Post Partum Hemorrhage
Conditions
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
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 morbidity and mortality (WHO, 2005; WHO, 2010). Maternal Mortality in Uganda is one of the highest in the world at 435 for every 100,000 and 25% of these are due to PPH happening within 24 hours after delivery. Oxytocin, the standard of care in PPH management has registered challenges like requirement of sterile injections, requirement of trained personnel, special supply chain/storage conditions like refrigeration and protection from light affecting maximum treatment outcomes especially in poorly resourced developing countries where these are not realized. It has been argued that any effort or developments based on physiological processes towards the reduction of this horrific PPH rate would greatly have a significant impact on the lives of families and women worldwide. Several scholars have thus stressed a vital need to develop simple, practical and inexpensive techniques relevant to prevent and treat PPH in developing countries.
Interventions
DRUGMisoprostol
Is a prostaglandin
Sponsors
Makerere University
University Ghent
Mbarara University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood loss | 24 hours | Estimated blood loss of more than or equal to 500ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss of more than 1000ml | 24 hours | Other secondary outcomes are: Hematocrit drop, additional uteretonic use |
| 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
| Measure | Time frame |
|---|---|
| Uteretonic use | 24 hours |
Countries
Uganda
Outcome results
None listed