Evaluating the Saving Babies Lives Care Bundle Version 2

Pregnancy Related Clinical Trial

— eVOLVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06453954
• Other study ID #: 325846
• Status: Completed
• Start date: October 17, 2023
• Est. completion date: February 21, 2024

Study information

• Verified date: June 2024
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1773
• Est. completion date: February 21, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delivery of Health Care
• Pregnancy Related

Locations

Country	Name	City	State
United Kingdom	Manchester Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

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