Hypertension in Pregnancy, Preeclampsia
Conditions
Keywords
hypertension in pregnancy, preeclampsia, anti-hypertension, labetalol, nifedipine, methyldopa
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.
Interventions
Sponsors
Government Medical College, Nagpur
Daga Memorial Women's Hospital, Nagpur, India
University of British Columbia
Bill and Melinda Gates Foundation
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful outcome | 6 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of hourly BP's in severe range | one hour | the number of hourly BP's in severe range |
Countries
India
Outcome results
None listed