A clinical trial to study the effectiveness of a care bundle to prevent bleeding after a woman has given birth (E-MOTIVE).
Not Applicable
- Conditions
- Pregnancy and Childbirth
- Registration Number
- PACTR202002791391791
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
Health facility is the randomisation unit. Health facilities are eligible for inclusion if they have 1000 to 5000 births a year and provide comprehensive obstetric care with ability to perform surgery for PPH.
Exclusion Criteria
Health facilities with pre-existing implementation of early detection or bundled approach are exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is a composite of the following three clinical outcomes: 1) Number of women with primary severe PPH defined as blood loss =1000 ml following a vaginal birth in the facility; 2) Number of postpartum laparotomies for bleeding until discharge from the healthcare facility; 3) Number of postpartum maternal deaths from bleeding until discharge from the healthcare facility.
- Secondary Outcome Measures
Name Time Method