Misoprostol for Preventing Postpartum Hemorrhage

Sponsor

Gynuity Health Projects (Other)

Overall Status

Completed

CT.gov ID

NCT00124540

Collaborator

University of Witwatersrand, South Africa (Other), Effective Care Research Unit (Other), Family Care International (Other)

1,200

Enrollment

Locations

Arms

Duration (Months)

240

Patients Per Site

9.2

Patients Per Site Per Month

Study Details

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	Phase
Postpartum Hemorrhage	Drug: misoprostol Drug: placebo	N/A

Study Design

Study Type:

Interventional

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 :

Aug 1, 2005

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: 1

placebo resembling misoprostol

Drug: placebo

placebo resembling misoprosotl

Experimental: 2

misoprostol

Drug: misoprostol

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

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

Locations

	Site	City	Country
1	University College Hospital	Ibadan	Nigeria
2	Tembisa Hospital	Johannesburg	South Africa
3	Rob Ferreira Hospital	Nelspruit	South Africa
4	Dora Nginza Hospital	Port Elizabeth	South Africa
5	Mulago Hospital	Kampala	Uganda

Sponsors and Collaborators

Gynuity Health Projects
University of Witwatersrand, South Africa
Effective Care Research Unit
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