An observational study in Pregnancy Related and Delivery of Health Care, sponsored by University of Manchester. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by University of Manchester · Observational
The purpose of this study is to learn about the implementation of NHS England's 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 women's 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:
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.
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.
121 studies on the registry are indexed under Stillbirth; 34 are open to participants now.
This study's enrollment of 1,773 is above the median of 794 across 52 observational studies indexed under Stillbirth.
Browse Stillbirth studies →University of Manchester is the lead sponsor of 201 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Phase 1: births in England.
Phase 2: women who received their antenatal care, labour and birth in 28 participating NHS maternity Trusts in England. Healthcare professionals currently employed in these 28 Trusts.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase 1:
All births in England.
Phase 2:
Inclusion Criteria:
Exclusion Criteria:
Number of stillbirths in England
A baby born after 24 or more weeks completed gestation and which did not, at any time, breathe or show signs of life
Time frame: Up to 60 months
Number of babies born preterm
A baby born before 37 weeks gestation
Time frame: Up to 60 months
Number of neonatal deaths in England
A live born baby (born at 20+0 weeks gestational age or later, or with a birthweight of 400g or more where an accurate estimate of gestation is not available), who died before 28 completed days after birth
Time frame: Up to 60 months
Number of babies born small for gestational age (SGA)
Birthweight less than the 10th percentile for gestational age
Time frame: Up to 60 months
Number of women who had a caesarean section
Women delivering by emergency or elective caesarean section
Time frame: Up to 60 months
Number of women who had induction of labour
Induced delivieries
Time frame: Up to 60 months
Number of women who had an instrumental delivery
Women who had a forceps or ventouse delivery
Time frame: Up to 60 months
Number of women who had a spontaneous delivery
Spontaneous delivery without forceps or ventouse delivery
Time frame: Up to 60 months
Number of babies admitted to neonatal care
A baby first admitted at the given quarter to any neonatal care unit
Time frame: Up to 84 months
Number of babies admitted to neonatal care by gestation
A baby first admitted at the given quarter to a neonatal care unit by gestation weeks at birth
Time frame: Up to 84 months
Number of babies admitted to neonatal care by cause of death
A baby first admitted at the given quarter to a neonatal care unit by clinical diagnosis
Time frame: Up to 84 months
Number of babies who died whilst on neonatal care
A baby first admitted at any given quarter to a neonatal care unit that died at any point
Time frame: Up to 84 months
Plan to share: No — If requested, site-specific data from the questionnaires may be shared with participating NHS Trusts. This data will be provided in an anonymous aggregated format, with only that specific site identified. No identifiable data will be shared with participating NHS Trusts (i.e. names and email addresses will not be shared with NHS sites). Following completion of the study, with consent a fully anonymised aggregated dataset [e.g. including anonymous aggregated questionnaire responses] will be deposited in Figshare at the University of Manchester library, which is an open data repository where it will be permanently stored. Researchers at other institutions and others can access the anonymised data directly from the repository and use it for further research or to check our analysis and results. Individual NHS Trusts will not be identified.
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in Jan 2024, 3 months.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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