Obstetric Bleeding Study UK (OBS UK)
Research type
Research Study
Full title
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
IRAS ID
326510
Contact name
Sarah F Bell
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
3 years, 8 months, 31 days
Research summary
Excess bleeding is the most common complication of childbirth. Every year about 50,000 women in the UK lose 1L (2 pints) of blood or more. Many women develop post-traumatic stress disorder, need blood transfusion or admission to intensive care.
There is a lack of knowledge about how best to treat the excess bleeding.A care bundle for managing bleeding after birth was developed in Wales and rolled out as a quality improvement programme called the ‘Obstetric Bleeding Strategy’ (OBS). The care bundle has four parts: 1) assessment of each woman’s bleeding risk, 2) accurate measurement of blood loss at all births, 3) a consistent approach to escalation of care to more senior clinicians and 4) bedside tests to identify and treat abnormal blood clotting.
The OBS was associated a reduction in major bleeding and blood transfusion but we do not know whether the improved outcomes were due to the OBS programme.
We will recruit about 189,000 women from 36 NHS maternity units over 30-months. All women giving birth in these units will be included, whether they have excess bleeding or not. Maternity units will have a period during which standard care will continue and data collected. Units will then adopt the care bundle over 9-months followed by at least 3-months of data collection. We will compare the rate of blood transfusion after childbirth before and after the OBS was introduced. The effect of the OBS on the psychological well-being of women and birthing partners and its financial cost will also be studied. To better understand how the OBS programme works we will conduct a detailed study of how units adopt it. This includes interviewing staff and women with excess bleeding before and after adoption to understand what they think of the care bundle and whether it changes how teams deliver care.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0242
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion