Postpartum haemorrhage Pregnancy and Childbirth
Conditions
Interventions
The study is a non-blinded, cluster randomised controlled pilot study where four hospitals will participate – two sites will be randomised to the intervention group and two to the standard group.
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Pregnant women at >24 weeks gestation, who are actively bleeding within 24 hours of delivery, and for whom at least one unit of RBC has been started or transfused to stem active bleeding
Exclusion criteria
Exclusion criteria: 1. Women who decline blood transfusion in advance 2. Women with inherited Factor XIII 3. Women with inherited fibrinogen deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women who were administered cryoprecipitate within 90 minutes of major haemorrhage protocol (MHP) activation, or request of the first unit of RBC transfusion (whichever is earlier) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Local rates of massive obstetric haemorrhage, measured as number of cases per week 2. Proportion of women who were recruited to the trial, and for whom complete outcomes were obtained 3. Proportion of women who were approached and did not consent to the trial 4. Proportion of women who were approached and agreed to routine data collection 5. Proportion of women where there was a study protocol violation 6. Time (in minutes) to first administration of cryoprecipitate from activation of MHP or request of first unit of RBC transfusion (whichever is earlier) 7. Preliminary clinical outcome data collected by accessing medical records between recruitment and hospital discharge (or until 28 days after recruitment, whichever is sooner); clinical outcome data that will be collected include: mortality (all cause), hysterectomy, surgical interventions to stop haemorrhage within 24 hrs, total transfusion requirements within 24 hours of first RBC unit issued to treat PPH, and until hospital discharge, transfusion-related reactions, length of stay (days) in high dependency unit, intensive care units and hospital, requirement for mechanical ventilation, any organ failure, symptomatic thrombotic events, which include: venous thromboembolism (i.e. pulmonary embolism, and/or deep vein thrombosis) and arterial thrombotic events (e.g. myocardial infarction or stroke). 8. Symptomatic thrombotic events (arterial or venous) up to 3 months after receiving the intervention 9. Mortality (all cause) up to 3 months after receiving the intervention 10. Maternal fatigue as measured by the Multidimensional Fatigue Inventory (MFI) questionnaire, completed between recruitment and discharge 11. Views of women on participation in a cluster randomised trial without advance consent, and of the intervention, through qualitative research interv | — |
Countries
England, United Kingdom
Outcome results
None listed