PEACE Trial: Postpartum Evaluation of Antihypertensive Cessation and Efficacy

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06915792
Phase
PHASE4
Status
Recruiting
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Conditions

  • Postpartum Hypertension (PPHT)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Labetalol — DRUG
    Labetalol is a beta-blocker commonly used to manage hypertension in pregnancy and postpartum. In this study, oral labetalol will be initiated at 200mg twice or three times daily and adjusted up to 2400 mg/day as needed for blood pressure control.
  • Nifedipine — DRUG
    Nifedipine is a calcium channel blocker commonly used to manage hypertension in pregnancy and postpartum. In this study, oral extended-release nifedipine will be initiated at 30mg once daily and adjusted up to 120mg/day as needed for blood pressure control.

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Continuation of antihypertensive medication [ Time Frame: 6 week postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIP
UCLA Ronald ReaganLos AngelesCalifornia90095

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UCLA Ronald Reagan· Los Angeles, CA