Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Preeclampsia; Hypertension in Pregnancy

Treatments: Drug: Nifedipine; Drug: Methyldopa; Drug: Labetalol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01912677

4000

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 894 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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894 participants in 3 patient groups

Nifedipine

Active Comparator group

Description:

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).

Treatment:

Drug: Nifedipine

Methyldopa

Experimental group

Description:

Women will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given.

Treatment:

Drug: Methyldopa

Labetalol

Experimental group

Description:

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).

Treatment:

Drug: Labetalol