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Completed

NCT Number: NCT03556761

Furosemide for Accelerated Recovery of Blood Pressure Postpartum

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

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral furosemide

Drug

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

Placebo oral tablet

Drug

Placebo, PO, daily

Primary outcomes

  1. Persistently Elevated Blood Pressures 7 Days Postpartum

    Time frame: 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.

  2. Time to Resolution

    Time frame: 0-14 days postpartum

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

Secondary outcomes

  1. Postpartum Readmission

    Time frame: 0-6 weeks postpartum

    Number of subjects with one or more readmission/ER visit that were hypertension related

  2. Number of Subjects Who Had Severe Hypertension Postpartum

    Time frame: 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

  3. Postpartum Length of Stay

    Time frame: 0-6 weeks postpartum

    Number of days postpartum participants stayed in the hospital

  4. Subjects With Complications During Hospitalization

    Time frame: 0-6 weeks postpartum

    Subjects with complications during hospitalization related to hypertensive disorders of pregnancy.

  5. Number of Subjects Experiencing One or More Adverse Effects

    Time frame: 0-6 weeks postpartum

    Number of subjects experiencing one or more adverse effects secondary to furosemide

  6. Number of Subjects That Required for Additional Antihypertensives

    Time frame: 0 to 6 weeks post-partum

    Number of subjects that required additional hypertensive medication after discharge

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: ForBP

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 14, 2018
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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