Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

Not Applicable

Withdrawn

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: misprostol; Device: UnijectTM

• Registration Number: NCT01487278
• Lead Sponsor: Gynuity Health Projects

Brief Summary

This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.

Detailed Description

This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

Study Timeline

• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-07
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• women delivering at home with a trained study provider who are able to provide informed consent

Exclusion Criteria

• women with known contraindications to prostaglandins

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	misprostol	600 mcg oral misoprostol administered during the third stage of labor
UnijectTM	UnijectTM	10 IU oxytocin delivered IM with UnijectTM during he third stage of labor

Primary Outcome Measures

Name	Time	Method
Mean change in hemoglobin	during 3rd trimester and 1-3 days postpartum	To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.

Secondary Outcome Measures

Name	Time	Method
additional interventions	during birth and 1-3 days postpartum	use of additional uterotonics, manual removal of placental fragments, etc
referrals	1-3 days postpartum	referral requested, transfers carried out, reasons for incomplete referrals/transfers
acceptability	1-3 days postpartum	acceptability according to woman of study medication, care received, side effects experienced
occurrence and management of side effects	1 hour postpartum	nausea, vomiting, diarrhea, shivering, fever
correct timing of drug administration	collected immediately following birth, verified 1-3 days postpartum	administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta
change in hemoglobin ≥ 2 g/dL	during third trimester and 1-3 days postpartum

Trial Locations

Locations (1)

Villages in Mopti; 🇲🇱 Mopti, Mali