Recruiting

Labetalol vs. Extended-Release Nifedipine

Sponsor:

UCLA

Code:

NCT06915792

Conditions

Postpartum Hypertension (PPHT)

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Labetalol

Nifedipine

Study Details

Brief 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.

Conditions

Postpartum Hypertension (PPHT)

Study ID

NCT06915792

Start date

Jun 1, 2025

Status verified date

Jun, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion criteria:

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

Exclusion criteria:

Treated with oral antihypertensive medications prior to delivery Known allergies or contraindications to nifedipine or labetalol History of moderate persistent to severe asthma, chronic obstructive pulmonary disease, heart failure, or greater than first-degree atrioventricular heart block Unable to provide written informed consent in English

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Labetalol

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

UCLA Ronald Reagan

Recruiting

Los Angeles, California, United States, 90095

Contacts

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • postpartum hypertension, blood pressure control, labetalol, nifedipine, antihypertensive therapy, pregnancy hypertension, maternal health, randomized controlled

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-06-05.