Post-Partum Haemorrhage Butterfly study (II): clinical testing and commercialisatio
- Conditions
- Specialty: Reproductive health and childbirth, Primary sub-specialty: General GynaecologyUKCRC code/ Disease: Reproductive Health and Childbirth/ Complications of labour and deliveryPregnancy and ChildbirthComplications of labour and delivery
- Registration Number
- ISRCTN15452399
- Lead Sponsor
- niversity of Liverpool
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36732101/ (added 03/02/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36906411/ Economic evaluation (added 13/03/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 57
1. Women with PPH following vaginal birth which is unresponsive to first line management (usually intravenous or intramuscular oxytocin +/- ergometrine)
2. Aged over 16
1. Women assessed antenatally to have learning difficulties that may have the potential to impair their decision making
2. Women aged < 16 years of age
3. Women who cannot read or understand the level of English used in the study documentation
4. Women whose baby is stillborn
5. Women whose PPH occurs more than 24 hours following birth
6. Women who have undergone Female Genital Mutilation/vaginal surgery which is unreversed (assessed antenatally)
7. Women with clotting disorders; either longstanding or following intrapartum events
8. Women in whom the third stage of labour is not complete (placenta remains in situ) or who had a retained placenta of over 30 minutes
9. Women who have had a caesarean section
10. Women who have fainted or who are unconscious (including those under anaesthetic) during the PPH
11. Women whose PPH is clinically diagnosed after 1 hour of baby’s birth
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method