Obstetric Bleeding Study UK (OBS UK): protocol for a stepped wedge cluster randomised trial investigating the clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth.
Kotecha SJ., Potter C., Hope-Bell J., Riddell NS., Munnery K., Onyimadu O., Liberty C., Taylor H., Dop C., De Lloyd L., Parry-Smith W., Townson J., Pallmann P., Moody G., Moriarty Y., Deere R., Barlow C., Dhadda A., Elsmore A., Willson S., Millward H., Siddall K., Sanders J., Stanworth SJ., Black M., Petrou S., Rai T., Slade P., Hinton L., Fye H., Gur Geden A., Collis RE., Collins P., Bell S.
INTRODUCTION: Bleeding during and after childbirth (postpartum haemorrhage, PPH) is the leading cause of severe maternal morbidity in the UK. Between 2017 and 2018, a PPH care bundle termed the Obstetric Bleeding Strategy (OBS) was implemented as a quality improvement project across all Welsh maternity units and improvements in maternal outcomes were observed. The OBS PPH care bundle incorporates assessment of bleeding risk, real-time cumulative quantification of blood loss, escalation of multiprofessional care including more senior staff at defined volumes of blood loss and point-of-care testing of coagulation at 1 L blood loss (or earlier if clinical concern) with targeted blood product transfusion in cases of haemostatic impairment. The Obstetric Bleeding Study UK (OBS UK) will evaluate this intervention in a larger number of maternity units across the UK. METHODS AND ANALYSIS: OBS UK is a stepped wedge cluster randomised trial designed to test the effectiveness of the OBS intervention compared with usual care on clinical and psychological PPH outcomes after childbirth, evaluate its cost-effectiveness and perform a process evaluation. The study will be capturing data from over 270 000 women and birthing people giving birth in the care of 36 participating maternity units during the 30-month study period. All maternity units will undertake a control period (lasting 3-18 months) during which usual PPH care will be provided, followed by a 9-month implementation period during which the OBS PPH care bundle will be introduced using quality improvement methods and then an OBS UK intervention period (lasting 3-18 months) during which OBS PPH care will be delivered.The primary outcome is the number of women receiving allogeneic red blood cell transfusion for PPH per 1000 maternities. Secondary outcomes are informed by the core PPH outcome set, psychological and cost-effectiveness measures for women and their partners and a mixed methods process evaluation exploring how the intervention was deployed and possible improvements to inform wider implementation. ETHICS AND DISSEMINATION: OBS UK will establish whether (and how) the OBS UK PPH care bundle improves outcomes and experiences of women and their partners. Published results will provide evidence to inform PPH maternity care across the UK and internationally. Dissemination of the findings will be made available to members of the public and participants. TRIAL REGISTRATION NUMBER: ISRCTN17679951.