NCT02450773

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2015

Longer than P75 for phase_2 hypertension

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

6.8 years

First QC Date

May 11, 2015

Last Update Submit

May 9, 2023

Conditions

Hypertension

Keywords

postpartumpreeclampsiagestational hypertension

Outcome Measures

Primary Outcomes (1)

  • Composite maternal morbidity

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

    0-6 weeks following delivery

Secondary Outcomes (5)

  • Adverse events associated with furosemide

    0-6 weeks following delivery

  • Adverse events associated with furosemide

    0-6 weeks following delivery

  • Adverse events associated with furosemide

    0-6 weeks following delivery

  • Adverse events associated with furosemide

    0-6 weeks following delivery

  • Adverse events associated with furosemide

    0-6 weeks following delivery

Other Outcomes (1)

  • Cardiovascular changes following delivery

    0-1 week following delivery

Study Arms (2)

Furosemide/Potassium chloride

EXPERIMENTAL

40 mg furosemide; 20 meq potassium chloride

Drug: FurosemideDrug: Potassium chloride

Placebo

PLACEBO COMPARATOR

Placebo #1, Placebo #2

Drug: Placebo #1Drug: Placebo #2

Interventions

FurosemideDRUG

40 mg furosemide on postpartum day 1-6

Also known as: Lasix
Furosemide/Potassium chloride
Potassium chlorideDRUG

20 meq potassium chloride on postpartum day 1-6

Also known as: KCl
Furosemide/Potassium chloride
Placebo #1DRUG

Placebo (for furosemide)

Placebo
Placebo #2DRUG

Placebo (for KCl)

Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University School of Medicine

Indianapolis, Indiana, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

HypertensionPre-EclampsiaHypertension, Pregnancy-Induced

Interventions

FurosemidePotassium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsPotassium Compounds

Study Officials

  • Methodius G Tuuli, MD, MPH

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 21, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

US(2)