Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Primary postpartum hemorrhage, PPH, uterine atony, high fever, hyperpyrexia, shock index
Eligibility Criteria
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
Sites / Locations
- Hospital Dr. A. Llano
- Hospital J.R. Vidal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PPH Treatment
Arm Description
800mcg sublingual misoprostol
Outcomes
Primary Outcome Measures
Rates of high fever (≥40.0°C)
Percentage of women with body temperature measures ≥40°C
Secondary Outcome Measures
Side effect profile of misoprostol for PPH treatment
Percentage of women experiencing any shivering and any fever or any other side effect
Acceptability of regimen and side effects to women
Percentage of women who rate side effects as acceptable, neutral, unacceptable, don't know
Shock index values
Pulse and blood pressure will be measured at pre-defined intervals (15, 30, 45, and 60 minutes)
Genetic factors responsible for elevated body temperature
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.
Full Information
NCT ID
NCT02163616
First Posted
June 6, 2014
Last Updated
April 20, 2017
Sponsor
Gynuity Health Projects
Collaborators
Centro Rosarino de Estudios Perinatales, University of Liverpool
1. Study Identification
Unique Protocol Identification Number
NCT02163616
Brief Title
Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study
Official Title
Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynuity Health Projects
Collaborators
Centro Rosarino de Estudios Perinatales, University of Liverpool
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Primary postpartum hemorrhage, PPH, uterine atony, high fever, hyperpyrexia, shock index
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
635 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PPH Treatment
Arm Type
Experimental
Arm Description
800mcg sublingual misoprostol
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
800 mcg of sublingual misoprostol
Primary Outcome Measure Information:
Title
Rates of high fever (≥40.0°C)
Description
Percentage of women with body temperature measures ≥40°C
Time Frame
First 2 hours postpartum
Secondary Outcome Measure Information:
Title
Side effect profile of misoprostol for PPH treatment
Description
Percentage of women experiencing any shivering and any fever or any other side effect
Time Frame
Side effects observed for 3 hours post-treatment with misoprostol for PPH
Title
Acceptability of regimen and side effects to women
Description
Percentage of women who rate side effects as acceptable, neutral, unacceptable, don't know
Time Frame
Interviewed prior to hospital discharge (about 24 hours postpartum)
Title
Shock index values
Description
Pulse and blood pressure will be measured at pre-defined intervals (15, 30, 45, and 60 minutes)
Time Frame
First hour of the puerperium
Title
Genetic factors responsible for elevated body temperature
Description
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.
Time Frame
sample taken 24-48 hours postpartum
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly Winikoff, MD, MPH
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillermo Carroli, MD
Organizational Affiliation
Centro Rosarino de Estudios Perinatales
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jill Durocher
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilana Dzuba, MPH
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Dr. A. Llano
City
Corrientes
Country
Argentina
Facility Name
Hospital J.R. Vidal
City
Corrientes
Country
Argentina
12. IPD Sharing Statement
Links:
URL
http://www.gynuity.org
Description
Gynuity Health Projects
Learn more about this trial
Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study
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