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Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

This study is currently recruiting participants.
Verified July 2017 by Gynuity Health Projects
Sponsor:
ClinicalTrials.gov Identifier:
NCT01912677
First Posted: July 31, 2013
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Government Medical College, Nagpur
Daga Memorial Women's Hospital, Nagpur, India
University of British Columbia
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Gynuity Health Projects
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 Outcome Measures:
  • number of hourly BP's in severe range [ Time Frame: one hour ]
    the number of hourly BP's in severe range


Estimated Enrollment: 894
Actual Study Start Date: April 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912677


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

Locations
India
Daga Women's Hospital Recruiting
Nagpur, Maharashtra, India, 440003
Contact: Vaishali Khedikar, MD       srmundle@gmail.com   
Principal Investigator: Vaishali Khedikar, MD         
Government Medical College Recruiting
Nagpur, Maharashtra, India, 440003
Contact: Shuchita Mundle, MD       srmundle@gmail.com   
Principal Investigator: Rajeshree Patil, MD         
Sponsors and Collaborators
Gynuity Health Projects
Government Medical College, Nagpur
Daga Memorial Women's Hospital, Nagpur, India
University of British Columbia
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Hillary Bracken, PhD Gynuity Health Projects
  More Information

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01912677     History of Changes
Other Study ID Numbers: 4000
First Submitted: July 29, 2013
First Posted: July 31, 2013
Last Update Posted: July 11, 2017
Last Verified: July 2017

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

Additional relevant MeSH terms:
Hypertension
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Antihypertensive Agents
Labetalol
Methyldopa
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Sympatholytics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists