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Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Primary Purpose

Hypertension in Pregnancy, Preeclampsia

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Nifedipine
Labetalol
Methyldopa
Sponsored by
Gynuity Health Projects
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension in Pregnancy focused on measuring hypertension in pregnancy, preeclampsia, anti-hypertension, labetalol, nifedipine, methyldopa

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Daga Women's Hospital
  • Government Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Nifedipine

Methyldopa

Labetalol

Arm Description

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).

Women will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given.

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).

Outcomes

Primary Outcome Measures

Successful outcome
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
the number of hourly BP's in severe range

Full Information

First Posted
July 29, 2013
Last Updated
November 6, 2018
Sponsor
Gynuity Health Projects
Collaborators
Government Medical College, Nagpur, Daga Memorial Women's Hospital, Nagpur, India, University of British Columbia, Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01912677
Brief Title
Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
Official Title
Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynuity Health Projects
Collaborators
Government Medical College, Nagpur, Daga Memorial Women's Hospital, Nagpur, India, University of British Columbia, Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy, Preeclampsia
Keywords
hypertension in pregnancy, preeclampsia, anti-hypertension, labetalol, nifedipine, methyldopa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
894 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nifedipine
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Methyldopa
Arm Type
Experimental
Arm Description
Women will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given.
Arm Title
Labetalol
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Nifedipine
Intervention Type
Drug
Intervention Name(s)
Labetalol
Intervention Type
Drug
Intervention Name(s)
Methyldopa
Primary Outcome Measure Information:
Title
Successful outcome
Description
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.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
number of hourly BP's in severe range
Description
the number of hourly BP's in severe range
Time Frame
one hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Bracken, PhD
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daga Women's Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Facility Name
Government Medical College
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
31378394
Citation
Easterling T, Mundle S, Bracken H, Parvekar S, Mool S, Magee LA, von Dadelszen P, Shochet T, Winikoff B. Oral antihypertensive regimens (nifedipine retard, labetalol, and methyldopa) for management of severe hypertension in pregnancy: an open-label, randomised controlled trial. Lancet. 2019 Sep 21;394(10203):1011-1021. doi: 10.1016/S0140-6736(19)31282-6. Epub 2019 Aug 1.
Results Reference
derived

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Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

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