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

• Sponsor: University of Manchester (Other)
• Overall Status: Completed
• CT.gov ID: NCT03231007
• Collaborator: Somerset NHS Foundation Trust (Other), Royal Devon and Exeter NHS Foundation Trust (Other), University Hospital Plymouth NHS Trust (Other), Royal United Hospital Bath NHS Trust (Other), North Bristol NHS Trust (Other), Liverpool Women's NHS Foundation Trust (Other), St Helens & Knowsley Teaching Hospitals NHS Trust (Other), Countess of Chester NHS Foundation Trust (Other), University Hospitals of Morecambe Bay NHS Trust (Other), Barnsley Hospital NHS Foundation Trust (Other), Doncaster And Bassetlaw Hospitals NHS Foundation Trust (Other), York Teaching Hospitals NHS Foundation Trust (Other), Hull University Teaching Hospitals NHS Trust (Other), Mid Yorkshire Hospitals NHS Trust (Other), Oxford University Hospitals NHS Trust (Other), Gateshead Health NHS Foundation Trust (Other), North Cumbria University Hospitals NHS Trust (Other), Sherwood Forest Hospitals NHS Foundation Trust (Other), Manchester University NHS Foundation Trust (Other), Birmingham Women's NHS Foundation Trust (Other)
• Enrollment: 4,952
• Locations: 20
• Actual Duration (Months): 11.8
• Patients Per Site: 247.6
• Patients Per Site Per Month: 20.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stillbirth	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 Design

• Study Type: Observational
• Actual Enrollment: 4952 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study
• Actual Study Start Date: Jul 10, 2017
• Actual Primary Completion Date: Feb 28, 2018
• Actual Study Completion Date: Jul 5, 2018

Arms and Interventions

Arm	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).

Outcome Measures

Primary Outcome Measures

1. Stillbirths [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 Outcome Measures

1. Term, normally formed singleton stillbirths (antepartum and intrapartum). [1st April 2012-1st October 2017]

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

2. Preterm births [1st April 2012-1st October 2017]

3. Babies' gestation [1st April 2012-1st October 2017]

4. Number of reported incidents [1st April 2012-1st October 2017]

5. Admission to NICU [1st April 2012-1st October 2017]

6. Antenatal triage numbers [1st April 2012-1st October 2017]

7. Emergency caesarean deliveries [1st April 2012-1st October 2017]

8. Induced deliveries [1st April 2012-1st October 2017]

9. Birthweight [1st April 2012-1st October 2017]

10. Birthweight centile [1st April 2012-1st October 2017]

    Using GROW-Centile software

11. Spontaneous deliveries [1st April 2012-1st October 2017]

12. Caesarean deliveries [1st April 2012-1st October 2017]

13. Instrumental deliveries [1st April 2012-1st October 2017]

Other Outcome Measures

1. Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women smoking at delivery [10th July 2017-31st August 2017]

2. Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women offered carbon monoxide (CO) test [10th July 2017-31st August 2017]

3. Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women accepting CO test [10th July 2017-31st August 2017]

4. Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation [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 [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 [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 [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 [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 [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 [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 [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) [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) [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 [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) [1st April 2012-1st October 2017]

16. Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Number of third trimester growth scans [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [1st April 2012 until 1st October 2017]

29. Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Number of babies therapeutically cooled [1st April 2012 until 1st October 2017]

30. Economic Outcome - Equipment required [10th July 2017-31st August 2017]

    (e.g. CO test kits)

31. Economic Outcome - Staff time required [10th July 2017-31st August 2017]

    (e.g. to conduct additional scans)

32. Economic Outcome - Antenatal triage numbers [10th July 2017-31st August 2017]

33. Economic Outcome - Number of triage women presenting with RFM on at least one occasion [10th July 2017-31st August 2017]

34. Economic Outcome - Emergency caesarean deliveries [10th July 2017-31st August 2017]

35. Economic Outcome - Induced deliveries [10th July 2017-31st August 2017]

36. Economic Outcome - Caesarean deliveries [10th July 2017-31st August 2017]

37. Economic Outcome - Number of third trimester growth scans [10th July 2017-31st August 2017]

38. Economic Outcome - Number of growth scans due to RFM [10th July 2017-31st August 2017]

39. Economic Outcome - Number of antenatal CTGs due to RFM [10th July 2017-31st August 2017]

40. Economic Outcome - Length of stay in NICU [10th July 2017-31st August 2017]

41. Economic Outcome - Length of stay in hospital [10th July 2017-31st August 2017]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barnsley Hospital NHS Foundation Trust	Barnsley		United Kingdom
2	Royal United Hospitals Bath NHS Foundation Trust	Bath		United Kingdom
3	Birmingham Women's and Children's NHS Foundation Trust	Birmingham		United Kingdom
4	North Bristol NHS Trust	Bristol		United Kingdom
5	North Cumbria University Hospitals NHS Trust	Carlisle		United Kingdom
6	Countess of Chester Hospital NHS Foundation Trust	Chester		United Kingdom
7	Doncaster and Bassetlaw Hospitals NHS Foundation Trust	Doncaster		United Kingdom
8	Royal Devon & Exeter NHS Foundation Trust	Exeter		United Kingdom
9	Gateshead Health NHS Foundation Trust	Gateshead		United Kingdom
10	Oxford University Hospitals NHS Trust	Headington		United Kingdom
11	Hull and East Yorkshire Hospital NHS Trust	Hull		United Kingdom
12	University Hospitals of Morecambe Bay NHS Foundation Trust	Kendal		United Kingdom
13	Liverpool Women's NHS Foundation Trust	Liverpool		United Kingdom
14	Central Manchester University Hospitals NHS Foundation Trust	Manchester		United Kingdom
15	Plymouth Hospital NHS Trust	Plymouth		United Kingdom
16	St Helens and Knowsley Teaching Hospitals NHS Trust	Prescot		United Kingdom
17	Sherwood Forest Hospitals NHS Foundation Trust	Sutton in Ashfield		United Kingdom
18	Taunton and Somerset NHS Foundation Trust	Taunton		United Kingdom
19	The Mid Yorkshire Hospitals NHS Trust	Wakefield		United Kingdom
20	York Teaching Hospital NHS Foundation Trust	York		United Kingdom

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 12, 2017

More Information

Publications

• 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.
• 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 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, 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. Erratum in: Lancet. 2021 Sep 25;398(10306):1132.
• 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.
• 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.
• 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.

• Responsible Party: Dr Alexander Heazell, Professor of Obstetrics, University of Manchester
• ClinicalTrials.gov Identifier: NCT03231007
• Other Study ID Numbers: R04666
• First Posted: Jul 27, 2017
• Last Update Posted: Dec 4, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stillbirth

Study Results

No Results Posted as of Dec 4, 2018