Clinical trial NCT01912677: Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
Official title: Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension in Pregnancy
Preeclampsia
Keywords: hypertension in pregnancy
preeclampsia
anti-hypertension
labetalol
nifedipine
methyldopa
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Government Medical College, Nagpur
name: Daga Memorial Women's Hospital, Nagpur, India
name: University of British Columbia
name: Bill and Melinda Gates Foundation
First posted: 2013-07-31
Enrollment: 894
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Successful outcome
timeFrame: 6 hours
Secondary outcomes:
measure: number of hourly BP's in severe range
timeFrame: one hour
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Daga Women's Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College
state: Maharashtra
Study officials:
affiliation: Gynuity Health Projects
name: Hillary Bracken, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.