Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study
Conditions: Stillbirth
Sponsor: University of Manchester

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SPiRE Protocol 
 
 
Saving Babies’ Lives Project Impact and Results Evaluation 
 
 
 
 
 
 
  
 
 
 
RESEARCH REFERENCE NUMBERS 
Sponsor 
University of Manchester 
Sponsor reference number 
R119547 
REC reference number 
17/WM/0197 
IRAS Project ID 
223553 
Funding source  
NHS England 
 
 
 
RE
SP

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ADMINISTRATION AND RESEARCH TEAM 
 
Sponsor 
University of Manchester 
Ms Lynne Macrae 
Faculty Research Practice Coordinator 
Faculty of Biology, Medicine and Health 
1.21a Simon Building 
The University of Manchester 
M13 9PL 
Tel: 0161 275 5436 
Email:  FBMHethicsapps@manchester.ac.uk 
 
Funder  
Julia Walker-Brown (RGN, RM) 
Team Manager 
Maternity and Women’s Health Team 
NHS England, National Team 
Medical Directorate 
Quarry House, Leeds 
LS2 7UE 
Telephone: (0113) 8249426  
Email: julia.walker-brown@nhs.net 
 
Chief Investigator 
Dr Alexander Heazell 
Senior Clinical Lecturer in Obstetrics 
Maternal and Fetal Health Research Centre 
5th Floor Research, St. Mary’s Hospital 
Oxford Road, Manchester 
M13 9WL 
Telephone: (0161) 701 0889 
E-mail: alexander.heazell@manchester.ac.uk 
 
 
 
 
 

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Co-Investigators 
Dr Kate Widdows (Day to Day Contact for Study Queries) 
Role: Project Manager 
Maternal and Fetal Health Research Centre 
5th Floor Research, St. Mary’s Hospital 
Oxford Road, Manchester 
M13 9WL 
Telephone: (0161) 276 6916 
Email: kate.widdows@manchester.ac.uk 
 
Holly Reid 
Role: Project Assistant 
Maternal and Fetal Health Research Centre 
5th Floor Research, St. Mary’s Hospital 
Oxford Road, Manchester 
M13 9WL 
Email: holly.reid@manchester.ac.uk 
 
Dr Stephen Roberts 
Role: Biostatistician 
Centre for Biostatistics 
Jean McFarlane Building 
Oxford Road, Manchester 
M13 9PL 
Telephone: (0161) 275 5192 
Email: steve.roberts@manchester.ac.uk 
 
Dr Elizabeth Camacho 
Role: Health Economist  
Centre for Health Economics 
Jean McFarlane Building 
Oxford Road, Manchester 
M13 9PL 
Telephone: (0161) 306 8008  
Email:elizabeth.camacho@manchester.ac.uk 
 
 

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Contents 
1 
BACKGROUND ........................................................................................................................................ 7 
1.1 
STUDY RATIONALE .......................................................................................................................................... 8 
1.1.1 
Justification for study sites .............................................................................................................. 8 
1.1.2 
Justification for design .................................................................................................................... 9 
2 
AIMS AND OBJECTIVES ......................................................................................................................... 10 
2.1 
AIMS ........................................................................................................................................................ 10 
2.2 
OBJECTIVES ................................................................................................................................................ 10 
2.2.1 
Primary Objective .......................................................................................................................... 10 
2.2.2 
Secondary Objectives .................................................................................................................... 10 
3 
OUTCOME MEASURES .......................................................................................................................... 11 
3.1 
CLINICAL OUTCOMES .................................................................................................................................... 11 
3.1.1 
Primary outcome .......................................................................................................................... 11 
3.1.2 
Secondary outcomes ..................................................................................................................... 11 
3.2 
PROCESS OUTCOMES ................................................................................................................................. 11 
3.2.1 
Element 1: Smoking in pregnancy ................................................................................................. 11 
3.2.2 
Element 2: Small for Gestational Age (SGA) detection ................................................................. 12 
3.2.3 
Element 3: Patient information provision and RFM management ............................................... 12 
3.2.4 
Element 4: Effective fetal monitoring during labour ..................................................................... 13 
3.3 
ECONOMIC OUTCOMES ................................................................................................................................. 13 
4 
STUDY DESIGN ...................................................................................................................................... 14 
4.1 
STUDY SETTING ........................................................................................................................................... 14 
4.2 
PLAN OF INVESTIGATION ............................................................................................................................... 14 
4.2.1 
Quantitative studies ...................................................................................................................... 16 
4.2.2 
Qualitative studies ........................................................................................................................ 16 
5 
DATA COLLECTION ................................................................................................................................ 16 
5.1 
QUANTITATIVE STUDY ................................................................................................................................... 16 
5.1.1 
Maternity Informatics Systems ..................................................................................................... 17 
5.1.2 
Case-note Audit ............................................................................................................................. 18 
5.2 
QUALITATIVE STUDY ..................................................................................................................................... 19 
5.2.1 
Questionnaires .............................................................................................................................. 19 
5.2.2 
Guideline appraisal ....................................................................................................................... 22 
6 
STATISTICAL ANALYSIS .......................................................................................................................... 23 
6.1 
SAMPLE SIZE CONSIDERATIONS ................................................................................................................. 23 
6.2 
DATA ANALYSIS........................................................................................................................................... 24 
6.2.1 
Analysis of outcome measures ...................................................................................................... 24 
6.2.2 
Care bundle compliance ................................................................................................................ 24 

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6.2.3 
Data validation ............................................................................................................................. 25 
6.2.4 
Statistical analysis ......................................................................................................................... 25 
6.3 
QUALITATIVE ANALYSIS ................................................................................................................................ 26 
6.4 
HEALTH ECONOMIC ANALYSIS ........................................................................................................................ 26 
7 
DATA HANDLING AND STORAGE........................................................................................................... 27 
7.1 
DATA PROCESSING ....................................................................................................................................... 27 
7.2 
DATA TRANSFER .......................................................................................................................................... 28 
7.3 
STORAGE ................................................................................................................................................... 28 
8 
QUALITY ASSURANCE AND CONTROL ................................................................................................... 29 
8.1 
SITE SET-UP AND INITIATION .......................................................................................................................... 29 
8.2 
DATA MONITORING ..................................................................................................................................... 29 
8.3 
ORGANISATION OF THE STUDY ....................................................................................................................... 30 
8.3.1 
Finance .......................................................................................................................................... 30 
8.3.2 
End of study .................................................................................................................................. 30 
9 
ETHICS .................................................................................................................................................. 30 
9.1 
POTENTIAL RISKS AND BENEFITS ...................................................................................................................... 31 
10 
CONFIDENTIALITY AND DATA PROTECTION .......................................................................................... 31 
11 
INSURANCE AND INDEMNITY ............................................................................................................... 31 
12 
DISSEMINATION OF STUDY FINDINGS ................................................................................................... 32 
12.1 
NATIONAL REPORT .................................................................................................................................. 32 
12.2 
PUBLIC AND PATIENTS ............................................................................................................................. 32 
13 
PUBLICATION POLICY ............................................................................................................................ 32 
14 
REFERENCES ......................................................................................................................................... 34 
15 
APPENDICES ......................................................................................................................................... 35 
 
 
 
 
 
 
 
 
 
 
 

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STUDY OVERVIEW  
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.  
 
The SPiRE (Saving Babies’ Lives Project Impact and Results Evaluation) 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 (SCNs) 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.  

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1 
BACKGROUND  
The challenge – Maternity services in England aim to deliver high quality care and outcomes 
for both mother and baby are improving. The stillbirth rate and neonatal mortality rate fell 
by 12% and 10% respectively between 2010 and 2015 [1]. However, comparison to other 
high income countries suggests that much more still needs to be done to reduce stillbirth 
rates in the UK. One in every 220 babies born in the UK are stillborn each year. In 2015, the 
UK ranked 24th out of 49 high income countries and the annual rate of reduction of 1.4% is 
much lower than comparable countries (e.g. 6.8% in the Netherlands) with about a 33% 
variation in rates between regions [2, 3]. There is a clear need to address the disparity in 
stillbirth rates between the UK and other European countries, as well as within the UK. 
Crucially, a recent Confidential Enquiry of term antepartum stillbirths (by MBBRACE-UK) 
revealed that almost half are potentially avoidable if improvements were made in at least 
one element of antenatal care [4]. To address this, in November 2015 the government 
launched a national Maternity Transformation Programme (MTP) to promote safer care for 
women and newborns with the ambition of reducing stillbirths and early neonatal deaths by 
20% by 2020 and by 50% by 2030 [5]. 
 
A care bundle to reduce stillbirth – As part of the MTP, in April 2015 NHS England launched 
the Saving Babies’ Lives (SBL) care bundle specifically designed to reduce stillbirths and early 
neonatal deaths [6]. It is a policy aimed at improving outcome by improving the quality of 
care during pregnancy and outcomes through four key elements, established using the best 
current practice/evidence in reducing stillbirth and early neonatal death by:  
Element 1. 
Reducing smoking in pregnancy 
Element 2. 
Improving detection and management of fetal growth restriction (FGR) 
Element 3. 
Improving awareness and management of reduced fetal movement (RFM) 
Element 4. 
Promoting effective fetal monitoring during labour 
These four elements are predicted to improve the identification of babies at greatest risk 
with particular application to term antepartum stillbirths that are potentially avoidable. It 
encompasses two key recommendations from the 2015 Confidential Enquiry (monitoring 
fetal growth [7] and managing reduced fetal movements [4]) as well as key public health 

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action to reduce smoking in pregnancy and the importance of effective fetal monitoring 
during labour [8-10].  
 
1.1 STUDY RATIONALE 
It is imperative that public health interventions to reduce stillbirths are based upon robust 
evidence. Although the elements were derived from widely accepted best practice, more 
primary data is needed to assess the effectiveness of the care bundle at reducing stillbirth 
rates. The implementation phase of the care bundle provides a unique opportunity to 
collect this evidence. The process of implementation (e.g. the interventions) must also be 
evaluated to determine what qualities underpin successful implementation and the needs 
of different maternity units in doing so. In this way we can, subject to the limitations of the 
available data and the observational nature of the study, determine to what extent the care 
bundle provides clinically effective interventions.  
 
1.1.1 Justification for study sites 
To determine how current practice already aligns with the care bundle and how maternity 
units are working towards implementation, a survey was sent by NHS England to all 
maternity units across the UK in 2015. Of the 99 units that responded, all were 
implementing at least one element of the care bundle and there was significant variation in 
the degree of implementation of the different elements both between and within units. 
Forty-nine of these volunteered to be Early Implementer sites. This study will focus on the 
Early Implementer sites who have been piloting the care bundle since its launch.   
 
Reasons for the national variation in implementation are likely to be centred on resource, 
structural and institutional influences. This study is designed to better understand these 
factors and will focus on a small number of maternity units as part of a detailed evaluation 
rather than a surface evaluation of a large number of hospitals. Twenty maternity units 
were selected as study sites from the Early Implementer’s according to Rogers Model of 
Innovation [11]. The diffusion of innovations is a theory that seeks to explain how 
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change. Study sites were categorised as innovators, early adopters, late adopters and low 
adopters according to their level of implementation for the care bundle as a whole (from 
the 2015 survey). The units vary in size (in terms of number of births per year) and a range 
of sites from across different strategic clinical networks are included to ensure that data is 
geographically representative. Based on the number of study sites involved, this provides us 
with an estimated 100,000 births per year. This equates to 15% of the total annual births in 
the UK (697,852 livebirths in UK) and will potentially include 470 stillbirths per year 
assuming a stillbirth rate of 4.7 per 1,000 total births (2014).   
 
1.1.2 Justification for design 
This study is a multicentre mixed-methods evaluation to determine the impact of the care 
bundle on maternity services and perinatal outcomes. As there was no opportunity to be 
involved in the implementation process, or access the services prior to the implementation, 
we have pragmatically adopted a pre-post study design using routinely collected data, 
augmented by cross-sectional targeted data collection in the post-implementation period. 
This design will provide evidence of the degree to which stillbirth rates and associated 
clinical and process outcomes have improved following implementation of the care bundle, 
accepting that causal attribution to the care bundle (as a whole or any element of the 
bundle) will be provisional. We have adopted an extended pre-implementation observation 
period to allow the discernment of time trends external to the bundle, and a range of 
implementation levels and times to allow some attribution to care bundle elements.  
 
As with any quality improvement, the measurement of key outcomes is critical and we have 
taken a pragmatic approach to assessing the various outcomes and processes for each 
intervention. The outcome measures being evaluated in this study were informed by a small 
feasibility study (Phase I of the project, May 2016 to January 2017) involving some of the 
innovator sites. This determined the availability and reliability of collecting data for each of 
the care bundle interventions. 
 

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2 
AIMS AND OBJECTIVES 
2.1 AIMS 
The overall purpose of the study is to determine the impact of the care bundle on UK 
maternity services and perinatal outcomes. It aims to: 
1) Evaluate the effectiveness of the care bundle in reducing stillbirth 
2) Assess the degree to which each specific element has been implemented  
3) Understand the processes and contexts of implementation success 
4) Estimate the cost of implementing the care bundle 
 
2.2 OBJECTIVES 
2.2.1 Primary Objective 
1a) To compare stillbirth rates before and after implementation of the care bundle  
2.2.2 Secondary Objectives 
1b) To explore factors associated with reduction in stillbirth and post-implementation rates 
1c) To assess the impact of the care bundle on other relevant clinical endpoints 
2a) To assess implementation stages for each element and change from pre-implementation 
3a) To explore leadership, governance and workforce culture with implementation success 
3b) To explore patient and staff views of antenatal care in relation to the care bundle 
4a) To estimate the resources required to implement the care bundle 
4b) To estimate the cost of implementing the care bundle per stillbirth avoided post-
implementation  
 

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3 
OUTCOME MEASURES 
3.1 CLINICAL OUTCOMES   
3.1.1 Primary outcome  
o 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 
[12]. 
3.1.2 Secondary outcomes 
o Term, normally formed singleton stillbirths (antepartum and intrapartum). This 
excludes issues of preterm birth and major mortality and morbidity associated with 
congenital anomalies.  
o Preterm births 
o Babies gestation 
o Number of reported incidents 
o Admission to NICU 
o Antenatal triage numbers 
o Emergency caesarean deliveries 
o Induced deliveries 
o Caesarean deliveries  
o Instrumental deliveries 
o Spontaneous deliveries 
o Birthweight  
o Birthweight centile (using GROW-Centile software)  
 
3.2 PROCESS OUTCOMES  
3.2.1 Element 1: Smoking in pregnancy  
Primary 
o Proportion of women smoking at delivery 
Secondary 
o Proportion of women offered carbon monoxide (CO) test  

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o Proportion of women accepting CO test 
o Proportion of women referred to smoking cessation 
o Proportion of women ceasing smoking between booking and delivery 
o Proportion of women referred to smoking cessation with a positive CO test 
 
3.2.2 Element 2: Small for Gestational Age (SGA) detection 
Primary 
o Proportion of SGA singletons detected prior to delivery 
Secondary 
o Proportion of all singletons with growth charts in notes 
o Proportion of SGA pregnancies with estimated fetal weight (EFW) plotted on growth 
chart  
o Proportion of SGA pregnancies with symphysis fundal height (SFH) plotted on growth 
chart  
o Proportion of SGA pregnancies with EFW correctly plotted on growth chart 
Exploratory 
o Proportion of babies identified as SGA during pregnancy that were appropriate for 
gestation age (AGA) at birth (false positives) 
o Proportion of babies identified as AGA during pregnancy that were SGA at birth 
(false negatives) 
o Proportion of pregnancies with customised growth chart 
o Birthweight centile at last scan (by EFW measurement) 
o Number of third trimester growth scans 
 
3.2.3 Element 3: Patient information provision and RFM management 
Primary 
o Proportion of women receiving RFM leaflet 
o Proportion of women with RFM managed according to checklist 
Secondary 
o Number of triage women presenting with RFM on at least one occasion  

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o Proportion of women with RFM who had scan   
Exploratory 
o Proportion of women with RFM who had FH monitoring 
o Gestation of baby at RFM episodes 
o Number of growth scans due to RFM  
o Time to scan from reporting RFM 
o Number of RFM episodes per pregnancy 
 
3.2.4 Element 4: Effective fetal monitoring during labour 
Primary 
o Proportion of deliveries where both buddy and stickers used 
Secondary 
o Proportion of staff completing annual CTG training 
o Proportion of pregnancies where escalation protocol was used 
o Number of babies therapeutically cooled 
 
3.3 ECONOMIC OUTCOMES  
Potential drivers of cost 
o Equipment required (e.g. CO test kits) 
o Staff time required (e.g. to conduct additional scans) 
o Antenatal triage numbers 
o Number of triage women presenting with RFM on at least one occasion  
o Emergency caesarean  deliveries 
o Induced deliveries 
o Caesarean deliveries  
o Number of third trimester growth scans  
o Number of growth scans due to RFM  
o Number of antenatal CTGs due to RFM  
o Length of stay in NICU  
o Length of stay in hospital 

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4 
STUDY DESIGN  
This study is a multicentre, mixed-methods evaluation of maternity care delivered as part of 
the Saving Babies’ Lives care bundle in NHS England hospitals. It involves participation by 
both service users and service providers. The evaluation will last for a period of 9 months 
commencing 1st March 2017 until 31st December 2017. Data collection will begin April 2017 
and end 1st October 2017. Data analysis, report writing and dissemination of research 
findings are anticipated to take place between October 2017 and January 2018. 
 
4.1 STUDY SETTING 
The study will be conducted in twenty NHS Hospital Trusts from six NHS Strategic Clinical 
Networks (SCNs). These include the South West, Thames Valley, North West Coast (formerly 
Lancashire and South Cumbria, and Cheshire and Merseyside), North East, Yorkshire and 
Humber, Greater Manchester and East Cheshire, and the East Midlands SCNs. See Appendix 
1 for list of participating study sites. Where there are multiple hospitals per NHS Trust, study 
sites will be asked to include data from all relevant hospitals. The Trust will be the unit of 
analysis (centre) for implementation measures. However, if on review substantive 
differences are identified between sites within Trusts (e.g. restructured Trusts) sites may be 
split prior to evaluation of the outcome data. 
 
All participating Trusts are currently implementing the Saving Babies’ Lives care bundle; 
however there is variation in terms of degree of implementation across Trusts. This 
sampling strategy aims to allow assessment of implementation success across a range of 
settings and the processes and contexts of implementation. Their active participation in the 
study (including extraction of historic data) is anticipated to last for a period of 8-12 months.  
 
4.2 PLAN OF INVESTIGATION 
The evaluation methodology is broadly categorised into two work streams; 1) a quantitative 
study and 2) a qualitative study. The overall plan of investigation is summarised below in 
relation to the study objectives. This mixed-methods approach will allow us to describe the 

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intervention characteristics, the setting, the characteristics of the individuals involved and 
the processes and impact of implementation. Figure 1 shows the overall workflow.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. Plan of Investigation 
 
Study 2 
Health Economic Analysis  
Unit Resource 
questionnaire for service 
providers 
Statistical and economic 
analysis 
Quantitative 
study 
Study 1 
Obtain outcome measures  
Maternity 
databases 
Case-note 
Audit 
Statistical analysis 
Patient & Staff 
questionnaires 
Statistical 
analysis 
Qualitative 
study 
Study 3 
Patient and Staff Views 
Questionnaires with service 
providers and users 
Framework analysis 
Study 4 
Assessment of clinical 
Guideline variability and quality 
Appraisal using AGREE II Tool 
Descriptive analysis 

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4.2.1 Quantitative studies  
Study 1: Objectives 1 and 2 will utilise routinely collected electronic data which will be 
extracted from maternity databases alongside targeted case-note audits of selected groups 
of patients. In addition, questionnaires with patients and healthcare professionals will be 
employed to obtain a small number of outcome measures. Implementation data will be 
obtained from the sites’ Clinical Directors or Head of Midwifery using a Unit Resource and 
Leadership questionnaire. This data will be analysed to estimate changes in stillbirth rates, 
the degree to which each element has been implemented and to explore associations 
between clinical outcomes and implementation. 
 
Study 2: Objective 4 will bring together outcome and process measures collected from the 
organisational lead questionnaires and routinely collected data from study 1 to estimate the 
cost of implementing the care bundle and cost per stillbirth avoided. The relationship 
between the degree of implementation and extent of resources used will also be explored.  
 
4.2.2 Qualitative studies 
Study 3: Objective 3b will involve open-ended questions administered as part of the 
questionnaires for patients and healthcare professionals to learn more about views and 
experiences of maternity care in relation to the care bundle.  
 
Study 4: Objective 3a will involve clinical guideline appraisal using the AGREE II Tool [13] to 
explore the variability and quality of guidelines between Trusts and the clinical credibility 
and reliability of guideline recommendations. 
 
5 
DATA COLLECTION  
5.1 QUANTITATIVE STUDY 
Outcome measures will be collected from three primary sources; Maternity Information 
systems (MIS), the GROW-AppTM, (a subsidiary online application for the generation of the 
Gestation Related Optimal Weight (GROW) curve [14]), and targeted case note audits on 

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selected subgroups of patients. A small number of outcomes will be collected from the 
patient questionnaire where they are not available in any routine records. The time periods 
for data collection are shown in Figure 2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2. Timeline for retrospective data collection  
 
5.1.1 Maternity Informatics Systems 
Data will be extracted retrospectively from electronic Maternity Informatics Systems (MIS) 
at each site. A full list is shown in Appendix 2. Data will be collected for all singletons and 
multiple births per hospital. Trusts will be asked to provide approximately 5 years of 
outcome data. This will comprise 3 years of baseline data pre-launch of the care bundle and 
at least 2 years of outcomes post-launch (pre-post period, Figure 2). Sites will be requested 
to submit data on two occasions. Once at the start of the study period for all pre-post 
launch data up until the study start date e.g. April 2017 (Dataset 1). Sites will then be 
required to submit data 2 years after the launch for a refresh of all post-launch data 
(Dataset 2). A Data Collection Proforma (DCP) (Microsoft Excel) will be provided to all sites 
to facilitate collection of data by a delegated team member at each trust.  
 
Apr 
2015 
Oct 
2017 
Apr 
2012 
Oct 
2015 
Apr 
2017 
Pre-post period 
Historical data 
Post-launch data 
Study period 
Post-launch period 
Care bundle 
Launch 
Period of data collection 

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5.1.1.1 GROW-AppTM 
A small number of outcomes relating to the antenatal detection of SGA babies will be 
collected for sites that are enrolled in the Perinatal Institute’s (PI) Growth Assessment 
Protocol (GAP) from data held in the GROW-App [14]. Researchers at the sponsor site will 
co-ordinate directly with the PI to retrieve this data (monthly figures). Data will be collected 
from the post-launch period only. A full list of data to be collected is shown in Appendix 2.  
 
5.1.2 Case-note Audit 
Case-note audit of patients’ antenatal records will be carried out to assess a small number 
of process outcomes from the care bundle interventions. Study sites will be required to 
carry out three separate case-note audits on different populations of patients as follows: 
general births, SGA pregnancies and RFM pregnancies. These are based on 20 or 40 
consecutive patients meeting the criteria in two specified collection periods as shown in 
Appendix 3. SGA pregnancies will either be identified via the GAP programme or from data 
submitted to the study team. Women attending with RFM will be identified from triage or 
antenatal assessment unit activity logs. In addition, it may be necessary for hospitals to 
review stillbirth cases should the information in Table 6 (Appendix 6) be unavailable from 
their MIS. Data will be provided as fully anonymised individual case records. Study sites will 
be provided with Audit Proformas to facilitate this process and will have 6 months (April 
until October September 2017) to submit the data.  
 
5.1.2.1 GAP SCORETM  
NHS Trusts using GAP-SCORE (Standardised Case Outcome Review and Evaluation) for the 
review of clinical care in the ‘missed case’ of fetal growth restriction will be encouraged to 
use the online audit tool to assess the Care Bundle’s “Algorithm and Risk Assessment Tool 
for Screening and Surveillance of fetal growth in singleton pregnancies.” The online audit 
should be carried out on the same 20 SGA singleton pregnancies (post-implementation) 
reviewed as part of the SGA case-note audit in section 5.1.2; this includes both missed and 
known SGA cases. NHS Trusts that are currently enrolled in GAP but are not yet using GAP 
SCORE are encouraged to perform the online audit but this is entirely optional. A full list of 

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outcomes and audit criteria are shown in Table 8 in Appendix 6. Data will be provided as 
fully anonymised individual case records. Individual Trusts will not be identified in any 
reports.  
  
5.2 QUALITATIVE STUDY 
5.2.1 Questionnaires  
Questionnaires will be used to explore the views of patients and healthcare professionals 
towards maternity care in relation to the care bundle including implementation practices. In 
addition, a small number of outcomes that are not routinely available in maternity 
databases will be collected using questionnaires (see Appendix 4). The questionnaire 
includes both close-ended and open-ended questions and should take no more than 15 
minutes to complete. Participants will be asked to provide basic demographic information 
once they have completed the questionnaire. Questionnaires are intended to be carried out 
at all relevant sites within the Trust where possible.  
 
5.2.1.1 Patient Questionnaire 
5.2.1.1.1 Eligibility  
Inclusion criteria 
 
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 
 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 
 

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5.2.1.1.2 Participant Recruitment 
Eligible women on the postnatal ward will be identified and approached by their midwife or 
doctor to ask if they would like to complete the questionnaire. Patients will be given 
information about the questionnaire and reassured that their responses will be anonymous. 
A proportionate approach to consent will be taken, i.e. by completing the questionnaire the 
respondent has consented to participating. Women will be reassured that the care they and 
their babies receive will not be affected by completing the questionnaire. All participants 
will be informed that completing the questionnaire is voluntary and will be explicitly 
informed prior to completing the questionnaire that once they submit their responses they 
will not be able to withdraw from the study (to ensure anonymity). Participants will have the 
option to be entered into a £100 prize draw for an Amazon voucher as a gesture of thanks 
for their participation, and will be given the option to provide their contact details in a 
separate document that will not be linked to the questionnaire responses to maintain 
anonymity. 
 
5.2.1.1.3 Procedure 
For hospitals with Wi-Fi access on the postnatal ward, participants will be given an 
electronic tablet to complete the questionnaires online. Data will be entered into Select 
Survey.NET which is the University of Manchester’s secure online survey tool. Electronic 
tablets will be provided for hospital sites where unavailable to facilitate online completion. 
Responses will be available immediately to the research team once participants submit the 
questionnaire online. Alternatively, questionnaires will be completed using pen and paper 
where study sites do not have Wi-Fi access. It will be the responsibility of the site PI to 
collect and securely store completed paper questionnaires prior to sending to the sponsor 
site. 
 
For each site, all patients delivering in the unit in a designated 2 week period (during the 
study period) should be asked to complete the questionnaire prior to discharge. Smaller 
units who deliver less than 50 babies per week will be asked to collect for 3 weeks to reduce 
the bias towards larger centres. It is not practical to translate the questionnaire into the 
large number of potential languages that may be required to accommodate all non-English 

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speakers. As translation services will be required to complete discharge procedures, centres 
will be asked to ensure that these services are available to aid questionnaire completion. 
The response rate across ethnic groups will be monitored to determine the extent of any 
bias due to non-provision of appropriate translation facilities. 
 
5.2.1.2 Healthcare Professional Questionnaire 
5.2.1.2.1 Eligibility 
Inclusion criteria 
 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 
 Staff who were employed after the care bundle was implemented  
 
5.2.1.2.2 Participant Recruitment 
Eligible healthcare professionals will be identified and recruited by members of the site 
research team. The online version (Select Survey. NET) of the questionnaire is intended be 
sent to all clinical staff who deliver maternity care as part of the care bundle. It will be the 
responsibility of the PI at each hospital site to distribute the link to all eligible healthcare 
professionals. The sample size for the Health Professionals Views questionnaire is 
determined by the unit size and number of eligible participants within each discipline. It is 
intended to survey all eligible professionals. A proportionate approach to consent will be 
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Participants will have the option to be entered into a £100 prize draw for an Amazon 
voucher as a gesture of thanks for their participation as outlined in section 5.1.3.1.2. The 
response rate for each site will be monitored and reported. It will be distributed to all 
eligible clinical staff within a three month period of the start of the study.  
 
5.2.1.3 Unit Resource and Leadership Questionnaire 
A Unit Resource and Leadership questionnaire will be used in this study to capture the 
structural and institutional characteristics of each maternity unit and resource usage for the 
health economic analysis. Organisational leads (e.g. Clinical Directors and Heads of 
Midwifery) at each hospital will be asked to complete the online questionnaire using the 
Select Survey Tool. This questionnaire contains a combination of closed-ended and open-
ended questions (see Appendix 5). It will be the responsibility of the PI at the sponsor site to 
distribute the link to the online questionnaire to the Clinical Director or Head of Midwifery. 
One Unit Resource and Leadership questionnaire is expected to be returned per hospital. 
The questionnaire should be completed by the end of July 2017.  
 
5.2.2 Guideline appraisal 
Study sites will be required to provide their antenatal and intrapartum care guidelines for 
quality appraisal. Guidelines will be independently scored by four members of the sponsor 
research team using the accredited Appraisal of Guidelines for REsearch and Evaluation tool 
(AGREE II)[13]. Study sites will be asked to provide guidelines as soon as enrolment is 
complete. Study sites will receive a breakdown of their guideline scores and potential 
recommendations for improvements following study completion. Data will be compared to 
a prior study of guidelines for element 3. The sponsor will not share guidelines scores with 
other study sites without prior approval.  
 

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6 
STATISTICAL ANALYSIS 
6.1 SAMPLE SIZE CONSIDERATIONS 
The sample sizes for the various datasets are largely determined pragmatically by the 
constraints of time and the need to have a reasonable pre and post launch period to assess 
trends, with an inevitably staggered true implementation.  
 
Based on a prevalence of 4.7 normally formed singleton stillbirths per 1000 total births [1], 
the potential annual number of stillbirths detected in this study will be 470 per 100,000 
total births estimated across all study sites. Around 30% of these would be expected to be 
normally–formed term singletons. Conservatively, (assuming we obtain 2/3 of the planned 
dataset) a two year pre versus one year post-comparison would be estimated to have 80% 
power to detect a drop in the primary stillbirth rate from 4.7 to 3.9/1000 – a 17% reduction. 
For normally formed term singletons we would expect to be able to detect a reduction in 
rate from 1.4 to 1.0/1000 –a 40% reduction in the subgroup where the bundle is expected 
to be most effective.  
 
The audit sample sizes are heavily constrained by feasibility. The targeted audits of specific 
interventions for RFM (post) and SGA (pre and post) with 20 per audit per site gives a total 
sample size of 400. This is sufficient to give overall estimates of compliance rates of ±5% on 
rates of ~50% and ±3% on rates ~90%. The sample size (with 40 events for a 10% non-
compliance rate) should allow some limited investigation of associations with 
implementation factors. The general audit (post only) has a doubled sample size reflecting 
the greater number of these patients and allowing somewhat more scope for exploration. 
 
The patient questionnaire sample size is determined by the need to focus on a fixed period 
of time to allow computation of completion rate, the need to rotate a limited number of 
data collection tools between sites (e.g. electronic tablets) and to encourage site 
compliance with a short focussed collection period. The primary consideration is the 
number in the at risk subgroups who smoke at booking or present with RFM. A collection 
period of 2 weeks should yield a total sample size of approximately 2300 with a 60% 

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completion rate. Across all study sites this will give 140-345 RFM pregnancies (based on an 
incidence of 6-15% of women presenting with RFM [16, 17] and 240 pregnancies in smokers 
(based on a prevalence of 10.6% of women smoking at the time of delivery [18]. These 
numbers again allow reasonable precision (e.g. ± 6% on prevalence of approximately 30% in 
240 smokers) albeit with little scope for exploration of association with implementation or 
case-mix factors. 
 
The sample size for the Health Professionals Views questionnaire is determined by the unit 
size and number of eligible participants within each discipline. It is intended to survey all 
eligible professionals. The response rate will be monitored and reported.  
 
6.2 DATA ANALYSIS 
6.2.1 Analysis of outcome measures 
All outcomes will be summarised using appropriate descriptive statistics. Data summaries 
will be presented prior to the care bundle launch and for the post-launch period (from 6 
months after the launch until the end of data collection). 
 
6.2.2 Care bundle compliance 
Site’s compliance with each element is assessed by a number of process measures. This is a 
dynamic process and it is not certain at the outset which summary measures will be 
appropriate to quantify compliance and allow meaningful comparisons of patient outcomes 
with compliance. Therefore the research team will review the entirety of the data set on 
compliance, visualising it graphically, without considering patient outcomes and 
anonymised to unit. The research team will review this data and select appropriate 
measures prior to any sight of outcome data. If any substantive differences are observed 
within any Trusts, consideration will be given to splitting that Trust into multiple sites for 
analysis. 
 

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6.2.3 Data validation 
Stillbirth and early neonatal death rates submitted by hospital sites to the University of 
Manchester will be cross-checked against other national sources of data to ensure that all 
cases have been reported. Incidence data will be checked against information that is 
routinely collected from the Office of National Statistics, MBRRACE and Each Baby Counts 
(EBC). Individual case reviews will not be carried out in this study; patient identifiable data 
will therefore not be required.  
 
Prior to analysis, data will be checked for outliers and invalid values and appropriate 
decision rules for inclusion/exclusion/correction agreed within the study team and 
documented. Rates of discarded data will be summarised by pre/post period. 
 
6.2.4 Statistical analysis 
Pre-Post Analysis: The primary outcome and other study outcomes captured as monthly 
counts will be formally analysed using a pre-post analysis by means of longitudinal logistic 
regression models with a centre random effect. Monthly proportions before the launch 
(April 2012- April 2015) will be compared with 6 month post-launch to the end of the study 
period (Oct 2015-Oct 2017). Covariate adjustment for calendar month and case-mix tariff 
and smoking rates at booking will be carried out.  
 
Interrupted Time Series Analysis: The pre-post analysis will be extended using interrupted 
time series (ITS) analysis. This will explicitly test for a “step change” following 
implementation in the possible presence of other time trends.  
 
Exploratory Analyses: The ITS model will be extended to test for changes associated with 
implementation times of each component at each study site (“unit-specific”). The pre-post 
model will be expanded to assess whether any changes in the outcomes arising from the 
implementation of the care bundle are associated with degree of compliance at the final 
audit date.  
 

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Mean data will be analysed using analogous ordinary regression models. Some outcomes 
may be better modelled as event rates with Poisson regression models and offset for the 
population size. Either General Estimating Equation (GEE) or Generalised Linear Mixed 
Model (GLMM) approaches will be used to fit the models depending on computational 
considerations. 
 
Pre-post Analysis – Audit data: A similar approach will be used to evaluate outcomes 
available only at two time points, albeit with more restricted longitudinal models.  
 
Post Launch Audit/Questionnaires: Single time point post-launch data will primarily be 
reported descriptively. Where appropriate sample/response weighting will be used to 
produce questionnaire-derived estimates relative to the sampled population. Exploratory 
analyses will assess the effect of the degree of implementation of the care bundle and 
organisational factors on the outcomes, adjusting as far as feasible for case-mix covariates. 
 
6.3 QUALITATIVE ANALYSIS  
The responses to the open-ended questions from the patient and health care professional 
questionnaires will be analysed using Framework Analysis, which focusses on identifying and 
giving meaning to patterns within the data set [19]. Responses will be submitted to 
inductive line-by-line coding to identify relevance to the research aims from as many 
different perspectives as possible. The first few responses will be coded independently by 
different members of the research team. After this, codes will be grouped into categories 
which will form the analytical framework. Subsequent responses will be indexed using the 
analytical framework. Data will then be charted into a framework matrix by case 
(participant) and category. Through interpretation of the matrix, theoretical concepts 
describing and explaining the similarities and differences in the data will be developed.  
 
6.4 HEALTH ECONOMIC ANALYSIS 
The quality and completeness of data will be initially reviewed prior to consideration of 
appropriate approach for the economic analysis. The economic analysis will explore and 

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present descriptive statistics for key drivers of cost and the resources (staff time, training, 
equipment) reported by each study site to implement the care bundle (overall and for each 
element). The costs will be presented from the perspective of the NHS and standardised to a 
single financial year (2015-16 is anticipated to be the most recent unit costs available at the 
time of the analysis). National birth data published annually by the Office for National 
Statistics (ONS) will be used to estimate the nationwide cost of implementing the care 
bundle (overall and for each element). 
 
The cost of implementing the care bundle in study sites will be presented alongside the 
number of stillbirths potentially avoided as a results of the care bundle (estimated from 
statistical analyses described in section 6.2.4 above). A formal cost-effectiveness analysis 
will not be conducted due to the limitations of the study design (see Justification of design, 
section 1.2.2). Uncertainty around the overall cost estimate will be explored using sensitivity 
analyses to test the impact of key assumptions. 
 
For each site the cost to implement the care bundle for a set number of births (e.g. 1000) 
will be calculated (as a pragmatic way to account for unit size). The correlation between 
level of compliance (derived as described in section 6.2.2) and implementation costs will be 
explored. The mean costs will be compared between high and low compliant sites using a t-
test. Differences between the resources required by different sites to achieve different 
levels of compliance will be explored in terms of potential trade-offs between input 
(resources) and output (level of compliance). The impact of case mix tariff and size of unit 
will be considered depending on the characteristics of available data. 
 
7 
DATA HANDLING AND STORAGE 
7.1 DATA PROCESSING  
Anonymous data retrieved from MIS and case-note audits will be transcribed into the DCP 
by the delegated site member. All proformas will be in Microsoft Excel format. We will 
receive the spreadsheets after extraction is complete at the study site. For ease of data 
entry and to minimise data entry errors, the database used to collect data in the study will 

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consist of text boxes, dropdown lists and checkboxes to minimise the use of free-text. 
Individual data items will be validated against a set of rules, for example gestational age can 
only be entered in days and not weeks and within a specified range. The spreadsheets will 
include a combination of individual and aggregated (monthly) patient datasets. No 
identifiable data will be included in these spreadsheets. Files will be saved as .xls using the 
existing study site names and password protected.  
 
Data from the online questionnaire will be exported from SelectSurvey.NET into an Excel 
workbook. This will be conducted by the research team at the sponsor site after the 
submission of all questionnaires. Questionnaires will be assigned a specific study number for 
analysis purposes. Names and contact details from participants who wish to be entered into 
the prize draw will be stored separately to the questionnaire responses. This information 
will be kept strictly confidential and all participant names and contact details will be 
permanently deleted after 6 months following completion of the study.  
 
 
7.2 DATA TRANSFER  
All data files will be returned electronically to the sponsor research team. A designated 
study email address has been established by the sponsor site to permit the secure transfer 
of data between study sites and the University. Data will be encrypted/password protected 
for transfer with the password details sent separately. Alternative secure file transfer 
arrangements are available and all data transfer will conform to University of Manchester 
guidelines. Any email attachments containing the submitted data will be permanently 
deleted following data transfer.  
 
7.3 STORAGE  
All data generated by the study will be preserved and stored with no identifiable details for 
5 years after completion of the study, except email addresses collected to notify 
participants of the publication of findings which will be destroyed once they are no longer 
needed (i.e. once participants have been notified of publication). Dr Alexander Heazell will 
be custodian of the data on behalf of the sponsor. Electronic data will be stored in 

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appropriate data storage devices. All electronic and hard-copy data files will be stored 
securely in accordance with local policy at University of Manchester. Electronic data will be 
stored on a secure University of Manchester server that complies with University data 
security policies or (temporarily) on University owned and fully encrypted laptops. Study 
data and material may be looked at by individuals from the University of Manchester, from 
regulatory authorities or from NHS Trust, for monitoring and auditing purposes and this may 
well include access to personal information.  
 
8 
QUALITY ASSURANCE AND CONTROL 
8.1 SITE SET-UP AND INITIATION 
Study sites will be required to identify a Principal Investigator (PI) at each site who will 
manage local data collection and communicate directly with the study co-ordinator 
regarding all aspects of the study. Site PIs will be asked to sign all necessary agreements 
relating to the collection and storage of data. Key members of the site research team will be 
required to undergo training prior to commencing the study regarding study design, 
identifying eligible patients, and the collection of data and record keeping. Participating 
sites will be required to notify the study co-ordinator of any changes in the site research 
team. Each site team and site R&D department will receive the local information pack and 
exchange agreements (i.e. the Statement of Activities) prior to commencing recruitment at 
the site.  
 
8.2 DATA MONITORING 
On-site monitoring will be carried out as required, for example due to poor completion of 
the DCPs, poor data quality, low participant recruitment or high withdrawal rates for 
questionnaires. Sites will be given advance notification of an on-site visit if required and the 
sponsor site will give written confirmation of the proposed date. All staff involved in the 
study sites will be given access to source data under these circumstances to facilitate 
review. The study co-ordinator will be in regular contact with study sites to assess progress 
with the data collection and address any potential queries. Sites will be asked for missing 
data and clarification for incomplete or inconsistencies in data where applicable.  

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8.3 ORGANISATION OF THE STUDY 
This study will be carried out at multiple sites across NHS England Regions. The sponsor is 
the University of Manchester. The sponsor study site is St Mary’s Hospital, Central 
Manchester Foundation Trust. This study site has a Chief Investigator - Dr Alexander Heazell 
and four co-investigators (Dr Kate Widdows; Dr Elizabeth Camacho, Dr Steve Roberts and 
Holly Reid). Dr Kate Widdows will be the Study Co-ordinator. They will oversee the day-to-
day management of the study, including monitoring protocol compliance, safeguarding 
participants and ensuring quality of data collection. Any problems or queries will be passed 
to the study co-ordinator at the sponsor site in the first instance. In her absence one of the 
co-investigators will deputise. 
 
The Study Stakeholder Committee (SSC) will consist of various representatives from third-
sector and professional stakeholders with relevant expertise in stillbirth research. The SSC 
will provide independent oversight of the study and will meet as required and at least twice 
during the duration of the study. Meetings will be conducted either face-to-face or via 
teleconference. The SSC will review the data collected on stillbirths and neonatal deaths 
before discharge and act in accordance with the SSC terms of reference (TOR).  
 
8.3.1 Finance 
The study is funded by NHS England and will be adopted onto the NIHR Clinical Research 
Network (CRN) portfolio.  
 
8.3.2 End of study 
The end of the study will be January 2018. The sponsor will notify the REC that the study has 
ended and a final study report will be provided within 12 months of the end date.  
 
9 
ETHICS 
Health Research Authority (HRA) approval will be sought, which includes a review by a NHS 
Research Ethics Committee, through the IRAS application system and will be in place prior to 

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the commencement of the trial. Study sites will not be permitted to recruit participants to 
the study until the PI at the sponsor site has received written confirmation of HRA approval. 
This study will be performed in accordance with the Research Governance Framework for 
Health and Social Care and the Data Protection Act 1998. 
 
9.1 POTENTIAL RISKS AND BENEFITS 
There is a possibility that service users may find the questionnaire upsetting if they have had 
a particularly negative pregnancy or birthing experience, although the questionnaire has not 
been designed to evoke upsetting or sensitive responses. However, some participants who 
choose to express their views anonymously via the questionnaire may find this beneficial. 
 
10 
CONFIDENTIALITY AND DATA PROTECTION 
Personal data recorded on all documents will be regarded as strictly confidential and will be 
managed and stored in accordance with the Data Protection Act 1998. Participants will be 
identified using a unique study ID number assigned to them throughout the study. The 
sponsor site will maintain the confidentiality of all study participants data and will not 
disclose information by which participants may be identified. Representatives from the 
sponsor site may be required to access patient notes for quality assurance purposes and will 
maintain confidentiality at all times. The site PI must maintain all study-related documents 
in strict confidence at each site.   
 
Centres will be allocated a study code by the trial co-ordinator. Data identifying individual 
Trusts and sites will not be presented in any reports. If the PI at any site requests to see 
their own data, site data will be made available to that site in summary form, with only that 
specific site identified. 
 
11 
INSURANCE AND INDEMNITY 
NHS indemnity and professional indemnity will be provided by the sponsor to meet the 
potential legal liability of investigators/collaborators arising from harm to participants in the 
management and conduct of the research. 

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12 
DISSEMINATION OF STUDY FINDINGS 
12.1 NATIONAL REPORT 
Following data analysis, a detailed national report will be produced which summarises the 
aggregate data from all hospital sites that participated in the study. Data analysis is 
anticipated to commence 6 months after study enrolment and so the earliest anticipated 
date for publication is December 2017. In addition to study outcomes, the report will 
contain high-level aggregated data such as the number of Trusts using the care bundle; the 
extent to which the care bundle is being implemented by UK hospitals; the completeness 
and quality of data collected in line with the care bundle by Trusts; action plans for 
improvements in implementing the care bundle and public involvement in policy 
recommendations. The report will be reviewed by the all third-sector and professional 
stakeholders prior to release.  Data relating to identifiable Trusts and Hospitals will not be 
published in any open reports or publications. If requested, Trusts may be provided with 
summaries of their own data in an appropriate format.  
 
12.2 PUBLIC AND PATIENTS  
The University of Manchester research team will produce a lay summary of the main 
national report which highlights key high-level data from the study. The report will be 
presented in an infographic format which is accessible to all families and the wider public. 
The lay report will be accessible online and through social networking activities such as 
Twitter. The report will also be disseminated via our Third-Sector Stakeholders who are 
already fully engaged with the work of the care bundle. 
 
13 
PUBLICATION POLICY 
After Research Ethics Committee approval has been obtained this protocol will be submitted 
for open access publication in an appropriate journal. Results of the study will be submitted 
for publication in a peer review journal following completion of the study. Manuscript(s) will 
be prepared by the study team and authorship will be mutually agreed prior to manuscript 

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preparation. Neutral or negative results will not delay publication of findings. A lay summary 
of results will be made available to all participants at the end of the trial.  
 
During the study, press releases regarding the study may be disseminated. All press releases 
will need prior authorisation from the sponsor and NHS England. No third party will be 
permitted to submit publicity material without prior approval from the sponsor. All 
conference presentations and abstracts relating to the study must be approved by the 
sponsor prior to submission to the event organiser or editors.  
 
All publications must acknowledge the support of NHS England in funding the study and the 
University of Manchester for sponsoring the study. All study sites and their participants 
must be acknowledged.  
 
 

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14 
REFERENCES 
1. 
Office of National Statistics. Characteristics of birth 1, England and Wales, 2013. 
London: ONS, 2014. 
2. 
Flenady, V., et al., Stillbirths: recall to action in high-income countries. Lancet, 2016. 
387(10019): p. 691-702. 
3. 
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. 
4. 
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. 
5. 
NHS England. NHS England Mandate 2014/2015-2016/2017. 
https://www.england.nhs.uk/wp-content/uploads/2014/04/nhse-mandate-wa.pdf, 
2016. 
6. 
NHS England. Saving Babies' Lives care bundle 2015. 
7. 
Gardosi, J., et al., Maternal and fetal risk factors for stillbirth: population based 
study. BMJ, 2013. 346: p. f108. 
8. 
Marufu TC, A.A., Coleman T, Lewis S, Maternal smoking and the risk of stillbirth: 
systematic review and meta-analysis. BMJ Public Health 2015. 15: 239. 
9. 
RCOG Green-Top Guideline 31 : The Investigation and Management of the Small-for-
Gestational Ages Fetus, Royal College of Obstetricians and Gynaecologists. 2013. 
10. 
Alfirevic, Z., D. Devane, and G.M. Gyte, Continuous cardiotocography (CTG) as a form 
of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane 
Database Syst Rev, 2006(3): p. CD006066. 
11. 
Rogers, E., Diffusion of Innovations. Fifth ed. 2003: Free Press: New York. 
12. 
Still-Birth Definition Act Great Britain Curr Law Statut Annot GB. 1. 
13. 
Brouwers M, K.M., Browman GP, Cluzeau F, Feder G, Fervers B, Hanna S, Makarski J 
on behalf of the AGREE Nest Steps Consortium, AGREE II: Advancing guideline 
development, reporting and evaluation in healthcare. Can Med Assoc J, Dec 2010. 
182:E839-842. 
14. 
Gardosi J, F.A., Customised Antenatal Growth Chart - GROW version 6.1. Gestation 
Network, www.gestation.net, 2016. 
15. 
Guest G, B.A., Johnson L, How many interviews are enough?: An experiment with 
data saturation and variability. Field Methods, 2006. 18: p. 59-82. 
16. 
Sergent, F., et al., [Decreased fetal movements in the third trimester: what to do?]. 
Gynecol Obstet Fertil, 2005. 33(11): p. 861-9. 
17. 
Tuffnell, D.J., R.S. Cartmill, and R.J. Lilford, Fetal movements; factors affecting their 
perception. Eur J Obstet Gynecol Reprod Biol, 1991. 39(3): p. 165-7. 
18. 
Centre, L.S.T.H.a.S.C.I., Statistics on Women's Smoking status at Time of Delivery: 
England, Quarter 3, October to December 2015. Available at content.digital.nhs.uk, 
March 2016. 
19. 
Gale, N.K., et al., Using the framework method for the analysis of qualitative data in 
multi-disciplinary health research. BMC Med Res Methodol, 2013. 13: p. 117. 

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15 
APPENDICES 
Appendix 1 
Table 1. Participating Study Sites 
 
NHS Trust and SCN 
Hospital(s) 
 
South West  
 
1 
Taunton and Somerset NHS Foundation Trust  
Musgrove Park  
2 
Royal Devon & Exeter NHS Foundation Trust  
Wonford Hospital  
3 
Plymouth Hospital NHS Trust  
Derriford Hospital  
4 
Royal United Hospitals Bath NHS Foundation Trust  
Royal United Hospital 
5 
North Bristol NHS Trust  
Southmead Hospital* 
Cossham Birth Centre  
Mendip Birth Suite  
 
North West Coast 
 
6 
Liverpool Women’s NHS Foundation Trust  
Liverpool Women's Hospital 
7 
St Helens and Knowsley Teaching Hospitals NHS Trust 
Whiston Hospital 
8 
Countess of Chester Hospital NHS Foundation Trust  
Countess of Chester 
9 
University Hospitals of Morecambe Bay NHS Foundation 
Trust  
Westmorland General* 
Royal Lancaster Infirmary  
Furness General Hospital  
Queen Victoria Hospital  
 
Yorkshire and Humber 
 
10 
Barnsley Hospital NHS Foundation Trust 
Barnsley Hospital 
11 
Doncaster and Bassetlaw Hospitals NHS Foundation Trust  
Doncaster Royal Infirmary  
Bassetlaw Hospital  
12 
York Teaching Hospital NHS Foundation Trust  
Scarborough Hospital  
The York Hospital 
13 
Hull and East Yorkshire Hospital NHS Trust 
Hull Royal Infirmary  
14 
The Mid Yorkshire Hospitals NHS Trust 
Pinderfields Hospital* 
Dewsbury Hospital  
Pontefract Hospital  
 
Thames Valley  
 
15 
Oxford University Hospitals NHS Trust  
John Radcliffe Hospital* 
Horton General Hospital  
Oxford Spires Birth Centre  
 
North East 
 
16 
Gateshead Health NHS Foundation Trust 
Queen Elizabeth Hospital 
17 
North Cumbria University Hospitals NHS Trust  
Cumberland Infirmary* 
West Cumberland Hospital  

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East Midlands 
 
18 
Sherwood Forest Hospitals NHS Foundation Trust  
Kings Mill Hospital 
 
Greater Manchester and East Cheshire 
 
19 
Central Manchester Foundation Trust  
St Mary's Hospital  
 
West Midlands 
 
20 
Birmingham Women’s NHS Foundation Trust 
Birmingham Women’s Hospital 
 * Lead study site 
 
 

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Appendix 2 Data items to be extracted from hospital Maternity Informatics Systems (MIS) 
Table 2. Data items collected from Maternity Informatics Systems   
1st Submission (April 2017) 
Data extracted from 1st April 2012 until 30th April 2017 
2nd Submission (October 2017)  Data extracted from 1st  April 2012 until 1st October 2017 
Per month 
1 
Women booked 
2 
Women delivered 
3 
Number of singleton births 
4 
Number of multiple births 
5 
Preterm births 
6 
Perinatal deaths 
7 
Induced deliveries 
8 
Caesarean deliveries  
9 
Emergency caesarean  deliveries 
10 
Instrumental deliveries 
11 
Spontaneous deliveries 
12 
Antenatal triage numbers (where recorded) 
13 
Number of women presenting with RFM at triage (where recorded) 
14 
Number of babies therapeutically cooled 
15 
Number of reported incidents 
16 
Number staff who received CTG training  
17 
Staff deemed competent in CTG  
18 
Staff completed mandatory annual CTG training  
19 
SGA rate at birth (post-only; GAP)  
20 
SGA babies born at term detected antenatally (post-only; GAP) 
21 
False positive SGA (post-only; GAP) 
22 
False negative SGA (post-only; GAP) 
Per pregnancy (mm/yr to de-identify) 
23 
Outcome 
24 
Birthweight 
25 
Babies gestation 
26 
Babies sex 
27 
Mothers age 
28 
Mothers ethnicity 
29 
Mothers height 
30 
Mothers weight 
31 
Parity 
32 
Women smoking at booking 
33 
Women smoking at delivery 

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34 
CO reading recorded 
35 
Smoking referral 
36 
Date of scan  (radiology) 
37 
Indication for growth scan (radiology) 
38 
Type of scan 
39 
Admission to NICU 
40 
Length of stay in NICU (where applicable) 
41 
Length of stay in hospital (where applicable) 
42 
Case-mix tariff 
43 
Postcode (post only) 
 
 

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 Appendix 3 Data items to be retrieved from Case-note Audit 
Table 3. General audit 
Sample 
Singleton births  
Sample size 
40 consecutive births 
Timing 
Study Period (from 1st April 2017) 
Outcomes 
1. Was growth chart used? 
2. Type of growth chart (e.g. customised or not)? 
3. Was a buddy system used? 
4. Was with a sticker system used? 
5. Was an escalation protocol was used? 
 
Table 4. SGA audit 
Sample  
SGA babies with birthweight ≤ 10th customised centile  
Sample size 
40 consecutive SGA births (20 pre- and 20 post-implementation) 
Timing 
Pre (From 1st April 2012) and post- implementation (from 1st April 
2015) 
Outcomes 
1. Was EFW plotted on growth chart? 
2. Was SFH plotted on growth chart 
3. Was EFW correctly plotted on growth chart  
4. add in 
5. Birthweight centile at last EFW measurement 
 
Table 5. RFM audit 
Sample  
All deliveries with RFM on at least one occasion 
Sample size 
20 consecutive RFM pregnancies 
Timing 
Study Period (from 1st April 2017) 
Outcomes 
1. Was patient managed according to checklist (in-house or NHSE) 
2. Did woman have FH monitoring 
3. Did woman have an ultrasound scan 
4. Number of episodes did woman report during the pregnancy 
5. Gestation of baby at each RFM episode 
6. Time to scan from presentation at each episode 
 
Table 6. Stillbirth audit (if unavailable in MIS) 
Sample 
All Antepartum and intrapartum stillbirths >24 weeks gestation 
Sample size 
All stillbirths 

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Timing 
Pre-post (April 2012-April 2017) 
Outcomes  
1. SGA at birth (Y/N) 
2. SGA before birth (Y/N) 
3. Any maternal perception or reporting of RFM  
4. Classification of Cause  
5. Birthweight  
6. Gestation  
7. Sex 
 
Appendix 4 Data items to be retrieved from Patient Questionnaires 
Table 6. Data items obtained using patient questionnaires 
1 
Women smoking at booking 
2 
Women smoking at delivery 
3 
Women with CO test offered 
4 
Women accepting a CO test 
5 
Women referred to smoking cessation 
6 
Women who recall receiving a leaflet 
7 
Women with RFM who recall receiving a leaflet 
 
Appendix 5 Data items to be collected using the Unit Resource and Leadership 
questionnaire 
 
Table 7. Data items to be collected from the Unit Resource and Leadership questionnaire 
(in addition to outcomes collected using MIS) 
1 
Number of employees (across disciplines)  
2 
Number of ultrasound machines (for obstetric scanning) 
3 
Number of CO monitors 
4 
Hours for staff training  
5 
Number of CTG machines 
 
 
 

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Appendix 6 Data items to be collected from Trusts using GAP-SCORE Missed Case Audit Tool  
 
Table 8. GAP-SCORE (Missed Case Audit Tool) 
Sample  
SGA babies with birthweight ≤ 10th customised centile  
Sample size 
20 consecutive SGA births (either missed or detected) 
Timing 
Between 1st April 2015 and 31st August 2017 
Maternal 
summary 
 
 
1. Increased maternal risk factors at booking? 
2. If yes, were serial growth scans arranged? 
3. Was a customised growth chart in maternal records? 
4. Were risk factors/complications identified during pregnancy? 
5. If yes, were serial growth scans arranged? 
Fundal Height 
Measurements 
 
6. How many fundal height measurements were performed? 
7. Gestation 
8. Plotted on growth chart? 
9. Plotted correctly? 
10. Suspected growth problem? 
11. Recognised? 
12. Referral for growth scans? 
13. Was scan performed? 
14. Time (days) between referral and growth scan 
15. Reason for delay 
Growth Scan  
 
16. Gestation 
17. Reason for scan 
18. Estimated fetal weight 
19. EFW plotted on GROW chart? 
20. Plotted correctly? 
21. EFW < 10th centile? 
22. Management plan initiated? 
23. UA Doppler assessment performed? 
24. UA Doppler assessment normal? 
25. Was a management plan initiated following UA Doppler? 
26. Presence of SGA documented?  
Birth details 
27. Labour induced? 
28. Reason labour induced 
29. Mode of birth 
30. Apgar score <7 at 5 mins of age 
31. Admission to neonatal unit 
32. Accuracy of EFW (%)