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Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Information source: Gynuity Health Projects
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension in Pregnancy; Preeclampsia

Intervention: Nifedipine (Drug); Labetalol (Drug); Methyldopa (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Gynuity Health Projects

Official(s) and/or principal investigator(s):
Hillary Bracken, PhD, Principal Investigator, Affiliation: Gynuity Health Projects

Overall contact:
Hillary Bracken, PhD, Phone: 2124481230, Email: hbracken@gynuity.org

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.

Clinical Details

Official title: Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Successful outcome

Secondary outcome: number of hourly BP's in severe range

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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 6 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

Locations and Contacts

Hillary Bracken, PhD, Phone: 2124481230, Email: hbracken@gynuity.org

Daga Women's Hospital, Nagpur, Maharashtra 440003, India; Not yet recruiting
Vaishali Khedikar, MD, Email: srmundle@gmail.com
Vaishali Khedikar, MD, Principal Investigator

Government Medical College, Nagpur, Maharashtra 440003, India; Recruiting
Shuchita Mundle, MD, Email: srmundle@gmail.com
Rajeshree Patil, MD, Principal Investigator

Additional Information

Starting date: November 2014
Last updated: September 12, 2014

Page last updated: August 23, 2015

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