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Prevention of Severe Postpartum Hypertension

Sponsor
Indiana University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02450773
Collaborator
(none)
248
Enrollment
2
Locations
2
Arms
81
Duration (Months)
124
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
248 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial
Study Start Date :
Aug 1, 2015
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Furosemide/Potassium chloride

40 mg furosemide; 20 meq potassium chloride

Drug: Furosemide
40 mg furosemide on postpartum day 1-6
Other Names:
  • Lasix

    • Drug: Potassium chloride
    20 meq potassium chloride on postpartum day 1-6
    Other Names:
  • KCl

    		•
    Placebo Comparator: Placebo

    Placebo #1, Placebo #2

    Drug: Placebo #1
    Placebo (for furosemide)

    Drug: Placebo #2
    Placebo (for KCl)

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Adverse events associated with furosemide [0-6 weeks following delivery]

      Hypokalemia

    2. Adverse events associated with furosemide [0-6 weeks following delivery]

      hyperglycemia

    3. Adverse events associated with furosemide [0-6 weeks following delivery]

      oliguria

    4. Adverse events associated with furosemide [0-6 weeks following delivery]

      hypotension

    5. Adverse events associated with furosemide [0-6 weeks following delivery]

      elevated serum creatinine

    Other Outcome Measures

    1. Cardiovascular changes following delivery [0-1 week following delivery]

      Maternal echocardiogram, renin, aldosterone, B-natriuretic peptide levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University School of Medicine Indianapolis Indiana United States
    2 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Indiana University

    Investigators

    • Principal Investigator: Methodius G Tuuli, MD, MPH, Indiana University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Method Tuuli, Professor of Obstetrics and Gynecology, Indiana University
    ClinicalTrials.gov Identifier:
    NCT02450773
    Other Study ID Numbers:
    • 201501157
    First Posted:
    May 21, 2015
    Last Update Posted:
    Mar 6, 2020
    Last Verified:
    Mar 1, 2020
    Keywords provided by Method Tuuli, Professor of Obstetrics and Gynecology, Indiana University
    postpartum
    preeclampsia
    gestational hypertension
    Additional relevant MeSH terms:
    Hypertension
    Furosemide

    Study Results

    No Results Posted as of Mar 6, 2020