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Misoprostol for Preventing Postpartum Hemorrhage

NCT00124540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2008-05-28

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

misoprostol

DRUG

placebo

placebo resembling misoprosotl

Sponsors & Collaborators

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • Effective Care Research Unit

    collaborator OTHER

  • Family Care International

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Lindeka Mangesi · Effective Care Research Unit, East London Hospital Complex, South Africa

  • G. J. Hofmeyr, MD · Effective Care Research Unit, Frere Maternity Hospital, East London Hospital Complex

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2007-09-30
Completion
2007-10-31

Countries

  • Nigeria
  • South Africa
  • Uganda

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00124540 on ClinicalTrials.gov