Mbarara Regional Referral Hospital
Mbarara, 1410, Uganda
NCT Number: NCT01866241
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
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Notify Me18 year–38 year
Female
Interventional
Phase 3
Mbarara, 1410, Uganda
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
Is a prostaglandin
Other names: Prostaglandin, Cytotec
Time frame: 24 hours
Estimated blood loss of more than or equal to 500ml
Time frame: 24 hours
Other secondary outcomes are: Hematocrit drop, additional uteretonic use
Time frame: 24 hours
Time frame: 24 hours
Time frame: 24 hours
Mbarara University of Science and Technology
Other
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