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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 furosemide

Adverse 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

Page last updated: August 23, 2015

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