Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Phase 4CompletedNCT01912677

Gynuity Health Projects894 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

894

Conditions

Hypertension in Pregnancy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

number of hourly BP's in severe range

the number of hourly BP's in severe range

Time frame: one hour