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

NCT ID: NCT01866241

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-10-31

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.

Conditions

Post Partum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm A: sublingual misoprostol 600µg

Misoprostol is a uteretonic drug

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

Is a prostaglandin

Arm B: 10 IU Oxytocin

Oytocin is a standard of care treatment for PPH

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Misoprostol

Is a prostaglandin

Intervention Type: DRUG

Other Intervention Names

Prostaglandin, Cytotec

Eligibility Criteria

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Makerere University

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: collaborator

Mbarara University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amon Agaba, PhD

Role: STUDY_CHAIR

Mbarara University of Science and Technology

Locations

Mbarara Regional Referral Hospital

Mbarara, Mbarara, Uganda

Countries

Uganda

References

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.

Reference Type: DERIVED

PMID: 25369200 (View on PubMed)

Other Identifiers

MUST-17-2012

Identifier Type: -

Identifier Source: org_study_id