Prevention of Severe Postpartum Hypertension

May 9, 2023 updated by: David Haas, Indiana University

Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial

The purpose of this study is to determine whether postpartum administration of furosemide to women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or elevated blood pressure in the first 24 hours following delivery reduces severe postpartum hypertension.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University School of Medicine
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Women > 18 years of age or emancipated minors

Women undergoing vaginal or cesarean delivery at > 23 weeks gestation with:

  • Antepartum diagnosis of gestational hypertension
  • Antepartum diagnosis of preeclampsia
  • Antepartum diagnosis of preeclampsia with severe features
  • Mild hypertension (<150/100) in first 24 hours following delivery

Exclusion Criteria:

  • Chronic hypertension
  • Allergy to furosemide
  • Pre-existing hypokalemia (serum K < 3.0 meq/L)
  • Chronic kidney disease
  • Serum Cr > 1.1
  • Inability to obtain informed consent
  • Pre-existing diuretic use
  • Oliguria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Furosemide/Potassium chloride
40 mg furosemide; 20 meq potassium chloride
Drug: Furosemide
40 mg furosemide on postpartum day 1-6
Other Names:
  • Lasix
Drug: Potassium chloride
20 meq potassium chloride on postpartum day 1-6
Other Names:
  • KCl
Placebo Comparator: Placebo
Placebo #1, Placebo #2
Drug: Placebo #1
Placebo (for furosemide)
Drug: Placebo #2
Placebo (for KCl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite maternal morbidity
Time Frame: 0-6 weeks following delivery
Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension
0-6 weeks following delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events associated with furosemide
Time Frame: 0-6 weeks following delivery
Hypokalemia
0-6 weeks following delivery
Adverse events associated with furosemide
Time Frame: 0-6 weeks following delivery
hyperglycemia
0-6 weeks following delivery
Adverse events associated with furosemide
Time Frame: 0-6 weeks following delivery
oliguria
0-6 weeks following delivery
Adverse events associated with furosemide
Time Frame: 0-6 weeks following delivery
hypotension
0-6 weeks following delivery
Adverse events associated with furosemide
Time Frame: 0-6 weeks following delivery
elevated serum creatinine
0-6 weeks following delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular changes following delivery
Time Frame: 0-1 week following delivery
Maternal echocardiogram, renin, aldosterone, B-natriuretic peptide levels
0-1 week following delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Methodius G Tuuli, MD, MPH, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Actual)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201501157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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