Furosemide for Accelerated Recovery of Blood Pressure Postpartum

Hypertension, Pregnancy-Induced Clinical Trial

— ForBP  

Official title:

Furosemide for Accelerated Recovery of Blood Pressure Postpartum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556761
• Other study ID #: 829444
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2018
• Est. completion date: February 5, 2020

Study information

• Verified date: August 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: February 5, 2020
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 <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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced

Intervention

Drug:
• Oral furosemide
Furosemide (Lasix), 20 milligram, PO, PO, daily
• Placebo Oral Tablet
Placebo, PO, daily

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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