A randomized trial of intravenous labetalol and oral nifedipine in severe pregnancy induced hypertension

Dhali, Badal; Bhattacharya, Shritanu; Ganguly, Rajendra Prasad; Bandyopadhyay, Shrirupa; Mondal, Mousumi; Dutta, Mousumi

doi:10.5455/2320-1770.ijrcog001912

Cited by 25 publications

(31 citation statements)

References 11 publications

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“…Mean age in the labetalol group was 23.74±3.9 and 24.36±3.9 in the nifedipine group comparable to the study conducted by Dhali B et al (8) With regard to gravida distribution maximum patients of pre-eclampsia were primigravida in both the groups, 58% in the labetalol and 50% in nifedipine group comparable with the study of Shekar et al 2013. (9) and Raheem et al (10) In the present study most patients with preeclampsia were between 33-36wks of gestation, 54% in labetalol and 64% in nifedipine group.…”

Section: Discussionsupporting

confidence: 86%

Oral Nifedipine Versus Intravenous Labetalol for Control of Blood Pressure in Severe Preeclampsia

Kumari¹,

Saraswathi²,

Srilaxmi³

2016

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OBJECTIVETo compare the efficacy of oral nifedipine and IV Labetalol in acute blood pressure control in severe preeclampsia. METHODS200 women with blood pressure ≥160mmHg systolic and/or ≥110mmHg diastolic were randomized to receive oral nifedipine (10 mg tablet orally up to five doses) or IV labetalol in escalating doses of 20mg, 40mg, 80mg, 80mg and 80mg. They were administered drugs every 15 minutes until blood pressure was less than or equal to 150mm Hg systolic and 100mm Hg diastolic. Crossover treatment was administered if the initial treatment failed. The time required to reduce blood pressure to target value, the number of doses required and the adverse effects were measured. The statistical value of significance was taken at P<0.05. RESULTSThe patients who came in the inclusion criteria were treated with either nifedipine or labetalol based on their randomization number. It was found that oral nifedipine required 34.77±4.8 minutes whereas Inj. labetalol required 36.61±5.2 minutes to control blood pressure. The P value was 0.29.This indicates that the difference was not significant. Oral nifedipine required two doses each of 10mg to reduce blood pressure whereas Inj. labetalol required 3 doses, a total of 140mg to reduce blood pressure to the target level. The p-value calculated was 0.43 indicating the difference was not significant. Patients were also monitored for any side effects that may arise from the drugs. The adverse effects noted were dizziness, sweating, flushing, nausea, vomiting, palpitations, headache, shortness of breath and foetal tachycardia. Adverse effects observed were very few and of minor degree. There was no statistical difference in adverse effects noted in both the groups. CONCLUSIONSOral nifedipine and IV labetalol are similarly effective in the control of severe hypertension in pregnancy. KEYWORDSPreeclampsia Labetalol Nifedipine Hypertension, Pregnancy. HOW TO CITE THIS ARTICLE: INTRODUCTIONHypertensive disorders are one of the most common medical disorders complicating pregnancy and form part of a deadly triad along with haemorrhage and sepsis in contributing greatly to the maternal morbidity and mortality. (1) The incidence of hypertensive disorders ranges from 2-8% of all pregnancies and contribute to 9% of maternal mortality in Asia and 12% in India. (2,3,4) It has been estimated by the WHO that worldwide approximately 45,000 women will die each year from hypertensive disorders of pregnancy. The spectrum of hypertensive diseases that can complicate pregnancy are broad ranging from gestational hypertension, preeclampsia, chronic hypertension and chronic hypertension with superimposed pre-eclampsia. Preeclampsia, a multisystem disorder defined as hypertension of 140/90mmHg or more associated with significant proteinuria (≥30mg/dl in random urine samples or >300mg/24hrs urine or on dipstick 1+ or more proteinuria), usually develops after 20wks of gestation.

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Section: Discussionsupporting

confidence: 86%

Oral Nifedipine Versus Intravenous Labetalol for Control of Blood Pressure in Severe Preeclampsia

Kumari¹,

Saraswathi²,

Srilaxmi³

2016

jemds

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“…Mean age in the labetalol group was 23±5 and 24±4 in the nifedipine group comparable to the study conducted by Dhali B et al 9 With regard to gravida distribution maximum patients of pre-eclampsia were primigravida in both the groups, 62% in the labetalol and 52% in nifedipine group comparable with the study of Shekar et al and Raheem et al 10,11 In the present study most of the patients with preeclampsia were between 33-36 weeks of gestation, 58% in labetalol and 62% in nifedipine group. Mean gestational age in labetalol group is 35.4±2.12 weeks and in nifedipine group 35.3±2.3 weeks.…”

Section: Discussionsupporting

confidence: 88%

Assessment of safety and efficacy of oral nifedipine and intravenous labetalol in management of increased blood pressure in severe preeclampsia

Thalamati

Bandaru

Bhumireddy

2018

Int J Reprod Contracept Obstet Gynecol

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Background: Pre-eclampsia (PE) is a disorder of pregnancy characterized by the onset of high blood pressure and often a significant amount of protein in the urine. Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. The objective of the present study was to assess and compare the safety and efficacy of oral nifedipine and intravenous labetalol in the management of severe pre-eclampsia.Methods: A double-blind, randomized, controlled trial was conducted at a tertiary care hospital in Andhra Pradesh, on pregnant women presenting with a systolic blood pressure of 160 mm Hg or more or diastolic blood pressure of 110 mm Hg or more. The pregnant women were randomized to receive Oral nifedipine (10 mg tablet orally up to five doses) and intravenous labetalol injection in escalating doses until the target blood pressure of 150 mm Hg systolic and 100 mm Hg diastolic, or lower, was achieved. The primary endpoint of the study was the time taken by each agent to achieve target blood pressure. Secondary endpoints were number of doses required, adverse maternal and neonatal effects, side effect profile, and perinatal outcome.Results: The study was conducted in a tertiary care hospital in Andhra Pradesh from July 2016 to October 2017, on 100 pregnant women presenting with preeclampsia. The median time taken to achieve target blood pressure was 44 minutes (range: 20-60 minutes) for Oral Nifedipine and 68 minutes (range: 40-85 minutes) for Intravenous labetalol (P=0.008). No serious adverse maternal or perinatal side effects were encountered in both the groups.Conclusions: Both oral nifedipine and intravenous labetalol are effective in the management of acute hypertensive emergencies of pregnancy; however, oral nifedipine effectively decreased the blood pressure rapidly compared to intravenous labetalol.

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“…Concurring views were expressed by CLIP working group [14] who observed no difference in adverse maternal outcomes in both the groups. Study by Dhali et al [16] showed significant increase in urinary output in nifedipine group.…”

Section: Blood Pressure Education Program Working Group 2000)mentioning

confidence: 88%

A comparative evaluation of intravenous labetalol versus oral nifedipine for control of severe pregnancy-induced hypertension with low-dose regimen

Mukherjee¹,

Khan²,

Jain³

et al. 2016

Int J Med Sci Public Health

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Background: Hypertensive disorders complicate 5%-10% of all pregnancies and contribute greatly to maternal morbidity and mortality rates. Dangerous hypertension can cause cerebrovascular hemorrhage, hypertensive encephalopathy, and can trigger eclamptic convulsions. Blood pressure (BP) ≥160/110 mmHg in pregnancy requires prompt treatment. Both nifedipine and intravenous (IV) labetalol are effective antihypertensive agents belonging to different pharmacological classes and with different mechanisms of action. This study compares both the drugs. Objective: To compare the efficacy and safety of oral nifedipine versus IV labetalol for control of BP in cases of severe pregnancy-induced hypertension (PIH) with low-dose regimen. Materials and Methods: Pregnant women aged 18-40 years admitted in obstetrics and gynecology department with severe PIH, that is, BP ≥160/110 mmHg were included in this randomized prospective study. Simple randomization was done. A total of 30 patients in group A were given 5 mg oral nifedipine, to be repeated after half an hour if target BP of 150/100 mmHg was not achieved. A total of 30 patients in group B were given IV labetalol 20 mg initially followed by doses of 20, 20, 40, 40, and 80 mg every 20 min, if target BP was not achieved (maximum dose not to exceed 220 mg). The primary outcome variable was time necessary to achieve target BP. The secondary outcome variables were number of doses, cost of drug, need of crossover treatment, and adverse maternal and fetal side effects. Result: Patients receiving oral nifedipine achieved the target BP in 43 ± 16.74 min as compared with 38.67 ± 19.43 min in labetalol group (p = 0.3589). This difference was not significant. No maternal or fetal side effects were observed in both the groups. Labetalol was the costlier drug. Conclusion: Both regimens were equally effective in management of severe PIH with respect to time taken to achieve target BP. The adverse events in mother and baby were also less in view of the lower doses of the two agents used. Oral nifedipine was significantly less costly whereas IV labetalol was preferred in patients who were unable to take drug orally as in immediate postoperative patients and patients with altered sensorium.

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A randomized trial of intravenous labetalol and oral nifedipine in severe pregnancy induced hypertension

Cited by 25 publications

References 11 publications

Oral Nifedipine Versus Intravenous Labetalol for Control of Blood Pressure in Severe Preeclampsia

Oral Nifedipine Versus Intravenous Labetalol for Control of Blood Pressure in Severe Preeclampsia

Assessment of safety and efficacy of oral nifedipine and intravenous labetalol in management of increased blood pressure in severe preeclampsia

A comparative evaluation of intravenous labetalol versus oral nifedipine for control of severe pregnancy-induced hypertension with low-dose regimen

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