Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Preeclampsia Clinical Trial

Official title:

Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912677
• Other study ID #: 4000
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 894
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Nifedipine

• Labetalol

• Methyldopa

Locations

Country	Name	City	State
India	Daga Women's Hospital	Nagpur	Maharashtra
India	Government Medical College	Nagpur	Maharashtra

Sponsors (5)

Lead Sponsor	Collaborator
Gynuity Health Projects	Bill and Melinda Gates Foundation, Daga Memorial Women's Hospital, Nagpur, India, Government Medical College, Nagpur, University of British Columbia

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 hours
Secondary	number of hourly BP's in severe range	the number of hourly BP's in severe range	one hour