Gynuity Health Projects, in collaboration with colleagues at Government Medical College, Nagpur and Daga Women’s Hospital are conducting 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 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 severe hypertension in pregnant women. We 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.
The study will enrol 894 women at the two study sites in Nagpur, India: Government Medical College (GMC) and Daga Women’s Hospital. Enrollment started in April 2015. In November 2016, an independent Data Safety Monitoring Board (DSMB) conducted a planned interim analysis after half of the women were enrolled. The board determined that the enrollment should continue. As of 1 March 2017, 694 women were enrolled. We anticipate trial enrollment will be completed in September 2017.