Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK) Stepped Wedge Cluster Randomised Trial

Cardiff University0 sites189,000 target enrollmentAugust 30, 2023

Overview

No summary available.

Registry

who.int

Start Date

August 30, 2023

End Date

January 31, 2027

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

•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

•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):