Prevention of Severe Postpartum Hypertension

Overview

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.

Full Title of Study: “Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2022

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Furosemide/Potassium chloride
    • 40 mg furosemide; 20 meq potassium chloride
  • Placebo Comparator: Placebo
    • Placebo #1, Placebo #2

Clinical Trial Outcome Measures

Primary Measures

  • Composite maternal morbidity
    • Time Frame: 0-6 weeks following delivery
    • Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension

Secondary Measures

  • Adverse events associated with furosemide
    • Time Frame: 0-6 weeks following delivery
    • Hypokalemia
  • Adverse events associated with furosemide
    • Time Frame: 0-6 weeks following delivery
    • hyperglycemia
  • Adverse events associated with furosemide
    • Time Frame: 0-6 weeks following delivery
    • oliguria
  • Adverse events associated with furosemide
    • Time Frame: 0-6 weeks following delivery
    • hypotension
  • Adverse events associated with furosemide
    • Time Frame: 0-6 weeks following delivery
    • elevated serum creatinine

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Indiana University
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Haas, Professor of Obstetrics and Gynecology – Indiana University
  • Overall Official(s)
    • Methodius G Tuuli, MD, MPH, Principal Investigator, Indiana University School of Medicine

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