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Trial record 16 of 242 for:    furosemide

Furosemide for Accelerated Recovery of Blood Pressure Postpartum (ForBP)

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ClinicalTrials.gov Identifier: NCT03556761
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Lisa Levine, 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

Condition or disease Intervention/treatment Phase
Hypertension, Pregnancy-Induced Drug: Oral furosemide Drug: Placebo Oral Tablet Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, randomized, placebo control design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Furosemide for Accelerated Recovery of Blood Pressure Postpartum
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Oral furosemide
Oral furosemide 20 mg/day for a total of 5 consecutive doses.
Drug: Oral furosemide
Furosemide (Lasix), 20 milligram, PO, PO, daily

Placebo Comparator: Placebo Oral Tablet
Placebo once per day for a total of 5 consecutive doses.
Drug: Placebo Oral Tablet
Placebo, PO, daily




Primary Outcome Measures :
  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: 0-7 days postpartum ]
    To compare the time (days) required to achieve a resolution of elevated blood pressure.


Secondary Outcome Measures :
  1. Postpartum readmission [ Time Frame: 0-6 weeks postpartum ]
    Number of readmission/ ER visit that is hypertension related

  2. Frequency of severe hypertension [ Time Frame: 0-6 weeks postpartum ]
    Frequency of severe hypertension (systolic blood pressure>160 millimeters of mercury or diastolic blood pressure>110 millimeters of mercury)

  3. Postpartum length of stay [ Time Frame: 0-6 weeks postpartum ]
    Postpartum length of stay

  4. Complications during hospitalization [ Time Frame: 0-6 weeks postpartum ]
    Composite of complications during hospitalization related to hypertensive disorders of pregnancy.

  5. Adverse effects [ Time Frame: 0-6 weeks postpartum ]
    Adverse effects secondary to furosemide



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 <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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556761


Contacts
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Contact: Valerie M Riis, MS 2154989099 valerie.riis@uphs.upenn.edu
Contact: Joana Perdigao, MD Joana.LopesPerdigao@uphs.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Valerie M Riis, MS    215-615-6047    valerie.riis@uphs.upenn.edu   
Principal Investigator: Lisa Levine, MD         
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: Lisa Levine, Assistant Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03556761     History of Changes
Other Study ID Numbers: 829444
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Lisa Levine, University of Pennsylvania:
Furosemide
Postpartum
Hypertension
Additional relevant MeSH terms:
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Furosemide
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action