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Prevention of Severe Postpartum Hypertension

Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02450773
Enrollment
0
Registered
2015-05-21
Start date
2015-08-31
Completion date
2022-05-31
Last updated
2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

postpartum, preeclampsia, gestational hypertension

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.

Interventions

DRUGFurosemide

40 mg furosemide on postpartum day 1-6

DRUGPotassium chloride

20 meq potassium chloride on postpartum day 1-6

DRUGPlacebo #1

Placebo (for furosemide)

DRUGPlacebo #2

Placebo (for KCl)

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frameDescription
Composite maternal morbidity0-6 weeks following deliveryRequiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension

Secondary

MeasureTime frameDescription
Adverse events associated with furosemide0-6 weeks following deliveryHypokalemia

Other

MeasureTime frameDescription
Cardiovascular changes following delivery0-1 week following deliveryMaternal echocardiogram, renin, aldosterone, B-natriuretic peptide levels

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026