Status:
COMPLETED
Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
Lead Sponsor:
Mbarara University of Science and Technology
Collaborating Sponsors:
Makerere University
University Ghent
Conditions:
Post Partum Hemorrhage
Eligibility:
FEMALE
18-38 years
Phase:
PHASE3
Brief 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 oxytoci...
Detailed Description
Background: In Sub- Saharan Africa, one in 35 women die in child birth, 1000 times higher than the western world and Post-Partum Hemorrhage (PPH) accounts for the biggest percentage of maternal morbid...
Eligibility Criteria
Inclusion
- Term mothers \[38-41 WOA\] above 18 years of age admitted at Mbarara Hospital, Uganda in active labor; anticipating vaginal delivery -
Exclusion
- Complicated labor:
- confirmed intra-uterine fetal death
- self-reported maternal heart disease
- current diagnosis of severe malaria or acute bacterial infection,
- multiple pregnancy,
- induced or augmented labor,
- elective Caesarean section,
- ante-partum hemorrhage,
- reported hypersensitivity to prostaglandins
- altered cognitive status (ACS) as assessed by the MRAs. -
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
1140 Patients enrolled
Trial Details
Trial ID
NCT01866241
Start Date
November 1 2012
End Date
October 1 2013
Last Update
September 8 2014
Active Locations (1)
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1
Mbarara Regional Referral Hospital
Mbarara, Mbarara, Uganda, 1410