Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Conditions
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Hypertension in Pregnancy, Preeclampsia

Intervention / Treatment
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* Drug: Nifedipine
* Drug: Labetalol
* Drug: Methyldopa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nifedipine<br>Women will receive an initial dose of oral nifedipine 10mg. If blood pressure exceeds 155mmHg systolic OR 105 mmHg diastolic after 1h, an additional 10mg dose can be provided each hour for two additional doses (30 mg total). | Drug: Nifedipine<br> <br> |
| Experimental: Methyldopa<br>Women will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given. | Drug: Methyldopa<br> <br> |
| Experimental: Labetalol<br>Women will receive an initial dose of oral labetalol 200mg. If blood pressure exceeds 155mmHg systolic OR 105 mmHg diastolic after 1h, an additional 200mg dose can be provided each hour for two additional doses (600 mg total). | Drug: Labetalol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of hourly BP's in severe range | the number of hourly BP's in severe range | one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension in pregnancy, preeclampsia, anti-hypertension, labetalol, nifedipine, methyldopa