Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

894 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension in Pregnancy Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

Methyldopa

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

Group Type EXPERIMENTAL

Methyldopa

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

Labetalol

Intervention Type DRUG

Interventions

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Nifedipine

Intervention Type DRUG

Labetalol

Intervention Type DRUG

Methyldopa

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No