Insertion of An Intrauterine Contraceptive Device After Induced or Spontaneous Abortion: A Review of The Evidence

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Insertion of an intrauterine contraceptive device after induced or

spontaneous abortion: a review of the evidence


Nancy L. Stanwood
a,b,
*
, David A. Grimes
b,c
, Kenneth F. Schulz
b,c
Objective Assess the safety and efcacy of intrauterine contraceptive device (IUCD) insertion immediately after
induced or spontaneous abortion.
Design Systematic search for randomised trials that had at least one treatment arm that involved IUCD insertion
immediately after an induced or spontaneous miscarriage using Medline, Popline, EMBASE, and review
articles supplemented by correspondence with investigators.
Population Women of any age or gravidity who had an IUCD inserted immediately after evacuation for
spontaneous or induced abortion.
Methods Articles were abstracted and the raw data from tables were analysed with RevMan 3.1 software. We
focused on Tietze-Potter gross life table probabilities with denominators of person-time of exposure.
Main outcome measures Rates of perforation, expulsion, pelvic inammatory disease, contraceptive failure,
and method continuation.
Results Complication rates for immediate post-abortal IUCD insertion were low. Perforation was rare with a rate
of approximately one per 1000 insertions. One year gross cumulative expulsion rates ranged from 1.8% to
12.6%, pregnancy rates from 0.6% to 2.1%, and continuation rates from 54% to 90%. The net discontinuation
rate due to pelvic inammatory disease was low, ranging from 0.0 to 0.8 per 100 women at one year.
Increasing gestational age at insertion was associated with increased expulsion rates.
Conclusions Post-abortal IUCD insertion is safe and effective. The risks of perforation, expulsion, pelvic
inammatory disease and contraceptive failure were low and similar to those reported for interval insertion.
Second trimester gestational age is associated with an increased risk of expulsion. Immediate insertion may
have a higher expulsion rate than delayed insertion. However, these risks may be outweighed by the benet of
immediate contraception.
INTRODUCTION
For those women who choose an intrauterine contra-
ceptive device (IUCD) as their post-abortal method of
contraception, immediate insertion has many benets
compared with later insertion. Ovulation returns soon
after abortion, with half of women ovulating by 21
days after the procedure
1
. Immediate post-abortal inser-
tion provides immediate contraceptive protection.
Furthermore, the woman avoids the potential inconveni-
ence, discomfort and bleeding of a separate insertion
procedure. Finally, her motivation for contraception is
often high.
However, clinicians have feared that rates of IUCD
perforation and expulsion may be higher in the post-
abortal uterus due to its softness and enlargement.
Immediate post-abortal IUCD insertion may increase
the risk of upper genital tract infection after abortion.
Finally, the contraceptive efcacy of the IUCD after
post-abortal insertion and the method continuation rate
are unclear. The purpose of this review was to assess the
safety and efcacy of immediate post-abortal IUCD
insertion.
METHODS
We performed a systematic search of the literature for
randomised controlled trials that had at least one treat-
ment arm that involved IUCD insertion immediately after
an induced or spontaneous abortion using Medline,
Popline, the Cochrane Controlled Trials Register and
EMBASE, complemented by review articles and contacts
with the investigators. We used the following key word
combinations: (post-abortal IUCD insertions or IUD or
IUCD or intrauterine devices) and (post-abortion or post-
abortal or abortion, induced or abortion, therapeutic or
abortion, spontaneous) and (random or randomized
controlled trial or controlled clinical trial or random
q RCOG 2001 British Journal of Obstetrics and Gynaecology
PII: S0306- 5456(01)00264-9 www.bjog-elsevier.com
a
Robert Wood Johnson Clinical Scholars Program,
University of North Carolina School of Medicine, Chapel
Hill, USA
b
Department of Obstetrics and Gynecology, University of
North Carolina School of Medicine, Chapel Hill, USA
c
Family Health International, Research Triangle Park,
North Carolina, USA
* Correspondence: Dr N. L. Stanwood, Department of Obstetrics and
Gynecology, University of Rochester Medical Centre, Box 668, 601
Elmwood Avenue, Rochester, New York 14642-8668, USA.
British Journal of Obstetrics and Gynaecology
November 2001, Vol. 108, pp. 11681173
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Table 1. Randomised controlled trials of immediate post-abortal IUCD insertion. MLCu multiload copper; NR not reported; Cu copper.
Follow up Cumulative incidence per 100 women at 1 year Continuation
at 1 year (%)
Study Participants n Years Woman-years Rate
a
Comparisons Expulsion PID Pregnancy Perforation
Gillett et al.
12
Women having rst-trimester vacuum 259 1 95 Net Immediate Insertion Copper 7 15.4 NR 2.3 NR NR
aspiration abortion at 3 sites in Canada. Delayed Insertion Copper 7 2.8 NR 0.0 NR NR
Lim et al.
16
Women aged 18-40 years having rst- 549 2 820 Gross MLCu 250 1.9 NR 0.8 NR 80
trimester suction curettage abortion in MLCu 375 1.8 NR 2.1 NR 71
Singapore
McCarthy et al.
13
Women age 16-40 years having 400 2 541 Gross Nova T 6.5 NR 1.8 NR NR
elective abortion in Singapore. MLCu 250 6.3 NR 0.6 NR NR
Nielson et al.
14
Women having vacuum aspiration 331 3 565 Gross
b
Nova T 17.3
b
11.2
b
2.0
b
NR 33.8
b
abortion (96% in the rst trimester) in Copper T 11.9
b
7.6
b
8.9
b
NR 37.5
b
Denmark & Finland.
Randic & Balogh
17
Women having rst-trimester D&C 464 2 NR NR Hydron-coated Spring Coil 3.4 NR 0.5 NR 90
abortion in Yugoslavia Spring Coil 3.6 NR 1.0 NR 91
Randic et al.
15
Women age 18-40 years having rst- 400 10 2057 Gross Lippes Loop D 12.6 NR 4.6 NR 78
trimester medical abortion in Lippes Loop D 1 Cu Sleeve 4.5 NR 0.6 NR 90
Yugoslavia.
WHO 1983a
6
Women having elective abortion (96% 2340 2 2887 Net TCu 220C 4.4 0.3 1.7 0.1 61
rst-trimester, 94% by suction and/or Lippes Loop D 9.6 0.3 3.7 0.0 55
sharp curettage) in eight countries
c
Copper 7 8.4 0.7 3.6 0.3 54
WHO 1983b
11
Women having evacuation of the uterus 1060 2 1364 Net TCu 220C 9.2 0.8 0.7 0.0 65
(89% ,13 weeks gestation, 99% by Lippes Loop D 13.2 0.0 2.4 0.3 60
D&C) for spontaneous abortion in six Copper 7 12.7 0.4 1.1 0.0 63
countries
d
a
Net (competing) and Gross (non-competing) cumulative rates.
b
Rates from Nielson et al.
14
reported at 3 years after insertion.
c
Cuba, Yugoslavia, United Kingdom, Zambia, India, South Korea, Singapore, Hungary.
d
Egypt, United Kingdom, Zambia, Philippines, Chile, Singapore.
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allocation or clinical trial or randomized controlled
trials.) We looked in the list of references from these
articles for additional citations. We also sent our list of
citations to investigators in the eld to seek other studies
we might have missed.
We included a study if it was a randomised controlled
trial with at least one treatment arm of post-abortal IUCD
insertion, but did not specify the randomised comparison
made. We found 12 such trials, but excluded one due to
alternate rather than random assignment
2
and one due to
lack of our main outcomes
3
. We excluded two studies
4,5
due to unethical practice. In each, the researchers
performed sham IUCD insertions during which the
women believed they received an IUCD and were
protected against pregnancy, but one was not inserted.
Additionally, these two studies had design aws that
would have disqualied them; one reported only bleeding
and pain outcomes at one month
5
and the other reported
outcomes at six months but did not provide data on
person-time exposure or loss to follow up
4
.
Of the resultant eight trials, seven compared different
devices in the post-abortal setting and one compared
immediate to delayed insertion timing (Table 1).
The trials enrolled women of any age or any gravidity
who underwent IUCD insertion immediately after curet-
tage for either spontaneous or induced abortion. In one
World Health Organisation (WHO) study
6
, nearly all
patients had suction curettage, but 2.3% of the subjects
underwent medical abortion with prostaglandins. The
nine trials took place in 11 countries (Canada, Singapore,
Denmark, Sweden, Yugoslavia, Finland, Egypt, England,
Zambia, Philippines, and Chile) during the 1970s and
1980s (Table 1).
Two reviewers read the titles and abstracts of all poten-
tial citations, reviewed the articles, and independently
examined each for possible inclusion and quality
7
. We
abstracted the resultant articles and formatted the data in
absolute risks with common person-time denominators
focusing on Tietze-Potter gross life table probabilities
8,9
.
Using Cochrane Collaboration RevMan 3.1 software, we
calculated Peto odds ratios for comparisons made within
each trial
10
.
We aggregated the results for all three devices within
each of the two WHO trials
6,11
. For pregnancy and pelvic
inammatory disease, the numerators were the number of
discontinuations for a given reason and the denominators
were person-time units of exposure. For perforation,
expulsion, and continuation the numerators were the
number of discontinuations for a given reason and the
denominators were the number of insertions. We aggre-
gated using the RevMan 3.1 software. It produced reason-
able results, but does not, as yet, fully handle survival
data
10
.
The main outcomes were rates of perforation, expul-
sion, upper genital tract infection, contraceptive failure,
and method continuation.
RESULTS
Eight trials met our inclusion criteria (Table 1). Over-
all, the two WHO studies were the largest and best, with
4476 woman-years of data
6,11
. They used standardised
denitions and explicit reporting of outcomes. They
reported their results in net (competing) cumulative
rates. Each trial compared three devices (TCu 220C,
Lippes Loop D, Copper 7), the rst in the setting of
insertion after induced surgical abortion
6
, the second
after curettage for miscarriage
11
. We derived the follow-
ing rates from these two WHO-conducted studies, pool-
ing data from all three devices within each trial.
At two years of follow up, the trial of IUCD insertion
immediately following induced abortion
6
reported three
perforations in 2348 insertions (one per 1000 insertions),
157 expulsions (7%), 70 intrauterine or ectopic pregnan-
cies (two per 100 woman-years), and 12 cases of pelvic
inammatory disease (0.4 per 100 woman-years). The
trial of IUCD insertion following miscarriage
11
reported
one perforation in 1060 insertions (0.9 per 1000 inser-
tions), 128 expulsions (0.9%), 21 intrauterine pregnan-
cies (two per 100 woman-years), and three cases of pelvic
inammatory disease (0.2 per 100 woman-years) at the
end of two years. For both trials, continuation rates at one
year ranged from 54% to 64%
6,11
.
In these WHO trials, the Copper T 220C proved super-
ior to the Lippes Loop D and Copper 7. The combined
data from both trials showed that the TCu 200C had
signicantly lower pregnancy and expulsion rates than
the other two devices. The likelihood of pregnancy for
the TCu 200C was 60% lower (OR 0.4, 95% CI 0.20.7)
than the Lippes Loop D and 50% lower (OR 0.5, 95% CI
0.30.8) than the Copper 7
6,11
.
1170 N. L. STANWOOD ET AL.
Fig. 1. Cumulative risk of expulsion at 12 months, by gestational age at
induced abortion and type of IUCD
6
. A TCu 220C; B Lippes Loop D; g
Copper 7.
q RCOG 2001 Br J Obstet Gynaecol 108, pp. 11681173
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Table 2. Study quality measures of randomised controlled trials of immediate post-abortal IUCD insertion.
Study A priori
hypothesis
Sample size or
power calculation
Computer-generated
random sequence
Allocation
concealment
Masked
assessment
Notes
Gillett et al.
12
No No Yes
a
Yes
a
No 40% of women assigned to delayed insertion did not return
Lim et al.
16
No No Yes
a
Yes
a
No
McCarthy et al.
13
No No Yes
a
Yes
a
No
Nielson et al.
14
No No Unknown Unknown No Rates given at 36 months only.
Randic & Balogh
17
No No Yes
a
Yes
a
Yes Reported only rates, not raw data.
Randic et al.
15
No No Yes
a
Yes
a
Yes
WHO 1983a
6
No No Yes
a
Yes
a
No Twelve patients with complications within 48 hours of insertion were
excluded from analysis.
WHO 1983b
11
No No Yes Yes No One patient with complications within 48 hours of insertion was
excluded from analysis.
a
Conrmed by communication with authors.
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In the one trial that directly compared immediate with
delayed post-abortal insertions
12
, the authors found no
statistically signicant differences. The study protocol
called for insertion of the Copper 7 device either imme-
diately after abortion or three to ve weeks later. The
higher expulsion rates in the immediate insertion groups
(OR 2.9, 95% CI 1.08.7) was not statistically signicant.
After abortion, 40% of women who were to receive
delayed insertion did not return for the procedure.
For contraceptive efcacy, the Multiload Copper 250
(MLCu 250) performed better than the Nova T
13
, which
performed better than the Copper T 200
14
. No other
signicant differences were found in these two compar-
isons. Addition of a copper sleeve to the Lippes Loop D
signicantly improved contraceptive efcacy and
reduced rates of expulsion
15
. No signicant differences
were found between the outcomes for the MLCu 250 and
the MLCu 375
16
or for the Spring Coil with and without
the hydrogel coating
17
.
Risk of expulsion increased with advancing gestational
age (Fig. 1). In the WHO study after induced abortion
6
,
this association was signicant for all three devices
tested. For the TCu 220C, the risk of expulsion rose 4.5
fold from late rst-trimester to second-trimester abor-
tions.
Overall, the trials were of fair quality (Table 2)
7
. None
reported a priori hypotheses or sample size or power
calculations. Most of the reports lacked specic informa-
tion about the methods of randomisation and allocation
concealment, and communication with authors was
required to conrm methodological details. Only two
trials
15,17
explicitly reported masking of the clinicians
who performed follow up exams.
DISCUSSION
Post-abortal IUCD insertion is both safe and effective.
The absolute rates of perforation, expulsion, upper geni-
tal tract infection, contraceptive failure and method
discontinuation were all low. These rates are comparable
to those reported for interval IUCDinsertion with modern
copper devices
1823
. Overall, devices with copper had
lower pregnancy rates than those without copper, and
devices with a T shape had lower expulsion rates
compared with other shapes. The risk of expulsion
increased with increasing gestational age
6,11
and expul-
sion may be higher in immediate compared with delayed
post-abortal insertion
12
.
Increasing gestational age increases the risk of expul-
sion, but no clear threshold exists. Although clinicians
may view a 30% risk of expulsion as excessive, a
woman may nd acceptable a 70% chance that she
needs only one procedure. Counselling her about the
chance of expulsion will allow her to decide what risk
of expulsion she is willing to take to avoid a second
procedure. In such cases, the one-month follow up exam-
ination may be crucial to identify asymptomatic expul-
sion.
In the one trial that directly compared timing of inser-
tion, there was a non-signicant trend toward higher
expulsion for immediate insertion compared with inser-
tion three to ve weeks after abortion. No other differ-
ences emerged
12
. Its small numbers, lack of a power
calculation, and high loss to follow up limit inferences
from this study. In the delayed insertion group, a signi-
cant proportion of women (40%) did not return. These
women may have begun alternative contraception or they
may have chosen to use no contraception.
Insertion of an IUCD at the time of abortion has
several benets. The woman initiates highly effective
contraception before her next ovulation and she avoids
the need for a separate insertion procedure. Clinicians
traditional fears of high rates of perforation or pelvic
inammatory disease appear unfounded. Low rates of
pelvic inammatory disease were also evident in the
treatment of miscarriage in settings where some sponta-
neous abortions may have been clandestine induced
abortion
11
.
Professional guidelines and industry package labelling
that argue against post-abortal IUCD insertion lack a
scientic foundation. While the risk of expulsion is
greater with increasing gestation and may be greater for
immediate than delayed insertion, these potential disad-
vantages may be outweighed by the ability to provide
immediate highly effective contraception to women
with one procedure.
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Accepted 10 July 2001
POST-ABORTAL IUCD INSERTION 1173
q RCOG 2001 Br J Obstet Gynaecol 108, pp. 11681173

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