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

Primary Purpose

Post Partum Hemorrhage

Status
Completed
Phase
Phase 3
Locations
Uganda
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
Mbarara University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Partum Hemorrhage

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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. -

Sites / Locations

  • Mbarara Regional Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A: sublingual misoprostol 600µg

Arm B: 10 IU Oxytocin

Arm Description

Misoprostol is a uteretonic drug

Oytocin is a standard of care treatment for PPH

Outcomes

Primary Outcome Measures

Estimated Blood loss
Estimated blood loss of more than or equal to 500ml

Secondary Outcome Measures

Blood loss of more than 1000ml
Other secondary outcomes are: Hematocrit drop, additional uteretonic use
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
7) placental retention 8) requirement for blood transfusion 9) requirement for additional therapeutic procedures or uterotonics 10) duration of the third stage of labor

Full Information

First Posted
May 28, 2013
Last Updated
September 5, 2014
Sponsor
Mbarara University of Science and Technology
Collaborators
Makerere University, University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01866241
Brief Title
Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
Official Title
Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mbarara University of Science and Technology
Collaborators
Makerere University, University Ghent

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: sublingual misoprostol 600µg
Arm Type
Experimental
Arm Description
Misoprostol is a uteretonic drug
Arm Title
Arm B: 10 IU Oxytocin
Arm Type
Placebo Comparator
Arm Description
Oytocin is a standard of care treatment for PPH
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Prostaglandin, Cytotec
Intervention Description
Is a prostaglandin
Primary Outcome Measure Information:
Title
Estimated Blood loss
Description
Estimated blood loss of more than or equal to 500ml
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Blood loss of more than 1000ml
Description
Other secondary outcomes are: Hematocrit drop, additional uteretonic use
Time Frame
24 hours
Title
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
Time Frame
24 hours
Title
7) placental retention 8) requirement for blood transfusion 9) requirement for additional therapeutic procedures or uterotonics 10) duration of the third stage of labor
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Uteretonic use
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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: confirmed intra-uterine fetal death self-reported maternal heart disease current diagnosis of severe malaria or acute bacterial infection, multiple pregnancy, induced or augmented labor, elective Caesarean section, ante-partum hemorrhage, reported hypersensitivity to prostaglandins altered cognitive status (ACS) as assessed by the MRAs. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amon Agaba, PhD
Organizational Affiliation
Mbarara University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Mbarara Regional Referral Hospital
City
Mbarara
ZIP/Postal Code
1410
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
25369200
Citation
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.
Results Reference
derived

Learn more about this trial

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

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