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NCT Number: NCT01912677

Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

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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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Daga Women's Hospital, Nagpur, Maharashtra, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nifedipine

Drug

labetalol

Drug

Methyldopa

Drug

Primary outcomes

  1. Successful outcome

    Time frame: 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 outcomes

  1. number of hourly BP's in severe range

    Time frame: one hour

    the number of hourly BP's in severe range

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Daga Memorial Women's Hospital, Nagpur, India
  • Government Medical College, Nagpur
  • University of British Columbia

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2013
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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