Trial | NCT01912677  Report issue

Official Title

Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    894
This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.
This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.
Study Started
Apr 30
2015
Primary Completion
Sep 30
2017
Study Completion
Dec 31
2017
Last Update
Nov 08
2018

Drug Nifedipine

Drug Labetalol

Drug Methyldopa

Nifedipine Active Comparator

Women will receive an initial dose of oral nifedipine 10mg. If blood pressure exceeds 155mmHg systolic OR 105 mmHg diastolic after 1h, an additional 10mg dose can be provided each hour for two additional doses (30 mg total).

Methyldopa Experimental

Women will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given.

Labetalol Experimental

Women will receive an initial dose of oral labetalol 200mg. If blood pressure exceeds 155mmHg systolic OR 105 mmHg diastolic after 1h, an additional 200mg dose can be provided each hour for two additional doses (600 mg total).

Criteria 

Inclusion Criteria:

Pregnant gestational age >= 28 weeks
Systolic blood pressure >=160 mm Hg OR a diastolic blood pressure of >=110 mm Hg measured twice more than 15 minutes apart
Able to swallow pills
>= 18 years

Exclusion Criteria:

Indication for emergent cesarean or known fetal anomaly
Anti-hypertensive therapy received in the past 12 hours
History of eclampsia or other adverse CNS complication (e.g., stroke or PRES) in this pregnancy
Actively wheezing at time of enrollment or history of asthma complications
Known coronary artery disease or type I DM with microvascular complications or signs of heart failure or clinical dissection of the aorta
No Results Posted