Postpartum haemorrhage Pregnancy and Childbirth
Conditions
Interventions
Current interventions as of 07/04/2025:
COPE aims to recruit 2000 women across 20 UK hospitals via two recruitment pathways:
1. Women at high risk of PPH (defined as relative risk of > 3) will be invi
Sponsors
University of Liverpool
Eligibility
Sex/Gender
Female
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. =16 years of age 2. Requirement for medical treatment for primary PPH
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 28/03/2025: 1. Known to have opted out of participation antenatally 2. Known oxytocin or carboprost hypersensitivity 3. Known active cardiac or pulmonary disease 4. Known to have previously been treated as part of COPE 5. Has already received carboprost prophylactically for postpartum haemorrhage 6. Has already received uterotonic drug treatment for postpartum haemorrhage (this does not include PPH prophylaxis) 7. Stillbirth Previous participant exclusion criteria: 1. Known to have opted out of participation antenatally 2. Known oxytocin or carboprost hypersensitivity 3. Known active cardiac or pulmonary disease 4. Known to have previously been treated as part of COPE 5. Has already received uterotonic drug treatment for postpartum haemorrhage (this does not include PPH prophylaxis) 6. Stillbirth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood transfusion - any RBC blood transfusion or cell salvage of = 300ml commenced any time between randomisation and 48 hours after randomisation (or hospital discharge if earlier than 48 hrs), measured using medical notes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Volume of blood transfusion from randomisation up to 48 hours (or hospital discharge if earlier), measured using medical notes 2. Use of a further uterotonic drug from randomisation up to 24 hours after randomisation, measured using medical notes 3. Composite outcome of any organ dysfunction based on WHO near-miss approach for maternal health (2) from randomisation up to hospital discharge (or 4 weeks whichever is earlier) 4. Hysterectomy from randomisation up to hospital discharge (or 4 weeks whichever is earlier) , measured using medical notes 5. Blood loss in ml commencing in the first 24 hours from randomisation, up to cessation of active bleeding, measured using medical notes 6. Blood loss = 1000 ml, measured using medical notes 7. Haemoglobin closest to 24 hours after randomisation, measured using medical notes 8. Shock within 24 hours of randomisation, measured using medical notes 9. Maternal death within 4 weeks of the birth where postpartum haemorrhage was a contributing factor (it does not need to be the primary cause), measured using medical notes 10. Non pharmacological approach to treat or investigate bleeding from randomisation up to hospital discharge, measured using medical notes 11. Manual removal of placenta post randomisation up to hospital discharge, measured using medical notes 12. Any adverse reactions of the intervention for the mother (hypotension occurring within 2 mins of IMP administration, all other adverse reactions occurring within 2 hrs of administration) , measured using medical notes 13. ‘Skin to skin’ care with baby within the first hour after birth, measured using medical notes 14. Separation from new-born in first hour after birth, measured using medical notes 15. Breastfeeding, measured using [method] at 24 hrs, 48 hrs (or hospital discharge if sooner) and 4 weeks 16. Woman’s experience, measured using Childbirth Experience Questionnaire (CEQ) at 4 weeks 17. Resource use, measured using EQ-5D-5L, resource use qu | — |
Countries
England, United Kingdom
Outcome results
None listed