Phase 2 N=384 Randomized Quadruple-blind Prevention

Furosemide for Accelerated Recovery of Blood Pressure Postpartum

Hypertension, Pregnancy-Induced

Bottom Line

View on ClinicalTrials.gov: NCT03556761 ↗

Enrolled (actual)

384

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Persistently Elevated Blood Pressures 7 Days Postpartum — 10; 23 Participants — p=0.03

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Oral furosemide (Drug); Placebo Oral Tablet (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Pennsylvania
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Persistently Elevated Blood Pressures 7 Days Postpartum	10; 23	0.03 sig
PRIMARY Time to Resolution	10; 10.5	0.12
SECONDARY Postpartum Readmission	9; 16	0.14
SECONDARY Number of Subjects Who Had Severe Hypertension Postpartum	81; 86	0.36
SECONDARY Postpartum Length of Stay	2; 2	0.76
SECONDARY Subjects With Complications During Hospitalization	3; 1	0.62
SECONDARY Number of Subjects Experiencing One or More Adverse Effects	0; 1	—
SECONDARY Number of Subjects That Required for Additional Antihypertensives	25; 39	0.03 sig

Summary

A randomized, double-blind, placebo-controlled single center investigation of furosemide's effect on postpartum blood pressure control in pregnancies affected by hypertensive disorders of pregnancy

Eligibility Criteria

Inclusion Criteria

Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum
Gestational hypertension
Pre-eclampsia with or without severe features
Superimposed pre-eclampsia with or without severe features
New diagnosis of HDP within 24 hours from delivery
Postpartum, delivery ≥ 20 weeks estimated gestational age
Age ≥18 years old

Exclusion Criteria

History of allergic reaction to furosemide
High risk comorbidities for which treatment may be indicated or contraindicated: class C or higher diabetes mellitus, chronic kidney disease or baseline creatinine >1.2, cardiac disorders including cardiomyopathy, congenital heart disease, angina or coronary heart disease, rheumatic disease (lupus), sickle cell disease
Baseline labs with K 1 dose), cephalosporins (ie Ancef >1 dose),
Patient unstable for protocol per investigator's judgement

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Data sourced from ClinicalTrials.gov (NCT03556761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.