Clinical trial NCT03231007: Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study
Official title: Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stillbirth
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Somerset NHS Foundation Trust
name: Royal Devon and Exeter NHS Foundation Trust
name: University Hospital Plymouth NHS Trust
name: Royal United Hospital Bath NHS Trust
name: North Bristol NHS Trust
name: Liverpool Women's NHS Foundation Trust
name: St Helens & Knowsley Teaching Hospitals NHS Trust
name: Countess of Chester NHS Foundation Trust
name: University Hospitals of Morecambe Bay NHS Trust
name: Barnsley Hospital NHS Foundation Trust
name: Doncaster And Bassetlaw Hospitals NHS Foundation Trust
name: York Teaching Hospitals NHS Foundation Trust
name: Hull University Teaching Hospitals NHS Trust
name: Mid Yorkshire Teaching NHS Trust
name: Oxford University Hospitals NHS Trust
name: Gateshead Health NHS Foundation Trust
name: North Cumbria University Hospitals NHS Trust
name: Sherwood Forest Hospitals NHS Foundation Trust
name: Manchester University NHS Foundation Trust
name: Birmingham Women's NHS Foundation Trust
First posted: 2017-07-27
Enrollment: 4952
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postnatal service users who have received antenatal care and given birth in one of the 20 study sites.

Healthcare professionals who are involved in delivering maternity care in one of the 20 study sites.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stillbirths
timeFrame: 1st April 2012-1st October 2017
Secondary outcomes:
measure: Term, normally formed singleton stillbirths (antepartum and intrapartum).
timeFrame: 1st April 2012-1st October 2017
measure: Preterm births
timeFrame: 1st April 2012-1st October 2017
measure: Babies' gestation
timeFrame: 1st April 2012-1st October 2017
measure: Number of reported incidents
timeFrame: 1st April 2012-1st October 2017
measure: Admission to NICU
timeFrame: 1st April 2012-1st October 2017
measure: Antenatal triage numbers
timeFrame: 1st April 2012-1st October 2017
measure: Emergency caesarean deliveries
timeFrame: 1st April 2012-1st October 2017
measure: Induced deliveries
timeFrame: 1st April 2012-1st October 2017
measure: Birthweight
timeFrame: 1st April 2012-1st October 2017
measure: Birthweight centile
timeFrame: 1st April 2012-1st October 2017
measure: Spontaneous deliveries
timeFrame: 1st April 2012-1st October 2017
measure: Caesarean deliveries
timeFrame: 1st April 2012-1st October 2017
measure: Instrumental deliveries
timeFrame: 1st April 2012-1st October 2017
Other outcomes:
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women smoking at delivery
timeFrame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women offered carbon monoxide (CO) test
timeFrame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women accepting CO test
timeFrame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation
timeFrame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women ceasing smoking between booking and delivery
timeFrame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation with a positive CO test
timeFrame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA singletons detected prior to delivery
timeFrame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of all singletons with growth charts in notes
timeFrame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with estimated fetal weight (EFW) plotted on growth chart
timeFrame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with symphysis fundal height (SFH) plotted on growth chart
timeFrame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with EFW correctly plotted on growth chart
timeFrame: 1st April 2012-1st October 2017
measure: 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)
timeFrame: 1st April 2012-1st October 2017
measure: 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)
timeFrame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of pregnancies with customised growth chart
timeFrame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Birthweight centile at last scan (by EFW measurement)
timeFrame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Number of third trimester growth scans
timeFrame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women receiving RFM leaflet
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM managed
timeFrame: 1st April 2012 until 1st October 2017
measure: 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
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM who had scan
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM who had FH monitoring
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Gestation of baby at RFM episodes
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of growth scans due to RFM
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Time to scan from reporting RFM
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of RFM episodes per pregnancy according to checklist
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of deliveries where both buddy and stickers used
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of staff completing annual CTG training
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of pregnancies where escalation protocol was used
timeFrame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Number of babies therapeutically cooled
timeFrame: 1st April 2012 until 1st October 2017
measure: Economic Outcome - Equipment required
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Staff time required
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Antenatal triage numbers
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Number of triage women presenting with RFM on at least one occasion
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Emergency caesarean deliveries
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Induced deliveries
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Caesarean deliveries
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Number of third trimester growth scans
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Number of growth scans due to RFM
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Number of antenatal CTGs due to RFM
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Length of stay in NICU
timeFrame: 10th July 2017-31st August 2017
measure: Economic Outcome - Length of stay in hospital
timeFrame: 10th July 2017-31st August 2017
Locations:
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: Birmingham Women's and Children's NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Carlisle
country: United Kingdom
facility: North Cumbria University Hospitals NHS Trust
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital NHS Foundation Trust
city: Doncaster
country: United Kingdom
facility: Doncaster and Bassetlaw Hospitals NHS Foundation Trust
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
city: Gateshead
country: United Kingdom
facility: Gateshead Health NHS Foundation Trust
city: Headington
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospital NHS Trust
city: Kendal
country: United Kingdom
facility: University Hospitals of Morecambe Bay NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Women's NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
city: Plymouth
country: United Kingdom
facility: Plymouth Hospital NHS Trust
city: Prescot
country: United Kingdom
facility: St Helens and Knowsley Teaching Hospitals NHS Trust
city: Sutton in Ashfield
country: United Kingdom
facility: Sherwood Forest Hospitals NHS Foundation Trust
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust
city: Wakefield
country: United Kingdom
facility: The Mid Yorkshire Hospitals NHS Trust
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
Study officials:
References:
citation: Office of National Statistics. Characteristics of birth 1, England and Wales, 2013. London: ONS, 2014.
citation: Flenady V, Wojcieszek AM, Middleton P, Ellwood D, Erwich JJ, Coory M, Khong TY, Silver RM, Smith GCS, Boyle FM, Lawn JE, Blencowe H, Leisher SH, Gross MM, Horey D, Farrales L, Bloomfield F, McCowan L, Brown SJ, Joseph KS, Zeitlin J, Reinebrant HE, Cacciatore J, Ravaldi C, Vannacci A, Cassidy J, Cassidy P, Farquhar C, Wallace E, Siassakos D, Heazell AEP, Storey C, Sadler L, Petersen S, Froen JF, Goldenberg RL; Lancet Ending Preventable Stillbirths study group; Lancet Stillbirths In High-Income Countries Investigator Group. Stillbirths: recall to action in high-income countries. Lancet. 2016 Feb 13;387(10019):691-702. doi: 10.1016/S0140-6736(15)01020-X. Epub 2016 Jan 19.
citation: Manktelow BN, S.L., Seaton SE, Hyman-Taylor P, Kurinczuk JJ, Field DJ. MBRRACE-UK Perinatal Mortality Surveillance Report, UK Perinatal Deaths for Births from Janurary to December 2014. Leicester: The Infant Mortality and Morbidity Studies, Department of Health Sciences, University of Leicester, 2016.
citation: Draper ES, K.J., Kenyon S (Eds) on behalf of MBRRACE-UK, MBRRACE-UK Perinatal Confidential Enquiry. Term, singleton, normally formed, antepartum stillbirth. Leicester: The Infant Mortality and Morbidity Studies, Department of Health Sciences, Univesity of Leicester. 2015.
citation: Widdows K, Roberts SA, Camacho EM, Heazell AEP. Stillbirth rates, service outcomes and costs of implementing NHS England's Saving Babies' Lives care bundle in maternity units in England: A cohort study. PLoS One. 2021 Apr 19;16(4):e0250150. doi: 10.1371/journal.pone.0250150. eCollection 2021.
citation: Gardosi J, Madurasinghe V, Williams M, Malik A, Francis A. Maternal and fetal risk factors for stillbirth: population based study. BMJ. 2013 Jan 24;346:f108. doi: 10.1136/bmj.f108.
citation: Marufu TC, Ahankari A, Coleman T, Lewis S. Maternal smoking and the risk of still birth: systematic review and meta-analysis. BMC Public Health. 2015 Mar 13;15:239. doi: 10.1186/s12889-015-1552-5.
citation: RCOG Green-Top Guideline 31: The Investigation and Management of the Small-for-Gestational Ages Fetus. Royal College of Obstetricians and Gynaecologists, 2013.
citation: Alfirevic Z, Devane D, Gyte GM. Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD006066. doi: 10.1002/14651858.CD006066.
citation: Widdows K, Reid HE, Roberts SA, Camacho EM, Heazell AEP. Saving babies' lives project impact and results evaluation (SPiRE): a mixed methodology study. BMC Pregnancy Childbirth. 2018 Jan 30;18(1):43. doi: 10.1186/s12884-018-1672-x.