PEACE Trial: Postpartum Evaluation of Antihypertensive Cessation and Efficacy

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-64
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: LabetalolExperimental treatment 1 intervention
Group B: NifedipineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Continuation of antihypertensive medication

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

Time frame
6 week postpartum

Secondary outcomes

1

Postpartum hospital readmission

The number of participants requiring hospital readmission for hypertension-related complications.

Time frame
6 weeks postpartum
2

Treatment failure

The proportion of participants requiring a medication switch or the addition of a second antihypertensive agent to achieve blood pressure control.

Time frame
6 weeks postpartum
3

Patient-reported medication side effects

The frequency and type of medication-related side effects reported by participants.

Time frame
6 weeks postpartum

Other outcomes

Sponsors and contacts

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