirm completeness of products.
uterine malformations, previous cervical surgery For medical abortion, mifepristone when used
or in women wishing to avoid surgical interven- in conjunction with misoprostol is most
tion the medical approach may be more appro- effective.
priate. Where there are constraints of time or Regimens include
when medical methods are contraindicated the
surgical method may be more suitable. Women • Upto 63 days: mifepristone 200 mg followed
opting for medical abortions should also be 24–48 h later by misoprostol 800 μg.
informed that this mimics a miscarriage and can • From 64 days to 14 weeks: mifepristone
take more time to complete the abortion and be 200 mg followed 24–48 h later by misoprostol
somewhat more unpredictable with more clinic 800 μg, followed by misoprostol 400 μg every
visits required. Whereas surgical abortions, 3 h until abortion occurs.
although quicker, requires uterine instrumenta-
tion and carries a small risk of uterine or cervical Where mifepristone is not available, misopro-
injury. The procedure for the abortion should be stol 800 μg, followed by misoprostol 400 μg
described and the patient informed of symptoms every 3 h until abortion occurs.
likely to be experienced. Pain management For pregnancy greater than 14 weeks, surgical
options should also be discussed. The time likely abortion can be undertaken using either a large
to be taken and the postoperative follow up bore cannula for vacuum aspiration or by dilata-
including contraceptive advice should be dis- tion and evacuation.
cussed. The emotional impact of an abortion Cervical preparation should be considered
should also be discussed. before surgical abortion and both mifepristone
Women should be informed that there is a and misoprostol are both suitable options. Where
small risk of failure to end the pregnancy (2/100 possible women’s contraceptive options should
procedures) and a risk of further intervention be provided as part of the package of care for
after the initial treatment (<2% in surgical and their abortion.
57 Termination of Pregnancy (Abortion) 315
Prompt identification of features of sepsis is All women undergoing an abortion should be

essential to prevent morbidity and mortality. appropriately counselled about their choices, and the
Features of infection include: options available to them. Patient information leaflets
should be provided, and complications discussed.
• Raised temperature Special consideration is required in cases where:
• Guarding and rebound on abdominal
examination • Patients lack mental capacity.
• Localised/generalised abdominal or uterine • The abortion is biased by gender selection.
tenderness • Objections to the termination are raised by the
• Foul smelling discharge or pus patient’s partner or family.
• Hypotension • The patient is under 16 years of age. The
• Tachycardia Gillick criteria are applied in cases where a
• Increased respiratory rate parent is not involved in the decision but a
doctor is justified in giving advice and treat-
ment. In these situations the patient should be
57.3 Reasons for Litigation encouraged to involve a parent. It is prudent to
involve the child protection team in cases
Most cases of litigation are settled out of court where the patient is under the age of 14 years.
and reasons for litigation include:
Patients should either be screened for STI
• Ongoing pregnancy/failed abortion (Sexually transmitted infections) and treated if
• Incomplete abortion or substantial retained positive or given prophylactic antibiotics if there
products is a failure to investigate.
• Infection In women who are rhesus negative, anti D IgG
• Infertility should be given intramuscularly within 72 h of
• Perforation of uterus/bowel the abortion.
• Undiagnosed ectopic Retained products are more likely to cause litiga-
• Cervical, uterine or bladder lacerations tion when there are identifiable fetal parts. When
• Sexual problems performing a surgical evacuation it is good practice
• Emotional trauma to observe whether fetal and placental tissue has
been removed. When a repeat evacuation is required
for retained products this should be done under anti-
57.4 Avoidance of Litigation biotic cover by a senior clinician as the risk of per-
foration is greater. Women with features of infection
Consenting women for an abortion should take should be identified and treated promptly. When
into account eligibility in relation to the Abortion there are features of severe sepsis/septic shock this
Act 1967. An ultrasound scan is now routinely should be acted on quickly and requires prompt
performed to establish the gestational age of the evacuation of the uterus in a unit with facilities for
pregnancy. In very early pregnancy a pseudo sac undertaking the procedure. Where these skills are
may be seen when there is actually an ectopic not available misoprostol can be used [2].
pregnancy. Where a definite intrauterine sac is Women who develop a complication such as a
not seen, the active exclusion of an ectopic is nec- perforation should be appropriately managed
essary. Another risk in very early abortions is the with laparoscopy or laparotomy and the uterine
possibility that only decidual endometrium has injury adequately treated.
been aspirated rather than the actual gestational Conscientious objection to an abortion can
sac, hence adequate safeguards are imperative to result in clinicians refusing to be involved in the
ensure the abortion is complete and include process. Whereas a refusal to sign the consent
visual inspection of the products removed. form would be acceptable, a refusal to deal with
316 S. Jha and L. Regan
a patient who becomes critically ill or requires

medical care whilst waiting for or following an Key Points: Abortion
abortion can lead to legal action against a medi- • Women requesting an abortion should
cal professional. There is no legal or ethical right be adequately counselled about their
to refuse to provide care on grounds of a consci- options and the risks and complications
entious objection in such situations. of the procedure.
Another cause for litigation related to abortion is • Preoperative investigations include an
a failure to offer a termination, and it is good prac- ultrasound scan and STI screening.
tice to have a detailed documented discussion about • When undertaking early abortions it is
prognosis and outcomes where abnormalities are important to confirm that it is complete.
detected on the anomaly scan. A failure to offer a • Special consideration is required when
termination in this setting can result in litigation. patients lacking mental capacity or is
under 16 years old.
• Doctors with a Conscientious objection
57.5 Case Study to abortions cannot refuse to treat a
patient who requires urgent care.
A 33 year old with two children and a past history • Women who carry a foetus with abnor-
of salpingitis found she was pregnant so made an malities should be given the option of an
urgent appointment for an abortion. On the initial abortion.
scan no intrauterine sac was seen, hence she was
asked to return 10 days later. On her return and
second scan an 8.5 mm intrauterine sac compatible
with 5 weeks gestation was seen. A Surgical termi- References
nation was carried out under local anaesthesia. The
procedure was straightforward. As per policy, no 1. Abortion Act 1967. London: HMSO; 1967. https://
histology was carried out. 10 days later the patient www.legislation.gov.uk/ukpga/1967/87/contents.
Accessed 25 Oct 2017.
attended with dizziness and abdominal pain. She 2. Scotland Act 2016. London: HMSO; 2016. https://
was treated for endometritis post abortion and was www.legislation.gov.uk/ukpga/2016/11/contents.
discharged home on antibiotics. A week later she Accessed 25 Oct 2017.
collapsed and was brought back to hospital and 3. Department of Health. Abortion Statistics, England
and Wales: 2016. Statistical Bulletin June 2017.
was reviewed by the same doctor who diagnosed London: DH; 2017.
with acute appendicitis. When the ultrasound scan 4. Decriminalisation of abortion: a discussion paper
revealed a large amount of free fluid in the pelvis a from the BMA; 2017. p 16. https://www.bma.org.
pregnancy test revealed she was pregnant and had uk//media/files/pdfs/collective%20voice/committees/
arm/2017/bma-2017-decriminalisation-of-abortion-
a ruptured ectopic. The patient received a pay out discussion-paper.pdf. Accessed 25 Oct 2017.
on the grounds of negligence. There was a failure 5. Best practice in comprehensive post abortion care.
to confirm an intrauterine pregnancy from the Paper No 3. RCOG; 2016.
products removed at the time of the termination as
well as the failure to perform a pregnancy test at
subsequent hospital admissions.
Hormone Replacement Therapy
(HRT) 58
Nick Nicholas
58.1 Background With longer use, HRT also increased the risk
of stroke, breast cancer, gallbladder disease and
About 36% of post-menopausal women in Britain death from lung cancer.
were taking HRT between 1996 and 2002 (38– Oestrogen-only HRT increased the risk of
40% in the USA). Use fell by 21% after 2001 [1] venous thrombosis after 1–2 years’ use: from 2
as a consequence of fear of cardiovascular dis- per 1000 to 2–10 per 1000. With longer use, it
ease and breast cancer attributable to HRT use. also increased the risk of stroke and gallbladder
The principal risks of HRT are thromboem- disease, but it reduced the risk of breast cancer
bolic disease (venous thromboembolism (VTE) (after 7 years’ use) from 25 per 1000 to between
and pulmonary embolism), stroke, breast and 15 and 25 per 1000.
endometrial cancer, and gallbladder disease. Among women over 65 years of age taking
Large studies, including the Women’s’ Health continuous combined HRT, the incidence of
Initiative (WHI) and the Million Women Study dementia was increased. Risk of fracture was the
(MWS), have cast concerns and controversy over only outcome for which results showed strong
the use of HRT. evidence of clinical benefit from HRT (both
types).
This study agreed with the initial WHI study
58.1.1 Cochrane Review (2017) [2] [3] although the coronary heart disease risk in
younger women was reduced in women within
This review included 22 double-blinded random- 10 years of the menopause by −6/10000 women
ized controlled trials (RCTs) (43,637 women). In years. Whereas the risk increased in women
relatively healthy postmenopausal women, using given HRT >20 years past the menopause to
combined continuous HRT for 1 year increased +17/10000women years.
the risk of a heart attack from about 2 per 1000 to Reanalysis of the WHI data [4, 5] revealed
between 3 and 7 per 1000, and increased the risk that HRT had a complex pattern of risks and
of venous thrombosis from about 2 per 1000 to benefits and concluded that HRT did NOT
between 4 and 11 per 1000. support its use for chronic disease prevention
but more so for symptomatic symptom
management.
The Million Women Study [6] was an obser-
N. Nicholas
Hillingdon Hospital NHS Trust, Uxbridge, UK vational study looking at the risks of breast can-
e-mail: nnicholas@nhs.net cer in >800,000 women on HRT concluded that

https://doi.org/10.1007/978-3-319-78683-4_58
318 N. Nicholas
combined HRT increased the risk of breast can- 1.7]), which is comparable with that for oestrogen-
cer more than estrogen only or Tibolone. The risk only HRT (1.3 [1.2–1.4]) and significantly lower
increased with more prolonged use, and transder- than that for combined HRT (2.0 [1.9–2.1]).
mal estrogen did not appear to be associated with There is limited evidence about HRT and risk
any prothrombotic risk. of breast cancer for women with a family history
Other studies KEEPS [7] and Schierbeck et al. of breast cancer. Available evidence suggests that
[8] looked at the timing and effect of long term family history has no additive impact on risk of
HRT use and confirmed the cardioprotective effect breast cancer with HRT usage [11, 12].
of early HRT use, and persistence of beneficial
effect for 6 years post stopping HRT. • Women with a family history of breast cancer
should be advised that family history does not
appear to have an additive impact on risk of
58.2 Minimum Standards breast cancer with HRT usage.
and Clinical Governance • Women with a family history of breast cancer
Issues with a prior hysterectomy should be advised
that short-term, oestrogen-only HRT would
NICE [9] have published guidance on the man- appear preferable to combined HRT.
agement of the menopause. It refers to an ‘indi-
vidualised approach’. Menopausal women should
be given information that includes: 58.2.1 BRCA Carriers
• An explanation of the stages of menopause. BRCA1 gene is associated with an increased risk
• Common symptoms and diagnosis. of breast cancer by age 70 years of 60–65% and
• Lifestyle changes and interventions that could of ovarian cancer of 39–59%. BRCA2 gene is
help general health and wellbeing. associated with risk of breast cancer by age
• Benefits and risks of treatments for meno- 70 years of 45–55% and of ovarian cancer of
pausal symptoms. 11–17%. Risk-reducing surgery with mastecto-
• Long-term health implications of menopause. mies and bilateral salpingo-oophorectomy (BSO)
is usually carried out when the family is com-
Women with menopausal symptoms should plete. The effect of this is a reduction in the inci-
weigh up the pros and cons of symptomatic relief dence of ovarian, fallopian tube and peritoneal
against the small absolute risk of harm arising cancer risks by 72–80%, and reduction of breast
from short-term use of low-dose HRT, provided cancer risks by 46–48% in premenopausal
they do not have specific contraindications such women [13].
as an increased risk of Cardiovascular Disease Findings suggest that a short course of HRT
(CVD), thromboembolic disease or breast and should not be contraindicated for BRCA1 mutation
endometrial cancer. carriers who have undergone menopause and who
Tibolone, a selective tissue estrogenic activity have no personal history of cancer [14]. The use of
regulator, is effective in treating symptoms in post- HRT following risk-reducing surgery appears to be
menopausal women. The LIBERATE study [10] safe with no additional increase of breast cancer,
demonstrated the risk of breast cancer recurrence especially if estrogen-only therapy is used [15].
was higher for women on tibolone compared to In April 2016 the International Menopausal
placebo (HR: 1.40, 95% CI: 1.14–1.70, p = 0.01). Society [16] published guidance on the risks and
The Million Women Study identified a signifi- benefits of HRT which differed with age and
cantly increased risk of breast cancer diagnosed in years since the last menstrual period.
tibolone users (relative risk [RR] 1.5 [95% CI 1.3– The Key Points were:
58 Hormone Replacement Therapy (HRT) 319
58.2.2 Postmenopausal Osteoporosis

• VTE risk increases with age and with
HRT is the most appropriate therapy for fracture thrombophilic disorders.
prevention in early menopause [A]. • The risk of VTE increases with oral
HRT but is rare below age 60.
• Observational studies and biological
Cardiovascular Disease plausibility point to a lower risk with
Key points low-dose transdermal therapy.
• In women under age 60 and recently • Some progestogens may be associated
postmenopausal with no evidence of with a greater VTE risk [C].
cardiovascular disease, the initiation of • The incidence of VTE is less frequent
estrogen-alone therapy reduces coro- amongst Asian women [C].
nary heart disease (CHD) and all-cause • Population screening for thrombophilia
mortality [A]. is not indicated prior to HRT use [C].
• Data on daily continuous combined
estrogen–progestin are less robust but
other combined therapy regimens
appear to be protective as shown in
Danish and Finnish studies [A]. Breast Cancer
• Recent meta-analyses and WHI 13-year Key points
follow-up data all show a consistent • The risk of breast cancer associated with
reduction in all-cause mortality for HRT in women over 50 is complex.
HRT users [A]. • The increased risk is primarily associ-
• It is not recommended to initiate HRT ated with the addition of a synthetic pro-
beyond age 60 years solely for primary gestogen to estrogen therapy and to
prevention of CHD [A]. duration of use [B].
• The risk may be lower with micronized
progesterone or dydrogesterone [C].
• The HRT attributable risk is small and
decreases when treatment stops [B].
Venous Thrombolembolism • There is a lack of safety data supporting
Key points HRT use in breast cancer survivors.
• A careful assessment of personal and • Breast cancer risk should be evaluated
family history of venous thromboembo- before HRT prescription [D].
lism (VTE) is essential before prescrib- • Any possible increased risk associated
ing HRT. with HRT may be decreased by select-
• Oral estrogen is contraindicated in ing women with lower baseline risk
women with a personal history of VTE including low breast density and by pro-
[A]. viding education on preventive lifestyle
• Transdermal estrogen should be first measures (reducing weight, reducing
choice in obese women with Vasomotor alcohol intake, increasing physical
symptoms (VMS) [B]. activity) [D].
320 N. Nicholas
Endometrial Safety and Bleeding Other Cancers

Key points Key points
• Postmenopausal bleeding is ‘cancer • In WHI there was no increase in risk of
until proven otherwise’. cervical cancer [A].
• 1–14% of women with postmenopausal • Long-term cohort studies have found no
bleeding will have endometrial cancer. increase in cervical cancer with HRT
• Blind endometrial sampling is an appro- use [B].
priate first-line investigation [B]. • The association between HRT and ovar-
• Unopposed estrogen therapy is associ- ian cancer remains unclear.
ated with a dose and duration-related • In WHI neither estrogen or estrogen +
increased risk of endometrial cancer [A]. progestin demonstrated a significant
• Endometrial protection requires an ade- increase in lung cancer incidence [A].
quate dose and duration of progestogen • There is no clear association between HRT
[A]. use and hepatocellular carcinoma [C].
• For doses of estradiol of 2 mg/50 μg, an • HRT use may be associated with
adequate dose of micronized progester- reduced risk of gastric cancer [C].
one appears to be 200 mg for 10–14 days • There are few good studies examining
per month or 100 mg daily for continu- links between upper GI cancers, meno-
ous therapy [B]. pause and HRT use.
• Higher doses of progesterone may be
required for higher estradiol doses or in
women with high body mass index. Androgen Therapy
• Testosterone therapy should be considered as
a clinical trial which should not be continued
if a woman has not experienced benefit by
6 months [A].
Colorectal Cancer
Key points
• Observational studies show a reduced
risk of colorectal cancer (CRC) amongst Complimentary Therapies and Bioidentical
users of oral HRT [B]. Therapies
• Three meta-analyses have reported a Key points
reduced risk of CRC with HRT use [A]. • Complementary therapies have limited
• Results from WHI showed no effect for evidence of efficacy and are not regu-
estrogen-only therapy on CRC risk [A]. lated by medicines agencies [B].
• Results from WHI showed reduced risk • Cognitive behavioral therapy, mindfulness
of CRC with estrogen + progestin ther- training, acupuncture, hypnosis and stel-
apy [A]. late ganglion blockade may be useful tech-
• There are limited data on the effect of niques to consider when treating VMS [A].
non-oral HRT on CRC risk. • Prescribing bioidentical hormone therapy
• One randomized, controlled trial in (BHT) is not recommended due to lack of
older osteoporotic women using tibo- evidence of efficacy, lack of quality con-
lone reported a reduced risk of colorec- trol and lack of regulatory oversight [B].
tal cancer [A]. • The use of serum or salivary hormone
• HRT should not be used solely for the levels is not recommended to assist in
prevention of CRC [D]. the management of HRT [B].
58.3 Reasons for Litigation it.’ The question is how to translate these precise
ideals into clinical practice.
• Doctors considering prescribing HRT to meno- When counseling patients about HRT, the doc-
pausal women seeking treatment for distress- tor is advised to refer to national or professional
ing symptoms have a duty of care to give their guidelines on the use of HRT. Unfortunately, the
patients the pros and cons of the proposed data is not absolute and patients should be made
treatments. Patients expect to be given all aware of the potential problems with the data. Data
‘material’ risks regarding the HRT so that they must be given in a comprehensible non technical
can make an ‘informed decision’. form. Any deviation from the guidelines must be
• Estrogen only HRT given in women with a clearly documented and the reasons given for doing
uterus. so. Deviation from any guideline is a risky strategy
• Unnecessary HRT prescribing. best avoided. Table 58.1 is a useful guide to help
• Failure to prescribe HRT when indicated. quantify risks associated with HRT use. It is by no
• Complications arising from HRT including means absolute but helpful during counseling.
VTE, Breast Ca, Ovarian Cancer, lymphoma, Wherever possible, patient information leaf-
strokes and heart attacks. lets and any other available resources should be
• Delay in diagnosis of these complications. given to the patient. Time must be allowed for the
patient to absorb and assimilate the information
and time given for more questions to be answered
58.4 Avoidance of Litigation and more than one appointment may be required.
Complete and contemporaneous records of all
There is still considerable confusion amongst consultations and discussions regarding risks and
GPs and hospital specialists as to what advice benefits of HRT usage should be documented.
menopausal women should be given so that they When a potential complication is diagnosed it
can make an informed decision as to whether or is important that appropriate steps are taken to
not the risk/benefit ratio is acceptable to them. exclude the diagnosis within a reasonable times-
Counseling patients on ‘material risks’ has to cale and depending on the seriousness of the
be documented and the doctor has a responsibil- problem.
ity to make sure that the patient has understood
and assimilated these risks.
Wherever possible, patients should be given 58.5 Case Study
absolute risks in order to be able to make an
informed judgment of the actual magnitude of A 51-year old woman first saw their GPT with
the risks involved. However, the risks are often menopausal symptoms. An FSH level of 66, indi-
based on inaccurate or skewed data and even with cated that the patient was menopausal.
the best intentions RCTs can be open to selection Following a discussion of the pros and cons of
bias and differences between study groups. HRT, the patient opted to commence treatment.
The law on consent has changed considerably Her GP prescribed Elleste-Solo tablets—an
in the past few year and is dealt with in detail in unopposed oestrogen treatment. She presented
the chapter on Consent after Montgomery [14]. 8 months later with vaginal bleeding after inter-
In relation to HRT a crucial part of the judgment course. An Ultrasound scan reported a bulky
in this case refers to ‘material risk’. uterus with several rounded mixed echo struc-
‘The test of materiality is whether, in the cir- tures suggestive of fibroids. Due to the
cumstances of the particular case, a reasonable Postmenopausal bleeding she was referred to
person in the patient’s position would be likely to a gynaecologist who performed a diagnostic
attach significance to the risk, or the doctor is or hysteroscopy and endometrial biopsy. The endo-
should reasonably be aware that the particular metrial biopsy showed moderate atypical glandu-
patient would be likely to attach significance to lar hyperplasia with no features of malignancy.
322 N. Nicholas
Table 58.1 Medicines and Health Regulatory Agency (MHRA) Guidance taken from the British National
Formulary [17]
Background Additional cases/1000
Age range risk/1000 non women on estrogen Additional cases/1000 women on E2 and
Risk (years) HRT user women only progesterone
Years of use >5 year >10 year >5 year >10 year >5 year >10 year
Breast 50–59 10 20 2 6 6 24
60–69 15 20 3 9 9 36
Endometrial 50–59 2 4 4 32 NS NS
60–69 3 6 6 48 NS NS
Ovarian 50–59 2 4 <1 1 <1 1
60–69 3 6 <1 2 <1 2
VTE 50–59 5 – 2 – 7 –
60–69 8 – 2 – 10 –
Stroke 50–59 4 – 1 – 1 –
60–69 9 – 3 – 3 –
CHD 70–79 29–44 – NS – 15 –
The patient was seen for follow up 1 month later.

The consultant explained that the findings indi- Key Points: HRT
cated that the endometrium had been affected by • Women experiencing a spontaneous or
the course of unopposed oestrogen. Although iatrogenic menopause before age 45 and
there was no absolute indication for a hysterec- particularly before age 40 are at higher
tomy, the patient was very anxious about the risk of cardiovascular disease and osteo-
results and opted to have a hysterectomy. porosis. In these women, in the absence
A claim for compensation was made on the of contraindications, HRT is advised at
basis that it had been negligent to prescribe unop- least until the average age of menopause.
posed oestrogen to a patient with an intact uterus, • Counseling on HRT should convey risks
leading to the patient undergoing an unnecessary and benefits in clear and comprehensi-
hysterectomy. The GP had documented in the ble terms, ideally expressed as absolute
notes that the patient would need combined ther- risk in real numbers.
apy because she had a uterus, but inadvertently • HRT should not be recommended with-
the wrong product had been selected from the out a clear indication for its use.
computer medication list, which went unnoticed • Women taking HRT should have at least
and was issued on repeat prescription. The GP an annual medical consultation.
accepted responsibility and the expert • There are no reasons to place a manda-
gynaecologist concluded that the moderate atypi- tory limit on the duration of HRT.
cal glandular hyperplasia was caused by the • Dose and duration of HRT should be
unopposed oestrogen. consistent with treatment goals.
The patients gynaecologist accepted that there • Whether or not to continue should be
was no absolute indication for a hysterectomy in decided at the discretion of the well-
this case and the the claim was subsequently set- informed woman and her health
tled for a sum of £28,000 in damages and professional.
£14,000 in legal costs.
References Effect of hormone replacement therapy on cardiovas-

cular events in recently postmenopausal women: ran-
domised trial. BMJ 2012;345:e6409 doi: https://doi.
1. Townsend J, Nanchahal K. Br J Gen Pract.
org/10.1136/bmj.e6409.
2005;55:555.
9. NICE. Menopause Diagnosis and Management. NG
2. Marjoribanks J, Farquhar C, Roberts H, Lethaby
23; 2015.
A, Lee J. Long-term hormone therapy for peri-
10. Sismondi P, Kimmig R, Kubista E, Biglia N, Egberts
menopausal and postmenopausal women. Cochrane
J, Mulder R, et al. Effects of tibolone on climac-
Database Syst Rev. 2017;1:CD004143. https://doi.
teric symptoms and quality of life in breast can-
org/10.1002/14651858.CD004143.pub5.
cer patients data from LIBERATE trial. Maturitas.
3. Chlebowski RT, Hendrix SL, Langer RD, Stefanick
2011;70:365–72.
ML, Gass M, Lane D, et al. WHI Investigators.
11. Rippy L, Marsden J. Is HRT justified for symptom
Influence of estrogen plus progestin on breast can-
management in women at higher risk of developing
cer and mammography in healthy postmenopausal
breast cancer? Climacteric. 2006;9(6):404–15.
women: The Women’s Health Initiative Randomized
12.
Colditz GA, Kaphingst KA, Hankinson SE,
Trial. JAMA. 2003;289:3243–53.
Rosner B. Family history and risk of breast can-
4. Rossouw JE, Prentice RL, Manson JE, Wu L, Barad
cer: Nurses’ Health Study. Breast Cancer Res Treat.
D, Barnabei VM, et al. Postmenopausal hormone
2012;133:1097–104.
therapy and risk of cardiovascular disease by age and
13. Domchek S, Kaunitz AM. Use of systemic hormone
years since menopause. JAMA. 2007;297:1465–77.
therapy in BRCA mutation carriers. Menopause.
5. Manson JE, Chlebowski RT, Stefanick ML, Aragaki
2016;23(9):1026–7.
AK, Rossouw JE, Prentice RL, et al. Menopausal
14. Montgomery v Lanarkshire Health Board. UKSC 11;
hormone therapy and health outcomes during the
2015.
intervention and extended post stopping phases of the
15. Domchek SM, Friebel TM, Singer CF, Evans DG,
women’s health initiative randomized trials. JAMA.
Lynch HT, Isaacs C, et al. Association of risk-reducing
2013;310(13):1353–68.
surgery in BRCA1 or BRCA2 mutation carriers with
6. Million Women Study Collaborators. Breast can-
cancer risk and mortality. JAMA. 2010;304:967–75.
cer and HRT in the Million Women Study. Lancet.
16. Recommendations on Women’s mid life health and
2003;362:419–27.
menopausal hormone therapy (MHT) in Climacteric.
7. Harman SM, Brinton EA, Cedars M, Lobo R, Manson
2016:19:109–50.
JE, Merriam GR, Miller VM, Naftolin F, Santoro
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N. KEEPS: the Kronos early estrogen prevention
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2007;1(2):2–6.
8. Schierbeck LL, Rejnmark L, Tofteng LC , Stilgren
L, , Eiken P, Mosekilde L, Køber L and Jensen JBE
Long-Acting Reversible
Contraception 59
Raj Mathur and Swati Jha

Access to safe and effective contraception is a
cornerstone of reproductive right and women’s NICE guidance covering the use of LARC (CG30)
health. Long-acting Reversible Contraception was published in 2005 and last updated in 2014
(LARC) methods are an important part of the [1]. It specifically aims at increasing the uptake of
options available to women and their doctors in LARC among women in the UK, by improving
providing good woman-centred care. In contrast professionals’ awareness and ability to offer this
to some other commonly used methods, such as as a choice to women. The guideline stresses the
oral contraceptives and barriers, the effectiveness importance of informed consent and addressing
of LARC does not depend on daily administra- patient preference. As in any other clinical situa-
tion or consistent techniques. tion, guidance on consent is relevant. In women
LARC refers to both hormonal and non- with reduced capacity, the Mental Capacity Act
hormonal methods that require use less frequently and Deprivation of Liberty Safeguards provide
than once every month or every cycle. Methods further guidance for clinicians.
include the copper Intra-uterine device, When prescribing LARCs in teenagers (under
progestagen-releasing intra-uterine system, depot 16 years of age) in the absence of an adult, it is
progestogen and progestogen implant. important to establish they are Gillick competent.
If felt to be Gillick competent, it should be dis-
cussed with the patient whether she has intent to
discuss or inform a trusted adult. If the child is
under 13 and seeking advice about contraception
or sexual activity, the safe guarding lead should
be informed. This should also be discussed with
R. Mathur (*) the child.
Manchester University NHS Foundation Trust, NICE CG30 lays down specific requirements
Manchester, UK for counselling patients, including the provi-
e-mail: rmathur@nhs.net
sion of detailed verbal and written information
S. Jha about contraceptive efficacy, duration of use,
risks and possible side effects, non-contracep-
Sheffield, UK tive benefits, the procedure for initiation and
e-mail: Swati.Jha@sth.nhs.uk removal/discontinuation as well as when to

https://doi.org/10.1007/978-3-319-78683-4_59
326 R. Mathur and S. Jha
seek help while using the method. Healthcare required if re-insertion occurs within 3 years of
professionals advising women on these options first insertion. If pregnancy is not desired imme-
should have the relevant competence, and those diately, contraceptive measures are needed fol-
carrying out insertion of intra-uterine and sub- lowing removal of an implant. Women should be
dermal contraceptives should have specific advised to seek medical help if they cannot feel
training for these. the contraceptive or it appears to have changed
Clinical guidance on specific LARC tech- shape. If the implant is not palpable, alternative
niques has been published by the Faculty of contraception should be advised until the loca-
Sexual and Reproductive Health (FSRH)—Intra- tion has been established. Removal of mis-
Uterine Contraception (IUC) [2], Progestogen- located implants should be carried out by an
only implants [3], Progestogen- only injectable expert, aided by imaging to determine the loca-
contraception [4]. Health professional should be tion of the implant. In the event of pregnancy,
familiar with UK Medical Eligibility Criteria women should be advised removal of the implant
(UKMEC) updated in 2016 [5]. although there is no clear evidence of harm if it is
The need for testing for sexually-transmitted not removed. Women should be informed that
infections should be based on an individual certain medications may reduce the effectiveness
assessment. In asymptomatic women, there is no of the implant and additional contraceptive mea-
requirement to await the results of testing before sures should be used for 28 days after the use of
inserting an intra-uterine device, provided the these medicines.
woman can be contacted and treated promptly in FSRH guidance on the use of Depo Medroxy-
the event of a positive result. The rate of uterine Progesterone Acetate (DMPA) advises that
perforation associated with IUC is up to 2 per women using this method should be reviewed
1000 insertions and is approximately sixfold every 2 years to assess benefits and potential
higher in breastfeeding women. The risk of risks. DMPA use is associated with weight gain,
expulsion with IUC is around 1 in 20 and is most particularly in women under the age of 18 who
common in the first year of use, particularly are obese. Women should be advised to return
within 3 months of insertion. Women should be every 13 weeks for a repeat DMPA injection, but
advised on how to check for threads and, to seek repeat injections can be given up to 14 weeks
medical advice and use alternative methods of apart without the need for additional precau-
contraception if the threads are not palpable. A tions. Following stopping DMPA, unless she
follow-up visit after insertion is not essential, wishes to conceive, the woman should be
provided appropriate information has been advised to use contraception from the date when
provided. her next injection would have been due, even if
The overall risk of ectopic pregnancy is she is still amenorrheic. Women should be
reduced with use of IUC when compared to using advised that fertility may take up to a year to
no contraception, but if pregnancy does occur the return following discontinuation of DMPA,
risk of an ectopic pregnancy is increased. FSRH hence this may not be a suitable method for
guidance states ‘IUC users should be informed women who may wish to start trying for a baby
about symptoms of ectopic pregnancy. The pos- in the near future, particularly if they are older
sibility of ectopic pregnancy should be consid- than their early thirties.
ered in women with an intrauterine method who Both implants and DMPA are associated with
present with abdominal pain especially in con- a reduction in bone density though this is rela-
nection with missed periods or if an amenor- tively small and stabilises after a few years.
rhoeic woman starts bleeding. If a pregnancy test Cessation of use is followed by improvement in
is positive an ultrasound scan is urgently required bone density. Caution is therefore required when
to locate the pregnancy.’ prescribing these in adolescents, women over the
For progestogen-only implants, FSRH guid- age of 40, with other risk factors for osteoporosis
ance states that no additional measures are or planning on using this long term.
59 Long-Acting Reversible Contraception 327
59.3 Reasons for Litigation • She has not had intercourse since last normal
menses.
1. IUC—uterine perforation, insertion of second • She has been correctly and consistently using
IUC with previous one in situ, insertion while a reliable method of contraception.
pregnant, unrecognized expulsion. • She is within the first 7 days of the onset of a
2. Progestogen-only implants—non-insertion, normal menstrual period.
deep insertion, neurovascular injury, adverse • She is not breastfeeding and less than 4 weeks
cosmetic outcome (scarring). from giving birth.
3. Progestogen-only injections—undiagnosed • She is fully or nearly fully breastfeeding,
vaginal bleeding due to unrelated organic amenorrhoeic, and less than 6 months’ post-
pathology, delayed return of fertility. partum. She is within the first 7 days post-
4. All methods—confidentiality, communication abortion or miscarriage.
and consent.
A negative pregnancy test, if available, adds
weight to the exclusion of pregnancy, but only if
59.4 Avoidance of Litigation ≥3 weeks since the last episode of unprotected
sexual intercourse (UPSI). In addition, health
NICE and FSRH guidance offers clinicians a reli- professionals should also consider whether a
able set of principles upon which to base their woman is at risk of becoming pregnant as a result
care. However, not all clinical situations can be of unprotected sexual intercourse within the last
covered by guidance and good clinical judgment 7 days.
and patient information is key. Counselling Ensuring adequate training and continued
should take into account patient preferences and competence is crucial for professionals providing
alternatives informed by evidence and good prac- intra-uterine or subdermal contraceptives. With
tice. Patients should be informed of failure rates, subdermal contraceptives, the introduction of the
risks and complications. Appropriate follow up single rod Nexplanon system is likely to reduce
should be set up. the risk of unrecognized non-insertion.
Adequate clinical records are critical in deliv- Nexplanon is radio-opaque, allowing easier
ering high quality care and handling complaints localization with X-ray. Manufacturer’s instruc-
and may help prevent litigation in the first place. tions on the site of insertion have been modified
The FSRH has developed service standards for to reduce the risk of injury to the neurovascular
record-keeping in contraception [6]. Concordance bundle.
with UKMEC should be recorded, along with Uterine perforation at the time of insertion of
patient consent, offer of chaperone and patient an IUC should be suspected if the inserter or uter-
participation in decision making. The informa- ine sound passes a greater distance into the uterus
tion provided should be recorded, along with than expected. In such a situation, the device
source and date. All letter, referrals and commu- should be withdrawn and the procedure aban-
nication by email, text and other means should be doned. More often, the perforation manifests as
recorded. A note should be made of the preferred pelvic pain persisting a few days after insertion.
mode of communication and any restrictions on IUC threads may not be present in the vagina if
communication. the device has migrated through the myome-
Adequate measures must be taken to exclude trium. An ultrasound scan should be arranged
pregnancy prior to starting any form of without delay, usually in a hospital setting.
LARC. FSRH guidance advises that Health pro- It should not always be assumed that missing
fessionals can be ‘reasonably certain’ that a IUC threads are due to expulsion of the device.
woman is not currently pregnant if any one or An ultrasound scan may show that the device is
more of the following criteria are met and there within the uterus, but the threads are not visible
are no symptoms or signs of pregnancy: due to short length or increased uterine size due
328 R. Mathur and S. Jha
to fibroids. In this situation, removal of the in situ

device is required before inserting a new IUC (or Key Points: LARC
advising another contraceptive method). • LARC refers to both hormonal and non-
hormonal methods that require use less
frequently than once every month or
59.5 Case Study every cycle and include the copper
Intra-uterine device, progestagen-
Case 1: Mrs. Blyth (Blyth vs. Bloomsbury releasing intra-uterine system, depot
Health Authority (1993) 4 Med LR 151) progestogen and progestogen implant.
brought an action of negligence for being pre- • Women considering LARC methods
scribed the depot without being informed of the should receive detailed information-
unpleasant side effects including spotting. This verbal and written to enable them to
was in spite of the patients manifest desire to be choose a method and use it effectively.
informed of these risks. Though there was no • Women should be informed of the effi-
proof that this actually was the case, it was cacy, duration of use, risks and possible
accepted that there had been some miscommu- side effects, non contraceptive benefits,
nication and a nominal pay out was made. the procedure for insertion and removal
Issues surrounding this case relate to consent and when to seek help. Informed con-
and disclosure and in the court of appeal it was sent is essential before fitting.
felt that the standard of disclosure should not be • Pregnancy should always be excluded
any different in cases where the patient has before commencing a LARC.
requested information. • Healthcare professionals should have
Case 2: A patient attended her GP practice adequate training and experience of pro-
to have a coil fitted. Although asked about the viding these methods.
date of her last period her GP failed to enquire • In women with learning difficulties and
whether she had had intercourse since this teenagers under 16, special caution is
date. A Mirena was fitted uneventful. Three required.
months later, the patient experienced heavy
bleeding and was prescribed hormonal treat-
ment to regulate her periods. Wishing a second
opinion the patient attended the walk in centre References
where a pregnancy test was positive. A subse-
1. NICE. Clinical guidance 30 Long-acting reversible
quent scan revealed a 17 week pregnancy. The contraception Published 2005; updated 2014. https://
fetus was abnormal and she went on to have a www.nice.org.uk/guidance/cg30.
termination. 2. FSRH. Clinical guidance: intrauterine contraception;
2015. file:///C:/Users/cumul/Downloads/ceuguidan-
There was a failure to follow national guide- ceintrauterinecontraception.pdf.
lines for fitting and was therefore felt to be negli- 3. FSRH. Clinical guidance: progestogen-only implants;
gent. The coil should have been fitted within 2014. file:///C:/Users/cumul/Downloads/cec-ceu-
7 days of the onset of menstruation or the possi- guidance-implants-feb-2014.pdf.
4. FSRH. Clinical guidance: progestogen-only
bility of pregnancy should have been excluded. injectable contraception; 2014. https://www.
Though the patient conceded that she would still fsrh.org/standards-and-guidance/documents/
have undergone a termination had the pregnancy cec-ceu-guidance-injectables-dec-2014/.
been diagnosed prior to the fitting of the coil, this 5. https://www.fsrh.org/standards-and-guidance/
external/ukmec-2016-digital-version/.
would have been less traumatic and avoided the 6. FSRH. Clinical standards record keeping; 2014. https://
discomfort, anxiety and bleeding caused by the www.fsrh.org/standards-and-guidance/documents/
Coil being fitted when pregnant. The patient clinical-standards-recordkeeping-july14/.
reported the doctor to the GMC and received a
pay out of £10,000.
Sterilisation
60
Janesh K. Gupta
60.1 Background There should be clear, contemporaneous doc-

umentation within the medical records and a pre-
Female sterilisation was one of the commonest operative check list should be completed with
procedures carried out in the UK but there has written consent obtained. This should include
been a decline over the past decade due to appropriate medical history and any clinical
increased use of alternative contraceptives e.g. examination. The records should document the
long acting reversible contraception (LARC). discussion that took place, requests made by
Female sterilisation is a permanent, non-revers- the individual and any information provided.
ible procedure. Therefore, patients need to be The reason for the sterilisation should be
certain that they have been counselled appropri- documented.
ately before undergoing such a procedure. There Legal advice should be sought if there is any
is now only one main type of female sterilisation: doubt as to whether a person has the mental
Filshie clip laparoscopic sterilisation. The previ- capacity to consent to a procedure that will per-
ous availability of the Essure hysteroscopic ster- manently remove their fertility.
ilisation procedure has now been withdrawn from Counselling for the permanency of the proce-
the UK market as of September 2017. dure and lifetime failure rate of 1:200, with a pos-
sibly increased failure risk if the sterilisation is
performed in the postpartum or post abortion
60.2 Minimal Standards period. In the postpartum period, the use of
and Clinical Governance Filshie clip and modified Pomeroy technique are
Issues equally effective except that Filshie clip applica-
tion is quicker to perform. Mechanical occlusion
Guidance on standards for female sterilisation using the Filshie clip should be the method of
have been issued by the RCOG and Clinical choice for laparoscopic tubal occlusion.
Effectiveness Unit (CEU) of the Faculty of Sexual Alternatives for permanent methods of sterili-
& Reproductive Healthcare (FSRH) [1–3]. sation should be discussed e.g. Mirena coil and/
or vasectomy. Women should be informed that
some of these procedures have a lower failure
J. K. Gupta rate (vasectomy), whereas others such as long-
acting reversible contraceptives (which include
Birmingham, UK injections, intrauterine devices (IUDs) and sub-
e-mail: j.k.gupta@bham.ac.uk dermal contraceptive implants) have a similar

https://doi.org/10.1007/978-3-319-78683-4_60
330 J. K. Gupta
failure rate and confer additional benefits related the fallopian tube. Steri-Shot™ disposable
to menstrual cycles. Filshie clip applicators should now be used in
There are few situations which preclude a preference to the older applicators that required
sterilisation but greater precautions are needed in maintenance on a yearly basis or every 100 appli-
women on anticoagulation therapy, cardiovascu- cations. The new disposable applicators have
lar disease, previous abdominal surgery and in removed the need to ensure that correct pressure
those who are obese. For a hysteroscopic sterili- closes and locks the Filshie clip. The Filshie clip
sation, nickel allergy would be a contraindica- should only be applied after identification of the
tion. Higher regret rate are known to occur if fimbrial end of the fallopian tube so that the cor-
sterilisation is performed in under 30 year olds, rect structure is occluded. Filshie clip should be
in nulliparous women, following a recent preg- applied slowly without tearing the fallopian
nancy or in women who have relationship issues. tubes, as this can result in a subsequent tubo-tubo
When sterilisation is performed during a fistula.
Caesarean section, counselling and consent Common mistakes are applying the Filshie
should be given at least 2 weeks in advance of the clip to the wrong structure i.e. the round liga-
procedure. ment. Photographs should be taken post proce-
It would be routine to provide a current valid dure for good clinical practice. The routine use of
written patient information leaflet, that includes more than one Filshie clip on each fallopian tube
operative risks from laparoscopy, that could lead is not recommended.
to a laparotomy, particularly if there are co- The use of other methods such as electrocau-
existing risks e.g. obesity or prior abdominal tery, Hulka, fallope rings should not be used as
surgery. the failure rates are much higher than the 2–3:
Assessment pre-operatively should include 1000 associated with the Filshie clip method.
routine use of pregnancy test, record of last Post procedure contraception should be con-
menstrual period, use of contraception during tinued preferably until the next menstrual period
the cycle. Tubal occlusion can be performed at starts. Removing a coil during the sterilisation
any time during the menstrual cycle as long as may inadvertently result in unintended pregnancy
the woman has used an effective method of con- if ovulation has occurred prior to the procedure
traception up to the day of the procedure. and a blastocyst has already passed the site of the
However, a luteal phase pregnancy cannot be tubal occlusion.
excluded with a negative pregnancy test hence
the importance of emphasising the use of con-
traceptive in the cycle that the sterilisation is 60.2.1 Specific Additional Aspects
performed. for Hysteroscopic Sterilisation
The procedure should be performed by an
experienced surgeon undertaking at least 25 pro- This procedure can be carried out without any
cedures per year. anaesthesia. Local anaesthesia may be used if
The laparoscopic tubal occlusion should be there is difficulty in passing the hysteroscope
with the use of a Filshie clip applied at the thin- through the cervix.
nest part of the fallopian tube i.e. at the isthmus Specific consent requires that contraception
level of the fallopian tube. It should be applied should be used for an additional 3 months until
perpendicular to the fallopian tube and the clip tubal occlusion has been confirmed by ultrasound
should be applied to fully envelope the fallopian scan or hysterosalpingogram. The latter is used if
tube without leaving a knuckle of fallopian tube. there was a difficulty in placing the Essure
This can be assured by having the ante-mesenteric devices. Counselling should also include the fail-
border of the fallopian tube sit at the level of the ure of placement of the second device in up to
hinge with no obvious gap between the hinge and 0–19% of cases, whereby an additional method
60 Sterilisation 331
may be required i.e. a repeat attempt for hystero- • Litigation occurs when the wrong structure
scopic sterilisation or undergoing a laparoscopic has been occluded e.g. round ligament rather
sterilisation procedure. than the fallopian tube. There is evidence that
Women who do not attend for confirmatory failure that occurs within 12 months of laparo-
tubal occlusion testing should continue using a scopic tubal occlusion this is likely to be due
reliable form of contraception. Essure is as effec- to operator error rather than a non-negligent
tive as laparoscopic tubal occlusion with a failure tubo-tubo fistula [8].
rate of approximately 1:200.
There is evidence that there is a 6–10 times
more likely increased risk of operative interven- 60.4 Avoidance of Litigation
tion within one year of Essure sterilisation pro-
cedures [4–6]. Around 2% of women within one It is important to follow the principles set out in
year require alternative methods of sterilisation the checklists given above for each type of sterili-
because of the inability to place the devices, sation method.
have the devices removed because of incorrect Adequate documentation of the reasons for
placement or due to symptoms causing pel- the sterilisation as well as the permanency of the
vic pain (https://www.fsrh.org/documents/fsrh- procedure, its alternatives, failure, ectopic preg-
statementessurebmj/fsrhstatementessurebmj. nancy and risks associated with the actual
pdf). procedure need to be clearly documented.

As a result of the continued debate regarding Contraceptive advice leading up to and follow-
the safety of the Essure method [7], the Essure ing the procedure must be given. Due care and
method has now been withdrawn from the UK diligence when performing the procedure should
market. However, patients who have already be taken to avoid failure. When a laparoscopic
had these devices fitted may present to clini- procedure is undertaken the fimbrial end of the
cians in the coming years and request them to tube should be identified before application of
be removed. the Filshie clip which should be placed over the
Late failures resulting in a pregnancy can isthmic (thinnest) portion of the tube to ensure
occur at any time after tubal occlusion with both complete tubal occlusion. When a hysteroscopic
methods. There is a higher risk of ectopic preg- procedure is performed additional counselling
nancy when failures occur. When a pregnancy should include the need for contraception fol-
occurs while an individual is on a waiting list for lowing the procedure and until confirmation of
sterilisation they should be offered further coun- tubal occlusion as well as the higher re-opera-
selling about future contraceptive choices due to tion rate in the first year.
change in their circumstances. Female sterilisation still represents a good
method for permanent contraception but patient
counselling and up to date written information is
60.3 Reasons for Litigation important to avoid litigation in the future.
The main reasons for litigation in cases of female

sterilisation relate to: 60.5 Case Study
• Counselling A 27-year-old woman with 3 normal vaginal

• Patient pregnant at the time of sterilisation deliveries was sterilised with placement of two
(luteal phase pregnancy) Filshie clips on the right fallopian tube and one
• Procedure related complications on the left. She had been appropriately coun-
• Post-operative care selled and the appropriate consent was taken.
• Failure During the application of the first Flishie clip
332 J. K. Gupta
application to the right fallopian tube, the pneu-

moperitoneum was not maintained and there- • Counselling of permanency, failure, alter-
fore a second Filshie clip was applied. She was natives, risks, complications and regret.
found to be pregnant 14 months later and deliv- • Contraceptive advice before and after the
ered a healthy baby. The photographs taken at procedure depending on the procedure
the time of sterilisation indicated that both of undertaken.
the right fallopian tube Filshie clips were • Due diligence when performing the pro-
applied distal to the isthmus i.e. beyond the cedure to avoid failure.
thinnest part of the fallopian tube. It is likely
that the occlusion was not complete with an
obvious gap between the fallopian tube and the
hinge of the Filshie clip indicating that there References
was likely to be a knuckle of tube left unoc-
cluded. The left Filshie clip was appropriately 1. Faculty of Sexual and Reproductive Healthcare
applied. (FSRH) Clinical Effectiveness Unit guideline. Male
and female sterilisation; 2014. http://www.fsrh.org/
Ultimately identification of the failure can pdfs/MaleFemaleSterilisationSummary.pdf.
only be determined by removal of both fallo- 2. NICE Clinical Knowledge Summaries.
pian tubes to assess histologically for the rea- Contraception – sterilisation. https://cks.nice.org.uk/
sons of failure and to complete the sterilisation contraception-sterilization#!scenario:1.
3. Varma R, Gupta JK. Failed sterilisation - evidence-
effect. based review and medico-legal ramifications. BJOG.
2004;111:1322–32.
4. Antoun L, Smith P, Gupta JK, Clark TJ. The feasibil-
ity, safety, and effectiveness of hysteroscopic steril-
ization compared with laparoscopic sterilization. Am
J Obstet Gynecol. 2017;217(5):570.e1–6. https://doi.
Key Points: Sterilisation org/10.1016/j.ajog.2017.07.011. pii: S0002-9378(17)
• There are two main methods for female 30853-0.
sterilisation: laparoscopic by Filshie 5. Mao J, Pfeifer S, Schlegel P, Sedrakyan A. Safety and
efficacy of hysteroscopic sterilization compared with
clips (usually by general anaesthesia) laparoscopic sterilization: an observational cohort
and hysteroscopic using Essure (outpa- study. BMJ. 2015;351:h5162.
tient under local anaesthesia). The latter 6. Perkins RB, Morgan JR, Awosogba TP, Ramanadhan
is now withdrawn from the UK marker S, Paasche-Orlow MK. Gynecologic Outcomes
After Hysteroscopic and Laparoscopic Sterilization
as of September 2017. Procedures. Obstet Gynecol. 2016;128(4):843–52.
• Essure hysteroscopic methods are asso- 7. Dhruva SS, Ross JS, Gariepy AM. Revisiting essure -
ciated with a higher re-operation rate in toward safe and effective sterilization. N Engl J Med.
the first year. 2015;373:e17.
8. Varma R, Gupta JK. Predicting negligence in female
• Clear, contemporaneous documentation sterilization failure using time interval to steriliza-
and a valid consent should be obtained. tion failure: analysis of 131 cases. Hum Reprod.
2007;22:2437–244.
Part VII
Oncology
Swati Jha and John Murdoch
Fast Track Referrals and GP
Perspectives 61
Rahul Kacker
61.1 Background have acquired the necessary knowledge skills and

through numerous patient contacts developed the
In providing clinical care from “cradle to grave” experience.
General practitioners are presented, in the para-
digm of Obstetrics, from pre-conception to the
postpartum and Gynaecological conditions from 61.2 Minimum Standards
menarche to post menopause. Unlike a hospital and Clinical Governance
clinic, patients present to a General Practice sur- Issues
gery, in an undifferentiated way, that is to say
with symptoms that often have differential diag- To improve care and cancerous disease detection
noses rather than a specific disease entity. General NICE introduce the “Fast track referral system”.
practitioners therefore manage symptoms not This, by active practicising GPs, is better known
only across a woman’s life span but also across as the “2 week wait referral” (2ww) after the time
the entire reproductive tract. Some GPs have just within which the patient much be seen by the rel-
a basic working knowledge the basis of which evant Consultant. Review of the publication will
may have been their Undergraduate studies only show that there are specific symptoms in specific
whereas others may have worked in a hospital age groups of women that on their own, necessi-
post as part of their Vocational training and may tate a “2ww”: this is a common notation seen
or may not, have taken the a Post graduate exam when reviewing computerised GP records [1].
in the field (The Diploma of the Royal College of The outcome is unpredictable and, that this pro-
Obstetricians & Gynaecologists i.e. (DRCOG)). cess although well established in contemporary
Yet others may had more specialist training in practice has not significantly improved gynaeco-
Obstetrics and Gynaecology and been awarded logical cancer rates is out of the scope of this
the MRCOG before changing career paths to publication, but knowledge that the process exists
become a General Practitioner, and some may be is empirical for both GPs managing such patients
General practitioners with special interests and medico-legal experts acting for either the
(GPwSI) with or without formal qualification but Plaintiff or Defendant. Borne out of the prevail-
ing austerity, and aside from the “cancer 2-week-
wait referrals” are the local guidelines for the
R. Kacker
management of women’ health symptoms. The
GP Medical Reports Limited Company,
Sheffield, South Yorkshire, UK purpose of these are to optimise the management
e-mail: rahul@kacker.co.uk by the General Practitioner of a symptom and if

https://doi.org/10.1007/978-3-319-78683-4_61
336 R. Kacker
the symptom does not improve only then to refer understand the care the patients have been given.
to secondary care. The authors of these are usu- Medical records provide the basis for future care
ally CCG GPs in collaboration with local and are the main way to share information with
Consultants, usually based on NICE guidance for other members of the practice team who may be
that conditions but refined and made more spe- providing care for a patient. Records of consulta-
cific in the knowledge of what investigations can tions should include the presenting problems,
and cannot be accessed by GPs locally. In results of relevant examinations or investigations
addressing Standards and Governance, attention undertaken, and an indication of the management
is drawn to when a GP does not manage a patient plan, including expressed patient wishes.” This
within the guidelines: but reflection and thought provides a recognised and authoritative bench
is called for they are after just that “guide”-lines mark against which the GPs records of the con-
not tramlines. Here the “art” of General Practice sultations regarding the care given will be mea-
comes to the fore. sured. In claims of negligence, not only is the
standard of care called into question so is the
standard of note keeping, To mitigate against liti-
61.3 Reasons for Litigation gation keeping records as described above is the
necessary goal and therein lies the challenge to
Common reasons for Litigation include: General Practitioners when a patient presents
with an undifferentiated women’s health symp-
• Missed diagnosis or a delay in referral. This is tom as opposed to a definitive diagnosis. A
usually due to a failure to investigate appropri- defence Expert and the legal team’s role will be
ately for persistent or frequent symptoms. greatly facilitated and more robust if notes are
• Failure to identify the criteria for referral as written to the standard described above, indeed,
stipulated in NICE Guidelines 12 (NG12) [1]. notes of the quality described above may even
• Failure to make patients aware of what to thwart any potential action by the claimant at the
expect in the referral pathway and how soon to screening stage.
expect a hospital appointment. Having detailed why the notes are as impor-
• Failure to document discussions with the tant as described, we turn now to suggest how the
patient about the reasons for the referral and notes could be structured to meet this description.
the advice provided. One suggested method is that the clinician having
• When a patient is not referred immediately, documented the presenting symptom or symp-
failure to schedule either a further review or in toms, then, ideally, asks and then documents all
what circumstances they need to seek further the positive and negative associated symptoms in
advice. the history of the presenting complaint. Asking
• Failure to ensure systems are in place to fol- and documenting of a familial history of wom-
low up investigation results. Where the en’s health illness in particular cancers and or the
requesting physician is unable to do so, this fact that they were screened for this, might prove
should be delegated appropriately. a powerful piece of evidence, should ones care be
questioned. Asking and then documenting the
patients thoughts and then later in the notes under
61.4 Avoidance of Litigation diagnosis or plan, addressing these, with a clini-
cal justification, also could proves helpful to
The Claimants Expert may be instructed to opine one’s Defence team. As can be seen form the
justifiably on what the standard of note-keeping description form Good Medical Practice there is
in the case being deliberated is thought to be. The no set method, the method suggested here is but
RCGP Good Medical Practice may well be cited one and is easy to reproduce day-in day-out, but
and or used to benchmark the standard of record the failure to ask, or least documents this infor-
keeping This state’s “documents should enable mation might p rovide the chink that can be made
you, other doctors and other clinical staff to a chiasm by the Claimants team:, on the other end
61 Fast Track Referrals and GP Perspectives 337
its presence may make the negligence claim –– In any woman over 50 years of age, if she
untenable: two sides of the same coin. has had:
Timely referral of suspicious gynaecological Symptoms suggestive of irritable bowel
symptoms should avoid litigation. To achieve this syndrome (IBS) within the last
knowledge of the current guidelines is needed. 12 months.
With the breadth and pace of the advancement of • Consider the possibility of ovarian cancer and
knowledge across the specialities that make up consider carrying out tests in any woman who
Clinical Medicine lies the challenge to keep up to reports any of the following unexplained
date. This is especially challenging as female symptoms:
patients often self select, where one is available, –– Weight loss.
female doctors therein over time serruptiously –– Malaise or fatigue.
deskilling male General Practitioners. It is impor- –– Change in bowel habit.
tant to ensure one is practising contemporarily by • Other symptoms of ovarian cancer that may be
using appropriate investigations, treatments and present include:
ensuring timely referral is best achieved and –– Abnormal or postmenopausal bleeding.
maintained. By identifying their Educational –– Gastrointestinal symptoms such as dyspep-
Needs and then by reading and documenting that sia, nausea, or bowel obstruction.
these have been addressed in the annual appraisal –– Shortness of breath (due to pleural
process, GPs demonstrate they are up-to-date effusion).
with the latest guidance. A more immediate way
of addressing a patient’s clinical need is triangu- A General practitioner will recognise that
lation with other General Practice Colleagues in these symptoms do not often present as such a
the practice and documentation there of as to clear cut constellation of symptoms, if they did;
“what would you do … in this case” might offer it would be more likely than not that the condi-
some mitigation should the care ever be tion was very advanced, perhaps incurable. The
scrutinised. General practitioner is faced with a plethora of
NICE or in the Consultation Room the readily symptoms but the favourable safeguard for the
accessible CKS: Clinical Knowledge Summaries GP, in this guidance, is the presence of defini-
(https://cks.nice.org.uk) are accessible and tion of “frequent” but this is countered by the
arranged alphabetically. Most of the letters have absence of a definition of “persistent”. The pur-
at least one women’s health related condition. In pose of citing this often emotional illness is to
an attempt to improve Cancer detection rates the highlight that the “guidelines” are not bespoke
threshold of the specificity of a symptom war- but can be used to challenge and question care
ranting a “2ww” was reduced from 5 to 3% and and it is only good record keeping justifying an
hence a GP faces the following guidance on, to action not to refer in the presence of such
take one example, When to suspect Ovarian symptoms.
Cancers (https://cks.nice.org.uk/ovarian-cancer): Given the nature of this specialty then the
role of Chaperones is a chapter in itself. In
• Suspect ovarian cancer and carry out tests: General practice, whether a chaperone is
–– In any woman (particularly if over 50 years offered or not should be documented, and
of age), if any of the following symptoms where one is refused this should also should be
are persistent or frequent (particularly documented.
more than 12 times per month):
Abdominal distension (bloating).
Feeling full (early satiety) or loss of appe- 61.5 Case Study
tite, or both.
Pelvic or abdominal pain. Mrs. A consulted her GP and was the last patient
Increased urinary urgency or frequency, or on the list on a Friday afternoon. She was known
both. to suffer Irritable Bowel syndrome and was
338 R. Kacker
worsened by stress. She accepted that she was

struggling to manage the multiple pressures she Key Points: Fast Track Referrals and GP
was under both on the domestic front and her Perspectives
professional life. During the examination she • Note keeping: notes documenting the
was noted to have abdominal tenderness but no presence or absence of relevant symp-
palpable masses. The GP asked her to return for toms and signs.
a blood test (Ca125) the next week, but advised • Ensure knowledge of investigations and
that the IBS was the probable cause of her symp- treatments are up to date and
toms. He advised her to contact one of the other contemporary.
doctors regarding her results. • GPs should be familiar with investigations
When she was not contacted by the GP prac- that should be done in primary care and
tice she assumed that the pain was indeed IBS indications for referral through the 2ww.
related. She returned three and a half months • When a GP suspects a diagnosis of
later to the practice to see a doctor for fatigue, Cancer this should be discussed with the
increased abdominal swelling and worsening patient and documented in the notes.
pain. She was found to have significant ascites • There should be systems in place to fol-
and it was recognised that the Ca125 though per- low up investigation results.
formed, the results had not been received. The • When patients are not being referred for
laboratory confirmed this was significantly raised non-specific symptoms, systems should
and an urgent referral made to gynaecology. Mrs. be in place to ensure these resolve and
A underwent a staging laparotomy and was diag- adequate follow up arrangements made
nosed with advanced Ovarian cancer with a poor or the patient advised of subsequent
prognosis. steps if symptoms persist.
The learning points included the lack of a
robust system to follow up test results. It was
also identified that though the GP Mrs. A saw
initially had concerns about ovarian cancer, he Reference
failed to relay these concerns to the patient
1. Suspected cancer: recognition and referral. NICE
and failed to put systems in place for her fol- guidelines (NG12); 2015.
low up.
The case was settled with a modest payout.
Running a Safe Rapid Access Clinic
62
Vivek Nama
62.1 Background disciplinary team (MDT) meetings, adhering to

national cancer waiting time targets and per-
The last decade has seen a change in the provi- forming audits. Delayed diagnosis is the single
sion of cancer services in the NHS. Previous most important factor responsible for poor sur-
reports have highlighted poorer survival out- vival rates in the UK. Therefore, meeting can-
comes in the UK compared to other European cer waiting times is a priority for rapid access
nations [1]. Delayed diagnosis and poorly coordi- clinics.
nated services are noted as significant contribut- The data generated is required to be entered in
ing factors. As a result, there is a restructuring of the National Cancer Waiting Times Monitoring
cancer services aiming for closer collaboration Data Set Overview databases. Trusts are required
between primary care, local cancer units and to submit these data within 25 working days of
regional cancer centres. This is facilitated by a 2 the month. Findings are used to evaluate the per-
week rule which states that all patients with sus- formance of local units, highlighting areas of
pected cancer referred by the GP on the urgent improvement to meet clinical standards.
referral pathway must be seen within 2 weeks of It is also mandatory for local cancer units to
the referral and a further 2 weeks to arrive at a hold regular MDT meetings attended by the
diagnosis. A further limit of 4 weeks is set to pro- named gynaecology lead, radiologist and a histo-
vide treatment. pathologist. The gynaecology lead is also respon-
sible for attending the MDT at the regional cancer
centre where all newly diagnosed cancer cases
62.2 Minimum Standards are discussed and management plans formulated.
and Clinical Governance Centralisation, specialisation and MDT input
Issues have minimised variations in clinical practice.
However, it is vital that all experts are present
There are increasing calls for the NHS to be during discussions as this can influence decisions
accountable for the quality of care and services regarding management leading to recommenda-
rendered. Safe delivery of services includes tions for the core member team.
participation in activities such as multi- Referrals to RAC clinic often fall into five cat-
egories: postmenopausal bleeding, suspected
ovarian, cervical, vulval or endometrial cancer.
V. Nama
Croydon University Hospital, London, UK Standardised forms allow a broader category
e-mail: Vivek.Nama@nhs.net ‘other’ to include non-specific concerns.

https://doi.org/10.1007/978-3-319-78683-4_62
340 V. Nama
62.2.1 Postmenopausal Bleeding based protocol that is currently proposed by the

and Pitfalls RCOG [3, 5].
Magnetic resonance imaging (MRI) may be
Postmenopausal bleeding (PMB) warrants an used as an adjunct imaging modality when the
urgent referral to gynaecological services and initial ultrasound characterisation of an adnexal
occurs in 10% of women over the age of 55. The mass as benign or malignant is inconclusive. A
risk of endometrial cancer in those presenting recent meta-analysis found that the sensitivity
with PMB is approximately 10% [2]. and specificity of MRI for correct detection of
An accepted protocol for managing women malignancy may reach 92 and 88%, respec-
with postmenopausal bleeding include clinical tively [6].
assessment, ultrasound to delineate endome-
trial thickness, opportunistic adnexal scanning,
endometrial biopsy if the endometrial thick- 62.2.3 Suspected Cervical Cancer
ness was more than 4 mm and hysteroscopy if
the ultrasound raised the possibility of a focal Patients with persistent post coital bleeding or
lesion. intermenstrual bleeding are often referred as sus-
picious of cervical cancer. In the presence of a
normal smear that is adequately performed,
62.2.2 Ovarian Cancer and Pitfalls including an endobrush the incidence of cervical
cancer is very low. Persistent symptoms, how-
The National guidance recommends the use ever, warrant a colposcopy unless there is another
the risk of Malignancy Index (RMI) to charac- cause found for these symptoms.
terise adnexal masses as low (RMI < 25), The incidence of cervical cancer is higher in
moderate (25–250), or high (above >250) risk patients who present with postmenopausal bleed-
of ovarian cancer [3]. RMI is calculated ing and have a thin endometrium. Smear history
according to menopausal status, CA 125 and is crucial, and an update smear test is indicated in
transvaginal ultrasound features. CA 125 lev- this group of patients.
els require careful interpretation as they can The safe and effective running of an urgent
be non-specific. Levels are raised in heart fail- suspected cancer referral also involves providing
ure, liver cirrhosis and non- gynaecological adequate information about the service, investi-
malignancies. Additionally, they are only gations involved and a specialist nurse to provide
increased in 50% of stage one epithelial ovar- support for anxious patients. Many units have a
ian cancers. The overall sensitivity of this patient liaison officer, who helps patients with
algorithm for diagnosing all borderline, inva- their appointments and answers queries. This is
sive ovarian, or primary peritoneal lesions was crucial to keep the patient informed and avoid
87.4%, and the positive predictive value was complaints.
86.8 [4].
Other models such as the International
Ovarian Tumour Analysis (IOTA) group col- 62.3 Reasons For Litigation
lected a large database of women with an
adnexal mass and developed logistic regression Postmenopausal bleeding:
models to calculate the risk of malignancy in
adnexal masses using clinical information and 1. Failure to investigate recurrent postmeno-

features derived from ultrasonography [5]. A pausal bleeding despite normal ultrasound.
meta-analysis conducted demonstrated that a 2. Decision based on biopsy from a polyp rather
management protocol based on triaging women than polypectomy.
using the IOTA logistic regression model LR2 3. Failure to discuss alternatives, including doing
performs significantly better than the RMI- nothing for complex medical patients.
62 Running a Safe Rapid Access Clinic 341
4. Failure to recognize a fibroid polyp which has risk factors before discharging both symptom-
undergone sarcomatous change in the post- atic and asymptomatic patients without endo-
menopausal group and not arranging immedi- metrial biopsy [8].
ate surgery or investigations.
Ovarian cysts: 62.4.2 Transvaginal Ultrasound

(TVS)
1. Failure to discuss complex ovarian cyst in

MDT. TVS is the first line investigation to determine the
2. Rupturing of the cyst during surgery, convert- endometrial thickness (ET) and to rule out focal
ing the staging to Ic. pathology. The endometrial thickness is subse-
3. Failure to arrange appropriate follow up for quently used to recommend further investigations
complex ovarian cyst with normal CA 125. such as outpatient endometrial sampling or hys-
4. Failure to evaluate un explained CA 125. teroscopy and biopsy.
Vulval cancer:
62.4.3 Endometrial Thickness
1 . Failure to recognize vulval cancer.
2. Failure to refer for ongoing long standing vul- Various units across the UK will implement val-
val symptoms. ues between 3 and 5 mm. Values of >3 mm have
3. Excision of vulva cancer with inadequate
a sensitivity of 98% and specificity of 0.6%, an
margins by a benign gynaecologist, which ET > 5 mm has a sensitivity of 90% and specific-
needs further excision and sentinel node ity of 1% [9]. Wong et al. [10] showed that the
assessment, which is not proven by sensitivity for 3-, 4-, and 5-mm cut-offs were
evidence. 97.0% (95% CI 94.5–99.6%), 94.1% (95% CI
90.5–97.6%), and 93.5% (95% CI 89.7–97.2%),
Cervical cancer: respectively. The corresponding estimates of
specificity at these thresholds were 45.3% (95%
1. Failure to refer persistent intermenstrual or CI 43.8–46.8%), 66.8% (65.4–68.2%), and
postcoital bleeding in young women. 74.0% (72.7–75.4%). Both these studies suggest
2. Hysterectomy for cervical cancer without
using 3 mm as the cut off for screening endome-
appropriate preoperative staging. trial cancers.
62.4 Avoidance of Litigation 62.4.4 Tamoxifen
62.4.1 Clinical Assessment Women using Tamoxifen have a risk of 10% of

endometrial cancer. Transvaginal ultrasound is
Many care providers ignore this aspect of the poor at differentiating between a thickened
evaluation. With the cancer services under pres- endometrium secondary to endometrial cancer
sure, there is an increasing drive to move or long-term Tamoxifen use. Typically, tamoxi-
straight to test. But with post-menopausal fen associated thickened endometrium has cys-
bleeding age and other risk factors for endome- tic spaces [11] on USS and using just endometrial
trial cancer like obesity, hypertension, hormone thickness becomes unreliable. Therefore,
replacement therapy usage [7] play a role. women on Tamoxifen presenting with a PMB
Though the models of prediction have a poor will require a hysteroscopy and biopsy as a first-
positive predictive value and an excellent nega- line investigation to exclude endometrial pathol-
tive predictive value [7] it is worth noting the ogy. However, there is no evidence to suggest
342 V. Nama
annual scans in patients on tamoxifen improve error in detecting abnormal endometrial lesions
outcomes [12]. [15]. Endometrial hyperplasia accounts for
10–15% of postmenopausal bleeding and can
occur as focal lesions or diffusely within the
62.4.5 Hormone Replacement endometrium. Diagnosis can be difficult during
Therapy (HRT) hysteroscopy as fluid distension compresses the
endometrium therefore discerning projections of
Bleeding within the first months of using contin- hyperplastic tissue are difficult.
uous HRT does not need any investigations. An
ultrasound performed after 6 months, a 4 mm cut
off for endometrial thickness is appropriate. This 62.4.8 Recurrent Post-Menopausal
increases the sensitivity but decreases the speci- Bleeding
ficity [13].
An episode of postmenopausal bleeding with an
endometrium of less than 4 mm, still increases
62.4.6 Endometrial Biopsy the risk of endometrial cancer in the first four
years [16] and many suggest a repeat USS in
Thick Endometrium with no focal lesion: In the 6 months to identify an increasing thickness.
presence of thick endometrium and an absence of Repeated negative biopsies of the endometrium
focal lesion, outpatient based endometrial biop- should warrant a hysterectomy as recurrent PMB
sies are sufficient. Various devices are compared, raises the possibility of endometrial cancer
and a pipelle aspirator seems to have the maxi- though the incidence is less than patients with the
mum sampling rate. However, there is a 7% risk first episode of PMB [17].
of inadequate sampling [14] with such methods.
Women with an inadequate sample, or who
remain symptomatic despite previous normal 62.4.9 Asymptomatic Women
sampling require a hysteroscopy and directed with Thickened Endometrium
biopsy for further evaluation.
Thick endometrium with focal lesions/ endo- There is no consensus in the management of
metrium not visible will need hysteroscopy and women with incidental thick endometrium in the
directed biopsy. Minimal evidence suggests that absence of symptoms. Poorly conducted studies
if the endometrium is not visualized there is a have suggested that a cut off of 11 mm be used
higher chance of malignancy. [18, 19]. Smith-Bindman showed that an ET of
Fluid in the cavity: An ultrasound report >11 mm would give an estimated risk of cancer
should mention, the echogenicity of the fluid. of 6.7% and if less than 11 mm an estimated risk
If the fluid is echogenic, an endometrial biopsy of 0.002% [20]. UKCTOCS divided the endome-
is indicated. If the fluid is clear could be trium into quartiles based on known risk factors
excluded before calculating the endometrial and defined high-risk as 6.75 mm [21]. Hence
thickness. consideration of risk factors rather than the thick-
ness of the endometrium is essential before
advising biopsy in asymptomatic women.
62.4.7 Office Hysteroscopy
OPH is indicated in the presences of a thick 62.4.10 Unexplained Raised CA 125

endometrium with a possibility of a focal lesion
or if the is endometrium not visualised clearly. There is no management protocol at present for
Hysteroscopic assessment enables visualisation post-menopausal women with an unexplained
of the uterine cavity. However, there is a reported rise in CA 125 level. Data from the Prostate,
2–4% false-negative rate secondary to operator Lung, Colorectal, and Ovarian Cancer Screening
62 Running a Safe Rapid Access Clinic 343
Randomised Controlled (PLCO) Trial indicated direct harm to the patient, the clinician did not
that approximately 3% of postmenopausal follow the usual standard of care. Ideally, she
women were found to have an abnormal CA 125 would have had a biopsy, which would have con-
level in the absence of ovarian cancer. Results firmed the sarcoma. If the staging CT showed
indicated that patients had a significantly higher metastasis, she wouldn’t have had a hysterec-
mortality than patients with all normal CA 125 tomy. Fortunately, the staging CT showed no
levels (p < 0.0001). This increased risk extended metastasis. Peer review recommendation is that a
throughout the follow-up period. Analysis of person who is part of the MDT and participates in
cause of death showed an excess mortality attrib- peer review process operates all cancers. The
utable to lung cancer, digestive disease, and patient was also given the diagnosis without con-
endocrine, nutritional, and metabolic disease. firming the histology at the MDT and in the
Evaluation of false positive screening test was absence of the gyn oncology specialist nurse,
associated with complications of 15% [22]. which is also a recommendation, by the NCRI.
Therefore, an elevated CA 125 in a menopausal
female without ovarian cancer should be regarded
with concern. These individuals appeared to be at
risk for premature mortality and continued health Key Points: Running a Safe Rapid
surveillance would appear prudent [23]. Access Clinic
• There should be clear pathways for
referral of women into the Rapid Access
62.5 Case Study Clinic (RAC).
• In women with PMB who do not
62.5.1 Case Study 1 (Direct Harm) undergo a biopsy, risk factor assessment
plays an important role.
A 69-year-old lady, presented with PMB. USS • With recurrent PMB and negative biopsy
showed an endometrial polyp and a complex a hysteroscopy should be considered.
ovarian cyst. CA 125 was 39. She went for an • Bleeding within the first few months of
outpatient hysteroscopy and as the polypec- HRT use does not need investigation,
tomy was not successful, was posted for polyp- however if problems persist an USS is
ectomy and BSO. RMI was calculated to be 351 recommended.
(39x3x3). She underwent a polypectomy and • There is no consensus to the manage-
Bilateral Salpingoopherectomy. Intraoperative ment of women with a thickened endo-
spillage occurred as the surgeon punctured the metrium in asymptomatic women, and
cyst to aid removal. The doctor did not perform units will have local guidelines in
either an omental biopsy nor peritoneal wash- place.
ings. Final histology turned out to be a high- • Post menopausal women with raised
grade serous cancer. She needed to have another CA 125 but no ovarian cancer should be
staging laparoscopy and chemotherapy. investigated to rule out malignancy
elsewhere.
62.5.2 Case Study 2 (No Direct Harm,

but Substandard Care)
References
A 59-year-old referred with postmenopausal
bleeding to the 2WW clinic. Outpatient hysteros- 1. Publication of Cancer Reform Strategy, In: Health
copy showed a large necrotic submucous fibroid. Do. London; 2007.
2. SIGN. Investigation of post-menopausal bleeding;
She had a hysterectomy performed without 2002.
biopsy of the polyp. The final histology turned 3. RCOG. Management of suspected ovarian masses in
out to be a uterine sarcoma. Though there was no premenopausal women; 2011.
344 V. Nama
4. Bailey J, Tailor A, Naik R, Lopes A, Godfrey K, 13. Epstein E, Valentin L. Managing women with post-
Hatem HM, et al. Risk of malignancy index for refer- menopausal bleeding. Best Pract Res Clin Obstet
ral of ovarian cancer cases to a tertiary center: does Gynaecol. 2004;18(1):125–43.
it identify the correct cases? Int J Gynecol Cancer. 14. Clark TJ, Mann CH, Shah N, Khan KS, Song F, Gupta
2006;16(Suppl 1):30–4. JK. Accuracy of outpatient endometrial biopsy in the
5. Timmerman D, Testa AC, Bourne T, Ferrazzi E, diagnosis of endometrial cancer: a systematic quanti-
Ameye L, Konstantinovic ML, et al. Logistic tative review. BJOG. 2002;109(3):313–21.
regression model to distinguish between the benign 15. Marchetti M, Litta P, Lanza P, Lauri F, Pozzan C. The
and malignant adnexal mass before surgery: a role of hysteroscopy in early diagnosis of endometrial
multicenter study by the International Ovarian cancer. Eur J Gynaecol Oncol. 2002;23(2):151–3.
Tumor Analysis Group. J Clin Oncol. 2005;23(34): 16. Visser NC, Sparidaens EM, van den Brink JW, Breijer
8794–801. MC, Boss EA, Veersema S, et al. Long-term risk of
6. Dodge JE, Covens AL, Lacchetti C, Elit LM, Le T, endometrial cancer following postmenopausal bleed-
Devries-Aboud M, et al. Preoperative identification of ing and reassuring endometrial biopsy. Acta Obstet
a suspicious adnexal mass: a systematic review and Gynecol Scand. 2016;95(12):1418–24.
meta-analysis. Gynecol Oncol. 2012;126(1):157–66. 17. Smith PP, O'Connor S, Gupta J, Clark TJ. Recurrent
7. Burbos N, Musonda P, Duncan TJ, Crocker SG, Morris postmenopausal bleeding: a prospective cohort study.
EP, Nieto JJ. Estimating the risk of endometrial can- J Minim Invasive Gynecol. 2014;21(5):799–803.
cer in symptomatic postmenopausal women: a novel 18. Seckin B, Cicek MN, Dikmen AU, Bostanci EI,

clinical prediction model based on patients' character- Muftuoglu KH. Diagnostic value of sonography for
istics. Int J Gynecol Cancer. 2011;21(3):500–6. detecting endometrial pathologies in postmenopausal
8. ACOG. The role of transvaginal ultrasonography in women with and without bleeding. J Clin Ultrasound.
the evaluation of postmenopausal bleeding; 2009. 2016;44(6):339–46.
9. Timmermans A, Opmeer BC, Khan KS, Bachmann 19. Jokubkiene L, Sladkevicius P, Valentin L. Transvaginal
LM, Epstein E, Clark TJ, et al. Endometrial thick- ultrasound examination of the endometrium in
ness measurement for detecting endometrial can- postmenopausal women without vaginal bleeding.
cer in women with postmenopausal bleeding: a Ultrasound Obstet Gynecol. 2016;48(3):390–6.
systematic review and meta-analysis. Obstet Gynecol. 20. Smith-Bindman R, Weiss E, Feldstein V. How thick
2010;116(1):160–7. is too thick? When endometrial thickness should
10. Wong AS, Lao TT, Cheung CW, Yeung SW, Fan HL, prompt biopsy in postmenopausal women with-
Ng PS, et al. Reappraisal of endometrial thickness out vaginal bleeding. Ultrasound Obstet Gynecol.
for the detection of endometrial cancer in postmeno- 2004;24(5):558–65.
pausal bleeding: a retrospective cohort study. BJOG. 21. Jacobs I, Gentry-Maharaj A, Burnell M, Manchanda
2016;123(3):439–46. R, Singh N, Sharma A, et al. Sensitivity of transvaginal
11. Timmerman D, Deprest J, Bourne T, Van den Berghe ultrasound screening for endometrial cancer in post-
I, Collins WP, Vergote I. A randomized trial on the use menopausal women: a case-control study within the
of ultrasonography or office hysteroscopy for endo- UKCTOCS cohort. Lancet Oncol. 2011;12(1):38–48.
metrial assessment in postmenopausal patients with 22. Buys SS, Partridge E, Black A, Johnson CC, Lamerato
breast cancer who were treated with tamoxifen. Am J L, Isaacs C, et al. Effect of screening on ovarian cancer
Obstet Gynecol. 1998;179(1):62–70. mortality: the Prostate, Lung, Colorectal and Ovarian
12. Love CD, Muir BB, Scrimgeour JB, Leonard RC, (PLCO) cancer screening randomized controlled trial.
Dillon P, Dixon JM. Investigation of endometrial JAMA. 2011;305(22):2295–303.
abnormalities in asymptomatic women treated with 23. Terada KY, Elia J, Kim R, Carney M, Ahn HJ. Abnormal
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Cervical Screening, Cytology
and Histology Laboratory Issues 63
Karin Denton

The factors leading to development of cervical Issues
cancer are well understood. In virtually all
women, the initial event is infection with the 63.2.1 Cervical Screening Principles
Human papilloma Virus, HPV. This is a very
common event with 80% of sexually active England, Wales, Scotland and Northern Ireland
women acquiring infection at some point in have separate but closely related programmes for
their lives. Up to 40% of women aged 24 in cervical screening, which aim to prevent the
England test positive for HPV, but most women development of cervical cancer by detection and
will clear the infection spontaneously within treatment of pre-malignant lesions.
2 years. These programmes are highly effective, pre-
In a small proportion or women, the HPV venting an estimated 80% of cases from occur-
changes the host DNA on a molecular level which ring. It is a common misconception that, for every
causes cells on the surface of the cervix to woman who develops cervical cancer despite
develop abnormalities which, if left untreated, being screened, something must have “gone
may develop into cervical cancer. This process wrong”, however this is not necessarily the case.
can spontaneously reverse before cervical cancer The programmes are nationally specified and
develops. all aspects of the process are standardised. There
In most cases, it takes a minimum of 10 years is a deeply embedded culture of quality assur-
to progress from HPV infection to cervical can- ance within delivery of the programmes.
cer, and often much longer. This offers opportu-
nities for screening before the cancer has become
invasive. 63.2.2 Cervical Screening
Programme Components
• GP registration, inclusion on national popula-

tion data base.
• Invitation at specified age and intervals.
• Sample taken by sample taker, usually a nurse
K. Denton
North Bristol NHS Trust, Bristol, UK in a primary care setting.
e-mail: Karin.Denton@phe.gov.uk • Sample submitted to laboratory for testing.

https://doi.org/10.1007/978-3-319-78683-4_63
346 K. Denton
• Result and management requirement commu- meant to detect obvious abnormalities but not
nicated to patient and national data base, next subtle or low grade changes.
test date recorded. If abnormal cells are suspected at any stage,
• Colposcopy referral (if required). the slide is passed to a second, more highly
• Biopsy and /or treatment. May produce a his- trained, member of staff, usually a biomedical
tology sample. scientist but sometimes a consultant.
• Multidisciplinary consideration of selected Cells with confirmed abnormality are reported
cases. by a consultant cytologist or cytopathologist.
• Failsafe. Abnormalities can be very subtle. This is
essentially a clinical interpretation process and
The cervical screening pathway is complex, differences in interpretation do occur. There are
and no single provider organisation is responsible well-recognised types of appearance likely to
for the whole pathway. cause difficulty (“pitfalls”), and these are the sub-
ject of regular training and updates. High-grade
intraepithelial lesions are usually not encoun-
63.2.3 Investigation of Symptoms tered in routine practice and there are many mim-
ics of benign and neoplastic changes that may
The investigation of symptoms which might be lead to errors in diagnosis. Pitfalls in cervical
attributable to cervical cancer, (chiefly intermen- cytology may therefore be divided into three
strual or post coital bleeding) is not part of the categories:
cervical screening programme. Guidance exists
for the investigation of such symptoms [1]. • Potential false negatives
In a number of cases, reliance by sample tak- • Potential false positives
ers on a negative cervical cytology result in the • Unnecessary atypical/borderline reports
presence of symptoms has delayed the diagnosis
of cervical cancer. Algorithms exist to specify which samples
require an HPV test (see below).
63.2.4 Cervical Cytology

63.2.5 Cervical Histology
This is currently the way in which samples are
primarily screened. There are systems in use, Histological samples may be taken for diagnostic
ThinPrep and SurePath. Each laboratory uses biopsy or treatment purposes. These are reported
only one system but some laboratories have by a consultant histopathologist. Diagnosis again
changed between them. Conventional cervical depends on clinical interpretation, but there are
cytology (“Smear”) has not been used in the UK extensive guidelines on how to report certain
since 2008 at the very latest. Most staff interpret- abnormalities.
ing cervical cytology are only trained and experi- There are two main conditions which are diag-
enced in one technique. nosed, Cervical Intraepithelial neoplasia (CIN)
Samples are prepared onto a glass slide which and cervical glandular intraepithelial neoplasia
must be screened. This means that, using a micro- (CGIN). These are the precursor lesions of squa-
scope, a screener must look at all the cells (num- mous and adenocarcinoma respectively.
ber ranges from 10,000 to over 100,000) and Cervical histology reporting of high grade
identify any which might be abnormal. This is abnormalities is generally very reliable,
known as primary screening, and the person though errors may occur. More common areas
doing this will be trained but is employed at a of difficulty are failure to identify very small
relatively junior level. areas of abnormality, errors regarding com-
If negative, the sample is checked by a second pleteness of excision and failure to identify
screener (rapid review) and then reported. This is foci of invasion. CGIN is particularly prone to
63 Cervical Screening, Cytology and Histology Laboratory Issues 347
being missed if there are other abnormalities majority of laboratories in England, but it is still
also present. acceptable to require the sample taker to make
It is important to ensure that all processes have the onwards referral. It is not uncommon for an
been correctly followed including the number of expert in primary care to contribute a report on
levels taken, appropriate use of immunohisto- liability and causation in these circumstances. All
chemistry and issuing a report which contains the such GP practices must operate a failsafe system
complete minimum data set. Histology results to ensure referral has been made.
which do not explain cytology findings should
prompt a discussion at a multidisciplinary team
meeting. 63.2.8 Audit
There is a mandatory audit of all cases of cervical

63.2.6 Testing for Human Papilloma cancer in England. This is undertaken to a stan-
Virus (HPV) dard national protocol [2] and is intended to be
educational. The approach taken on review of
HPV testing has been part of the English cervi- cervical cytology material is not that used in a
cal screening programme since 2001 in some medicolegal review.
areas, and fully implemented in England in Women are routinely offered the results of
2008. Practice in Scotland and Wales differs sig- this audit, which looks at the whole cancer path-
nificantly from England. HPV testing is a way. Results of the national audit have been
numerical analytic test which does not rely on published [3].
clinical interpretation but must be subject to Cervical cytology slides are retained for
laboratory quality assurance processes. Since 10 years, after which they will not be available
2013, six laboratories in England have been for review.
piloting the use of HPV as a primary screening
test, and there is a plan to fully implement this
change by April 2019. 63.3 Reasons for Litigation
There are numerous HPV test platforms in
existence but only a few are approved for use in • Missed abnormalities on cytology.
England. Their use is subject to rigorous internal • Incorrect attribution of adequacy on cytology.
and external quality control, and they are • Failure to undertake investigation of
extremely reliable. A sample which tests nega- symptoms.
tive for high risk HPV can be accepted as nega- • Missed abnormalities on histology, including
tive. A negative HPV test has an extremely high incomplete excision of abnormality and early
negative predictive value for cervical cancer, invasive lesions.
even in the presence of slightly abnormal cytol- • Failure of communication.
ogy. However, very rarely, cervical cancers do • Failure to refer.
occur in HPV negative women, and the test does • Multiple features may affect a single case,
not detect non-cervical cancers (e.g. of endome- often involving multiple organisations.
trial and ovarian origin).

63.2.7 Management
and Communication As with other areas of practice, adherence by the
of Results lab to the many quality standards and protocols
of the cervical screening programme in terms of
All women receive their results in writing, to quality processes, training and education, and
their registered address. Onward referral to col- technical standards will give some grounds for
poscopy is achieved by direct referral in the defence.
348 K. Denton
Many features of cervical cytology medico- showing that more than 50% of any type of
legal practice date back to the Kent and abnormality is missed.
Canterbury enquiry of 1997 [4]. This involved a Histology samples are slightly less irreplace-
laboratory with very poor quality management able, in that additional sections (levels) can be cut
and many abnormalities were missed on cytol- from the original wax block. However these will
ogy, resulting in harm to women. Many cases be very slightly different and very focal changes
were settled but the cases of several women with may not be reliably present in the same way as in
subtle abnormalities in their cervical cytology the original.
were contested, and subsequently referred to the Cervical screening is a complex pathway
Court of Appeal. This resulted in a judgement requiring a high degree of quality management,
introducing the concept of “absolute certainly”, and in general standards in the UK are very high.
whereby a sample could not be reported as neg- Cervical screening detects most cases of prema-
ative at screening in the absence of absolute cer- lignant disease before cancer has arisen, but can
tainty that there were no abnormal cells present. never prevent all cases.
This concept has made it challenging to defend The biggest risk factor for development of cer-
any case where an expert has identified abnor- vical cancer is failure to take up the offer of regu-
mal cells missed at the screening stage, and lar screening, but there are a number of cases
most such cases are settled. An exception is where cytology or histology diagnosis may be
where the abnormal cells are very few in num- revised on review.
ber, when it can be successfully argued that any Because treatment of non-invasive disease has
reasonable screener could have failed to identify very low morbidity and is highly effective,
them (Bolam test). There is research evidence missed opportunities to detect abnormalities will
for this in conventional smears [5]. This study often contribute strongly to causation in cervical
showed that if less than 50 abnormal cells were cancer with its associated morbidty of treatment
present, a competent screener was much less and significant mortality, often of young women.
likely to identify them than if there were more
than 200 cells present. However, the equivalent
number for Liquid based cytology is not known 63.5 Case Study
(but is certainly much lower). Conventional
smears are now almost never at issue in cases of Penney v East Kent HA [1999] Lloyd’s Rep.
cervical cancer. Med. 123 (QBD).
The Bolam Test applies to primary screening, P alleged that her cervical smear which was
and also in cases where cells have been queried at screened by biomedical scientists and screeners
primary screening but a consultant has decided had been negligently reported as negative. Her
they were not abnormal. smear should have been referred to a checker
A further area of contention is around samples who, if endorsing the classification, would pass it
incorrectly reported as adequate. Criteria for ade- on to a pathologist. P alleged that she was
quacy have varied, with an agreed range but no deprived of the opportunity of obtaining early
single national standard being agreed. treatment. The judge turned down the evidence
Review of cytology and histology material by the defendant that a reasonable body of screen-
will be a feature of many cases. Cytology mate- ers would have given a similar report.
rial is irreplaceable and all efforts must be made The court held, giving judgment for P, that [1]
to ensure the glass slides do not get lost or bro- the screeners’ observations were negligent in that
ken. If for whatever reason they do, the balance borderline smears had been incorrectly classified
of probability will be that they were correctly and not referred for further checking; [2] the
reported as there is no recent UK publication experts agreed the screeners had been wrong, the
63 Cervical Screening, Cytology and Histology Laboratory Issues 349
Bolam principle did not apply because it was

concerned with disapproval or disagreement of • All clinicians involved in cervical cytol-
aspects of professional conduct, and [3] even if ogy should keep upto date with their
the Bolam principle had applied, the defendants training.
opinions were not logical as the screeners did not • Cervical screening detects most cases of
have the ability to distinguish between pre can- premalignant disease before cancer has
cerous and benign cells, so should have classified arisen, but can never prevent all cases.
the cells as borderline.
Key Points: Cervical Screening, Cervical

References
Cytology and Histology
1. Clinical practice guidance for the assessment of young
• Symptoms which might be attributable women aged 20–24 with abnormal vaginal bleeding.
to cervical cancer, (chiefly intermen- Department of Health; 2010. https://www.gov.uk/
strual or post coital bleeding) is not part government/uploads/system/uploads/attachment_
data/file/436924/doh-guidelines-young-women.pdf.
of the cervical screening programme but 2. Audit of invasive cervical cancers. https://
should be investigated through other w w w. g o v. u k / g o v e r n m e n t / p u b l i c a t i o n s /
pathways. cervical-screening-auditing-procedures.
• Algorithms which specify which sam- 3. NHSCSP audit of Invasive cervical cancer. http://
www.wolfson.qmul.ac.uk/centres/ccp/news/profiles/
ples require an HPV test should be item/nhscsp-audit-of-invasive-cervical-cancer.
followed. 4. Wells W. Review of Cervical Screening Services at
• There should be absolute certainty when Kent and Canterbury Hospitals NHS Trust. London,
reporting a smear as “normal”. United Kingdom: NHS Executive South Thames;
1997.
• Guidelines on interpretation of histologi- 5. Mitchell H, Medley G. Differences between
cal abnormalities should be followed. Papanicolaou smears with correct and incorrect diag-
noses. Cytopathology. 1995;6(6):368–75.
MDT Function and the Law
64
Alan Farthing
64.1 Background Multidisciplinary Meeting each week in order to

discuss the management of patients. The hope
The Multidisciplinary Team (MDT) and its regu- was that this would prevent individual clinicians
lar meeting (Multidisciplinary Meeting or MDM) from treating patients in different ways and make
have been the cornerstone of specialist services cancer care across the country consistent.
for many decades. Most clinicians looking to pro- The National Cancer Plan published in 2000
vide excellence in clinical care would have a regu- [2] further supported the importance of the MDT
lar meeting with radiological expert colleagues to and laid down a series of standards on which the
run through images of their patients in order to team were to be judged in a process known as
help determine the best course of management. Peer Review.
Similarly they would often sit down with the All of this seems extremely logical and would
pathologist to discuss the appearance of a particu- undoubtedly improve the standard of care offered
lar tumour microscopically especially if the tissue to our patients.
type was rare. Such discussion would often be
informal and poorly documented but the purpose
was to seek the best possible opinions from those 64.2 Minimum Standards
who knew their subject in order to recommend to and Clinical Governance
the patient the best plan of treatment. Issues
In 1995 the Calman Hine report [1] was pub-
lished in England and Wales suggesting a reorga- “The characteristics of an effective Multidis
nization of cancer services into a model where ciplinary team (MDT)” was published in 2010 by
the diagnosis and some straightforward treatment NHS England [3] and details the necessity to have a
was given in a Cancer Unit and the difficult or Chair who takes responsibility for the performance
multimodal treatments were given in a cancer of the MDT. Core members are required and they
Centre that would have within it all the necessary need to attend in order to make any discussions
resources and expertise to provide such care. meaningful. A basic or minimum set of data needs
A fundamental part of providing this expert to be compiled prior to any discussion on a patient
care was the necessity to set up a formal in order to give the MDT a chance to make correct
recommendations. The outcomes from an MDT
meeting need to be appropriately recorded and
A. Farthing
Imperial College London, London, UK communicated to all the relevant clinicians includ-
e-mail: alanfarthing@aol.com ing the GP and in many cases the patient.

https://doi.org/10.1007/978-3-319-78683-4_64
352 A. Farthing
This document is so detailed and prescriptive time. However that still leaves many occasions
that it even states that mobile phones should be where an expert may not be present.
switched off and anyone answering one should The plan published in 2010 [3] states prompt
leave the room to do so. arrival time is essential but the practicalities of
Within Gynaecology the core members need the environment in which we work mean that we
to include a minimum of two surgeons, a medical will have to compromise on occasions. The post
oncologist, a clinical oncologist, a Clinical Nurse operative patient on the ward having life threat-
Specialist, a radiologist and pathologist with ening complications will undoubtedly take prior-
many other extended members such as palliative ity over arriving promptly for the start of the
care physicians, urologists, plastics and colorec- MDT.
tal surgeons. Many of the senior and more experienced cli-
All new patients need to be discussed in the nicians will have a greater demands on their time
MDT along with anyone with recurrent disease. with the need to lecture, attend meetings both
There are number of practical issues that arise clinical and managerial and using segments of
from the necessity to have an MDT the MDT for these can be common practice.
1. Resource 3. Accuracy of decision making
The resource required to manage the meetings Many patients referred from other hospitals
is substantial. Filtering referrals, determining will be discussed prior to any member of the
which patients need discussion, acquiring the team actually meeting them. Alternatively, a
imaging from other hospitals, sending for pathol- patient might have been met but that particular
ogy slides and compiling the list of patients for team member may not be present in the meeting.
discussion in most circumstances requires at least The data available in the MDT may not be
one fulltime administrator. Recording results, complete.
communicating these and keeping the database In order to make a sensible recommendation
often requires additional assistance. for treatment all the various factors affecting that
The Chair requires time to prepare for the patient need to be taken into consideration.
meeting and time to coordinate the results. The Clearly the pathology can be presented and the
radiologist and pathologist will often spend many images debated but in many circumstances the
hours in advance of the meeting preparing by correct management for a patient can only be
looking through images that have already been determined by talking to her and her family. An
reported by colleagues. obvious example is debulking surgery for
The meeting itself is often attended by up to advanced ovarian cancer. The pathology may
30 individuals all of whom are being paid for that make the diagnosis and the radiology may indi-
session. cate a certain type of surgery is necessary but
There is no question that the advent of MDTs only clinical assessment of the patient will deter-
has improved the quality of care offered to some mine whether that patient is fit enough to undergo
individuals but it has come at a significant cost. an extensive operation.
This ongoing significant expense will be the sub- It is only by talking to the patient that the
ject of much debate as we determine how best to options can be discussed fully. It is common-
use limited resources in the future. place for the MDT to make a recommendation
for treatment such as in early stage cervical can-
2. Attendance cer where a radical hysterectomy may be sug-
gested. Talking to the patient in detail and
The MDT is supposed to be attended by all determining her fertility wishes, presenting the
core members on a regular basis and it is a Peer data (so far as we know it) on the risks of alter-
review criteria they attend more than 67% of the native treatments and balancing a desire to be
64 MDT Function and the Law 353
cured against a desire to have children is not patient in the clinic needs to have a much more
something that can be fully recorded in an MDT extensive discussion than the one had by the
without the patient present. MDT.
The MDT sounds like a body with authority The MDT cannot be expected to take
but it is no more than its constituent parts. responsibility for a clinician who is unable to
Individuals make recommendations and those properly discuss the management and its con-
go out in the name of the MDT. It is akin to sequences. An example once again would be
blaming “The Government” or “The College” ovarian cancer debulking surgery. The MDT
for rules and regulations when it is in fact indi- may recommend extensive surgery which
viduals within that organization who make the would aim to remove all areas of disease.
decisions. It is therefore possible for individual Unless that patient is carefully consented
clinicians to make wrong decisions. This is par- including the understanding that a bowel resec-
ticularly likely where an individual is rather tion may be required which may result in a
dominant in their opinion or the way they colostomy the clinician has not had an appro-
express that opinion. priate discussion on the pros and cons of the
Although two surgeons need to be core mem- proposed management. A patient who is
bers it only requires one chemotherapy expert extremely averse to this risk may benefit more
and one radiotherapy expert. It is perfectly pos- from having chemotherapy first.
sible for their opinions to differ from a body of
chemotherapy experts or a body of radiotherapy
experts. Hence the decision recommended by the 64.3 Reasons for Litigation
MDT is not necessarily the same across the entire
country. There is no doubt that the clinicians who discuss
their patients in an MDT feel some security that,
4. Communication of results as a body of others also agreed, the management
is defensible. Litigation can occur in the follow-
Many MDT summaries will be short and to ing situations:
the point. Example “recommend laparoscopic
hysterectomy and removal of ovaries for endo- • Decision reached by the MDT fail to fulfil the
metrial cancer”. It is sometimes difficult for the Bolam principle in that a body of experts
summary to include the 10 or 15 min discussion would disagree with the treatment.
which preceded this conclusion. Subsequent • Failure to discuss a patient in an MDT which
team members including the GP may not fully implies they will not have been through the
appreciate the complexity of the discussion accepted or recommended processes. This
which led to that conclusion and recording all the opens up the possibility of an allegation of
factors or options that should be communicated incompetence simply in not following due
to the patient is difficult. process.
• Decisions reached in the MDT can become so
5. The patient should be the centre of any deci- defining that deviation from this decision
sion making automatically gets regarded as negligent.
• MDT decisions made are incorrect.
It is clear that modern medical practice • Where there are deviations from decisions
requires the clinician to discuss the options made in the MDT. This may arise in circum-
with the patient including all the pros and stances where the MDT has made one recom-
cons. The patient will not be present at any mendation but subsequent information shows
MDT discussion that results in a recommenda- there is a better form of management. In these
tion for management. It is therefore inevitable cases it is sensible to have a discussion with
that the clinician who subsequently sees the colleagues.
354 A. Farthing
An example would be the patient who is rec- delightful 54 years old lady who used to be a
ommended to have a laparoscopic hysterec- Ballet dancer and now works at her local primary
tomy with node removal for endometrial cancer school supervising music lessons. She has a
but the referring letter failed to mention her grade 3 endometrial cancer diagnosed on pipelle
previous three laparotomies and vascular dis- biopsy. I have organised an MRI and CT scan
ease that mean she is at particularly high risk of which should be available in time for your
thrombosis. A documented discussion with a MDT. She is supported by her husband, who is an
colleague who was present in the MDT and extremely busy garage mechanic, and two daugh-
recording that the laparoscopic route and the ters who live close by”.
lymphadenectomy might be contraindicated At the MDT the diagnosis of grade 3 endome-
would be sensible when changing the manage- trioid endometrial cancer was noted and the
ment plan. imaging demonstrated extension into the outer
Equally in this example, going ahead and half of myometrium with no metastases visible.
booking the laparoscopic hysterectomy and node A recommendation for laparoscopic hysterec-
removal because the MDT suggested it and fail- tomy with pelvic and para-arotic lymph node dis-
ing to take into consideration the contraindica- section was made.
tions is indefensible. When the surgeon saw her the following week,
they realised the patient had been previously
treated for lymphoma with radiotherapy to the
64.4 Avoidance of Litigation paraaortic region and she had a BMI of 40 with
bilateral leg lymphoedema causing her to be
The purpose of the MDT and its expected outputs wheel chair bound. Recognising that the MDT
should be clearly defined locally. The operating recommendation was not the most sensible way
of the MDT should be based on agreed policies, forward. A plan was made to proceed to a simple
guidelines and protocols. This should also deter- laparoscopic hysterectomy. The modified plan
mine the core and extended members and their was presented to the MDT post operatively when
roles. These policies should also be reviewed it was agreed that the use of adjunctive radiother-
annually. apy was contraindicated and chemotherapy
There should be mechanisms in place to would be likely to have more side effects than
record the MDT recommendation versus the benefits.This subsequent recommendation was
actual treatment and to alert the MDT if their rec- then discussed with the patient by the medical
ommendation are not adopted as well as the rea- oncologist.
sons for this. When serious treatment Learning points include:
complications arise the MDT should be alerted to
this. 1. The meeting at which management is sug-
Discrepancies in pathology, radiology or clini- gested (MDT) does not always have the
cal findings between local and specialist MDTs available facts and the data that comes out of
should be recorded and audited. the MDT can only be as good as the data that
goes in.
2. The Doctor seeing the patient has a duty to
64.5 Case Study re-evaluate the clinical situation when new
evidence becomes available.
A 54 year old presented to the GP with 3. It would have been medicolegally difficult to
Postmenopausal bleeding and was referred via defend surgical trauma to the Inferior Vena
the two week wait. Following an ultrasound and Cava during a para-aortic node dissection that
pipelle biopsy a referral made to the regional can- was done simply because the MDT recom-
cer centre. The referral letter read “Please see this mended it.
64 MDT Function and the Law 355
Key Points: MDT ers of assessment or discussing alterna-

• All new patients are to be discussed in tive treatments and their pros and cons.
an MDT and this is documented. • If changing an MDT recommendation,
• Ensure all the relevant details required document the process by which that
for decision making are given to the change was considered sensible.
MDT.
• Do not take the MDT recommendation
as law. Think, reason and take all factors
into consideration.
• Do not present the conclusions of the References
MDT to the patient as her only option.
1. Calman Hine report.
The MDT does not excuse the clinician 2. National Cancer Plan.
from using their medical training, pow- 3. The characteristics of an effective Multidisciplinary
team (MDT). http://www.ncin.org.uk/view?rid=136.
Colposcopy and Surgical
Management of Early Stage 65
Cervical Cancer
John Murdoch
65.1 Background while minimising morbidity to their physical,

reproductive and psycho-sexual health.
The assessment and treatment of patients with The core requirements of colposcopy are that
abnormal cervical cytology is tightly controlled the lesion and its extent are clearly defined
in the UK. There are strong audit and quality including documentation of the upper limit in the
assurance mechanisms. Deviation from well- endocervical canal; estimate of the severity of the
established pathways of care has a high risk of lesion in the context of the referral smear; appro-
litigation if there is an adverse outcome unless priate diagnostic biopsies are taken; and finally
that alternative treatment fits with that which sufficient treatment is performed.
would be offered by a responsible body of gynae- In the UK, with minor national variations, the
cologists (Bolam) and has been discussed and cervical screening programme is tightly controlled
documented with the patient (McDonald). by guidelines, which are effectively evolved instruc-
Colposcopy was first described by Hans tions, governing the delivery of service and quality
Hinselmann in Hamburg in 1925. A combination standards. These are promulgated by the British
of complex polysyllabic German terminology Society for Colposcopy and Cervical Pathology
and the political upheavals of the first half of the (BSCCP) and the National Health Service Cervical
twentieth Century ensured that it was not intro- Screening Programme (NHSCCP). Deviation from
duced generally until Papanicolaou [1] brought these guidelines has to be fully justified and recorded
cervical cytology to the fore. In the 1960s the to avoid the risk of litigation. The latest iteration of
only response to an abnormal smear was surgery the guidelines is Colposcopy and Programme
with unacceptably high morbidity [2]. Management NHSCSP Publication number 20 [3].
Colposcopy is the effector arm of the cervical The surgical management of early organ-
screening loop. Its function is to diagnose histo- confined cervical cancer has similarly progres-
logical abnormalities in women with abnormal sively moved towards the goal of maintaining
cervical screening tests so that progression to cure rates achieved by radical surgery whilst
cervical cancer can be prevented, or early treat- minimising morbidity and maintaining function.
ment instituted to maximise cancer cure rates, Modern practice disconnects treatment of the
cervical primary and assessment of the draining
lymphatics and lymph nodes. It stratifies surgery
according to sub-stage and related risk of recur-
J. Murdoch
University Hospitals Bristol NHS Trust, Bristol, UK rence. The management of early cervical cancer
e-mail: johnmurdoch@hotmail.co.uk is generally fairly clear-cut but clinicians need to

https://doi.org/10.1007/978-3-319-78683-4_65
358 J. Murdoch
be cautious about the introduction of more Colposcopist error in identification of inva-

conservative treatments without an evidence base sive cervical cancer is an issue with 2/3 of missed
which requires detailed counselling and docu- cancers at colposcopy due to colposcopist error
mented agreement with the patient. (Sect. 6.4). Most cases have one or more of the
following:
65.2 Minimum Standards, • High-grade cytological abnormality.

and Clinical Governance • Endocervical extension of lesions, even when
Issues the upper limit of these was thought to be
visible.
65.2.1 Colposcopy • Multifocal lesions.
• Large, complex lesions with raised irregular
The NHS Cervical Screening Programme surfaces.
Colposcopy and Programme Management • Under-evaluation of lesions by colposcopi-
NHSCSP, publication 20 [3] is a comprehen- cally directed biopsy.
sive prescription of minimum standards and
governance issues. The recognition of these pitfalls is a basic
Sections 4.9–4.11 of publication 20 cover the requirement of a competent colposcopist. To err
requirement for patients with moderate dyskary- on the side of ensuring an adequate excision
osis, severe dyskaryosis and query glandular neo- biopsy is wise. Difficulty occurs when there is a
plasia to be seen by a colposcopist within 2 weeks conflict between the reproductive aspirations of
of referral by the screening lab in 93% cases. young women and the need to avoid progressive
Section 4.15.1 considers symptomatic patients cancer. Clear assessment of the relevant risk and
who should again be seen within 2 weeks (93%) clear documentation is essential to ensure the
“by a gynaecologist experienced in the manage- patient makes an informed choice knowing the
ment of cervical disease”. risks involved.
These targets are a potential difficulty as a Section 8.4.3 deals with the depth of excision
result of the enthusiasm GPs exhibit for using of cervical tissue required to remove all the
the 2 week wait system for a variety of reasons. abnormal epithelium. The wording of the section
In many hospitals this has meant utilisation of is worth reproducing:
varying grades of gynaecologists with varying “Type I cervical transformation zone: for treat-
areas of expertise in a dedicated 2 week wait ing ectocervical lesions, excisional techniques
clinic. Such is the degree of sub-specialisation should remove tissue to a depth/length of more
within gynaecology that there are now gynae- than 7 mm (95%), though the aim should be to
cologists without the expertise to recognise cer- remove <10 mm in women of reproductive age.
vical cancer. It can be difficult or impossible to Type II cervical transformation zone: exci-
differentiate a benign ectopy from one with a sional techniques should remove tissue to depth/
small cancer in it with the naked eye especially length of 10–15 mm, depending on the position
in the under 25 year old where a cervical smear of the squamo-columnar junction within the
is contraindicated for screening purposes and endocervical canal.
unreliable as a diagnostic test. The solution is Type III cervical transformation zone: exci-
to stream these referrals through the colpos- sional techniques should remove tissue to a
copy clinic where the patient will be seen by depth/length of 15–25 mm”.
colposcopists who must be certified through the CIN extending to the resection margins of a
BSCCP/Royal College of Obstetricians and LLETZ is a risk factor for recurrent CIN both in
Gynaecologists (RCOG) scheme (Sect. 5.1.6). the short and long term but is not a justification
This is efficient but stretches colposcopy ser- for routine re-excision. “Incomplete” excision to
vices further. the endocervical margin in cases where the rele-
65 Colposcopy and Surgical Management of Early Stage Cervical Cancer 359
vant depths of excision mentioned above is not However, there are many areas where there is
achieved requires repeat LLETZ (see Sect. 8.6.1). a range of responsible opinion and properly doc-
However, when there is competition between umented reasoning for a particular course of
reproductive aspirations and re-treatment the cli- action would provide a solid defence, such as:
nician is obliged to ensure that the patient makes
an informed risk assessment and choice with • Selective histological assessment of lymph
clear documentation of the outcome of the nodes in stage 1a2 disease.
discussion. • The stratification of surgical radicality for
Finally, solicitors supporting a woman who is early stage 1 disease (a big cone, a trachelec-
contemplating litigation when cervical cancer is tomy or possibly a simple hysterectomy).
diagnosed know that the last 10 years of available • The place of radical fertility sparing surgery.
smears will be reviewed internally and that the • The place of sentinel node assessment versus
results should be made available to their Client systematic dissection.
(Chapter 63). It is essential that a mechanism for • The boundary between the use of primary sur-
full sensitive disclosure of the outcome is in place gery and chemo-radiotherapy.
(Sect. 5.1.4). Identified failures supported by
independent expert opinion on the standard of The key legal issue in the latter group is the
reporting will lead to successful litigation and quality of informed consent with the proper doc-
any obstruction to this process is wrong profes- umentation of discussion of all reasonable treat-
sionally and against GMC duty of candour ment options and agreement between the
requirements. gynaecological oncologist and the patient on the
treatment plan. While the vast majority of sur-
geons and patients agree about the optimal
65.2.2 Early Invasive Cancer choice, the surgeon must accept that a responsi-
ble patient may have a different view of the bal-
Since the introduction of the Improving Outcomes ance of risk in any treatment and may choose a
Guidance for gynaecological oncology in 1999 reasonable option which is not the first choice of
[4], there was a period where litigation centred on the surgeon. This includes options that the sur-
inappropriate treatment offered out-with the geon or the centre may not be able to provide and
Multidisciplinary Team (MDT) structure. That has referral on to an appropriate centre or surgeon is
now passed. The great strength of MDTs is the required. If the patient’s choice is not reasonable
inherent self-governance of team working where in the view of the surgeon, (s)he has the right to
ill-conceived decisions are far less likely. This is decline to treat but has an obligation to offer a
explored more fully in chapter 64. second opinion.
There are some absolutes in the spectrum of With the change from a paternalistic to a
treatment options which would attract litigation patient centred approach over the last 20 years
if not adhered to, such as: lately codified in case law, the issue of informed
consent has become very important in the man-
• Micro-invasive cervical cancer can be management of early cervical cancer. There is no
aged with complete local excision or simple one size fits all for the treatment of stage 1 dis-
hysterectomy in the presence of other gynae- ease. This mandates the careful counselling of
cological indications or patient request. It patients whose priorities and risk assessment
does not require radical surgery. may be very different from the attending
• Stage 1b1 cancer requires lymph-node doctor.
assessment. Full counselling of all patients with stage 1b
• Removal of healthy ovaries of women in the disease should include consideration of the risks
reproductive era with early squamous cancer and benefits of fertility sparing surgery, radical
is not required. hysterectomy and radical chemo-radiation with
360 J. Murdoch
documentation of the agreed decision. Failure to diagnosed or what treatment would have been
achieve this is against the spirit and intent of the available with avoidance of an adverse outcome
Montgomery decision. such as radiotherapy complications, loss of fertil-
ity or length of survival.
In recent years the concept of tumour dou-
65.3 Reasons for Litigation bling times has been used to calculate retrospec-
tively from a given tumour volume at diagnosis to
Common causes for litigation include important past events in the case. Some experts
used a paper by Steel [6] who attempted to sum-
• Failure to achieve the 93% 2 week target in marise knowledge in this area. Steel used the for-
referral of moderate to severe dyskaryosis. mula pi/6 (product of the three largest diameters)
• Failure to adequately counsel patients about to measure the volume of 15 metastatic adenocar-
subsequent pregnancy complications espe- cinomas from the uterus (not otherwise specified)
cially when CIN1/2 is diagnosed. serially measured on chest x-rays. He arrived at a
• Colposcopist error in identification of invasive mean tumour volume doubling time of 78 days.
cervical cancer. Despite Steel’s caveats and the multiple biologi-
cal and statistical flaws in such an analysis, these
In practice, many colposcopy services fail to data have been used to calculate tumour volumes
achieve the 93% target but avoid complaint which have been used to inform legal decisions.
because the vast majority of patients do not have However, the author has seen tumours measured
cancer. It is possible that litigation against the by MRI of 1/4th of the size which would have
Trust hosting the service could be based on a been arrived at using the formula and has had dis-
Claimant with cancer who is not seen within cussions with experts whose opinions about vol-
2 weeks and the service does not achieve the 93% ume doubling time ranged from 78 to 120 days.
target. This argument is unlikely to succeed In summary, there are no data to support the
because the Courts would have difficulty with the existence of a useful mean doubling time for pri-
idea that 7% of all patients are negligently man- mary cervical cancer which is precise enough to
aged and causation or harm is likely to be mini- identify when a cervical cancer passed any signifi-
mal. The only argument would be based on cant watershed volumes which radically altered
causation where the Claimant would have to treatment plans or outcomes. Such calculations are
demonstrate harm from the delay. This would be no better in assessing the size of a tumour at a
confined to anxiety and distress rather than a given time than study of information about symp-
worsening prognosis or morbidity from unneces- toms and signs available in the clinical records.
sary treatment except in extreme cases when the In cases where there is good MRI or CT data
culpable delay spanned months. from two or more examinations in that patient
Clarity that a single treatment to 7–10 mm in then a case specific doubling time may be
colposcopy has a minimal impact on future preg- helpful.
nancy but repeat or deep treatment probably has, is
a recent cause for litigation if the patient has been
denied the option of observation of low grade CIN 65.4 Avoidance of Litigation
or if the patient has not been informed of the risk
of miscarriage or prematurity when deeper treat- Publication 20 is a highly prescriptive document
ment is justified in the presence of CIN3 [5]. and deviation can only be justified if the reasons
Failure to identify a cancer is a reason for liti- are clearly documented and the patient clearly
gation which depends on the size and assessabil- understands and accepts the plan. Careful
ity of a cancer at a given examination date. documentation of findings in the management of
Arguments often arise about Causation related to early invasive cancer with full justification of the
the size of a tumour at some point in the past as a treatment plan and clear informed consent from
measure of whether the tumour should have been the patient are a good defence for the clinician.
65 Colposcopy and Surgical Management of Early Stage Cervical Cancer 361
65.5 Case Studies piece had a measured depth greater than 4 mm.
The colposcopist blindly followed the protocol to
1. A near miss not routinely offer re-excision and arranged fol-
low-up in 6 months when the endocervical cancer
A 40 year old woman presented with irregular was diagnosed. Compensation was awarded.
vaginal bleeding with a negative pelvic examina-
tion and transvaginal scan. Her smear history was 4. Tumour doubling times
complete and unblemished. She was seen by an
experienced nurse practitioner working alongside In a judgement, McGlone v GGHB [7], Lord
the author. The nurse practitioner asked for a sec- Tyre explored the question of tumour doubling
ond opinion because she was unhappy with the times. The case centred on mis-reporting of two
patient’s cervix but could not say what was wrong. cervical smears and a missed diagnosis of either
The cervix looked bulky in keeping with a parous glandular intraepithelial neoplasia or an early ade-
cervix but was otherwise normal, except that it felt nocarcinoma of the cervix of a size which could
firm to the touch and there was a trickle of fresh have been treated with fertility sparing surgery
blood issuing from the os. The unusual manoeuvre and radiotherapy could have been avoided. The
of an endocervical curettage revealed the large size of the tumour was estimated by mean tumour
stage 1b endocervical adenocarcinoma which doubling times according to Steel [6] from tumour
could easily have been missed by less experienced dimensions 2 years later at diagnosis. Lord Tyre’s
clinicians with resultant delay in diagnosis and a opinion was that these calculations were not accu-
worse prognosis. It was of a size that it would have rate enough to “afford a reliable estimate of the
been difficult to argue that it was not detectable at size of the pursuer’s tumour” at the time of the
the time. breach. Lord Tyre found a number of points in
Steel [6] to support that judgement. The interested
2. Another near miss reader will find the judgement a fascinating
insight into the approach of a legal mind to a clini-
A 44 year old woman again with irregular cal issue and the way in which lawyers assess and
bleeding and a negative pelvic examination includ- give credence to medical opinion.
ing a normal cervix, a negative transvaginal ultra-
sound and a negative smear history was assessed
by an experienced consultant general gynaecolo-
gist. By chance her smear was due and was taken.
It showed mild dyskaryosis and when she was Key Points: Colposcopy and Early Stage
seen in the colposcopy clinic 4 weeks later, the Cervical Cancer
cervix was still normal but the high endocervical • Colposcopy services should be organised
squamous carcinoma had invaded laterally and to ensure waiting time targets are met.
had broken through the skin of the right fornix. • Treatment should be sufficient to
Again, given the size of the lesion, it would have remove CIN lesions.
been difficult to defend the case if the smear had • Colposcopists should be aware of char-
not been taken, even though the first consultant’s acteristics of cases where early cancer is
assessment was not substandard. missed and have failsafe mechanisms in
place to prevent missed diagnosis.
3. An inadequate LLETZ • Rapid access referrals for suspicious cer-
vices should be directed to coloposcopy.
A 30 year old woman had a high grade smear • Patients must be informed of any risk to
and the colposcopy assessment revealed a lesion future reproductive performance after
in the endocervical canal. A fragmented LLETZ treatment.
was performed and CIN 3 was diagnosed but no
362 J. Murdoch
2. Way S, Hennigan M, Wright VC. Some experiences

with pre-invasive and micro-invasive carcinoma
• Patients must give informed consent for of the cervix. J Obstet Gynaecol Br Commonw.
management of early invasive cervical 1968;75(6):593–602.
cancer, taking into account their future 3. NHS Cervical Screening Programme Colposcopy and
reproductive needs. Programme Management NHSCSP Publication num-
ber 20. 3rd ed. Public Health England; 2016.
• Deviation from established protocols 4. Guidance on commissioning cancer services:
should be carefully justified. Improving outcomes in gynaecological cancers -
• Retrospective estimations of tumour The manual, Department of Health 1 January 1999
size and the ability to diagnose a Product number: 16149 Gateway reference; 1999
P. 85.
cancer at a given time point are not 5. Castanon,A, Brocklehurst P, Evans,H,Peebles, H,
precise. Singh N, Walker, P, Patnick, J, Sasieni, P, Risk of
preterm birth after treatment for cervical intraepithe-
lial neoplasia among women attending colposcopy in
England: retrospective-prospective cohort study. BMJ
2012; 345; e5174. https://doi.org/10.1136/bmj.e5174.
References 6. Steel GC. Growth kinetics of tumours. Oxford:
Clarendon Press; 1977.
1. Papanicolaou GN. Diagnosis of uterine cancer by 7. Opinion of Lord Tyre in the case of Helen McGlone
the vaginal smear. New York: The Commonwealth against Greater Glasgow Health Board. Outer Court
Fund; 1943. of Session; 2011. CSOH63.
Vulval Disorders and Neoplasia
66
Helen Bolton and Peter Baldwin
66.1 Background urgent suspected cancer pathway referral and she

should receive an appointment within two weeks
The management of vulval disorders can be com- [3]. Vulval carcinoma must be managed in a cancer
plex. They represent a wide group of conditions centre with appropriate multidisciplinary expertise.
including inflammatory dermatoses, infection,
pain-syndromes, premalignant, and malignant
disorders. Vulval carcinoma is rare, and delay in 66.2.1 Vulval Dermatoses with
diagnosis is common. Clinicians should be famil- Malignant Potential
iar with the potential range of disorders, and
know when to refer for specialist advice. Vulval skin disorders can predispose to vulval can-
cer. Vulval lichen sclerosus and lichen planus are
inflammatory conditions that are associated with
66.2 Minimum Standards an increased risk of invasive squamous cell carci-
and Clinical Governance noma (up to 5%). Symptoms frequently include
Issues itch, soreness, irritation, urinary symptoms and
dyspareunia. Introital narrowing and scarring with
National Guidance has been published on the man- subsequent sexual dysfunction can occur if left
agement of vulval conditions, including cancer [1, untreated. Both conditions have a characteristic
2]. Many cases require a multi-disciplinary approach, features, but biopsy may be required to make the
and clinicians should have access to a specialist mul- diagnosis. Management includes provision of
tidisciplinary vulval service, or there should be clear information about the condition and general advice
working arrangements between disciplines to on avoiding contact with potential irritants, the use
ensure patients receive appropriate care. NICE of emollients, and avoidance of tight-fitting clothes.
guidance recommends that when a woman presents Patients must be made aware of the small but sig-
with unexplained vulval ulceration, bleeding or a nificant risk of malignancy, and given clear instruc-
lump, then consideration should be given to an tions to seek medical advice if they notice any
change in appearance, texture or symptoms. First-
line treatment is with very potent topical steroids,
H. Bolton (*) · P. Baldwin administered initially as an intense regime until
Department of Gynaecological Oncology,
symptoms are brought under control, then reducing
Hospitals NHS Foundation Trust, Cambridge, UK slowly to a maintenance or ‘as required’ regime.
e-mail: helenbolton@me.com; pb@gyn.org.uk Biopsy is absolutely essential whenever the diag-

https://doi.org/10.1007/978-3-319-78683-4_66
364 H. Bolton and P. Baldwin
nosis is uncertain, if there are atypical appearances, mal skin. Removal of the entire lesion by exci-
if vulval intraepithelial neoplasia (VIN) or malig- sional biopsy should be avoided, as this may have
nancy is suspected, or if there has been an inade- an adverse impact on subsequent definitive treat-
quate response to treatment. These cases should ment. Examination under anaesthesia may be
also be referred onto a specialist vulval clinic. appropriate for locally advanced disease. Imaging
Follow-up is essential. All women should undergo is used to evaluate groin nodes, and any suspi-
early review to assess response to treatment. cious nodes should be sampled prior to definitive
Women with stable disease can then be reviewed treatment plans. Histology and imaging should
annually, which can be with their GP, provided be reviewed by the multidisciplinary cancer team
their condition is well controlled. An individualised prior to treatment. Treatment primarily consists
follow-up plan should be in place for women with of radical excision of the vulval lesion, with the
less well-controlled disease. aim of achieving a minimum of 10 mm of dis-
ease-free tissue. This may require excision of the
clitoris, and / or plastic surgical reconstruction.
66.2.2 Vulval Intraepithelial Treatment to the groin nodes is required for all
Neoplasia (VIN) but the earliest of tumours, and is usually surgi-
cal. Radiotherapy is predominantly used as an
Lichen sclerosus and high-risk human papilloma adjuvant to surgery. Treatment, particularly of the
virus (HPV) infection are associated with VIN, a groins, may be associated with significant mor-
rare vulval condition that can progress to invasion, bidity. The use of sentinel node dissection for
particularly if untreated. A high index of suspicion selected early cancers may help to reduce mor-
is required, especially for HPV-related VIN, which bidity. The management of patients with medical
tends to affect younger women. Symptoms and co-morbidities, and those with large tumours or
signs may be non-specific, and the appearance can lesions involving important perineal structures
be variable. Vulvoscopy can be helpful, but biopsy will be complex, and require a highly individual-
is essential for diagnosis. Multiple biopsies may be ised approach. Patients require long-term follow-
required to exclude invasion. Women with HPV- up so that recurrences are detected as early as
related VIN should be assessed for associated cer- possible.
vical, vaginal and perianal intraepithelial neoplasia
(20%). Advice on smoking cessation is essential
where appropriate. Standard treatment of unifocal 66.3 Reasons for Litigation
disease is by local excision, but the management of
multifocal disease can be complex and recurrence Potential reasons for litigation include:
risks are high. Preservation of function is important
and a highly individualised approach may be • Delay in diagnosis of cancer.
required, with the options of specialist treatments • Failure to consider multi-centric disease in
such as reconstructive surgery, ablative and medi- HPV-related VIN.
cal therapies available. VIN is therefore best man- • Failure to advise of potential impact of treat-
aged within a specialist vulval service. Close ment on sexual function or change in appear-
follow-up is mandatory. Other pre-invasive condi- ance of the vulva.
tions such as vulval Paget’s disease and melanoma • Inappropriate radical surgery and failure to
in situ also require highly specialist management. discuss or offer alternative more conservative
treatment options.
• Failure to advise on, or appropriately manage,
66.2.3 Vulval Cancer short and long term complications related to
treatment.
Women with suspected vulval cancer should be
referred to a cancer centre. Diagnosis should be There should be a low threshold for biopsy
confirmed by a representative incisional biopsy, and / or referral to a specialist service in patients
typically from the interface of normal and abnor- with vulval complaints. Robust communication
66 Vulval Disorders and Neoplasia 365
with the patient and their GP should minimise the possible management options. Where relevant,
risk of missing early malignancy and loss to fol- issues such as sexual function and changes in
low-up. Patients with HPV-related disease should appearance should be addressed directly by the
be assessed for multi-centric disease. Patients’ clinician, as patients may feel too embarrassed to
expectations require careful management to ask. Care must be taken not to make assumptions
ensure they are adequately prepared for, and sup- about these sensitive issues. Radical surgery can
ported through, the potential consequences of be associated with significant short and long-
their treatment. Ideally the operating surgeon term morbidity. This must be anticipated and
should undertake pre-operative counselling. If discussed prior to embarking on treatment.
this is not possible, then the surgeon must person- Patients should be offered appropriate support,
ally inspect the lesion prior to anaesthesia, and including the involvement of Specialist nurses
not rely solely on a colleague’s assessment. and psychosexual services. Counselling should
Detailed documentation is essential. Photographic be supplemented with patient-specific written
records of lesions can be invaluable, provided information, and thoroughly documented in the
consent is given and appropriate information medical records.
governance protocols are adhered to. A drawing Surgery should only be carried out by those
can suffice if photographs are not possible. with appropriate training, expertise and sufficient
Definitive histology must be available before caseload. A meticulous surgical technique must
radical treatment is carried out. Complications be employed, and steps to mitigate the impact on
must be managed proactively, and with an open vulval function should be utilised wherever pos-
and honest approach when things have gone sible, for instance by the use of multi-modality
wrong. Units providing specialist services should therapy or reconstructive techniques. When com-
undertake regular audit of their process, out- plications arise, the surgeon should remain
comes and complications, and benchmark their closely involved and committed to solving the
performance against nationally published guid- problem.
ance and datasets [1, 2, 4].
66.5 Case Study

66.5.1 P v Salford Royal Hospitals
Clinicians must be familiar with published NHS Trust [2002]
national guidance, be aware of their own limita-
tions, and recognise when specialist referral is A 40-year old woman was diagnosed with an early
required. vulval carcinoma arising in the posterior four-
Communication and managing patient expec- chette. The nearby tissue showed pre-malignant
tations is key to avoiding litigation. Patients must change, but the anterior aspect of her vulva was
be provided with sufficient appropriate informa- normal. She was advised to undergo surgery to
tion about their condition, especially the poten- remove the abnormalities, and her surgeon carried
tial risk of malignancy. The importance of out a vulvectomy. This included removal of her
attending for follow-up should be emphasized, entire vulva and clitoris. Consequently she was
and patients advised of symptoms that should unable to resume sexual activity, and subsequent
prompt them to seek earlier medical review. The surgical reconstruction failed. She alleged that her
patient’s GP and referring clinician should be treatment was negligent on three counts: (1) vul-
informed in writing. vectomy was inappropriate, as she should have
If surgery is required, then careful and sensi- had wide local excision; (2) she did not receive
tive pre-operative counselling is essential and appropriate pre-operative counselling; and (3) she
must cover all options, including non-surgical was not expressly informed that she may not be
approaches. Discussion should include an expla- able to resume normal sexual relations. Liability
nation of potential risks, benefits and likely con- was admitted, and the court awarded her
sequences of surgery and also of the other £65,786.63 in total damages. This case illustrates
366 H. Bolton and P. Baldwin
the importance of providing the correct treatment,

and addressing the potential impact on sexual both the patient and the GP are pro-
function. vided with robust information on the
condition.
• VIN and vulval malignancy must be
66.5.2 WR v Birmingham Women’s managed by specialist services with suf-
Healthcare NHS Trust (2004) ficient caseload, expertise and MDT
set-up.
A 37-year old woman underwent treatment for • Expectation management and careful
removal of a Bartholin’s cyst. During the proce- counselling is essential, with adequate
dure she sustained a tear in her labia minora, documentation of discussions.
resulting in a persistent skin tag, which required • Definitive histology should be obtained
surgical revision six months later. The case was before radical treatment is carried out.
settled out of court, and she received £12,000 in • Fail-safe systems should be in place to
damages for pain, suffering and loss of amenity. prevent loss to follow-up.
This case demonstrates the importance of metic-
ulous surgical technique and the post-surgical
appearance of the vulva to patients. This is appli-
cable in cases of vulval neoplasia as well. References
1. BASSH. UK National Guidance on the management
Key Points: Vulval Neoplasia of vulval conditions; 2014.
• A multidisciplinary approach is essential. 2. RCOG/BGCS. Guidelines for the diagnosis and man-
agement of vulval carcinoma; 2014.
• There should be a low threshold for 3. NICE. Suspected cancer: recognition and referral
biopsy. [NG12]; 2015.
• The follow-up of stable vulval derma- 4. Iyer R, Gentry-Maharaj A, Nordin A, Burnell M,
toses with malignant potential does Liston R, Manchanda R, et al. Predictors of com-
plications in gynaecological oncological surgery: a
not have to be in a specialist setting, prospective multicentre study (UKGOSOC-UK gyn-
provided the disease is stable and aecological oncology surgical outcomes and compli-
cations). Br J Cancer. 2015;112(3):475–84.
Uterine Cancer
67
Amit Patel
67.1 Background (NICE) [2]. There is heterogeneity in the assess-

ment methods offered at 2WW clinic. A pipelle®
With the incidence on the rise since 1970s, uterine endometrial sampling or hysteroscopic guided
cancer is now the most common gynaecological biopsy along with ultrasound scan is used alone
cancer in the United Kingdom (UK). About 9000 or often in combination. British Gynaecological
cases of endometrial cancer are diagnosed every Cancer Society (BGCS) guidelines on endome-
year with life time risk in general population at trial cancer recommend use of ultrasound as the
about 1:40 [1]. Although there is no screening first line triage to select women with endometrial
programme for endometrial cancer, a majority of thickness of 4 mm or more for endometrial sam-
the cases are diagnosed in early stage due to early pling preferably with pipelle® or if pipelle® fails
presentation with abnormal vaginal bleeding. Peak with out-patient hysteroscopy [3]. It is inevitable
incidence by age is 70–74 years. Postmenopausal that this may not be possible, suitable or even
bleeding (PMB) is considered suspicious and GPs yield intended results where an alternative plan
are expected to refer women urgently to a clinic may be required including but not limited to tests
(2WW clinic) to be seen within two weeks [1, such as a day-case general anaesthetic (GA) hys-
2] to rule out cancer. High BMI, Diabetes, teroscopy, MRI, CT scan or even hysterectomy.
Hypertension and unopposed use of oestrogen Full documentation of the investigations with
hormonal therapy are important risk factors along findings, difficulties, overall impression, track-
with nulliparity and late menopause. ing of the results and future plans in timely fash-
The most common type of endometrial cancer ion is expected from the clinician performing
is endometrioid type which carries a good prog- assessment.
nosis. Less common high-grade serous and clear Occasionally cancer may be diagnosed inci-
cell morphology have a poorer prognosis. dentally after having a hysterectomy for other
The 2WW service for PMB is designed for the reasons. All women with endometrial cancer
early detection and a diagnostic pathway for most should have as a minimum an x-ray of the chest.
women with endometrial cancer. Guidance on CT scan or MRI of pelvis may help with treat-
who to refer to this service is provided by The ment decisions but is not essential and their role
National Institute for Health and Care Excellence in early stage of disease is limited. However their
use in suspected advanced stage disease may
A. Patel
alter the treatment regime [3].
University Hospitals Bristol NHS Trust, Bristol, UK Treatment of uterine cancer is initially with
e-mail: amit.patel@uhbristol.nhs.uk surgery. Role of lymphadenectomy in early stage

https://doi.org/10.1007/978-3-319-78683-4_67
368 A. Patel
endometrial cancer has remained controversial. Table 67.1 Risk stratification of early stage endometrial
cancer for adjuvant treatment decisions (as described in
Two RCTs, a Cochrane review and a SEPAL
BGCS guideline)
study has failed to show a clear survival benefit
Low risk FIGO grade 1, No adjuvant
although the quality of some of these studies Stage Ia, Ib, no treatment
have been criticised [4–7]. There are, therefore, LVSI
two schools of thought; those who perform full FIGO grade 2,
surgical staging including full nodal assessment Stage Ia, no
LVSI
followed by selective adjuvant treatment based
Intermediate FIGO grade 2, Vaginal
on lymph node status and those who perform risk Stage Ib, no brachytherapy
only hysterectomy without lymph node excision LVSI
and offer liberal adjuvant treatment based on FIGO grade 3,
tumour characteristics. Either of these is consid- Stage Ia, no
LVSI
ered acceptable and would not form a ground for High- FIGO grade 3, Consider external
a claim of substandard treatment. New technol- intermediate Stage Ia, beam radiation
ogy of sentinel node detection shows good prom- risk regardless of versus vaginal
ise in early research and in time may help resolve LVSI brachytherapy if
FIGO grade 1, nodal status
the dilemma of lymph node assessment [8, grade 2, LVSI unknown.
9]. However if offered, sentinel node assessment unequivocally Consider adjuvant
should be thoroughly explained and consent positive, brachytherapy
should be sought with documentation of its role regardless of versus no adjuvant
depth of invasion therapy if node
compared to full and no lymph node assessment negative
at all [8]. High risk FIGO grade 3, Consider external
Adjuvant treatment with external-beam radio- Stage Ib beam radiation
therapy and vaginal brachytherapy in stage 1 and versus vaginal
2 endometrial cancer is based on risk-stratification brachytherapy.
Consider adjuvant
(see Table 67.1) [3]. For low-risk no adjuvant chemotherapy.
therapy, for intermediate-risk vaginal brachyther-
apy therapy alone, for node negative high-risk
vaginal brachytherapy therapy alone and for 67.2 Minimum Standards
remaining scenarios vaginal brachytherapy with and Clinical Governance
external-beam radiotherapy and consideration for Issues
chemotherapy is recommended by the BGCS
guidelines. The most up-to-date guidance on the manage-
FIGO Stage 3 and 4 patients may be offered ment of endometrial cancer is published by
surgery but if advanced stage is known pre- BGCS [3]. Although variations in the assessment
operatively they may have surgery after evidence of suspected endometrial cancer and treatment of
of response to pre-operative chemotherapy or confirmed cancer exists and is allowed within the
radiotherapy. scope of guideline due mainly to the lack of evi-
Women suitable but not fit for surgery may be dence, there are few points of absolute certainty
offered palliative chemotherapy or hormonal that, if remembered and practised, risk of litiga-
treatment with radiotherapy reserved for symp- tion can be reduced.
tom control.
Survival in uterine cancer depends on many 1. All suspected endometrial cancer referral
factors but mainly on the FIGO stage, grade, with endometrial thickness of 4 mm or more
morphology, age and fitness of patient. Although should have one or other form of endometrial
overall 5 year survival is 84%, survival in stage 1 biopsy.
is in excess of 95%. Survival has improved grad- 2. All women with negative biopsy or endo-
ually over last four decades [1]. metrial thickness less than 4 mm should be
67 Uterine Cancer 369
advised to see their GP again if their symp- • In cases of failure of investigation failure to
toms persist due to small false negative discuss and document altered plan of actions
test risk. This should be no more than six and its rationale.
months and preferably at the 3 months • Acting outside guideline recommendations
mark. without justifiable rationale.
3. In women where biopsy is not possible
(including consideration of GA), a choice of
MRI or hysterectomy should be discussed 67.4 Avoidance of Litigation
with woman and documented.
4. All women with completed family diagnosed When discussing the treatment options with a
with atypical complex hyperplasia should be woman, all available options of treatment (includ-
offered hysterectomy [10]. ing those not available in the department) should
5. All confirmed endometrial cancer cases be discussed without prior judgement allowing
should be discussed and registered with for her to weigh the information and decide for
regional cancer MDT prior to treatment. herself. Consent and clinical documentation
6. Grade 1 and 2 endometrial cancer requiring should be thorough and woman’s right of second
simple hysterectomy can be managed at opinion should be respected. A clinician has
diagnostic centre by clinician who is a mem- the right to decline to offer the treatment of her
ber of regional cancer MDT. choice but in such circumstances a second opin-
7. All women with endometrial cancer should ion must be offered to woman. When care is
have at minimum x-ray of chest. shared, it is crucial to have a clear communica-
8. Grade 1 endometrial cancers confined to tion with colleagues and patients regarding the
uterus do not require lymph node excision. process and steps in the patient pathway. This
9. Ovaries and tubes should be removed at the remains one of the common causes of litigation.
hysterectomy baring exceptional circum- Following areas are accepted as reasonable
stances in young premenopausal women. area of heterogeneity. Most of these are due to the
10. Low-risk endometrial cancer (see Table 67.1) lack of evidence one way or other. If proper doc-
do not require post-hysterectomy adjuvant umentation of reasoning and rationale in exercis-
treatment with radiotherapy or ing these options is carried out, it would offer
chemotherapy. good protection against litigation.
11. There is no proven therapeutic value of

removal of lymph nodes. Only prognostic 1. Temporary fertility sparing conservative

value and value in triaging for adjuvant treatment in an early stage endometrial can-
treatment. cer following a recognised practising body
guideline (e.g. ESGO) in a thoroughly
counselled woman is acceptable. There is a
67.3 Reasons for Litigation high-risk of poor outcome and higher risk of
litigation particularly if any deviation
• Missing indications for an urgent referral. from the guideline occurs.
• Prescribing Oestrogen only HRT to women 2. Lymph node dissection in grade 2+ and non-
with a uterus. endometrioid endometrial cancers.
• Delay in diagnosis. 3. External beam radiotherapy and chemother-
• Lack of or miscommunication. apy in high-risk endometrial cancer.
• Failure to implement Montgomery ruling in 4. Sentinel node assessment in endometrial can-
clinical practice. cer verses full or no lymph node assessment.
• Failure to recognise and take account of full 5. Open laparotomy surgery in cases where jus-
clinical problem. tification can be offered for not performing
• Deviation from the normal pathway for 2WW. through minimal access route.
370 A. Patel
67.4.1 Special Situations investigation was found to have a high-grade

endometrial cancer. Learning points here were
1. Incidental thickened endometrium in absence the mismatch between obvious uterine lesion on
of PMB scan and unexplained negative endometrial
assessment and failure of sharing and tracking of
There is no guidance available on incidentally additional suspicious symptoms at the time of
diagnosed thick endometrium in post-menopausal discharge. A further imaging such as MRI to
women in absence of PMB. However published exclude myometrial pathology would have been
literature and clinical consensus in these women justified prior to discharging woman and she
would be to not offer assessment unless they have should have been advised to return to clinic or GP
one of the aforementioned risk factors. These if bleeding persisted. Outcome of her rare cancer
women should be counselled to contact their GP despite aggressive treatment was poor. Whilst
as soon as possible if they have any PMB in the negative hysteroscopy and histology can be
future. defended with false negative rates of these tests it
would have been difficult to argue why mismatch
2. Detection of polyp on ultrasound scan in
of investigation was not further pursued.
absence of PMB
2. Another cases of harm not contested in the
If a polyp is seen during the clinical examina- court
tion and is deemed feasible to remove in out-
patient settings then removal should be attempted. A 61 year old asymptomatic woman with
Asymptomatic polyp detected on ultrasound scan thickened endometrium (8 mm) was referred to
does not require removal unless women have 2WW clinic where Pipelle® failed to obtain any
high risk factors for endometrial cancer. These sample. Woman was then subjected to general
women should be counselled to contact GP as anaesthetic hysteroscopy and polypectomy was
soon as possible if they have any PMB in the carried out by senior registrar on an afternoon
future. list. Woman stayed overnight due to pain and fol-
lowing a CT scan for continued pain returned to
theatre for suspected intestinal perforation. Three
67.5 Case Studies perforations were found and managed by intesti-
nal resection, anastomosis and protective tempo-
1. A missed endometrial cancer rary ileostomy. Histology was benign. This case
if went to litigation would have been difficult to
A 55 year old woman with post-menopausal defend.
bleeding was seen by consultant in a 2WW clinic.
The history taken by the GP included additional
symptoms of unintentional weight loss and Key Points: Uterine Cancer
abdominal pain. Ultrasound scan in clinic sug- • Referral standards: As described in 2015
gested 2 cm uterine tumour likely polyp. GA hys- National Institute for Health and Care
teroscopy was arranged. This was carried out by Excellence (NICE) guidance; Suspected
another consultant who found normal endome- cancer: recognition and referral.
trial cavity and endometrial biopsy was reported • Endometrial cancer treatment standards:
benign. Details of additional suspicious symp- As described in 2017 British
toms were not discovered and 2 cm tumour on Gynaecological Cancer Society (BGCS)
ultrasound scan remained unexplained. Woman guidance; Uterine Cancer Guidelines:
was discharged with no further follow-up. Recommendations for Practice.
Women returned to 2WW after several months
with continued bleeding and later on further
67 Uterine Cancer 371
4. Kitchener H, Swart AM, Qian Q, Amos C, Parmar

MK. Efficacy of systematic pelvic lymphadenectomy
• Endometrial hyperplasia treatment stan- in endometrial cancer (MRC ASTEC trial): a ran-
dards: As described in 2016 Royal domised study. Lancet. 2009;373(9658):125–36.
College of Obstetricians and 5. Keys HM, Roberts JA, Brunetto VL, Zaino RJ, Spirtos
Gynaecologists (RCOG) / British Society NM, Bloss JD, et al. A phase III trial of surgery with
or without adjunctive external pelvic radiation therapy
of Gynaecological Endoscopy (BSGE) in intermediate risk endometrial adenocarcinoma: a
Joint Guideline on the Management of Gynecologic Oncology Group study. Gynecol Oncol.
Endometrial Hyperplasia. 2004;92(3):744–51.
• Any deviation from recommended prac- 6. Frost JA, Webster KE, Bryant A, Morrison
J. Lymphadenectomy for the management of endome-
tice or situation not covered by guidance trial cancer. Cochrane Database Syst Rev. 2017;(10).
should be thoroughly discussed with Art. No.: CD007585.
patient and documented in details 7. Todo Y, Kato H, Kaneuchi M, Watari H, Takeda M,
including rationale taking into account Sakuragi N. Survival effect of para-aortic lymph-
adenectomy in endometrial cancer (SEPAL study):
recent Montgomery ruling. A retrospective cohort analysis. (Published erra-
tum appears in Lancet 2010; 376: 594.). Lancet.
2010;375:1165–72.
(RCOG), Sentinel Lymph Node Biopsy in Endometrial
References Cancer: Scientific Impact Paper No. 51; 2016. https://
www.rcog.org.uk/en/guidelines-research-services/
1. Cancer Research UK. http://www.cancerresearchuk. guidelines/sip51/. Assessed Oct 2017.
org/health-professional/cancer-statistics/statistics-by- 9. Rossi EC, Kowalski LD, Scalici J, et al. A compari-
cancer-type/uterine-cancer/incidence. Accessed Oct son of sentinel lymph node biopsy to lymphadenec-
2017. tomy for endometrial cancer staging (FIRES trial): a
2. National Institute for Health and Care Excellence multicentre, prospective, cohort study. Lancet Oncol.
(NICE). Suspected cancer: recognition and referral. 2017;18:384–92.
NICE Guideline; 2015. http://www.nice.org.uk/guid- 10. Royal College of Obstetricians and Gynaecologists
ance/ng12. Accessed Oct 2017. (RCOG)/British Society of Gynaecological
3. British Gynaecological Cancer Society (BGCS). Endoscopy (BSGE) Joint Guideline Management of
Uterine Cancer Guidelines: Recommendations Endometrial Hyperplasia, Green-top Guideline No.
for Practice; 2017.https://bgcs.org.uk/BGCS%20 67; 2016. https://www.rcog.org.uk/globalassets/docu-
Endometrial%20Guidelines%202017.pdf. Accessed ments/guidelines/green-top-guidelines/gtg_67_endo-
Oct 2017. metrial_hyperplasia.pdf. Assessed Oct 2017.
Ovarian and Tubal Cancer
68
Richard Clayton

The commonest type of ovarian cancer is epi-
thelial ovarian cancer (EOC) and within EOC, NICE issued guidance on the management of
high grade serous histology is the commonest. ovarian cancer in 2011; “Ovarian cancer, recog-
Non- epithelial types of cancer include sex nition and intial management” [1].
cord-stromal tumours (15–20%) and germ cell The British Gynaecological Cancer Society
tumours (5%). (BGCS) [2] have recently issued comprehensive
Epithelial ovarian cancer and fallopian tube guidelines for the management of epithelial ovar-
cancer are usually grouped together with primary ian/tubal/peritoneal cancer covering all aspects
peritoneal cancer and are all managed in a similar of care. These incorporate aspects of the NICE
fashion. The exact site of origin is often unclear, guidance, where relevant.
although there is increasing evidence that most
high grade serous ‘ovarian’ cancers in fact arise
from the fallopian tube. When there is no obvious 68.2.1 Initial Recognition
tumour involving the ovary or fallopian tube, the and Diagnosis
tumour will be regarded as primary peritoneal.
There were approximately 7400 new cases of NICE recommends referral to secondary care
ovarian cancer diagnosed in the UK in 2014 with if ascites or a pelvic mass is detected, which
approximately 4100 deaths from ovarian cancer. is not obviously fibroids. Otherwise a process
The high death rate compared to many other can- of ‘sequential testing’ in primary care is
cers is because the majority of ovarian cancer recommended;
will be diagnosed at an advanced stage i.e. stage “if a woman (especially if 50 or over) reports
3 or 4 (60–70%) as initial symptoms may be having any of the following symptoms on a per-
vague leading to inevitable delays in diagnosis. sistent or frequent basis—particularly more than
Ovarian cancer is staged according to FIGO cri- 12 times per month; persistent abdominal disten-
sion (women often refer to this as 'bloating');
teria (see appendix). feeling full (early satiety) and/or loss of appetite;
pelvic or abdominal pain; increased urinary
urgency and/or frequency. Consider carrying out
R. Clayton tests in primary care if a woman reports unex-
St Mary’s Hospital, Manchester, UK plained weight loss, fatigue or changes in bowel
e-mail: Richard.Clayton@cmft.nhs.uk habit.”

https://doi.org/10.1007/978-3-319-78683-4_68
374 R. Clayton
Initially a serum CA125 should be measured cer (stage I and II) is complete macroscopic
(this is a marker which is raised in some cases tumour resection and adequate surgical staging.
of ovarian cancer) and if this is above the nor- Patients suitable for fertility-sparing surgery
mal range, an ultrasound of the pelvis should be should be identified by the MDT and the pros and
requested. If both are abnormal then referral cons of this discussed with them, so that they can
into secondary care should take place, poten- make an informed choice”.
tially urgently, depending on the ultrasound When there is evidence of advanced disease
results. e.g. ascites or a raised CA125, a CT scan will be
requested to assess the extent of any metastatic
tumour. An MDT assessment should then take
68.2.2 Screening and Prevention place to review the findings on CT, in conjunction
of Ovarian Cancer with information about the patient’s performance
status and general health.
There is currently no established national pro- The standard of care in epithelial ovarian can-
gram for screening in the UK, even in women cer is to offer initial surgical ‘debulking’ i.e.
who are known to have an increased risk of ovar- removal of all areas of cancer. ‘Maximal surgical
ian cancer based on their family history, or effort’, which may involve surgical techniques
genetic testing for the presence of predisposing such as bowel resection or peritoneal stripping,
genes (BRCA1 and BRCA2). This is because the should be employed to facilitate this. Considerable
benefits of screening, unlike the situation with morbidity may be associated with this and the
some other cancers (e.g. cervix) are unclear. potential benefits have to be balanced against the
There are several on-going research studies risks of the surgery, particularly in a patient
looking at this area. The most effective tech- whose performance status or pre-existing medi-
nique for risk reduction in women at signifi- cal conditions suggest that prolonged and exten-
cantly increased risk is prophylactic bilateral sive surgery may cause significant complications.
salpingo-oophorectomy. This may be considered This decision is often not clear-cut and will
in women over the age of 35 who have com- involve assessment by the MDT and discussion
pleted their families. with the patient.
The alternative option of using initial chemo-
therapy (neo-adjuvant) with surgery at the mid-
68.2.3 Management in Secondary point of the treatment (interval debulking) is
Care thought to be non-inferior to initial surgery. This
may be employed, particularly if there are thought
When a pelvic mass is found on ultrasound imag- to be areas of non-resectable disease initially, or
ing, the risk of malignancy will be assessed using when the patient’s medical condition precludes
an RMI (Risk of Malignancy Index) scoring sys- aggressive surgery. A radiological guided biopsy
tem, based on the ultrasound findings and the of the tumour to confirm an epithelial ovarian-
CA125 level. This will be used to triage the type cancer is required before commencing
patient for further management; A high risk of chemotherapy.
malignancy will indicate management in a desig-
nated cancer centre. All patients thought to be at
high risk of malignancy must be discussed in a 68.2.4 Chemotherapy for Epithelial
multidisciplinary team meeting (MDT) to deter- Ovarian Cancer
mine optimal management.
The BGCS guidelines state; “Women with sus- Chemotherapy is not required following surgery
pected epithelial ovarian cancer should undergo for stage 1a/b grade 1/2 disease. Carboplatin is
surgery at a cancer centre by specialised sur- the main chemotherapy agent used and in
geons who are core members of a specialist advanced disease, it is usually combined with
MDT. The aim of surgery for early ovarian can- Paclitaxel. The treatment is given for 6 cycles at
68 Ovarian and Tubal Cancer 375
three weekly intervals. There are alternative recurrent situations can be used. Consideration
options for dosage and drug types depending on may be given to the use of hormonal manipula-
response or allergy/tolerance to these agents. tion as the tumours may be sensitive to the effects
Bevacizumab, an anti-angiogenic agent can be of oestrogen on their growth.
used in some advanced disease settings and Germ cell tumours; generally occur in young
results in a delay in progression of the disease women. Germ cell tumour markers should be
(progression free survival) but does not affect measured prior to surgery in any woman under
overall survival. 40, to try to exclude the diagnosis. It is usually
possible to preserve fertility when the patient
wishes; removal of the primary tumour with
68.2.5 Follow-Up adjuvant chemotherapy for high-risk or
advanced disease, is the mainstay of treatment.
The BGCS guidelines recommend regular The disease is usually extremely sensitive to
clinical follow-up visits with holistic assessment chemotherapy, and cure is usual even in
of the patient and examination to exclude recur- advanced disease.
rence. Most centres will follow-up for 5 years at
decreasing frequency. The guidelines point out
however, that there is no good evidence to sup- 68.3 Reasons for Litigation
port regular follow-up of this type compared with
an “individualized and symptom-led approach”. • Delay in diagnosis—particularly in primary care.
The use of CA125 during follow-up is not man- • Failure to act on suspicious or concerning
datory, as there is no survival benefit associated imaging findings in secondary care.
with its routine use. In practice, however, most • Failure to consent and discuss risk of compli-
centres will measure this. cations appropriately.
• Surgical complications; specifically injury to
viscera or major vessels. This is common to
68.2.6 Recurrent Cancer all gynaecological surgical procedures. Due to
the often extensive nature of the surgery the
The mainstay of treatment for recurrent epithelial risk of complications will be higher than in
ovarian disease is further chemotherapy. The type otherwise uncomplicated gynaecological
of chemotherapy will depend on the interval procedures.
since completion of previous chemotherapy; • Failure to discuss or appropriately consider
when a patient is sensitive to platinum based che- fertility sparing surgery.
motherapy, re-treatment will usually be given • Failure to recognise and manage post-
with further similar chemotherapy. Bevacizumab operative complications promptly.
may also be considered. • Failure to detect, or delay in detection of,
When there are a limited number of sites of recurrence of tumbour.
recurrent disease, a careful MDT discussion
should take place regarding the use of surgery to
remove the recurrent disease. There is currently 68.4 Avoidance of Litigation
limited evidence to support this approach.
• In General Practice, recognition that frequent
but often non-specific symptoms as outlined
68.2.7 Non-Epithelial Ovarian Cancer in NICE guidance, should lead to use of
sequential testing i.e. use of CA125 measure-
Sex cord-stromal tumours; treatment is primarily ment followed by ultrasound scan if required.
surgical. The tumours are relatively insensitive to • Documentation of appropriate history and pel-
chemotherapy but unlike epithelial ovarian can- vic examination in General Practice in order
cer, repeated surgical excision in advanced or to exclude a pelvic mass.
376 R. Clayton
• Appropriate referral to secondary care when Imaging review suggested that a CT scan had
the patient meets the NICE criteria for been misreported shortly after symptoms had
referral. started. Earlier diagnosis should have taken place
• Evidence of MDT discussion and agreed man- approximately 1 year before eventual diagnosis.
agement plan when the RMI is raised. Earlier diagnosis would have led to a reduced
• Documentation that discussion has taken duration of pain and suffering. Based on the find-
place regarding fertility preservation where ing of advanced metastatic disease at diagnosis,
appropriate. there was thought to be probable metastatic dis-
• Careful operative description detailing any ease one year before eventual diagnosis. The
difficulties encountered during surgery and chance of long term survival would only margin-
any departure from ‘straightforward’ surgery ally have improved with earlier diagnosis.
e.g. requirement to mobilise ureters in order to
perform a hysterectomy.
• Appropriate prescription of antibiotics and
prophylaxis for venous thromboembolism. Key Points: Ovarian/Tubal Cancer
• Careful post-operative documentation to rec- • Recognition of concerning symptoms in
ognise and assess potential post-operative General Practice with appropriate use of
complications with minimal delay. sequential testing and referral when
NICE criteria are met.
• Referral and management in a cancer
68.5 Case Study centre when the RMI is raised.
• Discussion and documentation by MDT
R v BUH NHS FT: Claimant was diagnosed of management plan.
with advanced ovarian cancer in 2012. She was • Careful documentation of operative dif-
treated with a combination of chemotherapy and ficulties encountered.
surgery, however the treatment was unsuccessful. • Careful documentation post-operatively
Prior to the diagnosis she suffered from abdomi- to recognise and address complications
nal symptoms which had started approximately promptly.
18 months before diagnosis.
68 Ovarian and Tubal Cancer 377
Appendix: FIGO Staging System

FIGO Ovarian Cancer Staging
Effective Jan. 1, 2014
(Changes are in italics.)
Stage III: Tumor involves 1 or both ovaries with cytologically or histologically confirmed spread to the peritoneum
outside the pelvis and/or metastasis to the retroperitoneal lymph nodes
Old New
IIIA Microscopic metastasis beyond IIIA (positive retroperitoneal lymph nodes and/or microscopic
the pelvis. metastasis beyond the pelvis)
IIIA1 Positive retroperitoneal lymph nodes only
IIIA1(i) Metastasis ≤ 10 mm
IIIA1(ii) Metastasis > 10 mm
IIIA2 Microscopic, extrapelvic (above the brim) peritoneal
involvement ± positive retroperitoneal lymph nodes
IIIB Macroscopic, extrapelvic, peritoneal IIIB Macroscopic, extrapelvic, peritoneal
metastasis ≤2 cm in greatest metastasis ≤ 2 cm ± positive retroperitoneal lymph
dimension. nodes. Includes extension to capsule of liver/spleen.
IIIC Macroscopic, extrapelvic, peritoneal IIIC Macroscopic, extrapelvic, peritoneal
metastasis >2 cm in greatest metastasis > 2 cm ± positive retroperitoneal lymph
dimension and/or regional lymph nodes. Includes extension to capsule of liver/spleen.
node metastasis.
Stage IV: Distant metastasis excluding peritoneal metastasis

Old New
IV Distant metastasis excluding IVA Pleural effusion with positive cytology
peritoneal metastasis. Includes hepatic IVB Hepatic and/or splenic parenchymal metastasis, metastasis to
parenchymal metastasis. extra- abdominal organs (including inguinal lymph nodes and
lymph nodes outside of the abdominal cavity)
Other major recommendations are as follows:
• Histologic type including grading should be designated at staging.

• Primary site (ovary, Fallopian tube or peritoneum) should be designated where possible.
• Tumors that may otherwise qualify for stage I but involved with dense adhesions justify upgrading
to stage II if tumor cells are histologically proven to be present in the adhesions.
References 2.
British Gynaecological Cancer Society (BGCS)
Epithelial Ovarian / Fallopian Tube / Primary Peritoneal
1. Ovarian cancer: recognition and initial management Cancer Guidelines 2017: Recommendations for
Clinical guideline [CG122]; 2011. https://www.nice. Practice. https://bgcs.org.uk/BGCS%20Guidelines%20
org.uk/Guidance/cg122. Ovarian%20Guidelines%202017.pdf.
Gestational Trophoblastic Disease
69
John Tidy
69.1 Background GTD must be registered with one of three screen-

ing centre, Ninewells Hospital, Dundee for
Gestational Trophoblastic Disease (GTD) is rela- Scotland, Charing Cross Hospital, London, for
tively rare in the UK with an incidence of 1 in southern England, South Wales and Northern
714 births. GTD includes complete and partial Ireland and Weston Park Hospital for the north of
molar pregnancies. The incidence is higher in England and North Wales. Categories of sus-
women of Asian ethnicity (1 in 450) and more pected GTD to be registered include:
common at the extremes of reproductive age with
an incidence of 1 in 500 in women under 15 years • Complete hydatidiform mole.
of age and 1 in 8 in women over 50 years. • Partial hydatidiform mole.
Gestational Trophoblastic Neoplastic (GTN) can • Twin pregnancy with complete or partial
develop after complete or partial moles, miscar- hydatidiform mole.
riage or a term pregnancy. Women who develop • Limited macroscopic or microscopic molar
GTN require treatment with chemotherapy. change suggesting possible partial or early
Women treated for GTN in the UK have very complete molar change.
high cure rates, 100% for low risk GTN and 94% • Choriocarcinoma.
for high risk GTN. • Epithelioid trophoblastic tumour.
• Placental site trophoblastic tumour.
• Atypical placental site nodules.
and Clinical Governance Most women with GTD now present with a
Issues history of abnormal vaginal bleeding in early
pregnancy. Late presentation with an enlarged
Guidance on the management of GTD is issued uterus, hyperemesis, early onset pre-eclampsia or
by the Royal College of Obstetricians and thyrotoxicosis is very rare. The diagnosis of
Gynaecologists (RCOG), Green Top Guidance molar pregnancy by ultrasound is unreliable in
No 38. All women with confirmed or suspected the early part of the first trimester, over 66% of
women with a complete mole will not be diag-
nosed as a complete mole by ultrasound prior to
J. Tidy uterine evacuation. The most common ultrasound
Sheffield Teaching Hospitals NHS Foundation Trust,
Sheffield, UK diagnosis is an anembryonic or delayed miscar-
e-mail: John.Tidy@sth.nhs.uk riage. Products of conception from all failing

https://doi.org/10.1007/978-3-319-78683-4_69
380 J. Tidy
pregnancies must be sent for histological • Failure to follow-up women with GTD.
examination to exclude GTD. All women with • Rare variants of GTN—Placental site tropho-
GTD must be reviewed following the pathologi- blastic tumour and epithelioid trophoblastic
cal diagnosis of GTD to inform them of the diag- tumour—can be difficult to diagnose.
nosis and gain consent for registration at one of
the screening centres. Registration can be online
or by paper form sent by fax or by post. Women 69.4 Avoidance of Litigation
with suspected molar pregnancy should undergo
surgical management and not medical or conser- The wide availability of emergency pregnancy
vative management. Conservative or medical units and early recourse to ultrasound scanning
management are associated with higher rates of of pregnancy has resulted in women being
GTN. All hospitals should audit the management referred at earlier gestations. The pathognomonic
of women with suspected or confirmed GTD to ultrasound and histological features of complete
ensure all cases are registered. When there is dif- molar pregnancies are present only at more
ficulty in reaching a pathological diagnosis the advanced gestation. The absence of any ultra-
local pathologist can seek help from the expert sound features of a molar pregnancy when inves-
pathologists associated with the screening cen- tigating a failing pregnancy does not exclude a
tres. If uncertainty persists the safest option is to molar pregnancy hence the need for histological
register the patient with the screening centre. assessment of all failing pregnancies. In one
Women who develop GTN after a miscarriage study 67% of women with a molar pregnancy had
or a term pregnancy can be difficult to diagnose. only features of an anembryonic pregnancy or
Women with persistent and unexplained vaginal delayed miscarriage.
bleeding after any pregnancy event may have Prolonged use of prostaglandins to induce ter-
GTN, a pregnancy test—urinary or serum should mination should be avoided however the use of
be performed in such cases. agents such as misoprostol, to ripen the cervix,
Rarely women can present with symptoms of administered per vaginum 1 hour before surgical
metastatic GTN including haemoptysis and evacuation is acceptable. The surgical evacuation
seizures. of an enlarged uterus with a suspected molar
pregnancy should be performed by an experi-
enced gynaecologist. Women should be coun-
69.3 Reasons for Litigation selled about the risk of perforation and
hysterectomy if excessive bleeding cannot be
The reasons for litigation following a GTD are controlled. Intra-uterine contraceptive systems
related to: should not be inserted at the time of evacuation
for a suspected molar pregnancy. The use of
• Delay in diagnosis [delay in producing pathol- ultrasound at the time of uterine evacuation is not
ogy report, failure to diagnose after non molar mandatory and has yet to be of any proven value
pregnancy]. in reducing the risk of GTN. In cases of suspected
• Delay in referring the woman to the screening molar pregnancy the products of conception
centre. should be sent for histological examination and
• Complications during/arising from the proce- appropriate follow up made to discuss the results
dure [Inexperienced surgeon, uterine perfora- in a timely manner. All women with a molar
tion, excessive bleeding leading to pregnancy must be registered at one of the three
hysterectomy]. screening centres and must consent to r egistration
• Misdiagnosis of ‘pregnancy of unknown loca- and follow-up. Women may be prescribed the
tion’ instead of GTD. combined oral contraceptive pill even when a
69 Gestational Trophoblastic Disease 381
molar pregnancy is suspected as there is no evi- fatigue, and hair loss. She also developed depres-
dence of an increased risk of GTN. Ideally sion related to her inability to have any children.
women should only undergo a repeat uterine In this case the medical staff were unaware of
evacuation after discussion with the screening the results following the initial uterine evacua-
centre unless the patient is in extremis due to pro- tion. The patient was not notified of the results
fuse vaginal bleeding. and not registered with a trophoblast screening
The development of GTN can occur after any centre. The patient represented with heavy vagi-
pregnancy event. Women who present with nal bleeding which was only controlled by hys-
abnormal vaginal bleeding after any pregnancy, terectomy. She had also developed vaginal and
which has failed to respond to appropriate treat- lung metastases. The patient took legal action in
ment should have a urine or serum pregnancy test light of the outcome claiming she had undergone
performed. a hysterectomy, causing infertility, and multi-
Audit of practice as recommended in RCOG agent chemotherapy because of the failure to
No 38 should be undertaken. review the initial histology report and register
her with a trophoblast screening centre. An out
of court settlement was made between the patient
69.5 Case Study and the hospital.
A 25-year-old woman attended an early preg-

nancy assessment unit in 2014 with a 4 day his- Key Points: Gestational Trophoblastic
tory of vaginal bleeding. Her last menstrual period Disease
was 8 weeks ago. Clinical examination revealed • Adequate assessment and investigation
some old blood in the vagina, the cervical os was of all failing pregnancies.
closed. She was haemodynamically stable. Trans- • All complete molar pregnancies man-
vaginal ultrasound was suggestive of a molar aged by surgical evacuation.
pregnancy and a surgical evacuation of the uterus • Procedure undertaken by adequately
was performed. Tissue was sent for histological trained surgeons with risk of excessive
examination, however the report, an early com- bleeding and potential for hysterectomy
plete mole, was filed in the patient’s notes without explained.
being reviewed by the medical staff. • Prompt diagnosis, review of patient in
Six months later the woman presented to acci- clinic and registration of patient at a
dent and emergency with a massive vaginal bleed. screening centre.
A dark blue nodule was noted on the anterior vagi- • Audit of management of molar
nal wall and there was fresh bleeding from the cer- pregnancies.
vical os. The beta hCG was more than 1,000,000
mIU/mL. The patient was haemodynamically
unstable with a pulse of 124 bpm and blood pres-
sure 70/30. An emergency hysterectomy was per- References
formed to control bleeding. After the surgery the
patient was referred to a trophoblast screening 1. The Management of Gestational Trophoblastic
Disease Green Top Guideline No38. Royal College of
centre. Examination confirmed a vaginal metasta- Obstetricians and Gynaecologists.
sis and metastatic disease in the lungs. The patient 2. Gestational trophoblastic disease. 4th edn; 2015.
underwent several months of multi-agent chemo- isstd.org/gtd-book/front-page/.
therapy, and experienced nausea, vomiting,
Chemotherapy and Radiotherapy
in Gynaecological Cancer 70
Paul Symonds
70.1 Background Chemotherapy kills cancer largely by damag-

ing tumour DNA and preventing replication. It
Radiotherapy and/or chemotherapy following can be used for cure, symptom control, to reduce
surgery for cervix, endometrial, ovary or vulval risks of recurrence or to make other cancer treat-
cancer can decrease recurrence rates and improve ments such as radiotherapy more effective. Side
prognosis. Combined radiotherapy and chemo- effects are seen in other rapidly dividing normal
therapy can cure inoperable cervix cancer in a tissue such as bone marrow.
substantial number of cases (5 year survival stage
IIb-68%, IIIb-48%) but is associated with dam-
age to pelvic organs in 5–10% of patients. 70.2 Minimum Standards
Litigation following treatment for gynaecologi- and Clinical Governance
cal cancer is often centred round failure to give Issues
adjuvant treatment or complications of treatment
which is claimed to be inappropriate or negli- 70.2.1 Cervical Cancer
gently applied.
Radiotherapy is the use of ionising radiation to Occasionally general gynaecologists will carry
kill cancers. It is usually given in multiple treat- out a simple hysterectomy containing an undiag-
ments (fractions) to minimise damage to normal nosed cervical cancer. Such patients require post-
tissue. Radiation can be administered by linear operative radiotherapy or chemo-radiotherapy. In
accelerators (external beam) or by inserting a retrospective study the 5 year survival for
gamma ray sources into the tumour (brachyther- patients treated by non-radical hysterectomy was
apy). Side-effects of radiotherapy during treatment 51.4% which rose to 71.4% if the patient received
such as diarrhoea are common but usually settle postoperative radiotherapy [1]. Patients with high
rapidly. Ten percent or less of patients develop risk of pelvic recurrence after radical hysterec-
serious late complications which may occur tomy should receive postoperative radiotherapy
6 months to 5 years after treatment. These include or chemo-radiotherapy. There is no absolute
occlusion of the vagina, narrowing of the bowel agreement on indications but these include pelvic
requiring surgery or fistulae in bladder or bowel. lymph node spread, positive or narrow excision
margins (<5 mm) parametrial spread and in some
MDT’s lymphovascular space involvement. A
P. Symonds
University of Leicester, Leicester, UK large randomised trial [2] has shown chemo-
e-mail: rps8@leicester.ac.uk radiotherapy is superior to radiotherapy alone in

https://doi.org/10.1007/978-3-319-78683-4_70
384 P. Symonds
patients who have spread to pelvic lymph nodes, as shown in the Dutch PORTEC-1 trial [5]. Loco-
positive parametrial involvement or a positive regional recurrence was reduced but overall sur-
surgical margin following radical hysterectomy. vival was similar in patients treated by external
The progression free survival at four years was beam radiotherapy or just followed up carefully.
63% in the radiotherapy group and 80% in the Brachytherapy, as shown in the PORTEC-2 trial
radiotherapy and chemotherapy arm. can reduce vaginal recurrence from about 14 to
0.9% [6]. Brachytherapy is easy to administer via
a vaginal cylinder that can be inserted without an
70.2.2 Chemoradiotherapy for Cervix anaesthetic. Using a high dose rate brachytherapy
Cancer machine the treatment takes only a few minutes
and is normally given in two or three fractions
Chemoradiotherapy is now the standard of care 1–2 weeks apart.
in the UK for patients suffering from bulky stage It is usual practice to offer patients suitable for
Ib, stage II, III or IVa carcinoma of cervix. The vaginal brachytherapy a choice between immedi-
chemotherapy mainly used is weekly Cisplatin. A ate treatment or close observation. If there is
systematic review and meta-analysis has shown recurrence in the vagina, delayed radiotherapy
that the addition of chemotherapy to radiotherapy can eliminate tumour in about 65% of cases [5].
resulted in an absolute benefit in overall survival In practice about three quarters of patients choose
of 12% [3]. immediate brachytherapy and a quarter a policy
Typical UK survival and complication rates of close observation.
can be found in results of a Royal College of There remains a case for giving external beam
Radiologists audit [4]. Following chemoradio- radiotherapy to patients with poorly differenti-
therapy the 5 year disease free survival for Stage ated tumours penetrating more than halfway
IIb disease was 68% and for those with Stage IIIb through the myometrium. A meta-analysis and
48%. systemic review [7] showed that pelvic radiother-
Serious late effects were seen in 10% of the apy gave a 10% survival advantage to this group
patients. Gross narrowing of the vagina was seen of patients. It is common UK practice to offer
in 5% of patients which may be inevitable if the such patients and patients with Stage 2 (involve-
vagina was heavily involved by tumour as heal- ment of cervix) endometrial cancer immediate
ing would be with fibrosis leading to stenosis. radiotherapy or until recently entry into the
Serious damage to bladder or bowel requiring Anglo-Dutch PORTEC-3 trial. In the PORTEC-3
surgery was seen in 1–3% depending on the site trial the patients were randomised to radiother-
of organ damage. apy or chemoradiotherapy. The basis of this was
the incidence of distant metastasis is higher
among patients with high risk disease and there is
70.2.3 Endometrial Cancer some evidence that postoperative chemoradio-
therapy can reduce the development of distant
The mainstay of treatment is simple hysterec- metastasis [8]. The results of the PORTEC-3 are
tomy. Overall cure rates are in excess of 75% five awaited but the use of chemotherapy as adjuvant
year survival and only 20–30% of patients require treatment in patients with endometrial cancer is
any form of adjuvant treatment in the form of still an open question.
radiotherapy or chemotherapy. Such is the state
of knowledge at present that the case could be
made for administering or withholding adjuvant 70.2.4 Ovarian Cancer
therapy in some patients. There is no case for giv-
ing routine postoperative external beam radio- Chemotherapy is an essential part of the treat-
therapy in patients with intermediate risk tumours ment regime for ovarian cancer patients.
70 Chemotherapy and Radiotherapy in Gynaecological Cancer 385
Response rates of 70% are seen in Stage III/IV lower pathological complete response rate of
disease. The standard chemotherapy is about one third which enables more conservative
Carboplatin and Paclitaxel and when factors such surgery to be carried out successfully.
as second line chemotherapy and possible sec- Preoperative chemoradiotherapy should be dis-
ondary debulking surgery are taken into account cussed with suitable patients prior to any surgery
the five year survival in Stage III/IV ovarian can- that may result in the loss of rectum or bladder in
cer as shown in the ICON7 trial [9] is 50%. patients or very extensive reconstruction.
However it must be noted that only between one Tumours which spread to inguinal lymph
third and one half of those patients surviving to nodes have a much poorer prognosis than those
five years are cured. Paclitaxel and Carboplatin without nodal metastasis. Generally inguinal
have more toxicity than Carboplatin alone. In spread results in a five year survival of less than
particular Paclitaxel causes hair loss (not seen 50%. Randomised trials [13, 14] and retrospec-
with Carboplatin) and about 20% of patients tive studies [15] have shown radiotherapy and
develop a peripheral neuropathy which in a chemoradiotherapy improve 5 year survival in
minority of patients can be permanent. The evi- node positive patients.
dence for the use of Paclitaxel and Carboplatin,
albeit the standard therapy is in fact thin. The
ICON 3 randomised trial showed no advantage 70.3 Reasons for Litigation
between single agent Carboplatin or Paclitaxel
and Carboplatin [9]. The ICON 4 trial did show a 70.3.1 Cervical Cancer
small survival advantage in patients relapsing
after primary chemotherapy with Paclitaxel plus In the past increased toxicity was associated with
Carboplatin rather than Carboplatin alone [10]. badly placed applicators for brachytherapy treat-
In elderly and frail patients, or women who do ment and administering doses higher than toler-
not want to lose their hair, Carboplatin alone, ated by critical organs such as the rectum. Serious
which is well tolerated is the treatment of choice. complications occur in less than 10% of patients
The NICE advice is to discuss the advantages and [4]. When serious late damage has occurred it is
disadvantages of single agent Carboplatin alone always worthwhile reviewing the radiotherapy
versus combinations with the patient. planning imaging to check radiotherapy planning
More recently Bevacizumab, a monoclonal anti- and the position of applicators. Radiotherapy
body against VEGF (vascular endothelial growth doses, especially to critical organs should be
factor) has shown in the ICON 7 trial to increase carefully reviewed to see that they are in line with
progression free survival but not overall survival accepted tolerable dosage.
[11]. Clearly the use of Bevacizumab has got to be As radiotherapy for cervical cancer patients is
balanced against side effects including hyperten- now concentrated in a relatively few hands and
sion, proteinuria and gastrointestinal fistula. most centres treat according to well established
protocols, negligent radiotherapy treatment is
much rarer than would have been seen 20 years
70.2.5 Vulval Cancer ago. In the vast majority of cases radiation com-
plications are due to the fact that the patient had
Surgery is the treatment of choice. However pre- abnormal anatomy or unusually radiosensitive
operative radiotherapy combined with Cisplatin normal tissues.
can result in tumour shrinkage and potentially Many oncology centres have a separate set of
sphincter saving operations especially in young case notes. When notes are requested by a solici-
women with HPV associated vulval cancer. tor only the main hospital case records are pro-
The literature quotes complete response rates vided unless the solicitor specifically requests the
of up to 71% [12] but personal experience is of a oncology notes.
386 P. Symonds
70.3.2 Endometrial Cancer patients treated by chemoradiotherapy and can

be minimised by adhering to accepted critical
As the indications for adjuvant treatment in endo- organ tolerance dosage and precise positioning
metrial cancer have changed and are changing, of brachytherapy applicators. Allegations of
attempts at litigation centre round failure to offer using too high a dose or treating too big a vol-
adjuvant treatment or side effects from alleged ume can be rebutted if normal tissue tolerance
inappropriate treatment. limits have not been exceeded and treatment
doses are consistent with international practice.
• Chemotherapy is an essential part of the treat-
70.3.3 Ovarian Cancer ment of the majority of ovarian cancer patients.
Even if eligibility protocols are followed exactly
In a medico-legal context chemotherapy dosage <5% may develop potentially life threatening
should be checked for eligibility factors for che- neutropenic sepsis which must be recognised
motherapy such as white blood cell count, plate- and treated promptly. Adherence to standard
let count and renal function prior to administering chemotherapy protocols, often derived from
chemotherapy. The use of electronic prescribing clinical trials, with appropriate adjustments for
systems has reduced drug dosage errors but has renal function and bone marrow capacity usually
not eliminated them completely. prevent allegations of under or over dosage.
Neutropenia and thrombocytopenia are recog- • Extravasation of chemotherapy (especially
nised hazards of chemotherapy treatment and anthracyclines) is rare but can cause devastat-
provided the neutrophil count, platelets and other ing normal tissue damage. Extravasation of
factors such as renal function were adequate prior Carboplatin and Cisplatin (the most com-
to chemotherapy these complications cannot be monly used agents in gynaecological cancer)
judged as negligence. Patients with suspected or rarely results in normal tissue damage.
confirmed neutropenic sepsis should have a broad • The vulval skin is very radiosensitive and easily
spectrum antibiotic administered within an hour damaged but judiciously applied chemoradio-
of attending hospital. Delayed administration of therapy can reduce the extent of surgery and
antibiotics can result in death. improve prognosis in node positive patients.
70.3.4 Vulval Cancer 70.5 Case Study
Vulval skin is thin and is easily damaged by radi- A problem can arise if the computer has initially
ation doses which are very well tolerated else- been programmed incorrectly as occurred in a
where in the body. Medico-legal allegations much publicised case of bleomycin induced
include toxicity induced by treatment or paradox- lethal pulmonary toxicity [16].
ically failure to offer these therapies. The patient was suffering from poor prognosis
metastatic testicular cancer. He was entered into
an MRC trial and was randomised to the high
70.4 Avoidance of Litigation dose arm. The dose of bleomycin was incorrectly
entered into a computer and this error remained
• Appropriate patients after surgery for cervical unnoticed until the patient developed severe
or endometrial cancer should be considered bleomycin lung toxicity which ultimately proved
for adjuvant treatment. fatal. This led to a successful compensation claim
• Chemoradiotherapy is standard of care for and referral of the clinician to the GMC. Although
patients with bulky Stage Ib to Stage IVa cer- this is a non-gynaecology case it is in the public
vical cancer. domain and illustrates an important general prin-
• Serious complications such as fistula or bowel ciple that clinicians may be too trusting of com-
damage can develop in <10% of cervical cancer puter derived data.
70 Chemotherapy and Radiotherapy in Gynaecological Cancer 387
5. Creutzberg CL, van Putten WL, Koper PC, et al.

Surgery and postoperative radiotherapy versus sur-
Key Points: Chemotherapy and
gery alone for patients with Stage 1 endometrial carci-
Radiotherapy noma: multicentre randomised trial. PORTEC Study
• When discussing treatment options, the Group. Postoperative radiation therapy in endometrial
pros and cons of chemotherapy and carcinoma. Lancet. 2000;355:1404–11.
6. Nout RA, Smit VT, Putter H, et al. Vaginal brachy-
radiotherapy should be discussed in therapy versus pelvic external beam radiotherapy for
addition to any alternative treatments. patients with endometrial cancer of high-intermediate
• Patients should be informed of risks of risk (PORTEC-2): an open-label, non-inferiority ran-
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Index
A post-partum, 289
Abdominal circumference (AC), 121 post-void residual volume, 288
Abdominal hysterectomy, see Hysterectomy recovery of bladder function, 289
Abortion, 58, 313, 315, 316 risk factors and prevention, 288
conscientious objection, 315 trial without catheter, 288, 289
infection, features of, 315 voiding dysfunction, 288–290
litigation, 77 Adenomyosis, 222
medical, 313, 314 Adnexal masses, ovarian cancer, 340
mifepristone and misoprostol, 314 Advanced life support in obstetrics (ALSO), 187
minimum standards and clinical Advanced stage disease, 232
governance issues, 313–315 Advanced training skills module (ATSM), 208, 261
patient screening, 315 Airway assessment
retained products of conception, 315 blood pressure, 79
rhesus negative women, 315 damage, surrounding structures, 80
salpingitis infection, 316 event of litigation, 79
special consideration, 315 failed intubation, 79
surgical, 314 oesophageal intubation, 79
uterine perforation, risk of, 314 preoperative, 79
Abortion Act 1967, 313, 315 preoxygenation, 79
Accident, 57 risk factors, 79
Accidental awareness under general anaesthesia (AAGA) American College of Obstetricians and Gynaecologists
considerations, 78, 79 (ACOG) report, 158
detection of, 78 American fertility scoring system (AFS), 221
dosing errors, 78 Amniotic fluid embolus (AFE), 186
failure reasons, 78 Amniotomy, 116, 180
incidence of, 78 Anaesthesia, 73, 77–81
management, suspected case, 78 epidural, 73
and medical expert review, 78 general
preoperative communication, 78 airway management, 79, 80
risk factors, 78 awareness during operation, 81
Accidental dural puncture, 70 hospital guidelines, 77
Acute bladder overdistension, 287, 289 hypertensive intracranial haemorrhage, 80
Acute collapse, 185 litigation reasons, 78–80
Acute urinary retention, 287–290 need for, 77
bladder care guidelines, 287 neonatal complications, 80
clean intermittent catheterisation, 289 nerve injury, 80
clinical governance issues, 287 patient deaths, 80
indwelling catheterisation, 288, 289 post operative observations, 80
litigation standards for, 77
avoidance of, 287–289 intraoperative, 81
prevention of, 290 regional (see Regional anesthesia)
reasons for, 287, 288 spinal, 73
NICE guidance, 287 volatile, 81
post-operative/post-delivery bladder monitoring, 288, 289 Analgesia, to labour, 71

https://doi.org/10.1007/978-3-319-78683-4
390 Index
Androgen therapy, 320 laparoscopic entry techniques, 252

Androstenedione, 229 laparoscopic related complications, 249
Anembryonic/delayed miscarriage, 379, 380 laparoscopic repair, 251
Angiotensin converting enzyme (ACE) laparoscopic sterilisation procedure, 251
inhibitors, 99, 109 laparoscopy, 249, 250
Antenatal care, 85 litigation, 250
Antepartum haemorrhage, 128 open laparotomy, 250
Anterior arm injuries, 158 post-operative care, 251
Anterior shoulder, 153, 158 surgical technique, 251
Anterior trauma, 199 Bowel syndrome, 337
Antiphospholipid syndrome (APS), 109 Brachytherapy, 384
Apgar scores, 119, 134, 149 BRCA1 gene, 318
Arterial suture, 253 Breach of duty report, 48
Artificial rupture of membranes (ARM), 94 Breast cancer, 319
Asherman’s syndrome, 127, 194 British Gynaecological Cancer Society (BGCS), 373
Aspirin, 110 British Society for Gynaecological Endoscopy
Assisted conception, 302–304 (BSGE), 217
communication from referring clinician, 303 British Society of Urogynaecology (BSUG)
complications, 302 database, 275, 277
couple/individual, inadequate evaluation of, 302 Buddy approach, 164
delayed provision, 302
description, 301
HFEA Code of Practice, 302 C
hysteroscopy, 303 Caesarean scar pregnancy, 226
inadequate counselling, 302 Caesarean section (CS), 93, 94, 150, 151
litigation advantages, 147
avoidance of, 303, 304 avoidance of litigation, 150
reasons for, 302 classification for urgency, 147, 148
monofollicular ovulation induction, 304 documentation, 150
patient information, 303 fetal complications, 149
pelvic sepsis, 304 full dilatation sections, 148
person responsible, in clinics, 302 lower uterine segment, 148
role of clinicians practicing, 303, 304 maternal governance issues, 149
with severe endometriosis, 304 midline abdominal incision, 149
UK practice features, 301 organisational issues, 149
Association of Anaesthetists of Great Britain and Ireland ping-pong ball skull fracture, 148
(AAGBI), 73, 77 placenta removal, 148
Autologous fascial sling, 270 prophylactic antibiotics, 148
Autonomy, 8 RCOG clinical governance advice, 149, 150
reasons, numbers and claims, 147, 148
regional anaesthesia, 148
B SD, 155
Bailey v Ministry of Defence, 28 short term risks, 149
Beneficence, 8 skin incision, 148
Bilateral salpingo-oophorectomy (BSO), 230, 231, 318 vaginal breech delivery, 180
Bioidentical hormone therapy (BHT), 320 WHO surgical safety checklist, 148, 149
Birth asphyxia, 115 Cancer 2-week-wait referrals, 335
Birth defects, 89 Cancer pathways, 230
Birth plan, 71 Carboplatin, 386
Bladder injury, 243–245 Cardiac disease, 106, 107
Bladder monitoring, acute urinary retention, 289 autonomy in decision-making, 107
Bladder overdistension, see Acute bladder overdistension incidence, 105
Blood pressure, 79, 110, 111, 113 litigation
Bolam approach, 10 avoidance of, 106, 107
Bolam principle, 12, 15 reasons for, 106
Bolam standard, 31 mortality rates, 105
Bolam v Friern Hospital Management Committee, 27 placenta removal, 106
Bowel injury principles of management, 105
gynaecological procedures, 249 Cardiotocography (CTG), 164
incidence, 249 interpretation
Index 391
as abnormal, 134 epigastric artery, 255

avoidance of litigation, 137 intra-abdominal pressure, 254
clinical governance issues, 134 litigation, 255
continuous fetal monitoring, 133 port placement, 255
decelerations, 133 preoperative preparation and consent, 255
intrapartum, 134, 137 workplace-based assessments, 254
NICE guidelines, 134–136 Clinical Knowledge Summaries (CSK), 337
reasons for litigation, 134, 135, 137 Clinical negligence, 9, 27, 28
reduced variability, 137 Clinical Negligence and Other Risks Indemnity Scheme
Cardiovascular disease, 319 (CNORIS) in Scotland, 115
Care Quality Commission (CQC), 23, 24 Clinical Negligence Scheme for Trusts (CNST) in
Causation, 28, 29, 48 England, 115
Cervical cancer, 320, 383–385 Cognitive behavioral therapy, 320
chemoradiotherapy, 384 Colorectal cancer (CRC), 320
RAC clinic, 340 Colposcopy
Cervical glandular intraepithelial neoplasia (CGIN), 346 cervical screening loop, 357
Cervical Intraepithelial neoplasia (CIN), 346 clinical issues, 358
Cervical ripening agents, 94 competent colposcopist, 358
Cervical screening processes core requirements, 357, 358
absolute certainly concept, 348 histological abnormalities, 357
audit, 347 history, 357
Bolam test, 348 type I, II and III cervical transformation zone, 358
case analysis, 348 Colposuspension, 269, 270
cervical cytology, 348 Combined spinal-epidurals (CSE), 69, 73
communication, 347 Complementary therapies, 320
cytology, 346, 348 Complete mole, 379, 381
histology, 346 Concurrent surgery
HPV testing, 347 complications, 262, 263
investigation of symptoms, 346 patient positioning, 263
litigation, 347 Congenital abnormalities, 89
management, 347 Consent form, 19, 20
pre-malignant lesions, 345 Consent notices, in registration of births, 308
programme components, 345, 346 Consent process, 11, 213, 218, 274
Chaperone Continuous electronic fetal monitoring (cEFM), 180
advantages, 61 Coronary heart disease (CHD), 319
criteria, 61 Coroner
litigation, 62, 63 abortion, 58
minimal standards and clinical governance accident/misadventure, 57
issues, 62 England and Wales, 55
Chemoradiotherapy, 384, 386 history, 55
Chemotherapy, 383, 384, 386 inquest, 56, 58
CHIPS trial, 110 judicial investigation, 56
Chorionicity, 174 still birth, 57
Chronic hypertension, 109 unlawful killing, 57
Cisplatin, 384 unnatural death, 57
Civil Justice Council’s Guidance, 45 verdict, 56
Civil procedure rules (CPR), 45, 52 Counselling, 20
Clean intermittent catheterisation, 289 Court of Appeal, 28, 29
Clinical effectiveness unit (CEU), 329 Crown rump length (CRL), 174
Clinical governance issues CTG training, 164
bowel injury, 250 Cystectomy, 230
laparotomy, 235–237 Cytology, cervical, 346
urological injuries
anatomical dissection, 244
bladder injuries, 244 D
informed consent, 244 Death, 80
intraoperative evaluation, 244 Decision record, 20, 21
postoperative recognition of injury, 244, 245 Deep infiltrative disease, 221
vascular injury Dementia assessment for elderly patients, 235
duplex ultrasonography, 254 Depo Medroxy-Progesterone Acetate (DMPA), 326
392 Index
Dermoids, 230 Elective caesarean section, 180

Diabetes, in pregnancy, 101 Endometrial ablation, 208
incidence, 99 Endometrial biopsy, 342
litigation, 101 Endometrial cancer, 341, 386
management, 100 age, 367
mode of delivery, 100 case analysis, 370
obesity, 99 clinical governance issues, 368, 369
pre-existing diabetes, 99, 100 clinical situations, 370
significance, 99 diagnosis, 367
vaginal birth after caesarean section (VBAC), 100 grade 1 and 2, 369
vaginal delivery, 100 hysteroscopic guided biopsy, 367
20-week fetal anomaly scan, 100 litigation, 369
Diagnosis/delayed diagnosis errors, 12, 13 ovaries and tubes removal, 369
Diagnostic hysteroscopy, 217 pipelle® endometrial sampling, 367
Diamorphine, 68 referral standard, 368
Dichorionic twins, 175, 177 risk stratification, 368, 369
Diploma of the Royal College of Obstetricians & survival rate, 368
Gynaecologists (DRCOG), 335 treatment, 367, 368
Directorate of Legal Services (DLS), 33 2WW service, 367
Dizygous twining, 173 Endometriosis, 229
Doctor–patient relationship, 61 causes, 221
Down’s syndrome, 87 classification, 221
Duty of candour litigation, 222
professional duty, 23–25 NICE guidance, 222
statutory duty, 24, 25 treatment, 221, 222
Dyspareunia, 273 Entrustable Professional Activity, 254
Entry-related vascular injuries, 256
Epidural anaesthesia, 73
E Epigastric pain, 112
Early stage cervical cancer, 357, 358, 360 Episiotomy, 154
colposcopy 45 degree angles, 202
cervical screening loop, 357 60 degree angled episiotomy, 200
clinical issues, 358 60 degree angled mediolateral episiotomy, 199
competent colposcopist, 358 mediolateral episiotomy, 200, 202
core requirements, 357, 358 operative vaginal delivery, 203
histological abnormalities, 357 routine, 202, 203
history, 357 selective, 202
type II and III cervical transformation zone, 358 Epithelial ovarian cancer (EOC), see Ovarian cancer
healthy ovaries, removal, 359 Essential hypertension, 109
improving outcomes guidance, 359 Essure hysteroscopic sterilisation, 329
informed consent, 359 Essure sterilisation procedures, 331
litigation, 360 Estrogen therapy, 320
LLETZ, 361 Ethical principles, 3, 4
MDTs, 359 European Convention on Human Rights (ECHR), 56
micro-invasive cervical cancer, 359 European Society for Gynaecological Endoscopy
patient centred approach, 359 (ESGE), 217
patients counselling, 359 Excision surgery, 223
solid defence, 359 EXP v Barker, 53
stage 1b cancer, 361 Expert evidence, 54
stage 1b1 cancer, 359 Expert witness, 51–54
surgical management, 357 External anal sphincter (EAS) repair, 292
tumour doubling times, 360, 361 External beam radiotherapy, 384
Early Warning Score (EWS), 185 External cephalic version (ECV), 117, 179,
Ectopic pregnancy, 326 181, 182
diagnosis, 225
incidence, 225
reasons for litigation, 226 F
risk factors, 225 Faculty of Sexual & Reproductive Healthcare
ultrasound scanning, 225, 226 (FSRH), 329
ECV, see External cephalic version Faecal incontinence, 293
Index 393
Fallopian tube cancer, see Ovarian cancer regulatory proceedings, 37

Familial cancer syndromes, 231 sanction, 42
Fast track referral system, 335 self-report, 38
Female sterilisation, 329, 331 statistical data, 37, 38
contraception, 331 General Medical Counsel (GMC), 33
Filshie clip laparoscopic sterilisation, 329 General practitioner with special interests (GPwSI), 335
guidance on standards, 329, 330 General practitioners (GP), 335–337
hysteroscopic sterilisation, 330, 331 Genital trauma, systematic assessment, 202
litigation, 331 Germ cell tumours, 375
Fertilisation, 229 Gestational diabetes (GDM), 99
Fertility investigations, 297–299 body mass index (see Diabetes in pregnancy)
clarity, 298 diagnosis of, 99
failed IVF treatment, 299 management, 100
hydrosalpinx removal, 299 recommendations, 100
informed consent, 299 screening, 100
litigation Gestational hypertension, 109, 110
avoidance of, 298, 299 Gestational trophoblastic disease (GTD), 379, 380
reasons for, 298 litigation, 380
NICE recommendations minimum standards and clinical issues, 379
female, 297, 298 Gestational trophoblastic neoplastic (GTN), 379–381
male, 297 Gillick competent, 325
Fetal abnormalities Gillick criteria, 315
detection rates, 89 Glucagon, 100
non-detection (see Ultrasound screening) Glucose intolerance, 100
Fetal anomaly screening programme (FASP), 85, 87, 90 Glycine solution, 219
Fetal complications, 149 Glycosylated haemoglobin levels (HbA1c), 99
Fetal growth restriction (FGR), 124, 125 GMC, see General Medical Council
aetiology, 121 GMC v Meadow, 52
babies with, 122 Good Medical Practice (GMP), 37
causes, 121 GTD, see Gestational trophoblastic disease
clinical governance issues, 122, 123 Gynaecological cancer, 335, 383
counselling, 124 Gynaecology Assessment and Treatment Unit
delivery at extreme prematurity, 124 (GATU), 195
RCOG guideline, 122, 124 Gynaecology, medicolegal issues in, 54
screening, 122
SGA, 123
in utero transfer, 124 H
very early onset, 124 Haemoglobinuria, 112
Filshie clip laparoscopic sterilisation, 329 Haemorrhage, 186
Filshie clip techniques, 329–332 Harris v Johnston, 53
First-degree perineal tears, 199 Head circumference (HC), 121
Fistulation, 245 Heart disease, see Cardiac disease
Fluid overload, 218 Heavy menstrual bleeding (HMB), 207
Folic acid, 99 HELLP syndrome, 112
Food and drug administration (FDA), 273 Hepatocellular carcinoma, 320
Fresh eyes approach, 164 Hereditary breast and ovarian cancer syndrome, 231
High index of suspicion, 215
Histology, cervical, 346, 347
G Hormone replacement therapy (HRT), 317–321, 342
Gamete donation, 309 cochrane review, 317, 318
Gastric cancer, 320 individualised approach, 318
General anaesthesia, see Anaesthesia, general BRCA carriers, 318
General Medical Council (GMC), 23–25 postmenuopasual osteoporosis, 319, 320
concerns to investigate, 38–40 litigation, 321
guidance, 37 pros and cons of, 321
investigation, 40, 41 thromboembolic disease, 317
IOT hearings, 40 Huddersfield Royal Infirmary, 159
MPT hearing, 40–42 Human Fertilisation and Embryology Act 2008, 307
notification of criminal investigation, 38–40 Human Fertilisation and Embryology Authority
referral sources, 38 (HFEA), 301, 307
394 Index
Human papilloma virus (HPV), 346, 347 Intra-uterine insemination (IUI), 301
Human Rights Act 1998, 56 Intrauterine pregnancy, 226
Human WORM, 117 Investigation and Management of Hypertensive
Hydatidiform mole, 379 Disorders of Pregnancy, 109
Hyperglycaemia, 100, 101 In-vitro fertilization (IVF), 173, 301
Hyperglycaemia and Adverse Pregnancy Outcomes Isophane (NPH) insulin, 100
(HAPO) study, 99
Hypertension
chronic, 109 J
clinical governance issues, 110, 111 Joint guidance, 23
litigation Jones v Kaney, 46, 53
avoidance of, 111, 112
reasons for, 111
mild gestational hypertension, 110 K
moderate gestational hypertension, 110 Kielland’s forceps, 141
moderate risk factors, 110
proteinuria, 110
severe gestational hypertension, 110 L
single plus proteinuria, 113 Labour analgesia
symptoms, 110 capacity for woman, 70
Hypertensive intracranial haemorrhage, 80 consent for, 70
Hypoglycaemia, 100 non-pharmacological analgesia, 67
Hypotonic media, 219 pharmacological analgesia, 67, 68
Hypoxic injury, 137, 160 regional analgesia, 68–70
Hypoxic ischaemic encephalopathy (HIE), 158, 176 Labour induction, 96, 97
Hysterectomy, 171, 193, 229, 381, 383, 384 advantage of, 95
informed consent, 208 care pathway guidelines, 94
laparoscopic surgery, 207 complications, 94, 97
management, 207 contraindications, 94
litigation electronic fetal monitoring, 94
avoidance, 209, 210 failure, 95
cause of, 209 and fetal distress, 94
reasons for, 208 fetal perspective, 93
patient assessment, 208 hyperstimulation, 94
risks and benefits, 208 incidence, 93
Hysteropexy, 284 indications, 94
Hysteroscopic sterilisation, 330, 331 litigation, 96, 97
Hysteroscopy, 218 and maternal age, 96
maternal perspective, 93
methods of, 94
I Montgomery ruling, 95
Incomplete abortion, 315 non-pharmacological methods, 94
Induction, labour, see Labour induction in overdue pregnancy, 95
Indwelling catheterisation, 288, 289 pharmacological methods, 94
Infertility, see Fertility investigations and pre-eclampsia, 97
Informed consent, 9, 10 and previous caesarean section, 94
Insulin, 100, 102 reasons for, 93, 96
Interim Orders Tribunal (IOT) hearings, 40 spontaneous labour, 94
Internal anal sphincter (IAS) repair, 292 stillbirth risk, 95
International Menopausal Society, 318 uterine rupture, 94
International Ovarian Tumour Analysis (IOTA), 340 Laparoscopic sacrohysteropexy
Intimate examination, 61–63 non-dissolvable polyester sutures, 284
Intra-abdominal bleeding, 280 substandard counselling and consent, 284, 285
Intra-abdominal injury, 251 type 1 macroporous polypropylene abdominal mesh
Intra-cytoplasmic Sperm Injection (ICSI), 301 implants, 281
Intra-uterine device, 326 Laparoscopic urogynaecology, 282–284
Intrauterine growth restriction (IUGR), 121 consent, 282, 283
Index 395
counselling, 283 therapeutic procedure, 235, 238

litigation thromboembolism risk assessment, 237
avoidance of, 283, 284 transverse incision, 239
reasons for, 283 LARC, see Long-acting reversible contraception
RCOG accredited Urogynaecology subspecialty Laser, 230
training program, 283 Lichen Sclerosus, 275
sepsis from bowel/urinary tract injury, 284 Lithotomy, 154
substandard surgery, 283 Litigation process, 9
Laparoscopy Long-acting reversible contraception (LARC), 325, 327
complications, 213 litigation, 327
and dye test, 298 minimum standards and clinical governance
gas pressure, 214 issues, 325, 326
independent performance, 214 Lung cancer, 320
litigation, 215 Lynch syndrome, 231
port-site hernia, 214
post-operative care, 215
pre-operative counseling, 213, 214 M
primary port insertion, 214 Major obstetric haemorrhage (MOH), 185, 187, 194
primary port site, 214 Management of obstetric emergencies and trauma
requisite training, 214 (MOET), 181, 187
risks, 213, 214 Manufacturer and User Facility Device Experience
secondary port insertion, 214 (MAUDE) Database, 273
Laparotomy Massive obstetric haemorrhage, 130, 131, 255
altered sensation, 237 Material risk, 10, 16, 321
bladder care guidelines, 240 Materiality test, 16
care, 239 Maternal anaemia, 128
case selection and delegation, 238 Maternal collapse, 188, 189
for cholecystectomy, 240 acute, 187
co-morbidities, 236 cardiac arrest, 186
complications, 237 causes of, 185, 186
consent, 236 clinical governance issues, 186, 187
diagnostic imaging, 235 definition, 185
elective surgery, 235, 236 litigation, reasons for, 187
emergency and elective surgical care, 235 resuscitation, 187, 188
expectant and medical management, 235 reversible causes of, 189
exploratory, 235 treatment of, 186
gossypiboma/textiloma, 241 UK Resuscitation Council guidelines, 187
gynaecological conditions, 235 Maternal mortality, 185
infra-umbilical midline incision, 239 Maximum vertical pool (MVP), 176
litigation, 237 McCalls Culdoplasty, 278
midline incisions, 236, 239 McRobert’s manoeuvre, 154
open surgical procedures, 236 MDT, see Multidisciplinary team meetings
patient communication, 237 Meconium, 133–135, 137
patient’s health record, 238 Medical device reports (MDRs), 273
Pfannenstiel incision, 236 Medical litigation process
pre-operative assessment screening, 238 doctors witness statement, 33
pre-operative imaging, 235 formal proceedings, 32
pre-operative planning, 238 letter before action, 31, 32
prophylactic antibiotics, 239 letter of claim, 32
scalpel/cutting diathermy, 239 pre-action protocol, 32, 33
scheduled surgical care, 235 trial, 33, 34
single layer mass closure, 240 Medical paternalism, 28
surgical approach, 236 Medical Practitioners Tribunal (MPT), 41
surgical complications, 237, 238, 240 Medical Practitioners Tribunal Service (MPTS), 37
surgical incision, 235, 236 Medicines and Health Regulatory Agency (MHRA), 322
surgical treatment, 240 Mediolateral episiotomy, 200, 202
team working, 238 Menopausal hormone, 231
396 Index
Menstrual cycle, 229 National Cancer Plan, 351

Mental Capacity Act 2005, 16 outcomes, 351
Metformin, 99 resource, 352–355
Methotrexate, 227 Multiple pregnancy, 173
Midurethral synthetic slings
colposuspension, 265
conservative treatments, 265 N
cystoscopy, 267 National Health Service Litigation Authority
efficacy and safety, 266 (NHSLA), 85, 89
litigation, 266 National Institute for Health and Care Excellence
obturator tape, 267 (NICE), 217
patient counselling, 266 National Screening Committee, 85
preoperative assessment, 266 Nerve damage, 74
quality of life questionnaires, 265 Neville Barnes Forceps, 144
retropubic and suburethral infiltration, 267 Nexplanon system, 327
stress urinary incontinence, 265 NHS Litigation Authority (NHSLA), 9, 33, 133
trans-obturator tapes, 267 NHS Wales shared services partnership, 33
urodynamics, 265 NICE guidance, antenatal care, 85
Mild gestational hypertension, 110 NICE Guidelines 12 (NG12), 336
Misadventure, 57 Non-dissolvable polyester sutures, 284
Miscarriage, 225, 226 Non-epithelial ovarian cancer, 375, 376
Mis-located implants, 326 Non-invasive prenatal test (NIPT), 85, 87, 174
Moderate gestational hypertension, 110 Nursing and Midwifery Council (NMC), 23
Modern hysteroscopy, 217
Modified early warning score (MEWS), 185, 187, 191
Modified Pomeroy technique, 329 O
Molar pregnancy, 379–381 Objective Structured Assessment of Technical Skill
Monochorionic pregnancies, 173 (OSATS), 292
Monochorionic twins, 174–176 Obstetric Anaesthetists Association (OAA), 77
Monopolar electrocautery (diathermy), 230 Obstetric anal sphincter injury (OASI), 199, 202, 293
Montgomery approach, 10 aseptic techniques, 293
Montgomery ruling buttonhole tears, 291
birth choices, 17 endoanal sonography, 294
court decisions, 17, 18 external sphincter tear, 291
exceptions to provision of information, 16, 17 follow up after delivery, 293
fundamentals of consent, 16 formal training in repair techniques, 291
risk assessment, 16 high risk groups, 200
sufficient consent, 16 incidence, 291
Morbidly adherent placenta litigation, 293
classification of, 127 NICE, 200
Grayscale ultrasonography, 128 prevention, 292
risk of, 128 RCOG Green-Top Guideline, 200
Moschcowitz repair, 278 repair of tears, 291
Multi-agent chemotherapy, 381 risks in future pregnancies, 292
Multidisciplinary care, 105 with selective episiotomies, 202
Multidisciplinary meeting (MDM), see Multidisciplinary structural internal and external sphincter defect, 294
team meetings vaginal and rectal examination, 291
Multidisciplinary surgery, 223 vaginal delivery, 201
Multidisciplinary team (MDT) meetings, 339 Obstetric brachial plexus injury, 153, 158
attendance, 351–355 Obstetric claims, 9
basic/minimum set of data, 351 Obstetric early warning score, 185
cancer services, 351 Obstetric haemorrhage, 127, 129, 191
clinical situation, 353 Obstetrics, medicolegal issues in, 54
communication of results, 353 Obturator approach, 266
core members, 351, 352 Oesophageal intubation, 79
decision making, 351–353 Oestrogen, 229
documentation, 352 Office hysteroscopy, 342
grade 3 endometrioid endometrial cancer, 354 Online Mendelian Inheritance in Man (OMIM), 106
litigation, avoidance of, 354 Oophorectomy, 229–232
Index 397
Operative hysteroscopy, 217, 218 labour analgesia, 67–71

Operative vaginal birth (OVB), 142, 144, 145 minimum standards and clinical governance
appropriate counselling, 144 issues, 67
vs. caesarean section, 139 Pain, during caesarean section, 74
claims, 144 Parenthood agreement, 308
clinical governance issues, 141, 142 Partial moles, 379
decision-making process, 144 Patient autonomy, 105
operator, higher rates of complications, 140 Patient controlled epidural analgesia (PCEA), 69
post-Montgomery context, 144 Patient controlled opioid analgesia (PCA), 68
prerequisites for, 140 Pearce v Ove Arup, 52
RCOG guideline, 141 Pelvic floor disorders, 277
reduced analgesia requirements, 139 Pelvic inflammatory disease, 229
rotational operative birth, 140, 141 Pelvic organ prolapse, 266, 281
sequential instruments, 141 and continence surgery urodynamic
ventouse, 140, 141 investigations, 263
in UK, 139 counselling women for surgery, 282
Opioids, 68 and incontinence surgery, 261
Organisational issues, 149 law on informed consent, 282
Ovarian cancer, 320, 337, 384–386 lifestyle changes, 282
CA125, 375 management, 263
chemotherapy, 374 morbidity reduction, 261
clinical follow-up, 375 over-activity, 262
FIGO staging system, 377 patient counselling, 263
incidence, 373 patient related outcome measures, 262
litigation, 375, 376 post void residuals, 262
NICE issued guidance, 373 preoperative assessment, 263
non-epithelial ovarian cancer, 375, 376 prevalence, 261
primary care, 373 prophylaxis, 263
RAC clinic, 340 treatment, 261
recurrence, 375 voiding dysfunction, 262
screening and prevention, 374 Pelvic organ prolapse (POP), 279
secondary care management, 374 ring pessaries, 282
Ovarian conservation, 231 synthetic mesh, 281
Ovarian cysts, 229 Pelvic sepsis, 304
Ovarian drilling, 229, 230, 232 Perinatal death, 115
Ovarian hyperstimulation syndrome, 302–304 Perineal repair technique, 201
Ovarian reserve testing, 230, 231, 297 Perineal tears, 200
Ovarian surgery Perineal trauma, 141
complications, 229, 231 digital rectal examination, 201
infertility treatment, 229 RCOG, 201
informed consent, 231 Sultan classification, 200
litigation, 231 training and good practice, 201
open abdominal/laparoscopic route, 229 in UK, 199
ovary removal, 229 visual assessment, 202
precautions, 232 Permanent brachial plexus injury, 158, 159
preoperative counselling, 229, 231 Personhood, 4, 5
womans reproductive capability, 229 Pethidine, 68
Ovarian torsion, 229, 230 Pharmacological analgesia, 68
Ovarian tumours, 229 Placenta accreta, 130
Ovarian/tubo-ovarian abscess, 229 care bundle for women, 130
Ovulation status, luteal phase progesterone for, 297 conservative management of, 129
Oxytocin, 94 diagnosis of, 128
haemorrhage, 128
incidence of, 127
P maternal anaemia, 128
Pain management, 237 obstetric haemorrhage and its complications, 127
Pain relief in labour pre-operative planning, 131
avoidance of litigation, 71 previous caesarean sections and risk of, 130
birth plan, 71 surgical approaches, 129
398 Index
Placenta praevia, 130 litigation

anterior, 128 avoidance of, 86, 87
care bundle for women, 130 reasons for, 86
haemorrhage, 128 minimum standards, 85
hysterectomy, 128 sources of error in, 86
incidence of, 127 Preoperative chemoradiotherapy, 385
major praevia, 128 Preoperative radiotherapy, 385
maternal anaemia, 128 Preoxygenation, airway assessment, 79
minor praevia, 128 Preterm delivery, 110
obstetric haemorrhage and its complications, 127 Primary postpartum haemorrhage (PPH), 191, 192
pre-operative planning, 131 Professional boundaries, 63
previous caesarean sections and risk of, 130 Professional duty of candour, 23–25
surgical approaches, 129 Progesterone, 222, 229
transabdominal ultrasound, 128 Progestogen-only implants, 326, 327
Polygalactin suture, 201 Progestogen-only injections, 327
Polypropylene implant, 281 Prognosis report, 48
Posterior perineal tears, 199 Prophylactic oophorectomy, 231
Postmenopausal bleeding (PMB), 321, 340 Prostaglandin, 94
Postmenuopasual osteoporosis, 319 Prosthetic mesh materials, 281
androgen therapy, 320 Protein-creatinine ratio (PCR), 110
breast cancer, 319 Psychological assessment, surrogacy, 309
cardiovascular disease, 319
cervical cancer, 320
colorectal cancer, 320 R
complementary therapies, 320 Radiotherapy, 383, 384
endometrial safety and bleeding, 320 Randomized controlled trials (RCTs), 317
gastric cancer, 320 RCGP Good Medical Practice, 336
lung cancer, 320 Rectal button-hole tears, 199
ovarian cancer, 320 Rectovaginal disease, 222
venous thromboembolism, 319 Recto-vaginal endometriosis, 223
Postoperative ischemia, 253 Recto-vaginal septum, 221
Post-partum haemorrhage, 192, 193, 196 Regional anaesthesia, 148
avoidance of litigation, 194–196 litigation, 74, 75
claims for, 192 minimum standards and clinical governance issues,
clinical governance issues, 193, 194 73, 74
hysterectomy, 196 Regional analgesia, 70
litigation, reasons for, 194 Remifentanil, 68
morbidity rate, 191 Renal tract function, 246
prediction/prevention, 191 Report writing
primary postpartum haemorrhage, 191 breach of duty, 47, 48
recognition, 191 causation, 48
risk factors for, 192 condition and prognosis, 48
secondary post-partum haemorrhage legal and ethical framework, 45, 46
antibiotics, 193 Retropubic approach, 266
definition, 192 Risk of Malignancy Index (RMI) scoring
ultrasound, 193 system, 340, 374
uterine evacuation and hysteroscopy, 193 Risk reducing salpingo-oophorectomy (RRSO), 231
transvaginal ultrasound scan, 193 Rotational forceps, 141
treatment, 192 Rotational ventouse delivery, 141
Postpartum period, 329 Royal College of Obstetricians and Gynaecologists
Post-traumatic stress disorder (PTSD), 160 (RCOG), 217
Practical Obstetric multi-professional training Running a safe rapid access clinic (RAC), 341–343
(PROMPT), 181 cervical cancer, 340, 341
Preconception counselling, 106, 107 endometrial polyp, 343
Pre-eclampsia, 175 large necrotic submucous fibroid, 343
and labour induction, 97 litigation, avoidance of
MBRRACE (UK), 109 asymptomatic women, with thick
mild gestational hypertension, 110 endometrium, 342
transaminases, 112 CA 125 level, 342
Prenatal screening, 86, 87 clinical assessment, 341
Index 399
endometrial biopsy, 342 McRobert’s manoeuvre, 154

endometrial thickness, 341 neonatal hypoxic morbidity, 158
HRT, 342 obstetric brachial plexus injury, 158
office hysteroscopy, 342 second line manoeuvres, 154
ovarian cyst, 343 transient injuries, 158
recurrent postmenopausal bleeding, 342 Wood’s Screw and Rubin’s II, 154
tamoxifen, 341 Sigmoidoscopy, 223
TVS, 341 Sling surgery, 269
MDT meetings, 339 Small for gestational age (SGA), 121–123
ovarian cancer, 340, 341 Spencer v Hillingdon Hospitals NHS Trust [2015]
postmenopausal bleeding, 340 EWHC 1058, 18
vulval cancer, 341 Spinal anaesthesia, 73
Spinal anaesthetics, 261
Statutory duty of candour, 24, 25
S Sterilisation, 329–331
Salpingectomy, 229 Steri-Shot™ disposable Filshie clip applicators, 330
Scar rupture, 163, 165 Still birth, 57
Scientific Committee on Emerging and newly identified Stress urinary incontinence (SUI), 264–267, 269, 273
Health Risks (SCENIHR) opinion, 274 adequate evidence, 270
Scottish Confidential audit of severe maternal morbidity surgical options, 269
(SCASMM), 185 Subarachnoid haemorrhage (SAH), 111
SD, see Shoulder dystocia Subfertility
Second degree perineal tears, 199, 203 NICE definition, 297
Secondary post-partum haemorrhage, 193 treatment, 301
antibiotics, 193 Sudden infant death syndrome, 51
definition, 192 Supraovulation therapies, 173
ultrasound, 193 Suprapubic pressure, 154
uterine evacuation and hysteroscopy, 193 Surgical techniques, 208
Semen analysis (SA), 297 Surrogacy, 309, 310
Sepsis, 170, 172 adherence, 310
antibiotics requirements, 170 consent forms, anomalies related to, 310
clinical governance issues, 170 duty of care, failure of, 309
decision making, 171 foreign clinics, use of, 309, 310
definition, 169 legal parentage, lose of, 310
group A streptococcal infection, 169 litigation
group B streptococcus, 171 avoidance of, 309, 310
hysterectomy, 171 reasons for, 309
infection control, 169, 171 registration of births, 308
life-threatening condition, 171 Surrogacy arrangements, 309
maternal sepsis, risk factors for, 169 Suspected uterine dehiscence, 166
severe, 169 Symphysis pubis dysfunction (SPD), 159
six care bundle, 170 Symphysis-fundal height (SFH), 122, 123, 125
source control, 171 Synthetic oxytocinon (Syntocinon), 94
vaccination, 169 Systemic lupus erythematosus (SLE), 109
Septic shock, 169
Severe gestational hypertension, 110
Sex cord-stromal tumours, 375 T
Sexual misconduct, 62 T early stage cervical cancer, 358
Sexually-transmitted infections, 326 Tension free vaginal tape (TVT®), 273
Shoulder dystocia, 15 Term breech trial (TBT), 179
definition, 153 Termination ethics, 4
incidence of, 153 Termination of pregnancy, see Abortion
medical theories and expert opinions, 153 Tertiary referral hospital, 276
Shoulder dystocia (SD), 155, 158–160 Testosterone therapy, 229, 320
ACOG report, 158 Third party reproduction
anterior arm injuries, 158 consent process, 307, 308
clinical governance issues, 155 legal advice during error, 308 (see also Surrogacy)
excessive traction, 158 Thromboprophylaxis, 111, 278
HIE, 159 Tibolone, 318
internal manoeuvres, 154 Traditional tests of negligence, 15
400 Index
Transvaginal mesh implants, 266 Urethral diverticulum, 246

Transvaginal ultrasound (TVS), 341, 381 Urgent referral pathway, 339
Transversus abdominis plane block, 74 Urinary incontinence, 261
Treatment/surgery errors, 11, 12 Urinary retention, see Acute urinary retention
Trisomy 18, 13 and 21, 85 Urinary tract injuries
Tubal cancer, see Ovarian cancer clinical symptoms, 244
Turner’s syndrome, 87 incidence, 243
Twins laparoscopic assisted vaginal hysterectomy, 243
antenatally, 176 laparoscopic gynecological surgery, 243
chorionicity, 174 laparoscopic sacrocolpopexy, 246
clinical governance issues, 175, 176 litigation, 245, 246
deferment of pregnancy, 173 obstetric surgery, 246, 247
dichorionic twins, 175, 177 pelvic surgery, 243
discordant for fetal abnormality, 176 peristalsis, 243
dizygous twining, 173 radical hysterectomy, 247
intrapartum, 176 ureteral dissection, 243
monochorionic twins, 174, 176 ureteral integrity, 243
risks of preterm delivery, 176 ureteric obstruction, 244
subfertility treatment, increased ues of, 173 vaginal delivery, 246
supraovulation therapies, 173 Urine pregnancy test, 226
tertiary centre, 177 Urodynamic stress incontinence, 264
ultrasound scan, 174 Urodynamics, 275
Type 1 macroporous polypropylene abdominal mesh Urogenital atrophy, 279
implants, 281 Urogenital prolapse assessment, 281
Type I and II diabetes, see Diabetes in pregnancy Uterine perforation, 327
Uterine prolapse, 279
Uterine rupture, 163, 166
U
Ultrasound screening, 91
congenital abnormalities, 89 V
errors relating to, 90 Vacuum assisted delivery, 140
fetal structural abnormalities, 89 Vaginal birth after caesarian section (VBAC), 165, 166
litigation avoidance of litigation
avoidance of, 91 antenatal, 165, 166
reasons for, 90, 91 intrapartum, 166
multi-disciplinary approach, 91 clinical governance issues, 164
and obesity, 90 contraindications, 163
operator-dependent errors, 90 and diabetes, 100
trust for wrongful birth, 92 English NHS statistics, 163
Umbilical cord prolapse (UCP), 119 maternal morbidity, 164
clinical governance issues, 116 NHS Litigation Authority, 163
fetal acidosis, 116 RCOG guidelines, 163, 164, 166
Human WORM, 117 risks and benefits of, 165
incidence, 115 trust’s own guidelines, 166
intense staff training, 117 uterine rupture, risks of, 164
management of, 115, 116, 118 Vaginal bleeding, 381
medico-legal risk free’ environment, 117 Vaginal brachytherapy, 384
optimising intrapartum outcomes, 117 Vaginal breech delivery, 181, 182
perinatal mortality, 115 amniotomy, 180
risk factors, 115, 117 avoidance of litigation
single prolonged deceleration, 117 experienced obstetrician in attendance, 182
urgent operative vaginal delivery, 117 intrapartum protocol, adherence to, 182
Unexplained subfertility, 298 strict selection criteria, 181
Unilateral oophorectomy, 230 caesarean section, 180
Unlawful killing, 57 clinical governance issues, 180, 181
Unnatural death, 57 ECV, 179
Unprotected sexual intercourse (UPSI), 327 incidence of, 179
Ureteric injury, 209, 243–245, 263 litigation, reason for, 181
Ureteric stents, 223 mode of delivery, 180
Uretero-uterine fistula, 247 TBT, 179
Index 401
Vaginal epithelium, 278 Visceral injury, 210, 250, 279

Vaginal hysterectomy, 277 Voiding dysfunction, 288–290
contraindications and caution, 277 Voiding problems, 271
pelvic floor repair, 279 Vulval cancer, 364, 385, 386
reasons for litigation, 278 Vulval dermatoses with malignant potential, 363
Vaginal surgery, 262, 273 Vulval disorders
Vasa praevia, 127, 130, 131 clinical studies, 365, 366
colour Doppler transvaginal scan, 131 litigation, 364, 365
colour Doppler ultrasound, 129 VIN, 364
Vascular endothelial growth factor (VEGF), 385 vulval dermatoses with malignant potential, 363, 364
Vascular injury Vulval intraepithelial neoplasia (VIN), 364
complications, 253
electrocoagulation, 256
entry-related laparoscopic injuries, 253 W
laparoscopic sterilisation, 256 Waterlow score, 256
management, 256 2 week wait referral (2ww), 335, 367
postoperative limb symptoms, 256 20-week anomaly scan, see Ultrasound screening
radical hysterectomy, 257 Welsh Risk Pool in Wales, 115
Vascular surgeon, 215 WHO surgical safety checklist, 237, 238
Vasectomy, 329 Wright v Cambridge Medical Group, 29
Vasoconstrictor agents, 278 Wrongful birth, 89
Vasomotor symptoms (VMS), 319
Venous thromboembolism (VTE), 148, 317, 319
Venous thrombosis, 317 Z
Ventouse delivery, 141 Zavanelli manoeuvre, 154
Veress needles injuries, 251

Medicolegal Issues in Obstetrics and Gynaecology: Swati Jha Emma Ferriman

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Medicolegal Issues

ISBN 978-3-319-78682-7 ISBN 978-3-319-78683-4 (eBook)

Library of Congress Control Number: 2018940256

© Springer International Publishing AG, part of Springer Nature 2018

The UK is experiencing a dramatic increase in medico-legal claims. The four

Sheffield, UK Swati Jha

1 Ethics in Medicine�������������������������������������������������������������������������� 3

Part II Anaesthesia in Obstetrics and Gynaecology

13 Pain Relief�������������������������������������������������������������������������������������� 67

Part III Obstetrics

16 Prenatal Screening and Diagnosis������������������������������������������������ 85

29 Vaginal Birth After Caesarean Section, Uterine Rupture���������� 163

Part IV General Gynaecology

36 Abdominal Hysterectomy�������������������������������������������������������������� 207

46 Vaginal Repair and Concurrent Prolapse

Part VI Infertility, Subfertility and the Menopause

54 Fertility Testing and Treatment Decisions ���������������������������������� 297

Part VII Oncology

61 Fast Track Referrals and GP Perspectives���������������������������������� 335

1.1  he Difference Between

© Springer International Publishing AG, part of Springer Nature 2018 3

­ anting to live” but that fact alone may not

2.1 Introduction Most clinical negligence claims in England and

Following the 2015 case of Montgomery [4], a doc-

© Springer International Publishing AG, part of Springer Nature 2018 9

respected professional opinion.” A doctor who

in the higher courts, the legal principles relating to

3.1 Background Mrs. Montgomery claimed that had she been

© Springer International Publishing AG, part of Springer Nature 2018 15

1. Where treatment is provided out of necessity 3.4  ourt Decisions Since

Key Points: Consent After Montgomery

4.1 Introduction and abbreviations that mean nothing to most lay

E. Thomas (*) · B. Leigh 1. It implies that consent was sought at the

© Springer International Publishing AG, part of Springer Nature 2018 19

5.1 Background and midwives work closely together, the GMC

© Springer International Publishing AG, part of Springer Nature 2018 23

5.4 Consequences of Not nal fistula. This had occurred as a consequence of

with another apology, and she was invited back to

© Springer International Publishing AG, part of Springer Nature 2018 27

7.1 Introduction 7.2 Letter Before Action

© Springer International Publishing AG, part of Springer Nature 2018 31

REQUEST FOR LETTER OF

• Claimant(s) suffers adverse • C requests copies of medical • C sends Letter of Notification

Fig. 7.1 The legal process simplified

Some cases will be settled out of court usually

justice.gov.uk/courts/procedure-rules/civil/protocol/ 7. NHS Resolution. Five years of cerebral palsy

8.1 Background and performance; safety and quality; communica-

© Springer International Publishing AG, part of Springer Nature 2018 37

Fig. 8.1 GMC 1451

• Repeated/pattern of concerns about clinical competence, a practitioner is likely to be invited

sumption of impaired fitness to practice because permitted except in exceptional circumstances

References 6. Which replaced the Notifiable Occupations Scheme

9.1 Introduction Key Legal and Ethical Principles

© Springer International Publishing AG, part of Springer Nature 2018 45

indemnity insurance in place which specifically

10.1 Background 10.2 D

© Springer International Publishing AG, part of Springer Nature 2018 51

11.1 History Coroners and Justice Act 2009. Strictly speak-

© Springer International Publishing AG, part of Springer Nature 2018 55

Sheffield, UK Swati Jha

1 Ethics in Medicine�� 3

Part II Anaesthesia in Obstetrics and Gynaecology

13 Pain Relief�� 67

16 Prenatal Screening and Diagnosis�� 85

29 Vaginal Birth After Caesarean Section, Uterine Rupture�� 163

36 Abdominal Hysterectomy�� 207

46 Vaginal Repair and Concurrent Prolapse

Part VI Infertility, Subfertility and the Menopause

54 Fertility Testing and Treatment Decisions �� 297

61 Fast Track Referrals and GP Perspectives�� 335

1.1 he Difference Between

anting to live” but that fact alone may not

2.1 Introduction Most clinical negligence claims in England and

3.1 Background Mrs. Montgomery claimed that had she been

1. Where treatment is provided out of necessity 3.4 ourt Decisions Since

4.1 Introduction and abbreviations that mean nothing to most lay

5.1 Background and midwives work closely together, the GMC

5.4 Consequences of Not nal fistula. This had occurred as a consequence of

7.1 Introduction 7.2 Letter Before Action

8.1 Background and performance; safety and quality; communica-

9.1 Introduction Key Legal and Ethical Principles

11.1 History Coroners and Justice Act 2009. Strictly speak-

11.3 The Investigation experts. The questioning of witnesses must be

12.1 Background –– Reassure the patient if they demonstrate signs

13.2 Minimum Standards A variety of psychological and physical methods

13.3.2.2 Systemic Opioids Table 13.1 Indications and contraindications for

13.3.3.3 Management of Inadequate the mechanics of labour or fetal pressure on nerves.

can be downloaded to facilitate discussion 13.5 Case Study

14.1 Background precautions. Ultrasound scanning provides real-

15.1 Background 15.2 M

15.3.3 Hypertensive Intracranial

15.3.5 Neonatal Harm

16.1 Background non-invasive prenatal testing (NIPT). Women

days is recommended. Women deemed to be 16.4 Reasons for Litigation

17.1 Background sonography service, whether the ultrasound scan

17.2 Minimum Standards an anomaly scan if they do not wish to be informed

18.1 Background tion of labour. For example, a previous history of

19.1 Background 19.2 Minimum Standards

Diabetes in pregnancy significantly increases 19.2.1 Pre-existing Diabetes

20.1 Background courage pregnancy in women with certain severe

21.1 Background better care [1]. In the most recent 2013–2015

22.1 Background artery. This appears to be an all or nothing event,

23.1 Background It is the identification of genuine FGR that is

24.1 Background Table 24.1 Classification of the morbidly adherent

25.1 Background cations for continuous fetal monitoring. These