Postpartum Hypertension Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Postpartum Preeclampsia; Hypertensive Emergency; Postpartum Pregnancy-Induced Hypertension; Pregnancy-Induced Hypertension in Postpartum
• Intervention / Treatment: Drug: Nifedipine; Drug: Labetalol

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral 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.	Drug: Nifedipine; Oral nifedipine, a short acting ant-hypertensive; Other Names: Oral Procardia
Active Comparator: Intravenous 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.	Drug: Labetalol; Intravenous labetalol, a short acting ant-hypertensive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Participants Who Need for Second Antihypertensive Agent	The need to use a second (alternative) antihypertensive medication.	Up to 48 hours
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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Whitney A. Booker, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): August 21, 2025
• Study Completion (Actual): August 21, 2025

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Postpartum; Preeclampsia; Hypertensive Emergency
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Hypertensive Crisis; Pre-Eclampsia; Hypertension; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amides; Amines; Alcohols; Amino Alcohols; Ethanolamines; Dihydropyridines; Salicylamides; Nifedipine; Labetalol
• Other Study ID Numbers: AAAT5925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No