Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
University of Liverpool
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01080846
First received: March 2, 2010
Last updated: November 9, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Drug: Misoprostol

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    % of women with body temperature measures ≥40°C


Secondary Outcome Measures:
  • Side effect profile of misoprostol for PPH treatment [ Time Frame: Side effects observed for 3 hours post-treatment with misoprostol for PPH ] [ Designated as safety issue: Yes ]
    % of women experiencing any shivering and any fever or any other side effect

  • Acceptability of side effect profile among women [ Time Frame: Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum) ] [ Designated as safety issue: No ]
    % of women who rate side effects as acceptable, neutral, unacceptable, don't know


Enrollment: 50
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 600 mcg of sublingual misoprostol Drug: Misoprostol
600 mcg of sublingual misoprostol

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080846

Locations
Ecuador
Hospital Gineco Obstetrico Isidro Ayora
Quito, Pichincha, Ecuador
Sponsors and Collaborators
Gynuity Health Projects
Bill and Melinda Gates Foundation
University of Liverpool
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Andrew Weeks, MD The University of Liverpool
Principal Investigator: Wilfrido Leon, MD Hospital Gineco Obstetrico Isidro Ayora
Principal Investigator: Gustavo Barrera, MD Hospital Gineco Obstetrico Isidro Ayora
Principal Investigator: Jill Durocher Gynuity Health Projects
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jill Durocher, Program Associate, Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01080846     History of Changes
Other Study ID Numbers: 2.4.6
Study First Received: March 2, 2010
Last Updated: November 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Gynuity Health Projects:
Primary postpartum hemorrhage
PPH
uterine atony
high fever
hyperpyrexia

Additional relevant MeSH terms:
Hemorrhage
Postpartum 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
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on September 18, 2014