Overview
Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
Status:
Completed
Completed
Trial end date:
2013-10-01
2013-10-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to 10 IU oxytocin and will not be more than 6% worse [than 10 IU oxytocin] in management of third stage of laborPhase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Mbarara University of Science and TechnologyCollaborators:
Makerere University
University GhentTreatments:
Misoprostol
Criteria
Inclusion Criteria:Term mothers [38-41 WOA] above 18 years of age admitted at MbararaHospital, Uganda in active labor; anticipating vaginal delivery -
Exclusion Criteria:
Complicated labor:
1. confirmed intra-uterine fetal death
2. self-reported maternal heart disease
3. current diagnosis of severe malaria or acute bacterial infection,
4. multiple pregnancy,
5. induced or augmented labor,
6. elective Caesarean section,
7. ante-partum hemorrhage,
8. reported hypersensitivity to prostaglandins
9. altered cognitive status (ACS) as assessed by the MRAs. -