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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stillbirth

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Innovators<br>Maternity units that implemented the Care Bundle to the highest level (according to an NHS survey in 2015) are categorised as 'Innovators'. | Other: Questionnaire<br>* 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).<br>|
| Early Adopters<br>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<br>* 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).<br>|
| Late Adopters<br>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<br>* 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).<br>|
| Low Adopters<br>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<br>* 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).<br>|

What is the study measuring?
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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 |