4170 15385 1 PB 2
4170 15385 1 PB 2
4170 15385 1 PB 2
DOI: http://dx.doi.org/10.18203/2320-1770.ijrcog20180201
Original Research Article
Department of Obstetrics and Gynecology, Government Medical College, Aurangabad, Maharashtra, India
*Correspondence:
Dr. Yogita Gavit,
E-mail: dryogita1990@gmail.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
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ABSTRACT
Background: This study was conducted to compare oral Nifedipine and intravenous Labetalol in control of acute
hypertension in severe pre-eclampsia and eclampsia. This study was observational study with 80 sample size in which
40 sample size treated with intravenous Labetalol and other 40 sample size treated with oral Nifedipine. The maternal
and perinatal outcome in two groups sample size with oral Nifedipine and intravenous Labetalol compared and found
that nevertheless these results do establish oral Nifedipine as an alternative to IV Labetalol in lowering BP in acute
severe hypertension. In summary oral Nifedipine may be preferable as it has a convenient dosing pattern orally.
Methods: The present study was conducted in tertiary care centre Mumbai from June 2016 to October 2016. All
pregnant woman diagnosed with acute hypertension in severe pre-eclampsia and eclampsia in labour room were
enrolled in the study.
Results: In the present study oral Nifedipine as an alternative to IV Labetalol in lowering BP in acute severe
hypertension. In summary oral Nifedipine may be preferable as it has a convenient dosing pattern orally.
Conclusions: A hypertensive disorder of pregnancy is one of the life-threatening complication encountered in obstetrics
and globally is major cause of maternal morbidity and mortality. Management of acute severe hypertension in
pregnancy is a challenging task. Present study compares the efficacy of oral Nifedipine and IV Labetalol in reaching
the therapeutic goal. From the results of this study we can well conclude that oral Nifedipine is more efficacious.
International Journal of Reproduction, Contraception, Obstetrics and Gynecology Volume 7 · Issue 2 Page 720
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(Group B): Oral Nifedipine 10 mg stat and then repeated Primigravida, Shekhar et al 58 out of 60 patients were
as 5mg dosage maximum upto 50mg at 20 minutes interval Primigravida, Swapan et al 49 out of 100 patients were
till satisfactory BP control is achieved. Maximum dose of Primigravida.14-16
oral Nifedipine can be given is 5 doses that is upto 50 mg
in dosage form.10-12 Table 2: Gravida distribution of the two groups.
During the study period maternal blood pressure will be IV Labetalol Oral Nifedipine
recorded at every fifteen minutes interval till first 30 Gravida
No % No. %
minutes after achieving target blood pressure equal to or Primi 17 42.5 18 45
less than 140/90 mmhg, then every 30 minutes for next 2 G2 14 35 14 35
hours followed by hourly for next 24 hours. Continuous P=0.574
G3 8 20 7 17.5
maternal vital parameters and fetal heart sounds via fetal
G4 1 2.5 1 2.5
Doppler will taken at the beginning and after every 30
Total 40 100 40 100
minutes after achieving target blood pressure equal to or
less than 140/90 mmhg. Selected patients will be analyzed
and comparison between the Group A and Group B will be Table 3 shows the gestational age at presentation in each
carried out. group. Most patients with pre-eclampsia belonged to 38-
39 weeks of gestational age 57.5% in the Labetalol group
and 50% in the Nifedipine group, followed by 37-38
Treatment will be considered as failure if blood pressure
weeks. The analysis derived states that severe pre-
does not decrease even after increasing the dosage to
eclampsia incidence in this study for IV Labetalol is
maximum. Additional antihypertensive agent will be
between 38-39 weeks gestation and for oral Nifedipine is
added and managed accordingly. If patient develops
37-38 weeks while the comparison between two is not
hypotension BP less than 90/60 mm hg then the trial will
significant. The result found in other studies was Raheem
be terminated and patient treated with intravenous fluids
et al, Shekhar et al, Swapan et al shows period of gestation
and ephedrine. If bradycardia develops pulse less than 60
in IV Labetalol and Oral Nifedipine are 36.3-38.6 and 35-
beat/min then the trial will be terminated, and patient
38.6, 36-38 and 37-38, 38-40 and 38-40 weeks
treated with atropine.
respectively. Hence Severe Pre-eclampsia condition often
seen in late trimester of pregnancy.14-16
RESULTS
Table 3: Comparison of gestational age of the two
When age distribution of PIH patients were analysed,
groups.
maximum number of patients were 25 to 30 years of age
followed by 19 to 24 years and > 30 years respectively in
IV Labetalol Oral Nifedipine
the descending order. Above analysis for age distribution GA (weeks)
in both groups found no significance. The mean age in our No. % No. %
study was 26.10 years. In following studies conducted the 36.1-37 2 5 2 5
maternal mean age in both the group in Shekhar et al was 37.1-38 13 32.5 16 40
25.9 years, Swapan et al was 25.4 years while in Raheem 38.1-39 23 57.5 20 50 P=0.325
et al was 31.4 years as the distribution of age was from 20 >39 2 5 2 5
to 40 years, and sample size was less (n=50) Total 40 100 40 100
(Table 1).14-16
Table 4: Comparison between systolic and diastolic
Table 1: Comparison of age distribution of the two BP of the two groups.
groups.
Oral
IV Labetolol
IV Labetalol Oral Nifedipine Nifedepine P
Age Variables (n=40)
No % No % (n=40) value
Mean±SD
19-24 19 47.5 18 45 Mean±SD
25-30 15 37.5 16 40 P = 0.329 Systolic BP
176.05±12.87 171.75±12.45 0.133
>30 6 15 6 15 (mm of Hg)
Total 40 100 40 100 Diastolic BP
112.35±5.10 112.85±5.29 0.668
(mm of Hg)
Table 2 shows the Gravida distribution of patients studied
in each group with a range of primigravida to 4th gravid. Table 4 Shows comparison of systolic and diastolic BP of
Maximum patients of severe pre-eclampsia were the two groups. Mean SBP was176.05±12.87 mm of Hg in
primigravida and second gravida in both the groups. The the IV Labetalol group and 171.75±12.45 mm of Hg in the
table analysis above mentioned states that high incidence Oral Nifedipine group, which was statically not significant
of pre-eclampsia found in primigravida. In other studies as ‘P’ value was 0.133. Mean diastolic BP was
carried out the maximum patients of severe pre-eclampsia 112.35±5.10 mm of Hg in the Labetalol group and
were primigravida Raheem et al 36 out of 50 patients were 112.85±5.29 mmHg in the Nifedipine group which was
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Gavit Y et al. Int J Reprod Contracept Obstet Gynecol. 2018 Feb;7(2):719-724
also statistically insignificant and ‘P value was 0.668 in severe pre-eclampsia in Raheem et al was 45 and 30
respectively. minutes, Shekhar et al was 60 and 40 minutes,
respectively. While in Swapan et al was 47.2 minutes and
The above mean blood pressure at first visit in my study is 45.6 minutes.14,16 Hence time required to control raised
comparable with the studies of Raheem et al where mean blood pressure is less with oral Nifedipine as compared
blood pressure at first visit was 170/108 mm hg in IV with IV Labetalol.
Labetalol and 175/110 mmhg in Oral Nifedipine group,
Shekhar et al mean blood pressure at first visit was168110 Table 8 shows mode of delivery of the two groups. Vaginal
7.8 mmhg in IV Labetalol and 165/108 mmhg in Oral delivery rate in the IV Labetalol group 62.5% while in oral
Nifedipine group, Swapan et al mean blood pressure at Nifedipine 65%. Caesareans section rate was 37.5% and
first visit was 186.28 mmhg in IV Labetalol and 175 8 35% in the IV Labetalol and oral Nifedipine group
mmhg in Oral Nifedipine group. No bias selection of respectively. The P value derived is 0.816 there is so
patients in both the groups.14,15 significant difference between two groups but in present
study more Vaginal deliveries rates as compared with
Table 5 shows comparison of No. of doses of drugs Ceasrean Section. In studies done by Raheem et al,
required to control BP between two groups. Most of the Shekhar et al and Swapan et al the percentage of vaginal
patients were controlled by two doses of each drug, 75% delivery and caesarean section in IV Labetalol group was
in the Labetalol group and 95% in the Nifedipine group. 48% and 52%, 66.6% and 33.3%, 54% and 46% while in
While no. of doses required to control blood pressure in oral Nifedipine 36% and 64%, 56.6% and 43.3%, 46% and
severe pre-eclampsia in other studies Raheem et al and 54% respectively.14-16 In this study and in Shekhar et al,
Shekhar et al was 3 doses in IV Labetalol group and 2 caesarean section rates were low, which may be due to
doses in Oral Nifedipine group, Swapan et al 2 doses n IV better management by antihypertensive agents and low
Labetalol and oral Nifedipine group.15,16 Thereby oral dose of Nifedipine required as it has tocolytic effect in
Nifedipine requires less number of doses to control raised large dose.14,16
blood pressure in Pre-eclampsia/eclampsia.
Table 7: Comparison of total antihypertensive doses
Table 5: Comparison of no. of doses of drugs required required to control BP between two groups, i.e. to
to control BP between two groups. achieve BP 140/90mm of Hg.
Labetalol Nifedipine P
P Mode of IV Labetalol Oral Nifedipine
Variables (n=40) (n=40) value
value delivery
Mean±SD Mean±SD No. % No. %
Total Vaginal
30 62.5 26 65
antihypertensive delivery
doses (mg) LSCS 10 37.5 14 35 0.816
45.00±17.97 12.63±2.99 0.0001 Total 40 100 40 100
requires to
achieve BP
140/90mm of Hg Table 9 shows Hyperbilirubinemia were 5% and 2.5% in
the Labetalol group and Nifedipine group respectively.
Table 6 shows comparison of time taken to control BP Respiratory distress neonates were 2.5% in each Labetalol
between two groups, i.e. to achieve BP 140/90mm of Hg. and Nifedipine group. There was 5% neonatal admission
The mean time required was 43±14.71 minutes in IV due to meconium aspiration in the IV Labetalol group and
Labetalol groups and 28±10.90 minutes in Oral Nifedipine 2.5% in oral Nifedipine group.
group. This comparison of time showed significant
difference in the two groups with a ‘P’ value of 0.0001. In the present study birth asphyxia and meconium
The results of studies conducted mean time required for IV aspiration mostly seen in patients with blood pressure
Labetalol and oral Nifedipine to achieve BP 140/90 mm hg ≥180/110 and required more dosages ≥3 to control blood
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Gavit Y et al. Int J Reprod Contracept Obstet Gynecol. 2018 Feb;7(2):719-724
pressure in both the groups while hyperbilirubinemia is not resulting in release of vasoactive substances. This causes
related to it. decreased intravascular volume and increased
extravascular volume. The effects of this are placental
Table 9: Comparison of indications of neonatal insufficiency resulting in complications.6-9
admission in NICU between two groups.
Controlling hypertension in pregnancy using
Oral antihypertensive drugs brings down these complications.
IV Labetalol
Variables Nifedipine The most extensively used antihypertensive drugs in
(%) (n=40)
(%) (n=40) pregnancy are β adrenoceptor antagonists, Nifedipine,
Hyperbilirubinemia 2 (5%) 1 (2.5%) methyldopa and Labetalol.13 These drugs are used alone or
Respiratory distress 1 (2.5%) 1 (2.5%) in combinations in routine obstetric practice in our
Meconium aspiration 2 (5%) 1 (2.5%) country. Each of these drugs have different mode of action.
Birth asphyxia 2 (5%) 0 (0%) Nifedipine is vasodilator and calcium channel blocker.
Methyl dopa is centrally acting antihypertensive. Labetalol
Table 10 shows the comparison of adverse effects of the is both α and β blocker. There were few clinical studies in
drugs. 2.5% patients had headache in each group. In the IV which these drugs were compared in the same setting,
Labetalol group 2.5% of the patients had postural when used orally with respect to their antihypertensive
hypotension, 5% of had drowsiness and 17.5% had efficacy, side effects, maternal and neonatal outcome both
palpitations. Adverse effects occurred during treatment in mild and severe PIH. Therefore, the present study was
with antihypertensive agents, were transient and tolerable. undertaken to evaluate and compare nifedipine and
There were no maternal adverse events, which resulted in labetalol in mild and severe PIH.
need for discontinuation of medication.
For this study pregnant women fulfilling the definition of
Table 10: Comparison of adverse effects of drugs pregnancy induced hypertension, inclusion and exclusion
between two groups. criteria were enrolled. They were divided into two groups
based on antihypertensive drugs used. Base line characters
Adverse effects IV Oral efficacy, maternal and neonatal outcomes were analysed
Labetalol Nifedipine separately in two treatment groups of PIH patients.
Postural hypotension 1 0
Drowsiness 2 0 CONCLUSION
Headache 1 1
Palpitation 7 0 A hypertensive disorder of pregnancy is one of the life-
Depression 0 0 threatening complication encountered in obstetrics and
Nausea 0 0 globally is major cause of maternal morbidity and
Hypersensitivity 0 0 mortality. Management of acute severe Hypertension in
Total 11 1 pregnancy is a challenging task, because drastic reduction
of BP leads to uteroplacental insufficiency and that may
lead to intrauterine fetal death and continuation of
DISCUSSION
pregnancy with severe hypertension leads to adverse feto-
maternal outcome. Therefore, there is a need for an ideal
Pregnancy induced hypertension or Pre-eclampsia is one
antihypertensive agent for effective control of severe
of the common medical disorders of pregnancy. It
hypertension in pregnancy.
complicates 6 to 8% of pregnancies and is the third
common cause for maternal mortality and morbidity next
Present study compares the efficacy of oral Nifedipine and
to haemorrhage and infections.13,2 18% of maternal deaths
IV Labetalol in reaching the therapeutic goal. From the
are due to pregnancy related hypertension complications.
results of our study we can well conclude that oral
It affects both mother and fetus.7-9 Hypertension during
pregnancy predisposes to complications like eclampsia, Nifedipine is more efficacious is at variance with results
of previously conducted trial with (similar design) that
Abruptio placentae, disseminated intravascular
both drugs are equally efficacious. Although we have tried
coagulation, pulmonary oedema, blindness,
to analyse almost all the possible factors it would be
cerebrovascular haemorrhages, HELLP syndrome, fetal
prudent to say that more analyses and large sample are
growth restriction and fetal demise. Controlling
hypertension in pregnancy prevents complications both in required to derive the definite conclusions regarding
mother and fetus. difference in effectiveness of oral Nifedipine as compared
with IV Labetalol and to assess this difference clinically
significant.
There are various theories for the aetiology of pregnancy
induced hypertension. The common pathophysiological
Nevertheless, these results do establish oral Nifedipine as
changes seen are imbalance between vasoconstrictor
an alternative to IV Labetalol in lowering BP in Acute
Thromboxane and vasodilator prostacyclin resulting in
generalized vasospasm. This leads to endothelial damage Severe Hypertension. In summary oral Nifedipine may be
preferable as it has a convenient dosing pattern orally.
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International Journal of Reproduction, Contraception, Obstetrics and Gynecology Volume 7 · Issue 2 Page 724