Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Phase 4

Completed

• Conditions: Hypertension in Pregnancy; Preeclampsia
• Interventions: Drug: Labetalol; Drug: Nifedipine; Drug: Methyldopa

• Registration Number: NCT01912677
• Lead Sponsor: Gynuity Health Projects

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 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.

Study Timeline

• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-07-31
• Study Start: 2015-04
• Primary Completion: 2017-09
• Study Completion: 2017-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 894

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Labetalol	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).
Nifedipine	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).
Methyldopa	Methyldopa	Women will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
number of hourly BP's in severe range	one hour	the number of hourly BP's in severe range

Trial Locations

Locations (2)

Daga Women's Hospital; 🇮🇳 Nagpur, Maharashtra, India

Government Medical College; 🇮🇳 Nagpur, Maharashtra, India