Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study
NCT03231007 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4952
Last updated 2018-12-04
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.
Conditions
- Stillbirth
Interventions
- OTHER
-
Questionnaire
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).
Sponsors & Collaborators
-
Somerset NHS Foundation Trust
collaborator OTHER -
Royal Devon and Exeter NHS Foundation Trust
collaborator OTHER -
University Hospital Plymouth NHS Trust
collaborator OTHER -
Royal United Hospital Bath NHS Trust
collaborator OTHER -
North Bristol NHS Trust
collaborator OTHER -
Liverpool Women's NHS Foundation Trust
collaborator OTHER -
St Helens & Knowsley Teaching Hospitals NHS Trust
collaborator OTHER -
Countess of Chester NHS Foundation Trust
collaborator OTHER -
University Hospitals of Morecambe Bay NHS Trust
collaborator OTHER -
Barnsley Hospital NHS Foundation Trust
collaborator OTHER -
Doncaster And Bassetlaw Hospitals NHS Foundation Trust
collaborator OTHER -
York Teaching Hospitals NHS Foundation Trust
collaborator OTHER -
Hull University Teaching Hospitals NHS Trust
collaborator OTHER_GOV -
Mid Yorkshire Teaching NHS Trust
collaborator OTHER -
Oxford University Hospitals NHS Trust
collaborator OTHER -
Gateshead Health NHS Foundation Trust
collaborator OTHER -
North Cumbria University Hospitals NHS Trust
collaborator OTHER -
Sherwood Forest Hospitals NHS Foundation Trust
collaborator OTHER -
Manchester University NHS Foundation Trust
collaborator OTHER_GOV -
Birmingham Women's NHS Foundation Trust
collaborator OTHER_GOV -
University of Manchester
lead OTHER
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-10
- Primary Completion
- 2018-02-28
- Completion
- 2018-07-05
Countries
- United Kingdom
Study Locations
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