Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
1 other identifier
interventional
1,140
1 country
1
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 oxytocin and will not be more than 6% worse \[than 10 IU oxytocin\] in management of 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 phase_3
Started Nov 2012
Shorter than P25 for phase_3
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
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 28, 2013
CompletedFirst Posted
Study publicly available on registry
May 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedSeptember 8, 2014
September 1, 2014
10 months
May 28, 2013
September 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Estimated Blood loss
Estimated blood loss of more than or equal to 500ml
24 hours
Secondary Outcomes (3)
Blood loss of more than 1000ml
24 hours
1) maternal death, 2) pre and post delivery hemoglobin changes 3) pre and post delivery hematocrit changes 4) >10% hemoglobin drop 5) mean postpartum hemoglobin and hematocrit, 6) mean measured blood loss
24 hours
7) placental retention 8) requirement for blood transfusion 9) requirement for additional therapeutic procedures or uterotonics 10) duration of the third stage of labor
24 hours
Other Outcomes (1)
Uteretonic use
24 hours
Study Arms (2)
Arm A: sublingual misoprostol 600µg
EXPERIMENTALMisoprostol is a uteretonic drug
Arm B: 10 IU Oxytocin
PLACEBO COMPARATOROytocin is a standard of care treatment for PPH
Interventions
Is a prostaglandin
Eligibility Criteria
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mbarara University of Science and Technologylead
- Makerere Universitycollaborator
- University Ghentcollaborator
Study Sites (1)
Mbarara Regional Referral Hospital
Mbarara, Mbarara, 1410, Uganda
Related Publications (1)
Atukunda EC, Siedner MJ, Obua C, Mugyenyi GR, Twagirumukiza M, Agaba AG. Sublingual misoprostol versus intramuscular oxytocin for prevention of postpartum hemorrhage in Uganda: a double-blind randomized non-inferiority trial. PLoS Med. 2014 Nov 4;11(11):e1001752. doi: 10.1371/journal.pmed.1001752. eCollection 2014 Nov.
PMID: 25369200DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Amon Agaba, PhD
Mbarara University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2013
First Posted
May 31, 2013
Study Start
November 1, 2012
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
September 8, 2014
Record last verified: 2014-09