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Misoprostol for Preventing Postpartum Hemorrhage

This study has been completed.
University of Witwatersrand, South Africa
Effective Care Research Unit, South Africa
Family Care International
Information provided by:
Gynuity Health Projects Identifier:
First received: July 26, 2005
Last updated: May 26, 2008
Last verified: May 2008
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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
Drug: misoprostol


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

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
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Please refer to this study by its identifier: NCT00124540

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
Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
Gynuity Health Projects
University of Witwatersrand, South Africa
Effective Care Research Unit, South Africa
Family Care International
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Justus Hofmyer, University of Witwatersrand Identifier: NCT00124540     History of Changes
Other Study ID Numbers: 2.4.5
Study First Received: July 26, 2005
Last Updated: May 26, 2008

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

Additional relevant MeSH terms:
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics processed this record on April 27, 2017