Clinical trial NCT06453954: Evaluating the Saving Babies Lives Care Bundle Version 2
Official title: Evaluating the Effectiveness of the Saving Babies Lives Care Bundle Version 2 on Reducing Perinatal Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Delivery of Health Care
Keywords: Saving Babies Lives Care Bundle Version 2
NHS Maternity Care
Pregnancy
Stillbirth
Perinatal death
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 1773
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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

Primary outcomes:
measure: Number of stillbirths in England
timeFrame: Up to 60 months
Secondary outcomes:
measure: Number of babies born preterm
timeFrame: Up to 60 months
measure: Number of neonatal deaths in England
timeFrame: Up to 60 months
measure: Number of babies born small for gestational age (SGA)
timeFrame: Up to 60 months
measure: Number of women who had a caesarean section
timeFrame: Up to 60 months
measure: Number of women who had induction of labour
timeFrame: Up to 60 months
measure: Number of women who had an instrumental delivery
timeFrame: Up to 60 months
measure: Number of women who had a spontaneous delivery
timeFrame: Up to 60 months
measure: Number of babies admitted to neonatal care
timeFrame: Up to 84 months
measure: Number of babies admitted to neonatal care by gestation
timeFrame: Up to 84 months
measure: Number of babies admitted to neonatal care by cause of death
timeFrame: Up to 84 months
measure: Number of babies who died whilst on neonatal care
timeFrame: Up to 84 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Foundation Trust
Study officials:
affiliation: The University of Manchester
name: Alexander Heazell, Prof
role: PRINCIPAL_INVESTIGATOR
References: