Postpartum Hypertension Study

Phase 4

Recruiting

• Conditions: Postpartum Pregnancy-Induced Hypertension; Postpartum Preeclampsia; Pregnancy-Induced Hypertension in Postpartum; Hypertensive Emergency
• Interventions: Drug: Labetalol; Drug: Nifedipine

• Registration Number: NCT05139238
• Lead Sponsor: Columbia University

Brief Summary

The purpose of this study is to assess which blood pressure medication (intravenous labetalol or oral nifedipine) works better in treating severely elevated blood pressure in women who have just delivered a baby.

Detailed Description

Hypertensive emergencies cause significant maternal morbidity and mortality in the postpartum period. In order to reduced these risks, the recommendation is to treat women with severe range blood pressure with either intravenous labetalol or oral nifedipine; it is unclear which medication is superior. The objective of this study is to prospectively enroll women who have hypertensive emergencies in the postpartum period; women will be randomized in a 1:1 fashion and treated with one of the two antihypertensives to see which one works better.

Study Timeline

• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-12-01
• Study Start: 2022-07-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intravenous labetalol	Labetalol	Intravenous Labetalol: Patients randomized to IV labetalol will receive 20mg initially, followed by escalating doses of 40mg, 80mg, 80mg, then 80mg every 20 minutes until the therapeutic goal is achieved, for a maximum of 5 doses. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
Oral Nifedipine	Nifedipine	Oral nifedipine: Once diagnosis of hypertensive emergency is confirmed on repeat blood pressure, patients randomized to oral nifedipine will receive 10mg initially, with repeated doses of 20mg every 20min, for up to a maximum of 5 doses or until the therapeutic blood pressure goal of \<160 systolic and \<105 diastolic is achieved. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.

Primary Outcome Measures

Name	Time	Method
Average Time to Initial Blood Pressure Control (minutes)	Up to 48 hours	The primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of \<160 mmHg systolic and \<110 mmHg diastolic.

Secondary Outcome Measures

Name	Time	Method
Average Number of Recurrence of Severe Blood Pressure	Up to 48 hours	The number of times a patient has recurrence of severe hypertensive necessitating treatment with an antihypertensive.
Total Number of Participants Who Need for Second Antihypertensive Agent	Up to 48 hours	The need to use a second (alternative) antihypertensive medication.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States