Postpartum Hypertension Study

Postpartum Preeclampsia Clinical Trial

Official title:

Oral Nifedipine Versus Intravenous Labetalol for Postpartum (PP) Hypertensive Emergency: A Randomized Clinical Trial (RCT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05139238
• Other study ID #: AAAT5925
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Whitney A. Booker, MD
• Phone: 212-305-7334
• Email: wb2322[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Patients admitted to labor and delivery (L&D) with blood pressure (BP) in severe range, defined as a systolic =160 mm Hg and/or diastolic =110 mm Hg

• Postpartum, immediately to 6 weeks postpartum

• With a prior diagnosis of chronic hypertension (not on medication) or hypertensive disorder of pregnancy

Exclusion criteria

• They may not have previously had exposure to either study medication within the previous 24-hour period.

• Patients with a known atrial-ventricular heart block or moderate to severe bronchial asthma will be excluded, or other contraindication to receiving either study medication

Related Conditions & MeSH terms

• Emergencies
• Hypertension
• Hypertension, Malignant
• Hypertension, Pregnancy-Induced
• Hypertensive Crisis
• Hypertensive Emergency
• Postpartum Preeclampsia
• Postpartum Pregnancy-Induced Hypertension
• Pre-Eclampsia

Intervention

Drug:
• Labetalol
Intravenous labetalol, a short acting ant-hypertensive
• Nifedipine
Oral nifedipine, a short acting ant-hypertensive

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Time to Initial Blood Pressure Control (minutes)	The primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of <160 mmHg systolic and <110 mmHg diastolic.	Up to 48 hours
Secondary	Average Number of Recurrence of Severe Blood Pressure	The number of times a patient has recurrence of severe hypertensive necessitating treatment with an antihypertensive.	Up to 48 hours
Secondary	Total Number of Participants Who Need for Second Antihypertensive Agent	The need to use a second (alternative) antihypertensive medication.	Up to 48 hours