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Completed

NCT Number: NCT03231007

Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study

The study is a multicentre evaluation of maternity care delivered through the Saving Babies' Lives care bundle using both quantitative and qualitative methodologies. The study will be conducted in twenty NHS Hospital Trusts from six NHS Strategic Clinical Networks totalling approximately 100,000 births. It involves participation by both service users and care providers.

To determine the impact of the care bundle on pregnancy outcomes, birth data and other clinical measures will be extracted from maternity databases and case-note audit from before and after implementation. Additionally, this study will employ questionnaires with organisational leads and review clinical guidelines to assess how resources, leadership and governance may affect implementation in diverse hospital settings. The cost of implementing the care bundle, and the cost per stillbirth avoided, will also be estimated as part of a health economic analysis. The views and experiences of service users and service providers towards maternity care in relation to the care bundle will be also be sought using questionnaires.

This study will provide practice-based evidence to advance knowledge about the processes that underpin successful implementation of the care bundle so that it can be further developed and refined. This has the potential to translate into substantial improvements in the rate of late stillbirth in the UK should the care bundle be proved effective.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barnsley Hospital NHS Foundation Trust, Barnsley, United Kingdom

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About this study

Reducing stillbirth and early neonatal death is a national priority. Best practice and key evidence indicates this is potentially achievable through application of four key interventions within routine maternity care delivered as NHS England's Saving Babies' Lives care bundle. However, adoption of the care bundle by UK maternity services is still in its infancy and there is significant variation in the degree of implementation between and within units. The effectiveness of the care bundle, when implemented as a package, in reducing stillbirth and service delivery has not yet been evaluated. This study aims to evaluate the impact of implementing the care bundle on UK maternity services and perinatal outcomes.

Who can participate

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

Inclusion criteria

for Maternity Service Users:

  • Women who received their antenatal care, delivered and were discharged from the same maternity unit
  • Women who have given birth after 28 weeks of gestation

Exclusion criteria

for Maternity Service Users:

  • Maternal age ≤ 16 years
  • Individuals who cannot understand/not fluent in English (to enable consent without interpreter)
  • Multiple pregnancy
  • Fetuses known to have any congenital or severe structural abnormalities
  • Home births

Inclusion criteria

for Maternity Healthcare Professionals:

  • Midwives working before and after implementation of the care bundle (including antenatal ward, antenatal clinic, community-based staff, antenatal assessment unit and labour ward)
  • Community midwives working before and after implementation of the care bundle
  • Sonographers working before and after implementation of the care bundle
  • Junior doctors working before and after implementation of the care bundle
  • Consultant obstetricians working before and after implementation of the care bundle
  • Clinical Directors and Heads of Midwifery working before and after implementation of the care bundle

Exclusion criteria

for Maternity Healthcare Professionals:

  • Staff who were employed after the care bundle was implemented

Treatment and study plan

Questionnaire

Other

A structured questionnaire will be administered to maternity service users. Another structured questionnaire will be administered to maternity healthcare professionals, and another to Organisational Leads (e.g. Clinical Directors at each site).

Primary outcomes

  1. Stillbirths

    Time frame: 1st April 2012-1st October 2017

    All stillbirths (singletons and multiples). Stillbirths will be defined according to the UK definition as the death of a baby before or during birth after 24 weeks of gestation.

Secondary outcomes

  1. Term, normally formed singleton stillbirths (antepartum and intrapartum).

    Time frame: 1st April 2012-1st October 2017

    This excludes issues of preterm birth and major mortality and morbidity associated with congenital anomalies.

  2. Preterm births

    Time frame: 1st April 2012-1st October 2017

  3. Babies' gestation

    Time frame: 1st April 2012-1st October 2017

  4. Number of reported incidents

    Time frame: 1st April 2012-1st October 2017

  5. Admission to NICU

    Time frame: 1st April 2012-1st October 2017

  6. Antenatal triage numbers

    Time frame: 1st April 2012-1st October 2017

  7. Emergency caesarean deliveries

    Time frame: 1st April 2012-1st October 2017

  8. Induced deliveries

    Time frame: 1st April 2012-1st October 2017

  9. Birthweight

    Time frame: 1st April 2012-1st October 2017

  10. Birthweight centile

    Time frame: 1st April 2012-1st October 2017

    Using GROW-Centile software

  11. Spontaneous deliveries

    Time frame: 1st April 2012-1st October 2017

  12. Caesarean deliveries

    Time frame: 1st April 2012-1st October 2017

  13. Instrumental deliveries

    Time frame: 1st April 2012-1st October 2017

Other outcomes

  1. Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women smoking at delivery

    Time frame: 10th July 2017-31st August 2017

  2. Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women offered carbon monoxide (CO) test

    Time frame: 10th July 2017-31st August 2017

  3. Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women accepting CO test

    Time frame: 10th July 2017-31st August 2017

  4. Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation

    Time frame: 10th July 2017-31st August 2017

  5. Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women ceasing smoking between booking and delivery

    Time frame: 10th July 2017-31st August 2017

  6. Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation with a positive CO test

    Time frame: 10th July 2017-31st August 2017

  7. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA singletons detected prior to delivery

    Time frame: 1st April 2012-1st October 2017

  8. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of all singletons with growth charts in notes

    Time frame: 1st April 2012-1st October 2017

  9. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with estimated fetal weight (EFW) plotted on growth chart

    Time frame: 1st April 2012-1st October 2017

  10. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with symphysis fundal height (SFH) plotted on growth chart

    Time frame: 1st April 2012-1st October 2017

  11. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with EFW correctly plotted on growth chart

    Time frame: 1st April 2012-1st October 2017

  12. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of babies identified as SGA during pregnancy that were appropriate for gestation age (AGA) at birth (false positives)

    Time frame: 1st April 2012-1st October 2017

  13. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of babies identified as AGA during pregnancy that were SGA at birth (false negatives)

    Time frame: 1st April 2012-1st October 2017

  14. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of pregnancies with customised growth chart

    Time frame: 1st April 2012-1st October 2017

  15. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Birthweight centile at last scan (by EFW measurement)

    Time frame: 1st April 2012-1st October 2017

  16. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Number of third trimester growth scans

    Time frame: 1st April 2012-1st October 2017

  17. Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women receiving RFM leaflet

    Time frame: 1st April 2012 until 1st October 2017

  18. Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM managed

    Time frame: 1st April 2012 until 1st October 2017

  19. Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of triage women presenting with RFM on at least one occasion

    Time frame: 1st April 2012 until 1st October 2017

  20. Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM who had scan

    Time frame: 1st April 2012 until 1st October 2017

  21. Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM who had FH monitoring

    Time frame: 1st April 2012 until 1st October 2017

  22. Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Gestation of baby at RFM episodes

    Time frame: 1st April 2012 until 1st October 2017

  23. Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of growth scans due to RFM

    Time frame: 1st April 2012 until 1st October 2017

  24. Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Time to scan from reporting RFM

    Time frame: 1st April 2012 until 1st October 2017

  25. Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of RFM episodes per pregnancy according to checklist

    Time frame: 1st April 2012 until 1st October 2017

  26. Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of deliveries where both buddy and stickers used

    Time frame: 1st April 2012 until 1st October 2017

  27. Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of staff completing annual CTG training

    Time frame: 1st April 2012 until 1st October 2017

  28. Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of pregnancies where escalation protocol was used

    Time frame: 1st April 2012 until 1st October 2017

  29. Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Number of babies therapeutically cooled

    Time frame: 1st April 2012 until 1st October 2017

  30. Economic Outcome - Equipment required

    Time frame: 10th July 2017-31st August 2017

    (e.g. CO test kits)

  31. Economic Outcome - Staff time required

    Time frame: 10th July 2017-31st August 2017

    (e.g. to conduct additional scans)

  32. Economic Outcome - Antenatal triage numbers

    Time frame: 10th July 2017-31st August 2017

  33. Economic Outcome - Number of triage women presenting with RFM on at least one occasion

    Time frame: 10th July 2017-31st August 2017

  34. Economic Outcome - Emergency caesarean deliveries

    Time frame: 10th July 2017-31st August 2017

  35. Economic Outcome - Induced deliveries

    Time frame: 10th July 2017-31st August 2017

  36. Economic Outcome - Caesarean deliveries

    Time frame: 10th July 2017-31st August 2017

  37. Economic Outcome - Number of third trimester growth scans

    Time frame: 10th July 2017-31st August 2017

  38. Economic Outcome - Number of growth scans due to RFM

    Time frame: 10th July 2017-31st August 2017

  39. Economic Outcome - Number of antenatal CTGs due to RFM

    Time frame: 10th July 2017-31st August 2017

  40. Economic Outcome - Length of stay in NICU

    Time frame: 10th July 2017-31st August 2017

  41. Economic Outcome - Length of stay in hospital

    Time frame: 10th July 2017-31st August 2017

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • Barnsley Hospital NHS Foundation Trust
  • Birmingham Women's NHS Foundation Trust
  • Countess of Chester NHS Foundation Trust
  • Doncaster And Bassetlaw Hospitals NHS Foundation Trust
  • Gateshead Health NHS Foundation Trust
  • Hull University Teaching Hospitals NHS Trust
  • Liverpool Women's NHS Foundation Trust
  • Manchester University NHS Foundation Trust
  • Mid Yorkshire Teaching NHS Trust
  • North Bristol NHS Trust
  • North Cumbria University Hospitals NHS Trust
  • Oxford University Hospitals NHS Trust
  • Royal Devon and Exeter NHS Foundation Trust
  • Royal United Hospital Bath NHS Trust
  • Sherwood Forest Hospitals NHS Foundation Trust
  • Somerset NHS Foundation Trust
  • St Helens & Knowsley Teaching Hospitals NHS Trust
  • University Hospital Plymouth NHS Trust
  • University Hospitals of Morecambe Bay NHS Trust
  • York Teaching Hospitals NHS Foundation Trust

Registry information

Acronym: SPiRE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 27, 2017
Registry last updated
Dec 4, 2018

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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