Obstetric bleeding Pregnancy and Childbirth
Conditions
Interventions
Maternity units will be randomised to one of six sequences, so there will be 6 maternity units in each sequence. Maternity units will initially collect data during a period of standard PPH care for be
Sponsors
Cardiff University
Eligibility
Sex/Gender
Female
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Site inclusion criteria: 1. Maternity unit with >2000 births per year 2. Local NHS maternity leaders support the implementation of the OBS UK intervention and quality improvement time for the local champion team. This must include protected midwifery time (4 hours/week) and non-clinical time for consultant obstetrician, anaesthetist, and haematologist from supporting professional activity during the 9-month implementation period For the psychology sub-study inclusion criteria are (requiring individual consent): 1. Women who have experienced a PPH of greater than 1L and their birth partners For the cost-effectiveness sub-study inclusion criteria are (requiring individual consent): 1. Women who have experienced a PPH of greater than 1L and their economic partners 2. Women who have a blood loss of less than 500mL and their economic partners For the process evaluation inclusion criteria are (interviews require individual consent, observation/ethnography study does not require individual consent): 1. Women and, if they would like to be involved, their birth partners who have experienced a PPH of greater than 1 L at one of four maternity units that were included in the pilot study (OBS Cymru) and selected for a site visit 2. Women and, if they would like to be involved, their birth partners who have experienced a PPH of greater than 1L at a maternity unit selected for a process evaluation site visit in the OBS UK study 3. Members of staff at four maternity units that were included in the pilot study (OBS Cymru) and are selected for a site visit 4. Members of the specialist and wider team who work in the maternity service at a maternity unit selected for a process evaluation site visit in the OBS UK study All patients are included in the primary outcome, whilst those opting out will not be included in the datasets/targeted source data. The lower age limit is only for the consenting sub studies.
Exclusion criteria
Exclusion criteria: Site exclusion criteria: 1. Maternity units that have adopted the entire OBS UK obstetric haemorrhage care bundle 2. Maternity units that use viscoelastic point-of-care tests of haemostasis on the consultant-led delivery suite or in obstetric theatres 3. If a Trust or Health Board has more than one maternity unit then only one can join the study For the psychology sub-study exclusion criteria are (requiring individual consent): 1. Age <16 years, prisoners and individuals who lack capacity 2. Women and birth partners who have had experienced a stillbirth or neonatal death will be excluded from the psychology study component For the cost-effectiveness sub-study exclusion criteria are (requiring individual consent): 1. Age <16 years, prisoners and individuals who lack capacity For the process evaluation exclusion criteria are (interviews require individual consent, observation/ethnography study does not require individual consent): 1. Age <16 years, prisoners and individuals who lack capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of women receiving allogenic red blood cell transfusion for PPH from 4 hours before birth until hospital discharge measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes measured using patient records: 1. Blood loss: Total blood loss volume within 4 hours prior to and 24 hours after birth 2. Hysterectomy: Number of women undergoing hysterectomy due to PPH 3. Maternal death: Number of women who died following PPH 4. Higher level of care: Number of women transferred to higher level of care (Level2/3) outside of the obstetric unit for complications following PPH 5. Cardiovascular shock: Number of women transferred to higher level of care outside of the obstetric unit for vasopressor infusion following PPH 6. Organ dysfunction: Number of women transferred to higher level of care outside of the obstetric unit for organ support following PPH 7. Blood transfusion: Number of women transfused cell salvage red blood cells and the volume within 4 hours before birth up until discharge for obstetric bleeding 8. Other blood components/products transfused: Number of women transfused coagulation products including type of product (FFP, cryoprecipitate, platelets or fibrinogen concentrate) and number of units within 4 hours before birth up until discharge for obstetric bleeding 9. Coagulopathy: Number of women with fibrinogen levels 1.5x midpoint of normal reference range and platelet count 1.5L and or receive a blood transfusion due to obstetric bleeding, 2. Case studies Prospective ethnographic and qualitative data collection from six sites (one per sequence) during standard care, implementation and OBS UK care periods and ethnographic and qualitative data collection in four maternity units in Wales where the intervention is embedded into standard care. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed