Postpartum Hypertension Study

NCT05139238 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: AAAT5925
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Pregnancy-Induced Hypertension; Postpartum Preeclampsia; Pregnancy-Induced Hypertension in Postpartum; Hypertensive Emergency

Keywords

Hypertension; Hypertensive Emergency; Postpartum; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Recurrence of Severe Blood Pressure

  Up to 48 hours

• Total Number of Participants Who Need for Second Antihypertensive Agent

  Up to 48 hours

Study Arms (2)

Oral Nifedipine

ACTIVE COMPARATOR

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

Intravenous labetalol

ACTIVE COMPARATOR

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

Interventions

Labetalol DRUG

Intravenous labetalol, a short acting ant-hypertensive

Intravenous labetalol

Nifedipine DRUG

Oral nifedipine, a short acting ant-hypertensive

Also known as: Oral Procardia

Oral Nifedipine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hypertensive Crisis; Hypertension; Pre-Eclampsia

Interventions

Labetalol; Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Whitney A. Booker, MD
• Organization: Columbia University

wb2322@cumc.columbia.edu

212-305-7334

Study Officials

• Whitney A. Booker, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: July 4, 2022
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-04

Locations

US (1)