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Prevention of Severe Postpartum Hypertension

Primary Purpose

Hypertension

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Furosemide
Potassium chloride
Placebo #1
Placebo #2
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring postpartum, preeclampsia, gestational hypertension

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University School of Medicine
  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Furosemide/Potassium chloride

Placebo

Arm Description

40 mg furosemide; 20 meq potassium chloride

Placebo #1, Placebo #2

Outcomes

Primary Outcome Measures

Composite maternal morbidity
Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension

Secondary Outcome Measures

Adverse events associated with furosemide
Hypokalemia
Adverse events associated with furosemide
hyperglycemia
Adverse events associated with furosemide
oliguria
Adverse events associated with furosemide
hypotension
Adverse events associated with furosemide
elevated serum creatinine

Full Information

First Posted
May 11, 2015
Last Updated
May 9, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT02450773
Brief Title
Prevention of Severe Postpartum Hypertension
Official Title
Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
postpartum, preeclampsia, gestational hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Furosemide/Potassium chloride
Arm Type
Experimental
Arm Description
40 mg furosemide; 20 meq potassium chloride
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo #1, Placebo #2
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Lasix
Intervention Description
40 mg furosemide on postpartum day 1-6
Intervention Type
Drug
Intervention Name(s)
Potassium chloride
Other Intervention Name(s)
KCl
Intervention Description
20 meq potassium chloride on postpartum day 1-6
Intervention Type
Drug
Intervention Name(s)
Placebo #1
Intervention Description
Placebo (for furosemide)
Intervention Type
Drug
Intervention Name(s)
Placebo #2
Intervention Description
Placebo (for KCl)
Primary Outcome Measure Information:
Title
Composite maternal morbidity
Description
Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension
Time Frame
0-6 weeks following delivery
Secondary Outcome Measure Information:
Title
Adverse events associated with furosemide
Description
Hypokalemia
Time Frame
0-6 weeks following delivery
Title
Adverse events associated with furosemide
Description
hyperglycemia
Time Frame
0-6 weeks following delivery
Title
Adverse events associated with furosemide
Description
oliguria
Time Frame
0-6 weeks following delivery
Title
Adverse events associated with furosemide
Description
hypotension
Time Frame
0-6 weeks following delivery
Title
Adverse events associated with furosemide
Description
elevated serum creatinine
Time Frame
0-6 weeks following delivery
Other Pre-specified Outcome Measures:
Title
Cardiovascular changes following delivery
Description
Maternal echocardiogram, renin, aldosterone, B-natriuretic peptide levels
Time Frame
0-1 week following delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Methodius G Tuuli, MD, MPH
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Prevention of Severe Postpartum Hypertension

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