Evaluating the Saving Babies Lives Care Bundle Version 2 (eVOLVE)

Evaluating the Effectiveness of the Saving Babies Lives Care Bundle Version 2 on Reducing Perinatal Mortality

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Delivery of Health Care

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.

• Study Type: Observational
• Enrollment (Actual): 1773

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Manchester Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of babies born preterm	A baby born before 37 weeks gestation	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	Up to 60 months
Number of babies born small for gestational age (SGA)	Birthweight less than the 10th percentile for gestational age	Up to 60 months
Number of women who had a caesarean section	Women delivering by emergency or elective caesarean section	Up to 60 months
Number of women who had induction of labour	Induced delivieries	Up to 60 months
Number of women who had an instrumental delivery	Women who had a forceps or ventouse delivery	Up to 60 months
Number of women who had a spontaneous delivery	Spontaneous delivery without forceps or ventouse delivery	Up to 60 months
Number of babies admitted to neonatal care	A baby first admitted at the given quarter to any neonatal care unit	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	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	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	Up to 84 months

Collaborators and Investigators

• Sponsor: University of Manchester
• Investigators: Principal Investigator: Alexander Heazell, Prof, The University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): February 21, 2024

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Stillbirth; Perinatal death; Saving Babies Lives Care Bundle Version 2; NHS Maternity Care
• Other Study ID Numbers: 325846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No