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Completed

NCT Number: NCT06453954

Evaluating the Saving Babies Lives Care Bundle Version 2

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.

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Key information

Conditions

Pregnancy Related Death Delivery of Health Care Female Urogenital Diseases and Pregnancy Complications Fetal Death Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Stillbirth Urogenital Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manchester Foundation Trust

Manchester, M13 9WL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of stillbirths in England

    Time frame: 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 outcomes

  1. Number of babies born preterm

    Time frame: Up to 60 months

    A baby born before 37 weeks gestation

  2. Number of neonatal deaths in England

    Time frame: 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

  3. Number of babies born small for gestational age (SGA)

    Time frame: Up to 60 months

    Birthweight less than the 10th percentile for gestational age

  4. Number of women who had a caesarean section

    Time frame: Up to 60 months

    Women delivering by emergency or elective caesarean section

  5. Number of women who had induction of labour

    Time frame: Up to 60 months

    Induced delivieries

  6. Number of women who had an instrumental delivery

    Time frame: Up to 60 months

    Women who had a forceps or ventouse delivery

  7. Number of women who had a spontaneous delivery

    Time frame: Up to 60 months

    Spontaneous delivery without forceps or ventouse delivery

  8. Number of babies admitted to neonatal care

    Time frame: Up to 84 months

    A baby first admitted at the given quarter to any neonatal care unit

  9. Number of babies admitted to neonatal care by gestation

    Time frame: Up to 84 months

    A baby first admitted at the given quarter to a neonatal care unit by gestation weeks at birth

  10. Number of babies admitted to neonatal care by cause of death

    Time frame: Up to 84 months

    A baby first admitted at the given quarter to a neonatal care unit by clinical diagnosis

  11. Number of babies who died whilst on neonatal care

    Time frame: Up to 84 months

    A baby first admitted at any given quarter to a neonatal care unit that died at any point

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

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

Acronym: eVOLVE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 12, 2024
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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