Prevention of Severe Postpartum Hypertension

NCT ID: NCT02450773

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Furosemide/Potassium chloride

40 mg furosemide; 20 meq potassium chloride

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

40 mg furosemide on postpartum day 1-6

Potassium chloride

Intervention Type DRUG

20 meq potassium chloride on postpartum day 1-6

Placebo

Placebo #1, Placebo #2

Group Type PLACEBO_COMPARATOR

Placebo #1

Intervention Type DRUG

Placebo (for furosemide)

Placebo #2

Intervention Type DRUG

Placebo (for KCl)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Furosemide

40 mg furosemide on postpartum day 1-6

Intervention Type DRUG

Potassium chloride

20 meq potassium chloride on postpartum day 1-6

Intervention Type DRUG

Placebo #1

Placebo (for furosemide)

Intervention Type DRUG

Placebo #2

Placebo (for KCl)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lasix KCl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indiana University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Haas

Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Methodius G Tuuli, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201501157

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preeclampsia Postpartum Antihypertensive Treatment
NCT04298034 ACTIVE_NOT_RECRUITING PHASE3
ToRsemide for pOstpartum HYpertension
NCT02813551 COMPLETED PHASE2
Intensive Postpartum Antihypertensive Treatment
NCT05687344 ACTIVE_NOT_RECRUITING PHASE3
Preeclampsia Intervention Netherlands
NCT06452498 NOT_YET_RECRUITING PHASE3
Uterotonics for Severe Preeclampsia
NCT04756661 COMPLETED NA