Stillbirth
Conditions
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.
Interventions
OTHERQuestionnaire
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).
Sponsors
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 Teaching 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
University of Manchester
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Birthweight | 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 | — |
| Birthweight centile | 1st April 2012-1st October 2017 | Using GROW-Centile software |
| Spontaneous deliveries | 1st April 2012-1st October 2017 | — |
| Induced deliveries | 1st April 2012-1st October 2017 | — |
| Babies' gestation | 1st April 2012-1st October 2017 | — |
| 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. |
| Number of reported incidents | 1st April 2012-1st October 2017 | — |
| Caesarean deliveries | 1st April 2012-1st October 2017 | — |
| Instrumental deliveries | 1st April 2012-1st October 2017 | — |
| Preterm births | 1st April 2012-1st October 2017 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Economic Outcome - Equipment required | 10th July 2017-31st August 2017 | (e.g. CO test kits) |
| Economic Outcome - Staff time required | 10th July 2017-31st August 2017 | (e.g. to conduct additional scans) |
| 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 | — |
| Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Number of babies therapeutically cooled | 1st April 2012 until 1st October 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 smoking at delivery | 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 | — |
Countries
United Kingdom
Outcome results
None listed