Misoprostol for Preventing Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

Misoprostol for Preventing Postpartum Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124540
• Other study ID #: 2.4.5
• Status: Completed
• Phase: N/A
• First received: July 26, 2005
• Last updated: May 26, 2008
• Start date: August 2005
• Est. completion date: October 2007

Study information

• Verified date: May 2008
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilSouth Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: October 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• misoprostol

• placebo
placebo resembling misoprosotl

Locations

Country	Name	City	State
Nigeria	University College Hospital	Ibadan
South Africa	Tembisa Hospital	Johannesburg
South Africa	Rob Ferreira Hospital	Nelspruit
South Africa	Dora Nginza Hospital	Port Elizabeth
Uganda	Mulago Hospital	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
Gynuity Health Projects	Effective Care Research Unit, South Africa, Family Care International, University of Witwatersrand, South Africa

Countries where clinical trial is conducted

Nigeria,  South Africa,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss =>500 mls within one hour after enrollment
Secondary	Blood loss =>1000 mls within one hour after enrollment
Secondary	Mean blood loss after enrollment
Secondary	Blood transfusion
Secondary	Hemoglobin level <8 g/dL 24 hours after delivery
Secondary	Maternal morbidity and mortality
Secondary	Side effects