Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Sponsor

Gynuity Health Projects (Other)

Overall Status

Completed

CT.gov ID

NCT01912677

Collaborator

Government Medical College, Nagpur (Industry), Daga Memorial Women's Hospital, Nagpur, India (Other), University of British Columbia (Other), Bill and Melinda Gates Foundation (Other)

894

Enrollment

Locations

Arms

Actual Duration (Months)

447

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension in Pregnancy Preeclampsia	Drug: Nifedipine Drug: Labetalol Drug: Methyldopa	Phase 4

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

894 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nifedipine 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
Experimental: Methyldopa 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
Experimental: Labetalol 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

Arm

Intervention/Treatment

Active Comparator: Nifedipine

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

Experimental: Methyldopa

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

Experimental: Labetalol

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

Outcome Measures

Primary Outcome Measures

Successful outcome [6 hours]
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.

Secondary Outcome Measures

number of hourly BP's in severe range [one hour]
the number of hourly BP's in severe range

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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