Furosemide for Accelerated Recovery of Blood Pressure Postpartum

NCT03556761 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 829444
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypertension, Pregnancy-Induced

Keywords

Furosemide; Postpartum; Hypertension

Outcome Measures

Primary Outcomes (2)

• Persistently Elevated Blood Pressures 7 Days Postpartum

  To compare the rate of persistently elevated blood pressures (\>140/90) in women that receive a five day furosemide course compared to those that receive placebo.

  0-7 days postpartum

• Time to Resolution

  To compare the time (days) required to achieve a resolution of elevated blood pressure, adjusted for mode of delivery.

  0-14 days postpartum

Secondary Outcomes (6)

• Postpartum Readmission

  0-6 weeks postpartum

• Number of Subjects Who Had Severe Hypertension Postpartum

  0-6 weeks postpartum

• Postpartum Length of Stay

  0-6 weeks postpartum

• Subjects With Complications During Hospitalization

  0-6 weeks postpartum

• Number of Subjects Experiencing One or More Adverse Effects

  0-6 weeks postpartum

Study Arms (2)

Oral furosemide

EXPERIMENTAL

Oral furosemide 20 mg/day for a total of 5 consecutive doses.

Drug: Oral furosemide

Placebo Oral Tablet

PLACEBO COMPARATOR

Placebo once per day for a total of 5 consecutive doses.

Drug: Placebo Oral Tablet

Interventions

Oral furosemide DRUG

Furosemide (Lasix), 20 milligram, PO, PO, daily

Oral furosemide

Placebo Oral Tablet DRUG

Placebo, PO, daily

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 \<3
• Use of furosemide or other diuretics antepartum or intrapartum
• Use of ototoxic agents including aminoglycosides (ie, Gentamicin for \>1 dose), cephalosporins (ie Ancef \>1 dose),
• Patient unstable for protocol per investigator's judgement

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Lopes Perdigao J, Lewey J, Hirshberg A, Koelper N, Srinivas SK, Elovitz MA, Levine LD. Furosemide for Accelerated Recovery of Blood Pressure Postpartum in women with a hypertensive disorder of pregnancy: A Randomized Controlled Trial. Hypertension. 2021 May 5;77(5):1517-1524. doi: 10.1161/HYPERTENSIONAHA.120.16133. Epub 2021 Feb 8.

  PMID: 33550824 DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Dr Lisa Levine
• Organization: University of Pennsylvania

lisa.levine@pennmedicine.upenn.edu

215-662-6913

Study Officials

• Lisa Levine, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study medication (furosemide) and placebo will be stored at room temperature at the University of Pennsylvania research pharmacy. Pharmacy will be responsible for labeling and randomizing the medications.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Double blind, randomized, placebo control design

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 14, 2018
• Study Start: June 20, 2018
• Primary Completion: December 4, 2019
• Study Completion: February 5, 2020
• Last Updated: September 10, 2020
• Results First Posted: September 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)