Prevention of Severe Postpartum Hypertension
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Furosemide (Drug); Potassium chloride (Drug); Placebo #1 (Drug); Placebo #2 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s): Methodius G. Tuuli, MD, MPH, Principal Investigator, Affiliation: Washington University School of Medicine
Overall contact: Shannon A Martin, RN, Phone: 314-362-8523, Email: martins@wudosis.wustl.edu
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.
Clinical Details
Official title: Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Composite maternal morbidity
Secondary outcome: Adverse events associated with furosemideAdverse events associated with furosemide Adverse events associated with furosemide Adverse events associated with furosemide Adverse events associated with furosemide
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Shannon A Martin, RN, Phone: 314-362-8523, Email: martins@wudosis.wustl.edu
Washington University School of Medicine, Saint Louis, Missouri 63110, United States; Recruiting Shannon Martin
Additional Information
Starting date: August 2015
Last updated: August 10, 2015
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