Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal

Gynuity Health Projects

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Device: UnijectTM; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01713153

2.4.9

Details and patient eligibility

About

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

Full description

This study will assess the programmatic implications (including feasibility, acceptability, 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.

Enrollment: 1,365 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• women delivering in community health centers (case de sante) with a trained study provider (matrone) who are able to provide informed consent

Exclusion criteria

• women with known contraindications to prostaglandins

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,365 participants in 2 patient groups

Misoprostol

Experimental group

Description:

600 mcg oral misoprostol administered during the third stage of labor

Treatment:

Drug: Misoprostol

UnijectTM

Experimental group

Description:

10 IU oxytocin delivered IM with UnijectTM during he third stage of labor

Treatment:

Device: UnijectTM