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Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

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: NCT02163616
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : April 24, 2017
Sponsor:
Collaborators:
Centro Rosarino de Estudios Perinatales
University of Liverpool
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE June 6, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date April 24, 2017
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Rates of high fever (≥40.0°C) [ Time Frame: First 2 hours postpartum ]
Percentage of women with body temperature measures ≥40°C
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
  • Side effect profile of misoprostol for PPH treatment [ Time Frame: Side effects observed for 3 hours post-treatment with misoprostol for PPH ]
    Percentage of women experiencing any shivering and any fever or any other side effect
  • Acceptability of regimen and side effects to women [ Time Frame: Interviewed prior to hospital discharge (about 24 hours postpartum) ]
    Percentage of women who rate side effects as acceptable, neutral, unacceptable, don't know
  • Shock index values [ Time Frame: First hour of the puerperium ]
    Pulse and blood pressure will be measured at pre-defined intervals (15, 30, 45, and 60 minutes)
  • Genetic factors responsible for elevated body temperature [ Time Frame: sample taken 24-48 hours postpartum ]
    Blood samples will be collected among women enrolled and sent to the Wolfson centre for personalized medicine at the University of Liverpool for genetic analysis to investigate genetic markers associated with misoprostol-induced fever.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • Side effect profile of misoprostol for PPH treatment [ Time Frame: Side effects observed for 3 hours post-treatment with misoprostol for PPH ]
    Percentage of women experiencing any shivering and any fever or any other side effect
  • Acceptability of regimen and side effects to women [ Time Frame: Interviewed prior to hospital discharge (about 24 hours postpartum) ]
    Percentage of women who rate side effects as acceptable, neutral, unacceptable, don't know
  • Shock index values [ Time Frame: First hour of the puerperium ]
    Pulse and blood pressure will be measured at pre-defined intervals (15, 30, 45, and 60 minutes)
  • Genetic factors responsible for elevated body temperature [ Time Frame: 3 months ]
    Blood samples will be collected among women enrolled at 1-2 study locations (where feasible) and sent to the Wolfson centre for personalized medicine at the University of Liverpool for genetic analysis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study
Official Title  ICMJE Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?
Brief Summary

This study seeks to assess whether populations of women in Latin America outside Quito, Ecuador are at increased risk for developing elevated body temperature above 40.0°C following PPH treatment with 800mcg sublingual misoprostol. The study will be carried out in hospitals representative of different regions of Latin America to explore environmental and genetic hypotheses related to the occurrence of misoprostol-induced fever. Postpartum blood loss, pulse and blood pressure will be systematically measured for all women enrolled to explore new clinical indicators for identifying women who require clinical intervention for excessive bleeding. Blood samples will be collected among women treated with misoprostol to investigate genetic factors responsible for elevated body temperature induced by misoprostol.

The investigators hypothesize that rates of high fever (≥40.0°C) following misoprostol treatment (800mcg given sublingually) will be variable across settings. The investigators expect that the side effect profile following 800 mcg misoprostol given sublingually, in particular the rates of any shivering and fever ≥38.0°C, will be comparable to previous results using misoprostol for PPH.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postpartum Hemorrhage
Intervention  ICMJE Drug: Misoprostol
800 mcg of sublingual misoprostol
Study Arms  ICMJE Experimental: PPH Treatment
800mcg sublingual misoprostol
Intervention: Drug: Misoprostol
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2017)
635
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
1400
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able and willing to give informed consent
  • Vaginal delivery
  • Postpartum hemorrhage due to suspected uterine atony
  • Able and willing to give informed consent

Exclusion Criteria:

  • Known allergy to misoprostol or other prostaglandins
  • Underwent a c-section during the current delivery
  • Unable to provide informed consent due to mental impairment, distress during labor or other reason
  • Unwilling and/or unable to respond to brief questionnaires or have her blood drawn
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries Colombia,   Ecuador
 
Administrative Information
NCT Number  ICMJE NCT02163616
Other Study ID Numbers  ICMJE 3003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynuity Health Projects
Study Sponsor  ICMJE Gynuity Health Projects
Collaborators  ICMJE
  • Centro Rosarino de Estudios Perinatales
  • University of Liverpool
Investigators  ICMJE
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Guillermo Carroli, MD Centro Rosarino de Estudios Perinatales
Principal Investigator: Jill Durocher Gynuity Health Projects
Principal Investigator: Ilana Dzuba, MPH Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date April 2017

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