Evaluating the Saving Babies Lives Care Bundle Version 2

NCT06453954 | Completed

• 1 other identifier: 325846
• Study Type: observational
• Target: 1,773
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Delivery of Health Care

Keywords

Saving Babies Lives Care Bundle Version 2; NHS Maternity Care; Pregnancy; Stillbirth; Perinatal death

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of babies born preterm

  Up to 60 months

• Number of neonatal deaths in England

  Up to 60 months

• Number of babies born small for gestational age (SGA)

  Up to 60 months

• Number of women who had a caesarean section

  Up to 60 months

• Number of women who had induction of labour

  Up to 60 months

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• women who have given birth in the last 12 months
• women who can understand English
• healthcare professionals involved in delivering the care bundle

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Manchester Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Stillbirth; Perinatal Death

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Heazell, Prof

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 12, 2024
• Study Start: October 17, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 21, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)