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

Stillbirth Clinical Trial

— SPiRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231007
• Other study ID #: R04666
• Status: Completed
• Start date: July 10, 2017
• Est. completion date: July 5, 2018

Study information

• Verified date: December 2018
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4952
• Est. completion date: July 5, 2018
• Est. primary completion date: February 28, 2018
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stillbirth

Intervention

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).

Locations

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

Sponsors (21)

Lead Sponsor

Collaborator

University of Manchester

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 and East Yorkshire Hospitals NHS Trust, Liverpool Women's NHS Foundation Trust, Manchester University NHS Foundation Trust, Mid Yorkshire Hospitals 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, St Helens & Knowsley Teaching Hospitals NHS Trust, Taunton and Somerset NHS Foundation Trust, University Hospital Plymouth NHS Trust, University Hospitals of Morecambe Bay NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

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. Review. Update in: Cochrane Database Syst Rev. 2013;5:CD006066. — View 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.

Flenady V, Wojcieszek AM, Middleton P, Ellwood D, Erwich JJ, Coory M, Khong TY, Silver RM, Smith GC, 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, Ravaldi C, Vannacci A, Cassidy J, Cassidy P, Farquhar C, Wallace E, Siassakos D, Heazell AE, Storey C, Sadler L, Petersen S, Frøen 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. Review. — View 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. — View 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.

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. Review. — View Citation

NHS England. Saving Babies' Lives care bundle 2015.

Office of National Statistics. Characteristics of birth 1, England and Wales, 2013. London: ONS, 2014.

RCOG Green-Top Guideline 31: The Investigation and Management of the Small-for-Gestational Ages Fetus. Royal College of Obstetricians and Gynaecologists, 2013.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women smoking at delivery		10th July 2017-31st August 2017
Other	Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women offered carbon monoxide (CO) test		10th July 2017-31st August 2017
Other	Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women accepting CO test		10th July 2017-31st August 2017
Other	Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation		10th July 2017-31st August 2017
Other	Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women ceasing smoking between booking and delivery		10th July 2017-31st August 2017
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of pregnancies with customised growth chart		1st April 2012-1st October 2017
Other	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
Other	Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Number of third trimester growth scans		1st April 2012-1st October 2017
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Number of babies therapeutically cooled		1st April 2012 until 1st October 2017
Other	Economic Outcome - Equipment required	(e.g. CO test kits)	10th July 2017-31st August 2017
Other	Economic Outcome - Staff time required	(e.g. to conduct additional scans)	10th July 2017-31st August 2017
Other	Economic Outcome - Antenatal triage numbers		10th July 2017-31st August 2017
Other	Economic Outcome - Number of triage women presenting with RFM on at least one occasion		10th July 2017-31st August 2017
Other	Economic Outcome - Emergency caesarean deliveries		10th July 2017-31st August 2017
Other	Economic Outcome - Induced deliveries		10th July 2017-31st August 2017
Other	Economic Outcome - Caesarean deliveries		10th July 2017-31st August 2017
Other	Economic Outcome - Number of third trimester growth scans		10th July 2017-31st August 2017
Other	Economic Outcome - Number of growth scans due to RFM		10th July 2017-31st August 2017
Other	Economic Outcome - Number of antenatal CTGs due to RFM		10th July 2017-31st August 2017
Other	Economic Outcome - Length of stay in NICU		10th July 2017-31st August 2017
Other	Economic Outcome - Length of stay in hospital		10th July 2017-31st August 2017
Primary	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	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
Secondary	Preterm births		1st April 2012-1st October 2017
Secondary	Babies' gestation		1st April 2012-1st October 2017
Secondary	Number of reported incidents		1st April 2012-1st October 2017
Secondary	Admission to NICU		1st April 2012-1st October 2017
Secondary	Antenatal triage numbers		1st April 2012-1st October 2017
Secondary	Emergency caesarean deliveries		1st April 2012-1st October 2017
Secondary	Induced deliveries		1st April 2012-1st October 2017
Secondary	Birthweight		1st April 2012-1st October 2017
Secondary	Birthweight centile	Using GROW-Centile software	1st April 2012-1st October 2017
Secondary	Spontaneous deliveries		1st April 2012-1st October 2017
Secondary	Caesarean deliveries		1st April 2012-1st October 2017
Secondary	Instrumental deliveries		1st April 2012-1st October 2017