Columbia University
Whitney Booker
The purpose of this study is to assess which blood pressure medication (intravenous labetalol or oral nifedipine) works better in treating severely elevated blood pressure in women who have just delivered a baby.
Postpartum Pregnancy-Induced Hypertension
Postpartum Preeclampsia
Pregnancy-Induced Hypertension in Postpartum
Hypertensive Emergency
Labetalol
Nifedipine
Phase 4
Hypertensive emergencies cause significant maternal morbidity and mortality in the postpartum period. In order to reduced these risks, the recommendation is to treat women with severe range blood pressure with either intravenous labetalol or oral nifedipine; it is unclear which medication is superior. The objective of this study is to prospectively enroll women who have hypertensive emergencies in the postpartum period; women will be randomized in a 1:1 fashion and treated with one of the two antihypertensives to see which one works better.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 104 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Treatment |
| Official Title : | Oral Nifedipine Versus Intravenous Labetalol for Postpartum (PP) Hypertensive Emergency: A Randomized Clinical Trial (RCT) |
| Actual Study Start Date : | August 2024 |
| Estimated Primary Completion Date : | January 1, 2025 |
| Estimated Study Completion Date : | January 1, 2026 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Oral Nifedipine Oral nifedipine: Once diagnosis of hypertensive emergency is confirmed on repeat blood pressure, patients randomized to oral nifedipine will receive 10mg initially, with repeated doses of 20mg every 20min, for up to a maximum of 5 doses or until the therapeutic blood pressure goal of <160 systolic and <105 diastolic is achieved. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur. |
Drug: Nifedipine |
|
Active Comparator: Intravenous labetalol Intravenous Labetalol: Patients randomized to IV labetalol will receive 20mg initially, followed by escalating doses of 40mg, 80mg, 80mg, then 80mg every 20 minutes until the therapeutic goal is achieved, for a maximum of 5 doses. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur. |
Drug: Labetalol |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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Not yet recruiting
Columbia University Irving Medical Center
New York, New York, United States, 10032