We are currently recruiting sites to participate in a study of PPH care
Aim: To test the effectiveness and cost-effectiveness of the OBS UK PPH intervention compared to standard care on clinical and psychological outcomes after childbirth and conduct a process evaluation.
Intervention: The OBS UK PPH care bundle (based on OBS Cymru)1,2 introduced within a quality improvement (QI) programme over 9 months. The OBS UK PPH care bundle consists of:
- Universal individual assessment of bleeding risk at labour onset,
- Real-time accurate measurement of blood loss at all births,
- A structured and consistent approach to escalation of care (based on measured blood loss) to more senior clinicians,
- A bedside test using TEG/ROTEM to rapidly identify abnormal blood clotting (within 10 minutes) and inform treatment if needed
Maternity unit eligibility criteria:
- UK NHS maternity unit with >2000 births/year
- Maternity unit has not adopted the entire OBS UK PPH care bundle including TEG/ROTEM (ie. will be eligible if have implemented up to 3 of 4 aspects of the bundle)
- Has the support of the local NHS maternity senior staff and managers. The unit will need to agree to begin implementation the OBS UK intervention at the time determined by the study randomisation (starting between 3 and 18 months after study start) and support QI time for the local champion team for the 9 months of the implementation of the intervention including: 4 hours/week protected midwifery time (above any funded research midwife time) and non-clinical time for a named lead consultant obstetrician, anaesthetist, and haematologist from supporting professional activity QI work
- Willingness of the whole maternity unit MDT (midwives, obstetricians, anaesthetists and local haematology/blood bank) to be trained in, and adopt the whole of the OBS UK PPH care bundle
- Ready to start data extraction in January 2024 (this is the designated start of the study for all sites) with research contracts signed and the research midwife allocated to the study 0.2wte
- An understanding that due to the randomised nature of the stepped wedge design, the intervention (which is the introduction of the care bundle including TEG/ROTEM) will happen at different times in centres between April 2024 and July 2025
- Agreement that the entire OBS UK PPH care bundle will not be implemented at unit level prior to the designated study implementation time
Background: Postpartum haemorrhage (PPH) is the leading cause of maternal morbidity in the UK. There is evidence that rates are increasing with ethnic minorities disproportionately affected. Recent national reviews and our patient representatives highlight the need to improve and standardise PPH treatment. A care bundle for managing PPH was developed in Wales, the ‘Obstetric Bleeding Strategy’ (OBS).1,2 This contrasts with current UK guidelines which recommend measuring blood loss only after excess bleeding is identified (leading to inconsistent identification and escalation) and giving transfusions based on fixed formulae whilst awaiting laboratory-based test results (around 1 hour). This leads to undertreatment of coagulopathy for some women and unnecessary treatment and transfusions for many others. Although the OBS intervention (OBS care bundle rolled out as a quality improvement (QI) programme) was successfully adopted by Welsh maternity settings (2017-18) and associated with a reduction in massive PPH and blood transfusion, the lack of control and robust clinical and cost effectiveness data has limited more widespread adoption.2 Maternity staff viewed the OBS intervention positively, with improved team-working, but further work is needed to establish how the care bundle works. We will therefore be undertaking a comprehensive evaluation of the OBS intervention in a RCT.
Methods: A stepped wedge cluster RCT in 36 maternity units over 30 months (approximately 189,000 maternities). The population will be all women giving birth under the care of a participating unit or Trust, including all births outside of the obstetric unit. Routinely collected NHS data will be used to measure. Starting in January 2023, maternity units will have an initial period of standard care (3-18 months) followed by the implementation of the OBS intervention (9 months) and follow up data collection (3-18 months). The comparator will be outcomes associated with standard PPH care provided by units prior to the OBS intervention.
Primary outcome: Proportion of women who receive red blood cell transfusion for PPH.
Secondary outcomes: PPH core outcome dataset (including blood transfusion, intensive care admission and hysterectomy rates), effect on psychological wellbeing, cost-effectiveness. The impact of ethnicity, other socio-demographic factors and organisational culture on outcomes will also be studied.
Anticipated impact: The study will establish whether (and how) the OBS intervention improves outcomes and experiences of women and reduces variation in PPH care. Findings will inform UK and international PPH practice.
The study will fund:
- Research midwifery time (Band 6, 0.2wte, for 35 months) to support study data collection (the study team will work with research midwives to report routinely collected data) and recruitment into specific integrated studies
- ROTEM/TEG device and consumables with support from industry in set up/ integrate into local point of care systems/ training packages for quality control and day to day use
- Fibrinogen concentrate which will be held in local blood bank facilities and integrated into local blood bank and obstetric haemorrhage guidelines
- There will be support from the Centre for Trials Research, Cardiff University, for study set up including contract signing with local R&D department (the support will enable units that are less experienced in intrapartum research to participate)
- Central QI team to cascade training and education to local leaders for OBS UK bundle and support interpretation of QI data and change management
The study will not fund staff support for local delivery of the QI project as the ethos of the study is that the bundle could be incorporated into normal NHS practice if shown to be effective.
For more information, or an informal chat, please email the OBS UK study team: OBSUK@cardiff.ac.uk