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Postpartum Management of Gestational Hypertensive Disorders Using Furosemide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343235
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Sheela Barhan, Wright State University

Brief Summary:
  • The main purpose of this study is to learn if incorporating a loop diuretic such as furosemide along with labetalol in the routine management of postpartum gestational hypertensive disorders could lower the need for additional anti-hypertensive agents to control blood pressures, improve blood pressures (as measured by systolic blood pressure, diastolic blood pressure and mean arterial blood pressures), shorten hospital stays and decrease readmissions for patients with gestational hypertensive disorders.
  • Based on a study by Veena et al1, there is reason to believe that the addition of furosemide to other anti-hypertensives may help decrease the need to add or increase the dose of medication to control blood pressures. There may be potential to shorten hospital stays and decrease readmissions, as well. Collecting data will be done using a prospective, randomized 1:1 controlled study assigning postpartum patients with a gestational hypertensive diagnosis to either labetalol alone or labetalol plus furosemide.
  • The study will be performed in the postpartum wing of Miami Valley Hospital Main Campus and would use patients who have consented to participate in the study with enrollees coming from the OB Staff population.

Condition or disease Intervention/treatment Phase
Hypertension, Pregnancy-Induced Drug: furosemide Drug: labetalol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Masking Description: randomized open label
Primary Purpose: Treatment
Official Title: Postpartum Management of Gestational Hypertensive Disorders Using Furosemide: A Randomized Controlled Trial
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: labetalol + furosemide
labetalol + furosemide
Drug: furosemide
five day course of furosemide 20mg QD
Other Name: lasix

Drug: labetalol
400mg labetalol BID
Other Name: trandate

Active Comparator: labetalol only
labetalol only
Drug: labetalol
400mg labetalol BID
Other Name: trandate




Primary Outcome Measures :
  1. escalation of antihypertensive therapy [ Time Frame: From date of randomization until the date of hospital discharge (up to 7 days) ]
    number of patients who require an increase in the dose of labetalol to control BP


Secondary Outcome Measures :
  1. Improvement of gestational hypertensive disorders (systolic BP) [ Time Frame: From date of randomization until the date of hospital discharge (up to 7 days) ]
    number of patients with reduced blood pressure (systolic) pressure

  2. Improvement of gestational hypertensive disorders (mean arterial pressure) [ Time Frame: From date of randomization until the date of hospital discharge (up to 7 days) ]
    number of patients with reduced mean arterial pressure

  3. Improvement of gestational hypertensive disorders (diastolic BP) [ Time Frame: From date of randomization until the date of hospital discharge (up to 7 days) ]
    number of patients with reduced blood pressure (diastolic)

  4. hospital length of stay [ Time Frame: From date of delivery until the date of hospital discharge (up to 7 days) ]
    days in hospital after delivery

  5. breastfeeding status [ Time Frame: at 1 week postpartum visit ]
    breastfeeding continuation after discharge

  6. hospital readmission [ Time Frame: up to 14 days after discharge ]
    readmission for hypertension management



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postpartum women delivering at Miami Valley Hospital
  • Diagnosis of gestational hypertension or preeclampsia
  • Able to provide written informed consent

Exclusion Criteria:

  • Diagnosis of chronic hypertension
  • Allergy to study medications
  • Unable to understand English

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): NCT04343235


Locations
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United States, Ohio
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Sponsors and Collaborators
Wright State University
Investigators
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Principal Investigator: Sheela Barhan, MD Wright State University
Additional Information:
Publications:

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Responsible Party: Sheela Barhan, Associate Professor, Wright State University
ClinicalTrials.gov Identifier: NCT04343235    
Other Study ID Numbers: Barhan-Candela-002
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared on a case by case basis

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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.: No
Keywords provided by Sheela Barhan, Wright State University:
pregnancy induced hypertension
preeclampsia
furosemide
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Labetalol
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists