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Postpartum Hypertension Study

Primary Purpose

Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia, Pregnancy-Induced Hypertension in Postpartum

Status

Not yet recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Labetalol

Nifedipine

About this trial

This is an interventional treatment trial for Postpartum Pregnancy-Induced Hypertension focused on measuring Hypertension, Hypertensive Emergency, Postpartum, Preeclampsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Oral Nifedipine

Intravenous labetalol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Average Number of Recurrence of Severe Blood Pressure

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

The need to use a second (alternative) antihypertensive medication.

Full Information

NCT ID

NCT05139238

First Posted

November 18, 2021

Last Updated

June 28, 2023

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT05139238

Brief Title

Postpartum Hypertension Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Hypertension, Hypertensive Emergency, Postpartum, Preeclampsia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral Nifedipine

Arm Type

Active Comparator

Arm Description

Arm Title

Intravenous labetalol

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Labetalol

Intervention Description

Intravenous labetalol, a short acting ant-hypertensive

Intervention Type

Drug

Intervention Name(s)

Nifedipine

Other Intervention Name(s)

Oral Procardia

Intervention Description

Oral nifedipine, a short acting ant-hypertensive

Primary Outcome Measure Information:

Title

Average Time to Initial Blood Pressure Control (minutes)

Description

The primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of <160 mmHg systolic and <110 mmHg diastolic.

Time Frame

Up to 48 hours

Secondary Outcome Measure Information:

Title

Average Number of Recurrence of Severe Blood Pressure

Description

The number of times a patient has recurrence of severe hypertensive necessitating treatment with an antihypertensive.

Time Frame

Up to 48 hours

Title

Total Number of Participants Who Need for Second Antihypertensive Agent

Description

The need to use a second (alternative) antihypertensive medication.

Time Frame

Up to 48 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Whitney A. Booker, MD

Phone

212-305-7334

wb2322@cumc.columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Whitney A. Booker, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Whitney A. Booker, MD

Phone

212-305-7334

wb2322@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Whitney A. Booker, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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