Effectiveness of a maternity improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK)

Not Applicable

• Conditions: Obstetric bleeding; Pregnancy and Childbirth

• Registration Number: ISRCTN17679951
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Last Update Posted: 15 April 2024
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 189000

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified