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Completed

NCT Number: NCT00124540

Misoprostol for Preventing Postpartum Hemorrhage

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.

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Key information

Conditions

Postpartum Hemorrhage Anemia Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University College Hospital, Ibadan, Nigeria

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Placebo

Drug

placebo resembling misoprosotl

Primary outcomes

  1. Blood loss =>500 mls within one hour after enrollment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Effective Care Research Unit
  • Family Care International
  • University of Witwatersrand, South Africa

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jul 28, 2005
Registry last updated
May 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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