drugset / Trial / NCT01912677
Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
Phase 4
Completed
894 enrolled
Gynuity Health Projects
Bill and Melinda Gates Foundation · collabDaga Memorial Women's Hospital, Nagpur, India · collabGovernment Medical College, Nagpur · collabUniversity of British Columbia · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-04
- Primary completion
- 2017-09
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Labetalol | Small molecule | 200 mg | Oral |
| Subject | Methyldopa | Unknown | 1000 mg | Oral |
| Comparator | Nifedipine | Other / unclassified | 10 mg | Oral |