Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study
- Conditions
- Stillbirth
- Interventions
- Other: Questionnaire
- Registration Number
- NCT03231007
- Lead Sponsor
- University of Manchester
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4952
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Innovators Questionnaire Maternity units that implemented the Care Bundle to the highest level (according to an NHS survey in 2015) are categorised as 'Innovators'. Early Adopters Questionnaire Maternity units that implemented the Care Bundle to the second-highest level (according to an NHS survey in 2015) are categorised as 'Early Adopters'. Late Adopters Questionnaire Maternity units that implemented the Care Bundle to the third-highest level (according to an NHS survey in 2015) are categorised as 'Late Adopters'. Low Adopters Questionnaire Maternity units that implemented the Care Bundle to the fourth-highest level (according to an NHS survey in 2015) are categorised as 'Low Adopters'.
- Primary Outcome Measures
Name Time Method Stillbirths 1st April 2012-1st October 2017 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.
- Secondary Outcome Measures
Name Time Method Admission to NICU 1st April 2012-1st October 2017 Antenatal triage numbers 1st April 2012-1st October 2017 Birthweight 1st April 2012-1st October 2017 Birthweight centile 1st April 2012-1st October 2017 Using GROW-Centile software
Caesarean deliveries 1st April 2012-1st October 2017 Preterm births 1st April 2012-1st October 2017 Number of reported incidents 1st April 2012-1st October 2017 Babies' gestation 1st April 2012-1st October 2017 Induced deliveries 1st April 2012-1st October 2017 Spontaneous deliveries 1st April 2012-1st October 2017 Term, normally formed singleton stillbirths (antepartum and intrapartum). 1st April 2012-1st October 2017 This excludes issues of preterm birth and major mortality and morbidity associated with congenital anomalies.
Instrumental deliveries 1st April 2012-1st October 2017 Emergency caesarean deliveries 1st April 2012-1st October 2017
Trial Locations
- Locations (20)
Royal Devon & Exeter NHS Foundation Trust
🇬🇧Exeter, United Kingdom
Barnsley Hospital NHS Foundation Trust
🇬🇧Barnsley, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
🇬🇧Bath, United Kingdom
North Cumbria University Hospitals NHS Trust
🇬🇧Carlisle, United Kingdom
North Bristol NHS Trust
🇬🇧Bristol, United Kingdom
Countess of Chester Hospital NHS Foundation Trust
🇬🇧Chester, United Kingdom
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
🇬🇧Doncaster, United Kingdom
Oxford University Hospitals NHS Trust
🇬🇧Headington, United Kingdom
Gateshead Health NHS Foundation Trust
🇬🇧Gateshead, United Kingdom
Hull and East Yorkshire Hospital NHS Trust
🇬🇧Hull, United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust
🇬🇧Sutton in Ashfield, United Kingdom
The Mid Yorkshire Hospitals NHS Trust
🇬🇧Wakefield, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
🇬🇧Kendal, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Liverpool Women's NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Plymouth Hospital NHS Trust
🇬🇧Plymouth, United Kingdom
St Helens and Knowsley Teaching Hospitals NHS Trust
🇬🇧Prescot, United Kingdom
Taunton and Somerset NHS Foundation Trust
🇬🇧Taunton, United Kingdom
York Teaching Hospital NHS Foundation Trust
🇬🇧York, United Kingdom