Overview

Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage

Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
0
Participant gender:
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 labor
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mbarara University of Science and Technology
Collaborators:
Makerere University
University Ghent
Treatments:
Misoprostol
Criteria
Inclusion Criteria:Term mothers [38-41 WOA] above 18 years of age admitted at Mbarara
Hospital, 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. -