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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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 4
Primary location
Daga Women's Hospital, Nagpur, Maharashtra, India
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
labetalol
DrugMethyldopa
DrugPrimary outcomes
-
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
-
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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