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Misoprostol for Preventing Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT00124540
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : May 28, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Postpartum Hemorrhage Drug: misoprostol Drug: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Misoprostol for Preventing Postpartum Hemorrhage
Study Start Date : August 2005
Primary Completion Date : September 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
placebo resembling misoprostol
Drug: placebo
placebo resembling misoprosotl
Experimental: 2
misoprostol
Drug: misoprostol


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

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): 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

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
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: May 28, 2008
Last Verified: May 2008

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
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics