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Prevention of Severe Postpartum Hypertension

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: NCT02450773
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Method Tuuli, Indiana University

Study Description
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Brief Summary:
The purpose of this study is to determine whether postpartum administration of furosemide to women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or elevated blood pressure in the first 24 hours following delivery reduces severe postpartum hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Furosemide Drug: Potassium chloride Drug: Placebo #1 Drug: Placebo #2 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial
Study Start Date : August 2015
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Furosemide/Potassium chloride
40 mg furosemide; 20 meq potassium chloride
 Drug: Furosemide
40 mg furosemide on postpartum day 1-6
Other Name: Lasix

Drug: Potassium chloride
20 meq potassium chloride on postpartum day 1-6
Other Name: KCl
Placebo Comparator: Placebo
Placebo #1, Placebo #2
 Drug: Placebo #1
Placebo (for furosemide)

Drug: Placebo #2
Placebo (for KCl)


Outcome Measures
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Primary Outcome Measures :
  1. Composite maternal morbidity [ Time Frame: 0-6 weeks following delivery ]
    Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension


Secondary Outcome Measures :
  1. Adverse events associated with furosemide [ Time Frame: 0-6 weeks following delivery ]
    Hypokalemia

  2. Adverse events associated with furosemide [ Time Frame: 0-6 weeks following delivery ]
    hyperglycemia

  3. Adverse events associated with furosemide [ Time Frame: 0-6 weeks following delivery ]
    oliguria

  4. Adverse events associated with furosemide [ Time Frame: 0-6 weeks following delivery ]
    hypotension

  5. Adverse events associated with furosemide [ Time Frame: 0-6 weeks following delivery ]
    elevated serum creatinine


Other Outcome Measures:
  1. Cardiovascular changes following delivery [ Time Frame: 0-1 week following delivery ]
    Maternal echocardiogram, renin, aldosterone, B-natriuretic peptide levels


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Women > 18 years of age or emancipated minors

Women undergoing vaginal or cesarean delivery at > 23 weeks gestation with:

  • Antepartum diagnosis of gestational hypertension
  • Antepartum diagnosis of preeclampsia
  • Antepartum diagnosis of preeclampsia with severe features
  • Mild hypertension (<150/100) in first 24 hours following delivery

Exclusion Criteria:

  • Chronic hypertension
  • Allergy to furosemide
  • Pre-existing hypokalemia (serum K < 3.0 meq/L)
  • Chronic kidney disease
  • Serum Cr > 1.1
  • Inability to obtain informed consent
  • Pre-existing diuretic use
  • Oliguria
Contacts and Locations
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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): NCT02450773


Locations
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United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Methodius G Tuuli, MD, MPH Indiana University School of Medicine
More Information
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Responsible Party: Method Tuuli, Professor of Obstetrics and Gynecology, Indiana University
ClinicalTrials.gov Identifier: NCT02450773    
Other Study ID Numbers: 201501157
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Keywords provided by Method Tuuli, Indiana University:
postpartum
preeclampsia
gestational hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Furosemide
Diuretics
 Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action