Misoprostol for Preventing Postpartum Hemorrhage

This study has been completed.
Sponsor:
Collaborators:
University of Witwatersrand, South Africa
Effective Care Research Unit, South Africa
Family Care International
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00124540
First received: July 26, 2005
Last updated: May 26, 2008
Last verified: May 2008
  Purpose

This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.


Condition Intervention
Postpartum Hemorrhage
Drug: misoprostol
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Misoprostol for Preventing Postpartum Hemorrhage

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Blood loss =>500 mls within one hour after enrollment

Secondary Outcome Measures:
  • Blood loss =>1000 mls within one hour after enrollment
  • Mean blood loss after enrollment
  • Blood transfusion
  • Hemoglobin level <8 g/dL 24 hours after delivery
  • Maternal morbidity and mortality
  • Side effects

Enrollment: 1200
Study Start Date: August 2005
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
placebo resembling misoprostol
Drug: placebo
placebo resembling misoprosotl
Experimental: 2
misoprostol
Drug: misoprostol

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who have given birth to 1 or more live-born infants (para 1 or more)
  • Vaginal delivery

Exclusion Criteria:

  • Refusal or inability to give informed consent
  • Delivery regarded as abortion according to local gestational age limits
  • Inability to take misoprostol sublingually
  • Cesarean section
  • Assisted vaginal delivery
  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: NCT00124540

Locations
Nigeria
University College Hospital
Ibadan, Nigeria
South Africa
Tembisa Hospital
Johannesburg, South Africa
Rob Ferreira Hospital
Nelspruit, South Africa
Dora Nginza Hospital
Port Elizabeth, South Africa
Uganda
Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
Gynuity Health Projects
University of Witwatersrand, South Africa
Effective Care Research Unit, South Africa
Family Care International
Investigators
Study Director: Lindeka Mangesi Effective Care Research Unit, East London Hospital Complex, South Africa
Principal Investigator: G. J. Hofmeyr, MD Effective Care Research Unit, Frere Maternity Hospital, East London Hospital Complex
  More Information

No publications provided by Gynuity Health Projects

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Justus Hofmyer, University of Witwatersrand
ClinicalTrials.gov Identifier: NCT00124540     History of Changes
Other Study ID Numbers: 2.4.5
Study First Received: July 26, 2005
Last Updated: May 26, 2008
Health Authority: South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council

Keywords provided by Gynuity Health Projects:
Misoprostol
Active management
Postpartum hemorrhage
Maternal morbidity
Anemia
Developing countries

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 August 28, 2014