Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453954
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-05-21
Brief Title:
Evaluating the Saving Babies Lives Care Bundle Version 2
Sponsor:
University of Manchester
Organization:
University of Manchester
Study Overview
Official Title:
Evaluating the Effectiveness of the Saving Babies Lives Care Bundle Version 2 on Reducing Perinatal Mortality
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eVOLVE
Brief Summary:
The purpose of this study is to learn about the implementation of NHS Englands Saving Babies Lives Care Bundle Version 2 to reduce perinatal mortality
It will explore whether the care bundle is effective at reducing stillbirth rates neonatal death rates and preterm births in England It will also explore the lived experiences of womens maternity care and their babies neonatal care and the views and experiences of healthcare professionals who are involved in delivering the care bundle
The main questions it aims to answer are
Does the care bundle reduce perinatal mortality rates
What are womens views and experiences of their maternity and neonatal care
What are the barriers around delivering the care bundle and how can this be improved
How do health inequalities affect the care women receive
How does the workforce culture affect how healthcare professionals use the care bundle
Perinatal mortality rates and other pregnancy outcomes will be obtained from national data sources Women and healthcare professionals will be asked to complete a survey and we will interview select groups of participants to further explore their experiences
Mortality rates will be compared before and after the implementationof the care bundle where data allows Data from the surveys will be descriptive Data from the interviews will be analysed using thematic analysis to determine patterns and recurring ideas in the data
It will explore whether the care bundle is effective at reducing stillbirth rates neonatal death rates and preterm births in England It will also explore the lived experiences of womens maternity care and their babies neonatal care and the views and experiences of healthcare professionals who are involved in delivering the care bundle
The main questions it aims to answer are
Does the care bundle reduce perinatal mortality rates
What are womens views and experiences of their maternity and neonatal care
What are the barriers around delivering the care bundle and how can this be improved
How do health inequalities affect the care women receive
How does the workforce culture affect how healthcare professionals use the care bundle
Perinatal mortality rates and other pregnancy outcomes will be obtained from national data sources Women and healthcare professionals will be asked to complete a survey and we will interview select groups of participants to further explore their experiences
Mortality rates will be compared before and after the implementationof the care bundle where data allows Data from the surveys will be descriptive Data from the interviews will be analysed using thematic analysis to determine patterns and recurring ideas in the data
Detailed Description:
In April 2022 NHS England commissioned the University of Manchester to conduct an independent evaluation of the effectiveness of the Saving Babies Lives Care Bundle Version 2 SBLCBv2 on reducing perinatal mortality in England The study was commissioned in two phases
Phase 1 comprises a national service evaluation of the impact of the SBLCBv2 on perinatal mortality rates associated clinical outcomes and any unintended consequences using routine data derived from national databases Phase 2 comprises a qualitative evaluation to further understand the impact on maternity services women and their families
Phase 2 will be conducted in a cohort of maternity units across England using a mixed-methods approach The views and experiences of women and healthcare professionals towards maternity care in relation to the SBLCBv2 will be sought using surveys and interviews Additionally this study will interview organisational leads to assess how resources leadership and governance may affect implementation in diverse hospital settings
Phase 1 comprises a national service evaluation of the impact of the SBLCBv2 on perinatal mortality rates associated clinical outcomes and any unintended consequences using routine data derived from national databases Phase 2 comprises a qualitative evaluation to further understand the impact on maternity services women and their families
Phase 2 will be conducted in a cohort of maternity units across England using a mixed-methods approach The views and experiences of women and healthcare professionals towards maternity care in relation to the SBLCBv2 will be sought using surveys and interviews Additionally this study will interview organisational leads to assess how resources leadership and governance may affect implementation in diverse hospital settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None