Comparing blood pressure medications for postpartum hypertension
Oral Nifedipine Versus Intravenous Labetalol for Postpartum (PP) Hypertensive Emergency: A Randomized Clinical Trial (RCT)
This study is testing which of two blood pressure medications works better for new moms with dangerously high blood pressure after giving birth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05139238 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the effectiveness of two blood pressure medications, intravenous labetalol and oral nifedipine, in treating severely elevated blood pressure in women who have recently given birth. Women experiencing hypertensive emergencies in the postpartum period will be prospectively enrolled and randomly assigned to receive one of the two medications. The goal is to identify which treatment is superior in managing severe hypertension to reduce maternal morbidity and mortality.
Who should consider this trial
Good fit: Ideal candidates are women who are within 6 weeks postpartum and have severe hypertension defined as a systolic blood pressure of 160 mm Hg or higher.
Not a fit: Patients with known contraindications to either medication or those who have received either treatment within the last 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for postpartum hypertension, enhancing maternal health outcomes.
How similar studies have performed: Other studies have explored treatments for postpartum hypertension, but this specific comparison of labetalol and nifedipine in a randomized setting is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Patients admitted to labor and delivery (L\&D) with blood pressure (BP) in severe range, defined as a systolic ≥160 mm Hg and/or diastolic ≥110 mm Hg * Postpartum, immediately to 6 weeks postpartum * With a prior diagnosis of chronic hypertension (not on medication) or hypertensive disorder of pregnancy Exclusion criteria * They may not have previously had exposure to either study medication within the previous 24-hour period. * Patients with a known atrial-ventricular heart block or moderate to severe bronchial asthma will be excluded, or other contraindication to receiving either study medication
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Whitney A. Booker, MD — Columbia University
- Study coordinator: Whitney A. Booker, MD
- Email: wb2322@cumc.columbia.edu
- Phone: 212-305-7334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.