PEACE Trial: Postpartum Evaluation of Antihypertensive Cessation and Efficacy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Labetalol, Nifedipine.
- Who it may be relevant to
- Registry conditions: Postpartum Hypertension (PPHT). Basic parameters: 18 years — 64 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Postpartum Evaluation of Antihypertensive Cessation and Efficacy (PEACE): A Randomized Controlled Trial Comparing Oral Labetalol and Oral Extended-Release Nifedipine for Managing Postpartum Hypertension
Overview
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.
Interventions
- Drug 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. - 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.
Primary outcome measures
- Continuation of antihypertensive medication [Time frame: 6 week postpartum]
Secondary outcome measures (3)
- Postpartum hospital readmission [Time frame: 6 weeks postpartum]
- Treatment failure [Time frame: 6 weeks postpartum]
- Patient-reported medication side effects [Time frame: 6 weeks postpartum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UCLA Ronald Reagan — Los Angeles
Identifiers
NCT: NCT06915792 · IRB-24-6051