A Phase 4 interventional study of Nifedipine and Labetalol in Hypertension in Pregnancy and Preeclampsia, sponsored by Gynuity Health Projects. Completed at 2 sites in India. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-11-08.
Sponsored by Gynuity Health Projects · Phase 4, Interventional, and Treatment
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.
882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.
This study's enrollment of 894 is above the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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).
Drug: Nifedipine
Women will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given.
Drug: Methyldopa
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).
Drug: Labetalol
Successful outcome
Successful outcome will be considered blood pressure that reaches the target (defined as 120-150mmHg systolic and 70-100 mmHg mm Hg diastolic) at 6h without an adverse outcome.
Time frame: 6 hours
number of hourly BP's in severe range
the number of hourly BP's in severe range
Time frame: one hour
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects