Status:
COMPLETED
Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
Lead Sponsor:
Gynuity Health Projects
Collaborating Sponsors:
Government Medical College, Nagpur
Daga Memorial Women's Hospital, Nagpur, India
Conditions:
Hypertension in Pregnancy
Preeclampsia
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
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 pregnan...
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 pregnan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
894 Patients enrolled
Trial Details
Trial ID
NCT01912677
Start Date
April 1 2015
End Date
December 1 2017
Last Update
November 8 2018
Active Locations (2)
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1
Daga Women's Hospital
Nagpur, Maharashtra, India, 440003
2
Government Medical College
Nagpur, Maharashtra, India, 440003