Trial record 1 of 104 for:    Open Studies | "Hypertension, Pregnancy-Induced"
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Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Gynuity Health Projects
Sponsor:
Collaborators:
Government Medical College, Nagpur
Daga Women's Hospital, Nagpur
University of British Columbia
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01912677
First received: July 29, 2013
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Hypertension in Pregnancy
Preeclampsia
Drug: Nifedipine
Drug: Labetalol
Drug: Methyldopa
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Successful outcome [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    Successful outcome will be considered blood pressure that reaches the target (defined as 130-150mmHg systolic and 80-100 mmHg mm Hg diastolic) at 6h without an adverse outcome.


Secondary Outcome Measures:
  • number of hourly BP's in severe range [ Time Frame: one hour ] [ Designated as safety issue: Yes ]
    the number of hourly BP's in severe range


Estimated Enrollment: 671
Study Start Date: November 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Drug: Nifedipine
Experimental: Methyldopa
Women will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given.
Drug: Methyldopa
Experimental: 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).
Drug: Labetalol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 6 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912677

Contacts
Contact: Hillary Bracken, PhD 2124481230 hbracken@gynuity.org

Locations
India
Government Medical College Recruiting
Nagpur, Maharashtra, India, 440003
Contact: Shuchita Mundle, MD       srmundle@gmail.com   
Principal Investigator: Rajeshree Patil, MD         
Daga Women's Hospital Not yet recruiting
Nagpur, Maharashtra, India, 440003
Contact: Vaishali Khedikar, MD       srmundle@gmail.com   
Principal Investigator: Vaishali Khedikar, MD         
Sponsors and Collaborators
Gynuity Health Projects
Government Medical College, Nagpur
Daga Women's Hospital, Nagpur
University of British Columbia
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Hillary Bracken, PhD Gynuity Health Projects
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01912677     History of Changes
Other Study ID Numbers: 4000
Study First Received: July 29, 2013
Last Updated: September 12, 2014
Health Authority: India: Ministry of Health

Keywords provided by Gynuity Health Projects:
hypertension in pregnancy
preeclampsia
anti-hypertension
labetalol
nifedipine
methyldopa

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Hypertension
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Nifedipine
Methyldopa
Labetalol
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists

ClinicalTrials.gov processed this record on October 19, 2014