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Prevention of Severe Postpartum Hypertension

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ClinicalTrials.gov Identifier: NCT02450773
Recruitment Status : Recruiting
First Posted : May 21, 2015
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Method Tuuli, Indiana University

Tracking Information
First Submitted Date  ICMJE May 11, 2015
First Posted Date  ICMJE May 21, 2015
Last Update Posted Date October 3, 2019
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
Composite maternal morbidity [ Time Frame: 0-6 weeks following delivery ]
Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02450773 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
  • Adverse events associated with furosemide [ Time Frame: 0-6 weeks following delivery ]
    Hypokalemia
  • Adverse events associated with furosemide [ Time Frame: 0-6 weeks following delivery ]
    hyperglycemia
  • Adverse events associated with furosemide [ Time Frame: 0-6 weeks following delivery ]
    oliguria
  • Adverse events associated with furosemide [ Time Frame: 0-6 weeks following delivery ]
    hypotension
  • Adverse events associated with furosemide [ Time Frame: 0-6 weeks following delivery ]
    elevated serum creatinine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 18, 2015)
Cardiovascular changes following delivery [ Time Frame: 0-1 week following delivery ]
Maternal echocardiogram, renin, aldosterone, B-natriuretic peptide levels
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Prevention of Severe Postpartum Hypertension
Official Title  ICMJE Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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
  • Drug: Placebo #1
    Placebo (for furosemide)
  • Drug: Placebo #2
    Placebo (for KCl)
Study Arms  ICMJE
  • Experimental: Furosemide/Potassium chloride
    40 mg furosemide; 20 meq potassium chloride
    Interventions:
    • Drug: Furosemide
    • Drug: Potassium chloride
  • Placebo Comparator: Placebo
    Placebo #1, Placebo #2
    Interventions:
    • Drug: Placebo #1
    • Drug: Placebo #2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2015)
248
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Maureen Mullen, BSN 317-948-7587 maamulle@iu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02450773
Other Study ID Numbers  ICMJE 201501157
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Method Tuuli, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Methodius G Tuuli, MD, MPH Indiana University School of Medicine
PRS Account Indiana University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP