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NCT02450773 Clinical Trial

Prevention of Severe Postpartum Hypertension

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02450773
Other study ID # 201501157
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date August 2015
Est. completion date May 2022

Study information
Verified date May 2023
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2022
Est. primary completion date May 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Furosemide
40 mg furosemide on postpartum day 1-6
• Potassium chloride
20 meq potassium chloride on postpartum day 1-6
• Placebo #1
Placebo (for furosemide)
• Placebo #2
Placebo (for KCl)

Locations
Country Name City State
United States Indiana University School of Medicine Indianapolis Indiana
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Cardiovascular changes following delivery Maternal echocardiogram, renin, aldosterone, B-natriuretic peptide levels 0-1 week following delivery
Primary Composite maternal morbidity Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension 0-6 weeks following delivery
Secondary Adverse events associated with furosemide Hypokalemia 0-6 weeks following delivery
Secondary Adverse events associated with furosemide hyperglycemia 0-6 weeks following delivery
Secondary Adverse events associated with furosemide oliguria 0-6 weeks following delivery
Secondary Adverse events associated with furosemide hypotension 0-6 weeks following delivery
Secondary Adverse events associated with furosemide elevated serum creatinine 0-6 weeks following delivery
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