Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

November 9, 2010 updated by: Gynuity Health Projects

Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study purpose is to confirm whether a lower, 600 mcg dose of sublingual misoprostol will reduce the incidence of elevated body temperature (≥40°C) associated with misoprostol. The study will compare the incidence of high fevers following treatment with 600 mcg sublingual misoprostol to previously documented rates using 800 mcg sublingual misoprostol. An additional line of research is to investigate whether some women are more susceptible to experiencing high fevers following misoprostol administration, and whether genetic factors are responsible for misoprostol-induced fevers.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Pichincha
      • Quito, Pichincha, Ecuador
        • Hospital Gineco Obstétrico Isidro Ayora

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Able and willing to give informed consent
  • Vaginal delivery
  • Postpartum hemorrhage due to suspected uterine atony
  • Oxytocin given during 3rd stage of labor

Exclusion Criteria:

  • Known allergy to prostaglandins or misoprostol
  • Underwent cesarean section
  • Postpartum hemorrhage NOT due to suspected uterine atony
  • Oxytocin NOT given during 3rd stage of labor
  • Severe ill health
  • Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 600 mcg of sublingual misoprostol
Drug: Misoprostol
600 mcg of sublingual misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of fever above 40.0 degrees centigrade
Time Frame: Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH
% of women with body temperature measures ≥40°C
Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effect profile of misoprostol for PPH treatment
Time Frame: Side effects observed for 3 hours post-treatment with misoprostol for PPH
% of women experiencing any shivering and any fever or any other side effect
Side effects observed for 3 hours post-treatment with misoprostol for PPH
Acceptability of side effect profile among women
Time Frame: Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum)
% of women who rate side effects as acceptable, neutral, unacceptable, don't know
Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Collaborators

Bill and Melinda Gates Foundation
University of Liverpool

Investigators

  • Principal Investigator: Jill Durocher, Gynuity Health Projects
  • Principal Investigator: Andrew Weeks, MD, The University of Liverpool
  • Principal Investigator: Wilfrido Leon, MD, Hospital Gineco Obstétrico Isidro Ayora
  • Principal Investigator: Gustavo Barrera, MD, Hospital Gineco Obstétrico Isidro Ayora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 4, 2010

Study Record Updates

Last Update Posted (Estimate)

November 11, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.4.6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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