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

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

Study Overview

• Status: Completed
• Conditions: Post Partum Hemorrhage
• Intervention / Treatment: Drug: Misoprostol

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.

• Study Type: Interventional
• Enrollment (Actual): 1140
• Phase: Phase 3

Contacts and Locations

Study Locations

• Uganda
  • Mbarara, Uganda, 1410
    • Mbarara Regional Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: sublingual misoprostol 600µg; Misoprostol is a uteretonic drug	Drug: Misoprostol; Is a prostaglandin; Other Names: Prostaglandin, Cytotec
Placebo Comparator: Arm B: 10 IU Oxytocin; Oytocin is a standard of care treatment for PPH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated Blood loss	Estimated blood loss of more than or equal to 500ml	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss of more than 1000ml	Other secondary outcomes are: Hematocrit drop, additional uteretonic use	24 hours
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 Outcome Measures

Outcome Measure	Time Frame
Uteretonic use	24 hours

Collaborators and Investigators

• Sponsor: Mbarara University of Science and Technology
• Collaborators: Makerere University; University Ghent
• Investigators: Study Chair: Amon Agaba, PhD, Mbarara University of Science and Technology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 5, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Death; Uterine Hemorrhage; Parental Death; Hemorrhage; Postpartum Hemorrhage; Maternal Death; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: MUST-17-2012