PEACE Trial: Postpartum Evaluation of Antihypertensive Cessation and Efficacy

NCT ID: NCT06915792

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-10-31

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.

Detailed Description

Hypertensive disorders complicate approximately 10% of pregnancies in the United States and are among the leading causes of maternal morbidity and mortality worldwide. These conditions often emerge or persist after delivery, leading to postpartum hypertension. Postpartum hypertension has been associated with the development of chronic hypertension and other cardiovascular concerns, as well as risk of severe complications such as stroke and seizure, and represents a substantial reason for hospital readmission. While oral labetalol and oral extended-release nifedipine are the most commonly prescribed antihypertensive medications, there is limited evidence comparing their efficacy in managing postpartum hypertension. This study aims to address this gap by evaluating the outcomes of these medications on sustained blood pressure control in the postpartum period.

This prospective randomized controlled trial plans to enroll 110 participants with 55 individuals randomized to receive either oral labetalol or oral extended-release nifedipine. The primary outcome is continuation of antihypertensive medication beyond 6 weeks postpartum. Secondary outcomes include postpartum hospital readmission, medication side effects, and medication failure, defined as the need to switch the study medication or to add a second antihypertensive agent.

The study population will consist of postpartum adults with hypertensive disorders of pregnancy admitted at a tertiary care center, Ronald Reagan UCLA Medical Center, following delivery at ≥28 weeks gestation. Eligible individuals will have elevated postpartum blood pressures requiring initiation of an oral antihypertensive medication during their postpartum hospital stay or within 7 days of discharge. Individuals who have been treated with oral antihypertensive medication prior to delivery, contraindications to nifedipine or labetalol, or severe comorbidities will be excluded. On discharge, participants will be enrolled in remote blood pressure monitoring; blood pressure logs will be monitored daily by a dedicated nurse and overseen by a maternal-fetal medicine specialist who will make any necessary medication adjustments. Apart from random assignment of the study medication, all postpartum care will proceed as usual according to the study institution's standard clinical protocols.

This study is designed to provide evidence to inform clinical guidelines that address the clinical needs of high-risk patients, potentially reducing maternal morbidity and improving care. Participation is voluntary, with informed consent obtained prior to enrollment. Close monitoring through remote monitoring and follow-up visits with the research team and primary obstetrician will ensure participant safety throughout the study.

Conditions

Postpartum Hypertension (PPHT)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Labetalol

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Nifedipine

Intervention Type: 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.

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Tina A. Nguyen, MD

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Tina A Nguyen, MD

Role: CONTACT

tinaanguyen@mednet.ucla.edu

310-794-7274

Sonia S Raghuram, MS

Role: CONTACT

sraghuram@mednet.ucla.edu

408-896-8704

Other Identifiers

IRB-24-6051

Identifier Type: -

Identifier Source: org_study_id