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Postpartum Evaluation of Antihypertensive Cessation and Efficacy (PEACE): A Randomized Controlled Trial Comparing Oral Labetalol and Oral Extended-Release Nifedipine for Managing Postpartum Hypertension

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This randomized controlled trial compares two common medications, labetalol and extended-release nifedipine, to determine which is more effective at managing postpartum high blood pressure. We hypothesize that extended-release nifedipine will better control blood pressure and reduce the need for continued medication beyond six weeks postpartum. The study will enroll 110 postpartum participants, randomly assigning them to one of the two medications, with remote blood pressure monitoring to evaluate treatment effectiveness and inform postpartum hypertension management.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• Age ≥18 years Delivery at study institution at ≥28 weeks gestation Postpartum SBP \> 150 and/or DBP \> 100 OR 2 or more SBP \> 140 and/or DBP \> 90 within a 24-hour period Require initiation of an oral antihypertensive medication during postpartum hospital stay or within 7 days of discharge Treating obstetric team amenable to starting either study medication

Locations
United States
California
UCLA Ronald Reagan
RECRUITING
Los Angeles
Contact Information
Primary
Tina A Nguyen, MD
tinaanguyen@mednet.ucla.edu
310-794-7274
Backup
Sonia S Raghuram, MS
sraghuram@mednet.ucla.edu
408-896-8704
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 110
Treatments
Experimental: Labetalol
Participants in this arm will receive oral labetalol to manage postpartum hypertension. The starting dose will be 200 mg twice or three times daily (BID or TID), with adjustments up to 2400 mg/day (800 mg TID) as needed.
Experimental: Nifedipine
Participants in this arm will receive oral extended-release nifedipine to manage postpartum hypertension. The starting dose will be 30 mg once daily, with adjustments up to 120 mg/day as needed
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov