PReventing Severe Maternal Morbidity and mortality through a national programme of interventions

What is the research question? Can a new complex intervention delivered by the NHS reduce maternal mortality and morbidity nationally? Background In England, one in every 10,000 women dies during pregnancy or shortly after giving birth. For every woman that dies, more than 100 experience severe morbidity. Whilst maternal deaths are investigated through a national confidential enquiry, there is no monitoring of maternal morbidity. The government has identified reducing maternal mortality as a priority. NHS England and the Department of Health and Social Care have committed to a flagship policy called the ‘Saving Mother’s Lives Care Bundle’ (SMLCB). This will be a complex intervention to prevent and treat the underlying factors leading to severe maternal morbidity and mortality. It will reduce variation in clinical practice, benchmark clinical standards, aiming to reducing inequitable maternity care. PREMAT will support the development of the SML complex intervention, ensuring an evidence-based approach is used. We will then enable the implementation, monitoring, and clinical and economic evaluation, collecting necessary data that is not available from other sources. Aim To improve outcomes for women and babies receiving NHS maternity care through a new “care bundle” to prevent and treat maternal complications Objectives 1. Support evidence-based SMLCB development 2. Pilot the SMLCB to understand implementation, and iterate the intervention 3. Develop a new monitoring system using new data flows of linked, individual patient data embedded within the Secure Data Environment (SDE) network 4. Use the monitoring system to study outcomes of the SMLCB roll out, including clinical, cost effectiveness, and impacts on health inequalities 5. Provide robust evidence on national trends in maternal morbidity, highlighting areas for action to improve outcomes in maternity care Methods Systematic review of interventions; feasibility assessments of interventions; qualitative research of acceptability, facilitators and barriers to implementation; set up of data mechanism in sub-national SDEs; data linkage from electronic patient records; epidemiologic and economic analyses; creating and analysing real-time data flows Timelines: 60 months: 6 months set up; 6 months pilot testing; 6 months pilot analysis and iteration; 12 months implementation; 24 months data collection; 6 months data analysis and reporting Knowledge Mobilisation and Impact PREMAT will be the first prospective, powered study to use such a data platform to iterate and evaluate a universal, nationally implemented complex intervention into NHS maternity care. The results will be highly valuable to families, charities, policy makers and government. We will publish findings in high-impact peer-reviewed journals and present results at national and international conferences. Findings will inform future government policy direction, and national maternity safety ambitions. Research Inclusion PREMAT has been co-designed with women with lived experience of maternal morbidity. We will report clinical outcomes with data on ethnicity and socioeconomic status, ensuring that inequalities can be measured and understood. Qualitative aspects of the pilot study prioritise the experiences of women from diverse backgrounds. Study oversight will be provided by a diverse patient advisory group (PAG). Interpretation and dissemination will be co-led with our PAG, PPIE and PPI/charity co-applicants.