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Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

NCT01912677 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 894

Last updated 2018-11-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nifedipine

DRUG

Labetalol

DRUG

Methyldopa

Sponsors & Collaborators

  • Government Medical College, Nagpur

    collaborator INDUSTRY

  • Daga Memorial Women's Hospital, Nagpur, India

    collaborator OTHER

  • University of British Columbia

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Hillary Bracken, PhD · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-09-30
Completion
2017-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01912677 on ClinicalTrials.gov