Saving babies' lives project impact and results evaluation (SPiRE): a mixed methodology study.

<bold>Background: </bold>Reducing stillbirth and early neonatal death is a national priority in the UK. Current evidence indicates this is potentially achievable through application of four key interventions within routine maternity care delivered as the National Health Service (NHS) England's Saving Babies' Lives care bundle. However, there is significant variation in the degree of implementation of the care bundle between and within maternity units and the effectiveness in reducing stillbirth and improving service delivery has not yet been evaluated. This study aims to evaluate the impact of implementing the care bundle on UK maternity services and perinatal outcomes.<bold>Methods: </bold>The Saving Babies' Lives Project Impact and Results Evaluation (SPiRE) study is a multicentre evaluation of maternity care delivered through the Saving Babies' Lives care bundle using both quantitative and qualitative methodologies. The study will be conducted in twenty NHS Hospital Trusts and will include approximately 100,000 births. It involves participation by both service users and care providers. To determine the impact of the care bundle on pregnancy outcomes, birth data and other clinical measures will be extracted from maternity databases and case-note audit from before and after implementation. Additionally, this study will employ questionnaires with organisational leads and review clinical guidelines to assess how resources, leadership and governance may affect implementation in diverse hospital settings. The cost of implementing the care bundle, and the cost per stillbirth avoided, will also be estimated as part of a health economic analysis. The views and experiences of service users and service providers towards maternity care in relation to the care bundle will be also be sought using questionnaires.<bold>Discussion: </bold>This protocol describes a pragmatic study design which is necessarily limited by the availability of data and limitations of timescales and funding. In particular there was no opportunity to prospectively gather pre-intervention data or design a phased implementation such as a stepped-wedge study. Nevertheless this study will provide useful practice-based evidence which will advance knowledge about the processes that underpin successful implementation of the care bundle so that it can be further developed and refined.<bold>Trial Registration: </bold>www.clinicaltrials.gov NCT03231007 (26th July 2017). [ABSTRACT FROM AUTHOR]