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

July 29, 2013
September 12, 2014
November 2014
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01912677 on ClinicalTrials.gov Archive Site
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
  • 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
  • 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 (>160mm Hg sBP and/or >110mm Hg dBP)
Not Provided
Not Provided
 
Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension in Pregnancy
  • Preeclampsia
  • Drug: Nifedipine
  • Drug: Labetalol
  • Drug: Methyldopa
  • 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).
    Intervention: 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.
    Intervention: 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).
    Intervention: Drug: Labetalol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
671
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
No
Contact: Hillary Bracken, PhD 2124481230 hbracken@gynuity.org
India
 
NCT01912677
4000
Yes
Gynuity Health Projects
Gynuity Health Projects
  • Government Medical College, Nagpur
  • Daga Women's Hospital, Nagpur
  • University of British Columbia
  • Bill and Melinda Gates Foundation
Principal Investigator: Hillary Bracken, PhD Gynuity Health Projects
Gynuity Health Projects
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP