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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03231007
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Dr Alexander Heazell, University of Manchester

Tracking Information
First Submitted Date July 6, 2017
First Posted Date July 27, 2017
Last Update Posted Date December 4, 2018
Actual Study Start Date July 10, 2017
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 26, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 26, 2017)
  • 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.
  • Preterm births [ Time Frame: 1st April 2012-1st October 2017 ]
  • Babies' gestation [ Time Frame: 1st April 2012-1st October 2017 ]
  • Number of reported incidents [ Time Frame: 1st April 2012-1st October 2017 ]
  • Admission to NICU [ Time Frame: 1st April 2012-1st October 2017 ]
  • Antenatal triage numbers [ Time Frame: 1st April 2012-1st October 2017 ]
  • Emergency caesarean deliveries [ Time Frame: 1st April 2012-1st October 2017 ]
  • Induced deliveries [ Time Frame: 1st April 2012-1st October 2017 ]
  • Birthweight [ Time Frame: 1st April 2012-1st October 2017 ]
  • Birthweight centile [ Time Frame: 1st April 2012-1st October 2017 ]
    Using GROW-Centile software
  • Spontaneous deliveries [ Time Frame: 1st April 2012-1st October 2017 ]
  • Caesarean deliveries [ Time Frame: 1st April 2012-1st October 2017 ]
  • Instrumental deliveries [ Time Frame: 1st April 2012-1st October 2017 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 26, 2017)
  • Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women smoking at delivery [ Time Frame: 10th July 2017-31st August 2017 ]
  • 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 ]
  • Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women accepting CO test [ Time Frame: 10th July 2017-31st August 2017 ]
  • Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation [ Time Frame: 10th July 2017-31st August 2017 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Economic Outcome - Equipment required [ Time Frame: 10th July 2017-31st August 2017 ]
    (e.g. CO test kits)
  • Economic Outcome - Staff time required [ Time Frame: 10th July 2017-31st August 2017 ]
    (e.g. to conduct additional scans)
  • Economic Outcome - Antenatal triage numbers [ Time Frame: 10th July 2017-31st August 2017 ]
  • Economic Outcome - Number of triage women presenting with RFM on at least one occasion [ Time Frame: 10th July 2017-31st August 2017 ]
  • Economic Outcome - Emergency caesarean deliveries [ Time Frame: 10th July 2017-31st August 2017 ]
  • Economic Outcome - Induced deliveries [ Time Frame: 10th July 2017-31st August 2017 ]
  • Economic Outcome - Caesarean deliveries [ Time Frame: 10th July 2017-31st August 2017 ]
  • Economic Outcome - Number of third trimester growth scans [ Time Frame: 10th July 2017-31st August 2017 ]
  • Economic Outcome - Number of growth scans due to RFM [ Time Frame: 10th July 2017-31st August 2017 ]
  • Economic Outcome - Number of antenatal CTGs due to RFM [ Time Frame: 10th July 2017-31st August 2017 ]
  • Economic Outcome - Length of stay in NICU [ Time Frame: 10th July 2017-31st August 2017 ]
  • Economic Outcome - Length of stay in hospital [ Time Frame: 10th July 2017-31st August 2017 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition 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).
Study Groups/Cohorts
  • Innovators
    Maternity units that implemented the Care Bundle to the highest level (according to an NHS survey in 2015) are categorised as 'Innovators'.
    Intervention: Other: Questionnaire
  • 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'.
    Intervention: Other: Questionnaire
  • 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'.
    Intervention: Other: Questionnaire
  • 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'.
    Intervention: Other: Questionnaire
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 3, 2018)
4952
Original Estimated Enrollment
 (submitted: July 26, 2017)
4000
Actual Study Completion Date July 5, 2018
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03231007
Other Study ID Numbers R04666
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr Alexander Heazell, University of Manchester
Study Sponsor University of Manchester
Collaborators
  • 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 Not Provided
PRS Account University of Manchester
Verification Date December 2018