Trial | NCT01713153  Report issue

Title

Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal
Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    misoprostol ...

  • Study Participants

    1365
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
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.
Study Started
Jun 30
2012
Primary Completion
Jan 31
2014
Study Completion
Jan 31
2014
Last Update
Feb 25
2016
Estimate

Drug Misoprostol

600 mcg misoprostol oral

  • Other names: Cytotec, Misoclear

Device UnijectTM

10 IU oxytocin delivered intramuscularly with UnijectTM

Misoprostol Experimental

600 mcg oral misoprostol administered during the third stage of labor

UnijectTM Experimental

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

Criteria 

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
No Results Posted