- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02450773
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Withdrawn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
-
-
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
|
40 mg furosemide on postpartum day 1-6
Other Names:
20 meq potassium chloride on postpartum day 1-6
Other Names:
|
Placebo Comparator: Placebo
Placebo #1, Placebo #2
|
Placebo (for furosemide)
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
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
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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