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

Mbarara University of Science and Technology

Status and phase: Completed; Phase 3

Conditions: Post Partum Hemorrhage

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01866241

MUST-17-2012

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,140 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,140 participants in 2 patient groups, including a placebo group

Arm A: sublingual misoprostol 600µg

Experimental group

Description:

Misoprostol is a uteretonic drug

Treatment:

Drug: Misoprostol

Arm B: 10 IU Oxytocin

Placebo Comparator group

Description:

Oytocin is a standard of care treatment for PPH