Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stillbirth
- Sponsor
- University of Manchester
- Enrollment
- 4952
- Locations
- 20
- Primary Endpoint
- Stillbirths
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Dr Alexander Heazell
Professor of Obstetrics
University of Manchester
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Stillbirths
Time Frame: 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 Outcomes
- Emergency caesarean deliveries(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)
- 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)
- Instrumental deliveries(1st April 2012-1st October 2017)
- Admission to NICU(1st April 2012-1st October 2017)