Prevention of Severe Postpartum Hypertension

NCT02450773 — Phase 2, Withdrawn, Indiana University

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

Registry	NCT02450773
Status	Withdrawn
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Sponsor	Indiana University (Other)
Conditions	Hypertension
Interventions	Furosemide, Potassium chloride, Placebo #1, Placebo #2 (Drug)
Dates	start 2015-08-01, primary completion 2022-05-01 (estimated), completion 2022-05-01 (estimated), first posted 2015-05-21, last updated 2023-05-11
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Furosemide/Potassium chloride	Experimental	Drug: Furosemide; Drug: Potassium chloride	40 mg furosemide; 20 meq potassium chloride
Placebo	Placebo comparator	Drug: Placebo #1; Drug: Placebo #2	Placebo #1, Placebo #2

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

+Outcome measures

Primary outcomes

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

Secondary outcomes

Adverse events associated with furosemide [0-6 weeks following delivery]: Hypokalemia
Adverse events associated with furosemide [0-6 weeks following delivery]: hyperglycemia
Adverse events associated with furosemide [0-6 weeks following delivery]: oliguria
Adverse events associated with furosemide [0-6 weeks following delivery]: hypotension
Adverse events associated with furosemide [0-6 weeks following delivery]: elevated serum creatinine

Other outcomes

Cardiovascular changes following delivery [0-1 week following delivery]: Maternal echocardiogram, renin, aldosterone, B-natriuretic peptide levels

+Eligibility

Sex: Female, accepts 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

+Locations (2)

Facility	City	Country	Status
Indiana University School of Medicine	Indianapolis, Indiana	United States
Washington University School of Medicine	St Louis, Missouri	United States

+Investigators

Methodius G Tuuli, MD, MPH, Principal investigator, Indiana University