Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborators: Bill and Melinda Gates Foundation; Daga Memorial Women's Hospital, Nagpur, India; Government Medical College, Nagpur; University of British Columbia
• Treatments: Antihypertensive Agents; Labetalol; Methyldopa; Nifedipine

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