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

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.

Study Overview

• Status: Completed
• Conditions: Stillbirth
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 4952

Contacts and Locations

Study Locations

• United Kingdom
  • Barnsley, United Kingdom
    • Barnsley Hospital NHS Foundation Trust
  • Bath, United Kingdom
    • Royal United Hospitals Bath NHS Foundation Trust
  • Birmingham, United Kingdom
    • Birmingham Women's and Children's NHS Foundation Trust
  • Bristol, United Kingdom
    • North Bristol NHS Trust
  • Carlisle, United Kingdom
    • North Cumbria University Hospitals NHS Trust
  • Chester, United Kingdom
    • Countess Of Chester Hospital NHS Foundation Trust
  • Doncaster, United Kingdom
    • Doncaster and Bassetlaw Hospitals NHS Foundation Trust
  • Exeter, United Kingdom
    • Royal Devon & Exeter NHS Foundation Trust
  • Gateshead, United Kingdom
    • Gateshead Health NHS Foundation Trust
  • Headington, United Kingdom
    • Oxford University Hospitals NHS Trust
  • Hull, United Kingdom
    • Hull and East Yorkshire Hospital NHS Trust
  • Kendal, United Kingdom
    • University Hospitals of Morecambe Bay NHS Foundation Trust
  • Liverpool, United Kingdom
    • Liverpool Women's NHS Foundation Trust
  • Manchester, United Kingdom
    • Central Manchester University Hospitals NHS Foundation Trust
  • Plymouth, United Kingdom
    • Plymouth Hospital NHS Trust
  • Prescot, United Kingdom
    • St Helens and Knowsley Teaching Hospitals NHS Trust
  • Sutton in Ashfield, United Kingdom
    • Sherwood Forest Hospitals NHS Foundation Trust
  • Taunton, United Kingdom
    • Taunton and Somerset NHS Foundation Trust
  • Wakefield, United Kingdom
    • The Mid Yorkshire Hospitals NHS Trust
  • York, United Kingdom
    • York Teaching Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Innovators; Maternity units that implemented the Care Bundle to the highest level (according to an NHS survey in 2015) are categorised as 'Innovators'.	Other: Questionnaire; 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).
Early Adopters; Maternity units that implemented the Care Bundle to the second-highest level (according to an NHS survey in 2015) are categorised as 'Early Adopters'.	Other: Questionnaire; 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).
Late Adopters; Maternity units that implemented the Care Bundle to the third-highest level (according to an NHS survey in 2015) are categorised as 'Late Adopters'.	Other: Questionnaire; 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).
Low Adopters; Maternity units that implemented the Care Bundle to the fourth-highest level (according to an NHS survey in 2015) are categorised as 'Low Adopters'.	Other: Questionnaire; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stillbirths	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.	1st April 2012-1st October 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Term, normally formed singleton stillbirths (antepartum and intrapartum).	This excludes issues of preterm birth and major mortality and morbidity associated with congenital anomalies.	1st April 2012-1st October 2017
Preterm births		1st April 2012-1st October 2017
Babies' gestation		1st April 2012-1st October 2017
Number of reported incidents		1st April 2012-1st October 2017
Admission to NICU		1st April 2012-1st October 2017
Antenatal triage numbers		1st April 2012-1st October 2017
Emergency caesarean deliveries		1st April 2012-1st October 2017
Induced deliveries		1st April 2012-1st October 2017
Birthweight		1st April 2012-1st October 2017
Birthweight centile	Using GROW-Centile software	1st April 2012-1st October 2017
Spontaneous deliveries		1st April 2012-1st October 2017
Caesarean deliveries		1st April 2012-1st October 2017
Instrumental deliveries		1st April 2012-1st October 2017

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women smoking at delivery		10th July 2017-31st August 2017
Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women offered carbon monoxide (CO) test		10th July 2017-31st August 2017
Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women accepting CO test		10th July 2017-31st August 2017
Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation		10th July 2017-31st August 2017
Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women ceasing smoking between booking and delivery		10th July 2017-31st August 2017
Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation with a positive CO test		10th July 2017-31st August 2017
Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA singletons detected prior to delivery		1st April 2012-1st October 2017
Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of all singletons with growth charts in notes		1st April 2012-1st October 2017
Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with estimated fetal weight (EFW) plotted on growth chart		1st April 2012-1st October 2017
Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with symphysis fundal height (SFH) plotted on growth chart		1st April 2012-1st October 2017
Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with EFW correctly plotted on growth chart		1st April 2012-1st October 2017
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)		1st April 2012-1st October 2017
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)		1st April 2012-1st October 2017
Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of pregnancies with customised growth chart		1st April 2012-1st October 2017
Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Birthweight centile at last scan (by EFW measurement)		1st April 2012-1st October 2017
Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Number of third trimester growth scans		1st April 2012-1st October 2017
Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women receiving RFM leaflet		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM managed		1st April 2012 until 1st October 2017
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		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM who had scan		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM who had FH monitoring		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Gestation of baby at RFM episodes		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of growth scans due to RFM		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Time to scan from reporting RFM		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of RFM episodes per pregnancy according to checklist		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of deliveries where both buddy and stickers used		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of staff completing annual CTG training		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of pregnancies where escalation protocol was used		1st April 2012 until 1st October 2017
Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Number of babies therapeutically cooled		1st April 2012 until 1st October 2017
Economic Outcome - Equipment required	(e.g. CO test kits)	10th July 2017-31st August 2017
Economic Outcome - Staff time required	(e.g. to conduct additional scans)	10th July 2017-31st August 2017
Economic Outcome - Antenatal triage numbers		10th July 2017-31st August 2017
Economic Outcome - Number of triage women presenting with RFM on at least one occasion		10th July 2017-31st August 2017
Economic Outcome - Emergency caesarean deliveries		10th July 2017-31st August 2017
Economic Outcome - Induced deliveries		10th July 2017-31st August 2017
Economic Outcome - Caesarean deliveries		10th July 2017-31st August 2017
Economic Outcome - Number of third trimester growth scans		10th July 2017-31st August 2017
Economic Outcome - Number of growth scans due to RFM		10th July 2017-31st August 2017
Economic Outcome - Number of antenatal CTGs due to RFM		10th July 2017-31st August 2017
Economic Outcome - Length of stay in NICU		10th July 2017-31st August 2017
Economic Outcome - Length of stay in hospital		10th July 2017-31st August 2017

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Office of National Statistics. Characteristics of birth 1, England and Wales, 2013. London: ONS, 2014.
• 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. Erratum In: Lancet. 2021 Sep 25;398(10306):1132.
• 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.
• 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.
• NHS England. Saving Babies' Lives care bundle 2015.
• 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.
• 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.
• RCOG Green-Top Guideline 31: The Investigation and Management of the Small-for-Gestational Ages Fetus. Royal College of Obstetricians and Gynaecologists, 2013.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth
• Other Study ID Numbers: R04666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No