Prevention of Severe Postpartum Hypertension

Phase 2

Withdrawn

• Conditions: Hypertension
• Interventions: Drug: Placebo #1; Drug: Furosemide; Drug: Placebo #2; Drug: Potassium chloride

• Registration Number: NCT02450773
• Lead Sponsor: Indiana University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-21
• Study Start: 2015-08
• Primary Completion: 2022-05
• Study Completion: 2022-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo #1	Placebo #1, Placebo #2
Placebo	Placebo #2	Placebo #1, Placebo #2
Furosemide/Potassium chloride	Furosemide	40 mg furosemide; 20 meq potassium chloride
Furosemide/Potassium chloride	Potassium chloride	40 mg furosemide; 20 meq potassium chloride

Primary Outcome Measures

Name	Time	Method
Composite maternal morbidity	0-6 weeks following delivery	Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension

Secondary Outcome Measures

Name	Time	Method
Adverse events associated with furosemide	0-6 weeks following delivery	elevated serum creatinine

Trial Locations

Locations (2)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States