The 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 from six NHS Strategic Clinical Networks totalling 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. This study will provide practice-based evidence to advance knowledge about the processes that underpin successful implementation of the care bundle so that it can be further developed and refined. This has the potential to translate into substantial improvements in the rate of late stillbirth in the UK should the care bundle be proved effective.
Reducing stillbirth and early neonatal death is a national priority. Best practice and key evidence indicates this is potentially achievable through application of four key interventions within routine maternity care delivered as NHS England's Saving Babies' Lives care bundle. However, adoption of the care bundle by UK maternity services is still in its infancy and there is significant variation in the degree of implementation between and within units. The effectiveness of the care bundle, when implemented as a package, in reducing stillbirth and 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.
Study Type
OBSERVATIONAL
Enrollment
4,952
A structured questionnaire will be administered to maternity service users. Another structured questionnaire will be administered to maternity healthcare professionals, and another to Organisational Leads (e.g. Clinical Directors at each site).
Barnsley Hospital NHS Foundation Trust
Barnsley, United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
North Cumbria University Hospitals NHS Trust
Carlisle, United Kingdom
Countess of Chester Hospital NHS Foundation Trust
Chester, United Kingdom
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Doncaster, United Kingdom
Royal Devon & Exeter NHS Foundation Trust
Exeter, United Kingdom
Gateshead Health NHS Foundation Trust
Gateshead, United Kingdom
Oxford University Hospitals NHS Trust
Headington, United Kingdom
...and 10 more locations
Stillbirths
All stillbirths (singletons and multiples). Stillbirths will be defined according to the UK definition as the death of a baby before or during birth after 24 weeks of gestation.
Time frame: 1st April 2012-1st October 2017
Term, normally formed singleton stillbirths (antepartum and intrapartum).
This excludes issues of preterm birth and major mortality and morbidity associated with congenital anomalies.
Time frame: 1st April 2012-1st October 2017
Preterm births
Time frame: 1st April 2012-1st October 2017
Babies' gestation
Time frame: 1st April 2012-1st October 2017
Number of reported incidents
Time frame: 1st April 2012-1st October 2017
Admission to NICU
Time frame: 1st April 2012-1st October 2017
Antenatal triage numbers
Time frame: 1st April 2012-1st October 2017
Emergency caesarean deliveries
Time frame: 1st April 2012-1st October 2017
Induced deliveries
Time frame: 1st April 2012-1st October 2017
Birthweight
Time frame: 1st April 2012-1st October 2017
Birthweight centile
Using GROW-Centile software
Time frame: 1st April 2012-1st October 2017
Spontaneous deliveries
Time frame: 1st April 2012-1st October 2017
Caesarean deliveries
Time frame: 1st April 2012-1st October 2017
Instrumental deliveries
Time frame: 1st April 2012-1st October 2017
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