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
1 other identifier
interventional
1,365
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFebruary 25, 2016
February 1, 2016
1.6 years
October 22, 2012
February 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in hemoglobin
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
during 3rd trimester and 1-3 days postpartum
Secondary Outcomes (6)
Occurrence and management of side effects
1 hour postpartum
correct timing of drug administration
collected immediately following birth, verified 1-3 days postpartum
change in hemoglobin ≥ 2 g/dL
during third trimester and 1-3 days postpartum
additional interventions
during birth
referrals
0-3 days postpartum
- +1 more secondary outcomes
Study Arms (2)
Misoprostol
EXPERIMENTAL600 mcg oral misoprostol administered during the third stage of labor
UnijectTM
EXPERIMENTAL10 IU oxytocin delivered IM with UnijectTM during he third stage of labor
Interventions
Eligibility Criteria
You may qualify if:
- women delivering in community health centers (case de sante) with a trained study provider (matrone) who are able to provide informed consent
You may not qualify if:
- women with known contraindications to prostaglandins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynuity Health Projectslead
- ChildFund Internationalcollaborator
Study Sites (1)
Health huts in the district of Thiadiaye and Kolda
Thiadiay and Kolda, Thiadiaye and Kolda, Senegal
Related Publications (1)
Diop A, Daff B, Sow M, Blum J, Diagne M, Sloan NL, Winikoff B. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial. Lancet Glob Health. 2016 Jan;4(1):e37-44. doi: 10.1016/S2214-109X(15)00219-3.
PMID: 26718808DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 24, 2012
Study Start
June 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
February 25, 2016
Record last verified: 2016-02