Delivery of Health Care, Pregnancy Related
Conditions
Keywords
Saving Babies Lives Care Bundle Version 2, NHS Maternity Care, Pregnancy, Stillbirth, Perinatal death
Brief summary
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: * Does the care bundle reduce perinatal mortality rates? * What are women's 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.
Interventions
None listed
Sponsors
University of Manchester
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1: All births in England. Phase 2: Inclusion Criteria: * women who have given birth in the last 12 months * women who can understand English * healthcare professionals involved in delivering the care bundle
Exclusion criteria
* women who gave birth more than 12 months ago * women who cannot understand English * women without access to the internet for online survey completion * healthcare professionals not involved in delivering the care bundle
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of stillbirths in England | Up to 60 months | A baby born after 24 or more weeks completed gestation and which did not, at any time, breathe or show signs of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of babies born preterm | Up to 60 months | A baby born before 37 weeks gestation |
| Number of neonatal deaths in England | Up to 60 months | 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 |
| Number of babies born small for gestational age (SGA) | Up to 60 months | Birthweight less than the 10th percentile for gestational age |
| Number of women who had a caesarean section | Up to 60 months | Women delivering by emergency or elective caesarean section |
| Number of women who had induction of labour | Up to 60 months | Induced delivieries |
| Number of babies who died whilst on neonatal care | Up to 84 months | A baby first admitted at any given quarter to a neonatal care unit that died at any point |
| Number of women who had a spontaneous delivery | Up to 60 months | Spontaneous delivery without forceps or ventouse delivery |
| Number of babies admitted to neonatal care | Up to 84 months | A baby first admitted at the given quarter to any neonatal care unit |
| Number of babies admitted to neonatal care by gestation | Up to 84 months | A baby first admitted at the given quarter to a neonatal care unit by gestation weeks at birth |
| Number of babies admitted to neonatal care by cause of death | Up to 84 months | A baby first admitted at the given quarter to a neonatal care unit by clinical diagnosis |
| Number of women who had an instrumental delivery | Up to 60 months | Women who had a forceps or ventouse delivery |
Countries
United Kingdom
Outcome results
None listed