PEACE Trial: Postpartum Evaluation of Antihypertensive Cessation and Efficacy

NCT06915792 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB-24-6051
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Continuation of antihypertensive medication

  The proportion of participants who continue to require antihypertensive medication beyond 6 weeks postpartum

  6 week postpartum

Secondary Outcomes (3)

• Postpartum hospital readmission

  6 weeks postpartum

• Treatment failure

  6 weeks postpartum

• Patient-reported medication side effects

  6 weeks postpartum

Study Arms (2)

Labetalol

EXPERIMENTAL

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.

Drug: Labetalol

Nifedipine

EXPERIMENTAL

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

Drug: Nifedipine

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.

Labetalol

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.

Nifedipine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Labetalol; Nifedipine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Tina A Nguyen, MD

CONTACT

310-794-7274; tinaanguyen@mednet.ucla.edu

Sonia S Raghuram, MS

CONTACT

408-896-8704; sraghuram@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: April 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: October 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share