NCT01912677

Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 894 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypertension in Pregnancy
• Preeclampsia

Interventions

Type	Name	Description
DRUG	Nifedipine
DRUG	Labetalol
DRUG	Methyldopa

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2013-07-31
• Last updated: 2018-11-08

Locations

2 sites across 1 country: India