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Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

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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

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.


Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Misoprostol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 635 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?
Actual Study Start Date : September 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: PPH Treatment
800mcg sublingual misoprostol
Drug: Misoprostol
800 mcg of sublingual misoprostol




Primary Outcome Measures :
  1. Rates of high fever (≥40.0°C) [ Time Frame: First 2 hours postpartum ]
    Percentage of women with body temperature measures ≥40°C


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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.



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

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): NCT02163616


Locations
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Argentina
Hospital Dr. A. Llano
Corrientes, Argentina
Hospital J.R. Vidal
Corrientes, Argentina
Sponsors and Collaborators
Gynuity Health Projects
Centro Rosarino de Estudios Perinatales
University of Liverpool
Investigators
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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

Additional Information:
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02163616     History of Changes
Other Study ID Numbers: 3003
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Keywords provided by Gynuity Health Projects:
Primary postpartum hemorrhage
PPH
uterine atony
high fever
hyperpyrexia
shock index
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics