Clinical Trial: Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Brief 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 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.
Sponsor: Gynuity Health Projects

Current Primary Outcome: Successful outcome [ Time Frame: 6 hours ]

Successful outcome will be considered blood pressure that reaches the target (defined as 130-150mmHg systolic and 80-100 mmHg mm Hg diastolic) at 6h without an adverse outcome.


Original Primary Outcome: Same as current

Current Secondary Outcome: number of hourly BP's in severe range [ Time Frame: one hour ]

the number of hourly BP's in severe range


Original Secondary Outcome:

  • number of hourly BP's in severe range [ Time Frame: one hour ]
    the number of hourly BP's in severe range
  • number of hourly BP's in severe range [ Time Frame: one hour ]
    the number of hourly BP's in severe range (>160mm Hg sBP and/or >110mm Hg dBP)


Information By: Gynuity Health Projects

Dates:
Date Received: July 29, 2013
Date Started: April 2015
Date Completion: June 2017
Last Updated: July 14, 2016
Last Verified: July 2016