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

Post Partum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866241
• Other study ID #: MUST-17-2012
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2013
• Last updated: September 5, 2014
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: Mbarara University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and TechnologyUganda: National Drug Authority
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1140
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Maternal Death
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
Is a prostaglandin

Locations

Country	Name	City	State
Uganda	Mbarara Regional Referral Hospital	Mbarara

Sponsors (3)

Lead Sponsor	Collaborator
Mbarara University of Science and Technology	Makerere University, University Ghent

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Uteretonic use		24 hours	No
Primary	Estimated Blood loss	Estimated blood loss of more than or equal to 500ml	24 hours	No
Secondary	Blood loss of more than 1000ml	Other secondary outcomes are: Hematocrit drop, additional uteretonic use	24 hours	No
Secondary	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	Yes
Secondary	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	Yes