Furosemide for Accelerated Recovery of Blood Pressure Postpartum

Phase 2

Completed

• Conditions: Hypertension, Pregnancy-Induced
• Interventions: Drug: Oral furosemide; Drug: Placebo Oral Tablet

• Registration Number: NCT03556761
• Lead Sponsor: University of Pennsylvania

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

Detailed Description

Hypertensive disorders of pregnancy are recognized causes of significant maternal/fetal morbidity and mortality, accounting for approximately 18% of maternal deaths worldwide. While significant research has been done on the evaluation and management of hypertension during pregnancy, studies of postpartum hypertension (PPHTN) are usually limited by their retrospective design and focus on inpatients in the immediate postpartum period (2-6 days), or patients who were readmitted due to complications related to hypertension. Few studies have investigated the incidence and proper management of hypertension in the postpartum period. Furthermore, in the United Kingdom, a review of maternal deaths determined that 10% were related to hypertensive disorders in pregnancy (HDP) in the postpartum period. Postpartum hypertension is also the cause of approximately 27% of readmissions to the hospital. These studies clearly show that PPHTN is associated with significant morbidity and that it is important to develop interventions that can reduce its effects.

In patients with HDP, postpartum blood pressure has been shown to decrease in the first 48 hours postpartum only to then increase in days 3-6 postpartum. This phenomenon is thought to be secondary to large fluid shifts, both secondary from fluid retention during the pregnant state as well as from fluids given intrapartum. Furthermore, large volumes of sodium are also mobilized into the intravascular compartment at this time. Given the latter, furosemide, a loop diuretic that mobilizes sodium and fluid excretion has been posed as a method to prevent severe range blood pressures and their associated maternal morbidity in the postpartum period.

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-14
• Study Start: 2018-06-20
• Primary Completion: 2019-12-04
• Study Completion: 2020-02-05
• Status Verified: 2020-08
• Results First Submitted: 2020-08-02
• Results First Submitted QC: 2020-08-26
• Last Update Submitted: 2020-08-26
• Results First Posted: 2020-09-10
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 384

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

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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 <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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral furosemide	Oral furosemide	Oral furosemide 20 mg/day for a total of 5 consecutive doses.
Placebo Oral Tablet	Placebo Oral Tablet	Placebo once per day for a total of 5 consecutive doses.

Primary Outcome Measures

Name	Time	Method
Time to Resolution	0-14 days postpartum	To compare the time (days) required to achieve a resolution of elevated blood pressure, adjusted for mode of delivery.
Persistently Elevated Blood Pressures 7 Days Postpartum	0-7 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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Who Had Severe Hypertension Postpartum	0-6 weeks postpartum	Number of women who had severe hypertension (systolic blood pressure\>160 millimeters of mercury or diastolic blood pressure\>110 millimeters of mercury) postpartum
Postpartum Length of Stay	0-6 weeks postpartum	Number of days postpartum participants stayed in the hospital
Subjects With Complications During Hospitalization	0-6 weeks postpartum	Subjects with complications during hospitalization related to hypertensive disorders of pregnancy.
Number of Subjects That Required for Additional Antihypertensives	0 to 6 weeks post-partum	Number of subjects that required additional hypertensive medication after discharge
Number of Subjects Experiencing One or More Adverse Effects	0-6 weeks postpartum	Number of subjects experiencing one or more adverse effects secondary to furosemide
Postpartum Readmission	0-6 weeks postpartum	Number of subjects with one or more readmission/ER visit that were hypertension related

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States