Promoting Awareness Fetal Movements and Focussing Interventions Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
Phase: NA
Conditions: Decreased Fetal Movements Affecting Care of Mother, Pregnancy, Stillbirth
Sponsor: University of Edinburgh

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Study Protocol 
Can Promoting Awareness of Fetal movements and Focussing Interventions Reduce Fetal 
Mortality - a stepped wedge cluster randomised trial? 
AFFIRM  
 
Co-sponsors 
University of Edinburgh & NHS Lothian 
ACCORD 
The Queen’s Medical Research Institute 
47 Little France Crescent 
Edinburgh 
EH16 4TJ 
Funder 
Chief Scientist Office, Scottish Government  
Funding Reference Number 
CZH/4/882 
 
Chief Investigator 
Professor Jane E Norman  
IRAS Number 
122383 
REC Number 
13/SS/0001  
Clinical trials Number 
NCT01777022 
Version Number and Date 
Version 6, 27th February 2017 
 
 
 

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COORDINATING CENTRE 
Chief Investigator 
Professor Jane E Norman  
University of Edinburgh MRC Centre for 
Reproductive Health 
Queen's Medical Research Centre 
47 Little France Crescent 
Edinburgh 
EH16 4TY  
Tel: 0131 242 2694  
Fax: 0131 242 6441 
Email: jane.norman@ed.ac.uk  
Co-sponsor Representative 
Raymond French 
University of Edinburgh 
The Queen’s Medical Research Institute 
47 Little France Crescent 
Edinburgh 
EH16 4TJ 
 
Tel: 0131  242  6226  
Fax: 0131  242  9447 
Email: ray.french@ed.ac.uk 
 
 
Trial Manager 
Sonia Whyte  
Clinical Trial Manager  
Room S7128, Simpson Centre for 
Reproductive Health 
Royal Infirmary 
51 Little France Crescent 
EDINBURGH 
EH16 4SA 
Tel: 0131 242 2693  
Fax: 0131 242 2686  
Email: sonia.whyte@ed.ac.uk  
Trial Statistician 
Professor Christopher Weir  
Professor of Medical Statistics and Clinical 
Trials 
Edinburgh Clinical Trials Unit 
Usher Institute of Population Health 
Sciences and Informatics 
University of Edinburgh Medical School 
Teviot Place 
Edinburgh 
EH8 9AG      
Tel:  0131 650 3230      
Fax:  0131 650 6909      
Email:  Christopher.Weir@ed.ac.uk     
 
 

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CONTENTS 
 
List of abbreviations ......................................................................................... 6 
Summary ............................................................................................................ 7 
1 
INTRODUCTION ........................................................................................ 8 
1.1 
BACKGROUND ................................................................................. 8 
1.2 
RATIONALE FOR STUDY ............................................................... 11 
2 
STUDY OBJECTIVES .............................................................................. 12 
2.1 
OBJECTIVES .................................................................................. 12 
2.2 
ENDPOINTS .................................................................................... 12 
3 
STUDY DESIGN ....................................................................................... 13 
4 
STUDY POPULATION ............................................................................. 14 
4.1 
NUMBER OF PARTICIPANTS ......................................................... 14 
4.2 
INCLUSION CRITERIA .................................................................... 14 
4.3 
EXCLUSION CRITERIA ................................................................... 14 
5 
PARTICIPANT SELECTION AND ENROLMENT ..................................... 15 
5.1 
IDENTIFYING PARTICIPANTS ....................................................... 15 
5.2 
CONSENTING PARTICIPANTS ...................................................... 15 
5.3 
SCREENING FOR ELIGIBILITY ...................................................... 15 
5.4 
INELIGIBLE AND NON-RECRUITED PARTICIPANTS .................... 15 
5.5 
RANDOMISATION ........................................................................... 15 
6 
STUDY ASSESSMENTS .......................................................................... 16 
6.1 
SAFETY ASSESSMENTS ............................................................... 16 
6.2 
STUDY ASSESSMENTS ................................................................. 16 
7 
DATA COLLECTION ................................................................................ 17 
8 
STATISTICS AND DATA ANALYSIS ........................................................ 18 
8.1 
SAMPLE SIZE CALCULATION ........................................................ 18 
8.2 
PROPOSED ANALYSES ................................................................. 19 
9 
ADVERSE EVENTS ................................................................................. 19 
10.    PREGNANCY ........................................................................................... 20 
11 
TRIAL MANAGEMENT AND OVERSIGHT ARRANGEMENTS ................ 20 
11.1 
TRIAL MANAGEMENT GROUP ...................................................... 20 
11.2 
TRIAL STEERING COMMITTEE ..................................................... 20 
11.3 
INSPECTION OF RECORDS .......................................................... 20 
11.4 
RISK ASSESSMENT ....................................................................... 20 
11.5 
STUDY MONITORING AND AUDIT ................................................. 20 
12 
GOOD CLINICAL PRACTICE ................................................................... 20 
12.1 
ETHICAL CONDUCT ....................................................................... 20 
12.2 
REGULATORY COMPLIANCE ........................................................ 20 
12.3 
INVESTIGATOR RESPONSIBILITIES ............................................. 20 
13 
STUDY CONDUCT RESPONSIBILITIES ................................................. 21 

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13.1 
PROTOCOL AMENDMENTS ........................................................... 21 
13.2 
PROTOCOL VIOLATIONS AND DEVIATIONS ................................ 22 
13.4 
STUDY RECORD RETENTION ....................................................... 22 
13.5 
END OF STUDY .............................................................................. 22 
13.6 
INSURANCE AND INDEMNITY ....................................................... 22 
14 
REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS ....... 23 
14.1 
AUTHORSHIP POLICY ................................................................... 23 
14.2 
PUBLICATION ................................................................................. 23 
14.3 
PEER REVIEW ................................................................................ 23 
15 
REFERENCES ......................................................................................... 24 
APPENDIX 1: Trial Steering Committee ......................................................... 26 
APPENDIX 2: Participating sites .................................................................... 27 
APPENDIX 3: Information for women about fetal movements ..................... 28 
APPENDIX 4: UPDATED 09/01/2015 ............................................................... 29 
APPENDIX 5: APPENDIX 5: AUDIT OF COMPLIANCE…………………………32 
 

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PROTOCOL APPROVAL 
Does promoting increased awareness of decreased fetal movements reduce stillbirth, a 
stepped wedge cluster randomised trial? 
Signatures 
 
Jane E Norman 
 
 
 
Chief Investigator 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
Chris Weir 
 
 
 
Trial Statistician 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
      
_______________________ 
 
_____________ 
Sponsor(s) Representative 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
      
_______________________ 
 
_____________ 
Principal Investigator 
Signature 
 
Date 
 
 
 

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LIST OF ABBREVIATIONS 
 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonisation 
IMP 
Investigational Medicinal Product 
ISF 
Investigator Site File 
RFM 
Reduced Fetal Movements 
TMF 
Trial Master File 
SOP 
Standard Operating Procedure 
CRF 
Case Report Form 
ACCORD 
Academic and Clinical Central Office for Research & Development - 
Joint office for University of Edinburgh and NHS Lothian 

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SUMMARY 
Rates of stillbirth in Scotland are amongst the highest in resource rich countries. The majority 
of stillbirths occur in normally formed infants, with (retrospective) evidence of placental 
insufficiency being the commonest clinical finding. Maternal perception of decreased fetal 
movements appears to be an early biomarker both of placental insufficiency and subsequent 
stillbirth.  
The study proposed here will test the hypothesis that rates of stillbirth will be reduced by 
introduction of a package of care consisting of strategies for increasing pregnant women’s 
awareness of the need for prompt reporting of decreased fetal movements, followed by a 
management plan for identification of placental insufficiency with timely delivery in confirmed 
cases. The odds of stillbirth fell by 30% after the introduction of a similar package of care in 
Norway but the efficacy of this intervention (and possible adverse effects and implications for 
service delivery) have not been tested in a randomized trial.  
We plan a stepped wedge cluster design trial, in which participating hospitals in the UK will be 
randomized to the timing of introduction of the care package. Outcomes (including the primary 
outcome of stillbirth) will be derived from Scotland and Ireland’s detailed routinely collected 
maternity data, allowing us to robustly test our hypothesis. A nested qualitative study will 
examine the acceptability of the intervention to patients and health care providers and identify 
process issues (barriers to implementation).   

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1 
INTRODUCTION 
1.1 
BACKGROUND 
Stillbirth (defined in the UK as a baby born dead after 24 weeks of completed pregnancy) 
remains the major cause of perinatal mortality in resource rich environments, with a recent 
series of papers in the Lancet on stillbirth issue calling for major action in this area (1). There 
is no single “cause” of stillbirth, and many stillbirths remain unexplained, but fetal growth 
restriction, hypertension and low socioeconomic status are amongst the identifiable risk 
factors (2). 
 
The purpose of this study is to test the efficacy of a package of interventions consisting of 
strategies for increasing pregnant women’s awareness of the need to report early when they 
perceive a reduction in fetal movements, in combination with a management plan for 
identification and delivery of the “at risk” fetus in such women. Our primary outcome is 
stillbirth. 
 
The concept that more can be done to reduce stillbirth in the UK and Ireland is supported by 
data showing a marked variation in rates between resource rich countries, when similar 
definitions of stillbirth are used (3). Notably, the UK has the highest rates amongst a group of 
resource rich countries such as Germany, Spain, New Zealand and Italy, with rates in the UK 
some 50% greater than those of Germany. Rates of stillbirth in Scotland and Ireland, at 4.9 
per 1000 livebirths (Scotland, 2010 and Ireland 2009 (4, 5)) are only marginally better than 
rates in England and Wales at 5.1 per 1000 livebirths (England and Wales, 2010)(5).  
 
So what can be done to reduce rates of stillbirth further? Scottish ministers see the reduction of 
avoidable harm for women and babies as a major priority and asked the Scottish Government 
(SG) Health Department to set up the Stillbirth Working Group in 2011. This group works to 
implement SG policy within the Scottish Government Refreshed Framework for Maternity 
Services, and works in partnership with Sands (the Stillbirth and Neonatal Death Society). SG, 
through the Stillbirth Working Group has provided funding for Sands to improve bereavement 
services. As a result of this and other initiatives, many Health Boards in Scotland have already 
invested heavily in applying current best evidence, including addressing social inequalities, 
encouraging smoking cessation programmes and initiating strategies to prevent and / or 
manage obesity and to identify and tailor care for those at high risk. The equivalent bodies in 
England, Wales and Ireland (in Ireland through Perinatal Ireland) are also working on similar 
strategies. However, many evidence gaps remain. 
 
So what research is needed on prevention of stillbirth? Using a robust priority setting strategy 
(6) the Lancet Stillbirth’s series steering committee identified issues around detection and 
management of reduced fetal movements amongst the top ten key research questions on 
prevention and management of stillbirth (3) . In this study, we will test an intervention package 
aiming to encourage early presentation of women experiencing decreased fetal movement, 
followed by appropriate investigation and targeted intervention, in order to reduce stillbirth. The 
intervention package is informed by current understanding of the risk factors / aetiology of 
stillbirth and will be evaluated in a stepped wedge cluster randomised trial.  
 
Association between decreased fetal movements, placental dysfunction and stillbirth 
There is a clear association between maternal perception of decreased strength of fetal 
movement and late stillbirth. In a recent series of 2000 women, the adjusted OR (95% CI) of 
late stillbirth in women with decreased fetal movement (compared with controls) was 2.37 
(1.29-4.35) (7).  Although the mechanisms have not been fully delineated, it is likely that 
decreased fetal movement and stillbirth are linked by a common pathology, that of placental 
dysfunction. There is good evidence linking placental dysfunction and decreased fetal 
movement. Women who have fewer fetal movements on ultrasound immediately prior to 
caesarean section are more likely to have umbilical cord gas measurements indicative of 
acidaemia, hypoxaemia, and hypercapnia, compared with controls (8). Applicant Heazell has 
shown that women delivering within one week of an episode of decreased fetal movement 
show differences in placental structure and function, including greater signs of infarction 
(compared to those with normal fetal movements) (9). Additionally, in a series of over 2000 

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women (conducted by applicant Froen), the odds of fetal growth restriction (FGR, defined as 
being at less than the 10th centile for gestation adjusted birthweight) were greater in women 
with decreased fetal movement compared with controls, with adjusted OR of 1.6, 95% CI 1.1–
2.2 (10). Taken together these data are strong evidence that placental dysfunction is 
associated with decreased fetal movement, and a causative pathway seems likely.  
 
The evidence linking placental dysfunction and stillbirth is even stronger. Amongst the 291 
stillbirths in Scotland in 2010, 137 (47%) had evidence of placental dysfunction (4). Given that 
the placenta was examined in only 80% of stillbirths, the true prevalence of placental 
dysfunction is likely to be higher. Over 20% of stillborn babies had FGR. Additionally, the 
Lancet reports notes that “placental pathologies accounted for one in four deaths across all 
gestational ages, and were contributory or causal in more than half of cases” (11).  
If decreased fetal movement is a “biomarker” of placental dysfunction, and placental 
dysfunction itself is associated with stillbirth, then better management of women presenting 
with decreased fetal movement might reduce the risk of stillbirth. Although prenatal detection 
of fetal growth restriction is improved by fetal movement counting (12), a systematic review 
(13), and a large and influential cluster randomised trial (which dominates the systematic 
review) showed that routine fetal movement counting had no effect on perinatal mortality (14). 
Thus after reviewing the literature, the National Institute for Clinical Excellence (NICE) 
recommended that “Routine formal fetal movement counting should not be offered” (15). 
Importantly, the large cluster randomised trial tested a specific alarm limit for decreased fetal 
movement, but did not inform management of women who did present with decreased fetal 
movement. More women in the fetal movement counting arm came in with a live baby who 
subsequently died compared with the control arm (19 vs 11), suggesting that the strategy 
failed because of inadequate investigation and management of those presenting with 
decreased fetal movements. 
 
Efficacy of a package of interventions around decreased fetal movement 
Supportive data on the package of interventions we propose comes from a large study 
observational cohort “clinical quality improvement study” in Norway led by applicant Froen 
(16). In this study, a significant fall in rates of stillbirth (from 3.0/1000 to 2.0/1000 [OR 0.67 
95% CI 0.48–0.93]) was observed after introduction an intervention package consisting of 
written information for women about detection of decreased fetal movements combined with 
consensus guidelines for health professionals about their management (16). Although this 
study was not randomised, and therefore constitutes only level II-3 evidence, it has led to new 
recommendations from the Royal College of Obstetricians and Gynaecologists that “women 
should be advised to be aware of their baby’s individual pattern of movements and that if they 
are concerned about a reduction in or cessation of fetal movements …..they should contact 
their maternity unit” (17). Importantly, in the Norwegian study, there was no increase in the 
proportion of women who presented with decreased fetal movement when rates were 
compared before and after the intervention (16). However, women with decreased fetal 
movements presented significantly earlier to hospital with decreased fetal movements than 
they had hitherto. Taken together, these data suggest that a package of interventions 
encouraging women with decreased fetal movements to present early to hospital, combined 
with a structured approach to the management of women with decreased fetal movement 
might reduce rates of stillbirth without contributing to a large increase in admissions 
antenatally. In the study described in this application we plan to formally test (using gold 
standard methodologies) whether a similar package of interventions really does decrease 
stillbirth, whether it does any harm (e.g. by increasing rates of caesarean section or induction 
of labour) and how it can be implemented to best effect in a very different setting. 
 
Optimal strategy for quantification of decreased fetal movement. 
A systematic review has failed to define an optimal strategy for the quantification of decreased 
fetal movement (13). We are currently in the process of performing an up to date systematic 
review, although a preliminary literature search (see above) has revealed no new information.  
There is no uniform threshold of fetal movements above which perinatal morbidity increases 
(18), so that guidelines from the RCOG (17), informed by the Norwegian study (16) suggest 
that it is maternal perception of decreased fetal movement which is important. We will use a 
similar approach, encouraging women to present early if they have this perception. A leaflet 
will be developed emphasizing the importance of decreased fetal movement as a signal to 

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seek immediate advice from a midwife / maternity centre. The effects of the leaflet will be 
amplified by a web based education package developed for midwives and other clinicians to 
teach them to encourage behaviour change in pregnant women, with re-enforcement at 
several times during pregnancy. We will also encourage clinicians to take maternal perception 
of decreased fetal movements seriously, and to follow a structured management plan in 
further risk stratification to determine which babies should be delivered promptly.  
 
Optimal strategy for investigation and management of women presenting with 
decreased fetal movement. 
As shown in a recent systematic review, there are no proven strategies for the investigation 
and management of women presenting with decreased fetal movement (19). 
Cardiotocography (CTG) (either analogue or digital) is routinely used to ascertain fetal 
wellbeing, and it is the cornerstone of the RCOG guideline around decreased fetal movement 
(17). However, data from Norway, suggests that ultrasound assessment of fetal size is often 
the most helpful investigation, performing well on both an absolute basis, and compared with 
other interventions (20). In a series of over 3000 women with decreased fetal movements, 
ultrasound (including measurement of liquor volume and growth measurements) was found to 
be useful in detecting abnormalities in 11.6% of scans. In 71% of women in whom an 
abnormality was found, ultrasound was the only technique that detected an abnormality. 
Additionally, 85% of abnormalities detected by ultrasound, were important in informing the 
clinical management of the woman (20). These data are supported by our own recent smaller 
UK study, where we found that abnormal CTG and abnormal ultrasound scan were the two 
investigations most strongly associated with poor outcome in women presenting decreased 
fetal movements, with identification of abnormal estimated fetal growth centile on scan being 
the test most highly predictive of poor outcome (21). Perhaps this is not surprising, given the 
strong association between small for gestational age babies and the central importance of 
ultrasound in the identification and management of such cases (22). Given these data, it is 
worrying that a survey of clinicians in Scotland (described in detail below) shows that less than 
5% would routinely refer women with decreased fetal movements for ultrasound examination. 
We believe that current investigation of women presenting with decreased fetal movement is 
inadequate, hence using best available evidence, we have drafted what we consider to be a 
robust evaluation protocol for investigation of women with decreased fetal movement 
(attached in Appendix 4). This guideline will be further modified in consensus workshops 
informed by ongoing cohort studies with all relevant stakeholders (including representatives 
from each unit, whom we are beginning to identify) before the commencement of the study. 
 
Potential harms of a package of care around increased awareness and optimised 
management of decreased fetal movements. 
Any clinical intervention which aims to improve outcomes also has the ability to do harm. Thus 
it is essential that the intervention proposed is rigorously evaluated using the gold standard 
technique of a randomised trial, rather than being introduced as a service development.  There 
is a small window of opportunity to do this, as the Stillbirth Working Group’s enthusiasm to 
improve current management is such that routine introduction of the package of care is unlikely 
to be delayed much further than the current scheduled end date of this study. Possible harms 
of a package of care consisting of a management plan for identification and delivery of the “at 
risk” fetus, together with strategies for increasing pregnant women’s awareness of the need to 
report early include increased maternal anxiety and increased intervention (including hospital 
admission, induction of labour and caesarean section) which itself is associated with pregnancy 
related complications. The available evidence is reassuring on some of these issues. 
Encouraging women to be aware of fetal movement does not increase maternal anxiety (23), 
and it has a neutral effect on maternal- infant attachment (24), however further research is 
required. In the Norwegian service development study, the package of care increased rates of 
follow up of women, but there was no increase in admissions overall, admissions for induction 
or admissions for emergency caesarean section (16) – again, whilst reassuring these outcomes 
require formal evaluation in a randomised and relevant setting.  
 
The final possible harm of the package is around increased health care costs. We will not have 
sufficient resource to perform a formal economic evaluation in this application, but we would be 
happy to apply for separate funding for this if considered appropriate. 

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Literature search 
A literature search on “decreased fetal movement” and “detection” generated 12 publications, 
most of which were not relevant, and none of which were randomised trials evaluating different 
strategies for detection of decreased fetal movement. We are aware of a systematic review on 
fetal movement counting for assessment of fetal wellbeing (13), which we will update 
immediately prior to starting this study. 
 
A second literature search on “decreased fetal movement” and “management” generated 30 
publications, including a Cochrane systematic review published in April 2012 (19) .No 
randomised trials were identified as suitable for inclusion in this review. The applicants have 
looked at the remaining 29 papers from this literature search, and many, including the most 
relevant one of the “clinical quality improvement” unrandomised observational study in Norway 
by applicant Froen (16) have informed the design of our interventions and are cited in this 
application.  
 
Results of pilot studies 
Applicants Heazell and Froen both have an extensive track record on fetal movement counting 
- many of these studies have informed the background to this application and are cited in the 
text. The most relevant is the Norwegian observational cohort study (16). We have conducted 
two surveys of clinician practice around encouraging maternal fetal movement detection 
(including seeking advice of perceived movement decreases) and management of women 
presenting with decreased fetal movements. The first survey conducted in England and Wales 
in 2008 by Heazell, prior to the introduction of the RCOG guideline (17) had responses from 223 
clinicians (58% of whom were obstetricians and the remainder midwives). The survey suggested 
that clinicians accept “maternal perception of decreased fetal movements” as a reliable indicator 
of fetal (in)activity with 74% of responders using this definition, in contrast to 2-65% for any 
numeric definition (25). The second survey (conducted by Dr Oonagh Keog in collaboration with 
applicants Norman, Calderwood and Ross Davie in Scotland in June 2012) was completed by 
two hundred clinicians, of whom 68% were midwives and the remainder obstetricians. In this 
second survey, 80% of clinicians accepted “maternal perception of decreased fetal movements” 
as a reliable indicator of fetal activity, reflecting concordance with the RCOG guideline. However 
only 80% advised women to attend when there was a reduction in perception of fetal movement, 
with less than 10% providing written information about this to women. 
 
Regarding investigation and management of women presenting with decreased fetal 
movements, our first survey showed wide variation in clinical practice, with the majority (90%), 
but not all clinicians performing a CTG and with only 20% routinely requesting an ultrasound 
scan to assess fetal growth and liquor volume (25). Our second survey identified that, despite 
the introduction of RCOG guidelines in 2011, only 68% of responders had a policy to investigate 
women who report reduced fetal movements. Only a very small minority (less than 5%) would 
routinely request ultrasound in women presenting with reduced fetal movements, with the 
majority reserving ultrasound for women with further additional risk factors. The second survey 
also showed that access to ultrasound for women with decreased fetal movement with or without 
risk factors was suboptimal, with only 52% able to access within a 24hr period. Enthusiasm for 
induction of labour at term for women with more than one episode of decreased fetal movements 
was low, with nearly 25% of respondents suggesting that they would never offer induction of 
labour before 41 weeks in this scenario.  
 
Taken together, the data from these two surveys suggest that that a trial based on increasing 
maternal awareness of decreased fetal movement would be acceptable to clinicians. 
Importantly, by standardizing management, greater access to scanning would occur, allowing 
identification of a greater number of women with FGR. Additionally, standardization of 
management around early delivery for those with identified fetal compromise or those at 
additional risk should improve outcomes.  
 
1.2 
RATIONALE FOR STUDY 

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The aim of this study is to test the hypothesis that a package of interventions consisting of 
strategies for increasing pregnant women’s awareness of the need to report early when they 
perceive a reduction in fetal movements, followed with a management plan for identification and 
delivery of the “at risk” fetus in such women, will reduce rates of stillbirth. 
2 
STUDY OBJECTIVES 
2.1 
OBJECTIVES 
2.1.1 
Primary Objective 
The primary objective is to answer the research question:Q1. Does the introduction of a protocol 
for detection and management of decreased fetal movements reduce rates of stillbirth? 
2.1.2 
Secondary Objectives 
The secondary objectives are to answer the research questions: 
Q2. What is the effect of the above intervention on rates of caesarean section and induction of 
labour? 
Q3. What is the effect of the above intervention on rates of admission to the neonatal intensive 
care unit? 
Q4. What is the effect of the above intervention on the proportion of women with fetal growth 
restriction remaining undelivered by 40 weeks gestation? 
Q5. What is the acceptability of such a package of care to pregnant women and their health 
care providers?  
Q6. What other process outcomes are influenced by the intervention, such as health care 
provider/patient interactions? 
 
2.2 
ENDPOINTS 
2.2.1 
Primary Endpoint 
The primary endpoint is stillbirth (antepartum and intrapartum). We will use the CEMACH 
definition of stillbirth which is “a baby delivered without signs of life after 23+6 weeks”. Where 
gestation is uncertain we will include all babies with a birth weight of 500g or more. 
2.2.2 
Secondary Endpoints 
Other measures of perinatal mortality including: 
 
Stillbirth at 28 weeks gestation and above (WHO definition of stillbirth) 
 
Stillbirth at 22 weeks gestation and above  
 
Stillbirth at 37 weeks gestation and above 
 
Stillbirths amongst normally formed infants of 22 weeks gestation and above, 24 weeks 
gestation and above, 28 weeks gestation and above and 37 weeks gestation and above 
 
Perinatal mortality (defined as stillbirth at 24 weeks gestation and above and deaths in 
the first seven days of life) 
 
Rates of caesarean section 
 
Rates of induction of labour (overall) 
 
Rates of elective delivery (induction of labour and caesarean section prior to the onset 
of labour) overall 
 
Rates of induction of labour at 39 weeks 0 days gestation or later 
 
Rates of elective delivery (induction of labour and caesarean section prior to the onset 
of labour) in women delivered at 39 weeks 0 days gestation or later 
 
Mean gestation at delivery for women having induction of labour 

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 
Rates of admission to the neonatal unit (and their reasons) 
 
Rates of admission to the neonatal unit for more than 48 hours 
 
Rates of admission to the neonatal unit for term babies (those born at 37 weeks 0 days 
or greater) 
 
Proportion of women with fetal growth restriction (less than the 10th centile, customised 
for gender) remaining undelivered at or after 40 weeks gestation 
 
Rates of spontaneous vaginal delivery 
 
Other secondary outcomes are the baby parameters: 
 
Gestation at delivery 
 
Proportion of babies born preterm (≤ 37 weeks and 0 days gestation) 
 
Sex baby  
 
Birthweight of baby 
 
Birthweight centile (according to the Intergrowth birthweight centile calculator at  
https://intergrowth21.tghn.org) 
 
Apgar score at 5 minutes 
 
Proportion of babies with 5 minute Apgar score < 4 
 
Proportion of babies with 5 minute Apgar score  < 7 
 
Resuscitation required at birth 
 
We will also collect the following data:  
maternal age, maternity unit of delivery, birthweight, gestation of delivery, parity, gestation, sex, 
smoking (current and ever), maternal BMI, number of babies (one or more), ethnicity (to allow 
a customised birthweight centile to be generated), method of delivery, Scottish index of multiple 
deprivation (or other deprivation scores) (where available) other neonatal variables: Apgar 
score, resuscitation required at birth, encephalopathy etc. 
 
Adjustment will be made for the following variables: (maternal age, maternity unit of delivery, 
parity, smoking status, maternal BMI, number of babies [one or more] and ethnicity) 
3 
STUDY DESIGN 
This is a multicentre, stepped wedge cluster randomised trial of a package of care consisting 
of a management plan for identification and delivery of the ‘at risk’ fetus, together with strategies 
for increasing pregnant women’s awareness of the need to report decreased fetal movements 
early. A nested qualitative study will examine the acceptability of the intervention to patients 
and health care providers and identify process issues (barriers to implementation). Clinical audit 
(before and after the change in practice) will be used to determine the effect of interventions on 
process outcomes (eg number of ultrasound scans, number of admissions for induction of 
labour). The study will take place in participating hospitals in the UK. 
The interventions will be introduced over a 33 month period. Data will be collected over a 36 
month period.  
Data in the ‘active phase’ after introduction of the intervention will be compared to data in the 
‘control phase’ – the time from study start to the time of introduction of the intervention. Given 

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that it will take individual units some time (a) to effect change in management in their unit from 
time of introduction of the intervention and (b) that it will take some time for this change in 
practice to impact on clinical outcomes, we plan a “washout” period after the introduction of the 
intervention during which data will not be included in either group for analysis. We anticipate 
that this washout period will be of two months duration – this will be finalised in the statistical 
analysis plan. 
Outcomes will be measured from routinely collected data. For consistency, we will normally 
only include data items which become available within four months after the delivery date in 
question, although we may seek advice from the TSC about exceptions as they arise. 
A diagram indicating randomisation of hospital groupings in the stepped wedge design is shown 
below: 
 
 
This is a cluster randomised trial and individual patient consent is not required for the package 
of care. However, participants’ will be asked to sign a study specific ethically approved consent 
form for the qualitative interviews which are planned with both women and health care 
professionals. . There are no stopping rules for the study. 
4 
STUDY POPULATION 
4.1 
NUMBER OF PARTICIPANTS 
Participants will be those delivering at all the sites described in Appendix 2 over the study period 
(36 months). 
All eligible women will be recruited to the cluster RCT (Q1-4). Based on previous delivery 
numbers, after accounting for a washout period of two months (and assuming no withdrawals 
or losses to follow up) this is a total of around 300,000 women. 
A subset of around 30 participating women and 30 midwives, sonographer and obstetricians 
will be recruited to address Q5. 
4.2 
INCLUSION CRITERIA 
For Q1-4, we will include all women delivering at one of the maternity units involved in for the 
duration of the study. Women who have been seen at any of the maternity units but who deliver 
at home will not be included. The duration of the study will be 42 months from the start of the 
trial. The precise start date of the trial will be formally recorded and published in a future version 
of this protocol. 
Participants for Q5 will be recruited from the participating units. 
4.3 
EXCLUSION CRITERIA 
We will exclude women as follows: 
 
Women for whom data on delivery outcomes is still unavailable four months 
after the date of delivery   

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 
Women delivering in the “washout” period in each unit. 
Members of the trial management group and participants who do not speak/understand English 
will be excluded from those participating in Q5. 
5 
PARTICIPANT SELECTION AND ENROLMENT 
5.1 
IDENTIFYING PARTICIPANTS 
Women will be identified from those whose data is included in routine data returns from each 
unit.  
Participants for Q5 will be identified from those attending antenatal clinics in participating 
hospitals, and/or local staff. 
5.2 
CONSENTING PARTICIPANTS 
Q1-4 is a cluster randomised trial of a package of care which would be introduced in many of 
the participating units regardless of whether the trial was on-going or not. As such, it is not 
considered that formal individual patient consent is necessary. 
Q5 will require individual patient / participant consent.  
5.3 
SCREENING FOR ELIGIBILITY 
No specific screening tests will be performed for Q1-4 of this project. 
Participants for Q5 will be  
(i) Pregnant women attending hospitals (who are participating in the main trial) in Scotland. 
Purposive sampling will ensure that the final sample set includes women who have and who 
have not experienced decreased fetal movement, both before and after the introduction of the 
intervention.  
(ii) Hospital staff (including midwives, ultrasonographers and obstetricians/radiologists) working 
in participating hospitals in Scotland. 
There will be no specific screening tests for eligibility for Q5, other than a policy whereby women 
who have experienced a stillbirth in the index pregnancy will not be approached. 
5.4 
INELIGIBLE AND NON-RECRUITED PARTICIPANTS 
Potential participants for Q5 who are not approached or who decline will have no specific 
interventions / procedures. 
5.5 
RANDOMISATION 
5.5.1 
Randomisation Procedures 
This is a cluster-randomised, stepped-wedge design trial wherein maternity units rather than 
individual patients are randomised.  All units will implement the fetal movement monitoring 
intervention at some point during the trial; the random element is the time point at which this 
will occur, the so-called “step” of the stepped-wedge design.   
Participating maternity units will be blinded to their randomly allocated time point until the time 
this is required to be revealed to enable the necessary training in the implementation of the 
intervention to be delivered.  Primary and secondary outcomes of the trial will be gathered in a 
blinded manner via routinely collected data sources. 
Groups of units which are in close proximity to each other will be treated as strata for the 
purposes of randomisation (see section 9.1).  This will assist with the feasibility of delivering the 
training for and implementation of the intervention as the units will be near one another.  
Furthermore, this local synchronisation of the intervention implementation will minimise the 
chances of contamination from maternity units which have already implemented the 
intervention to those not yet randomised. 
The order in which the strata of units step in to implement the intervention will be determined 
by computer generated random numbers from a uniform distribution. 

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The randomisation list will be held by the ECTU. The identities of the research team staff whose 
roles in the trial require them to be unblinded to randomisation codes will be recorded in the 
trial master file (TMF). 
 
5.5.2 
Treatment Allocation 
Centres will be randomised to “active” or conventional treatment. All units will be providing 
conventional treatment at baseline according to local practice– this is the treatment established 
before the study starts. Centres will be randomised to “active” treatment in turn as described 
above. Active treatment will consist of a package of care consisting of a management plan for 
identification and delivery of the ‘at risk’ fetus, together with strategies for increasing pregnant 
women’s awareness of the need to report decreased fetal movements early. A draft 
management plan for identification and delivery of the “at risk” fetus is shown in Appendix 4 
Practice change in the active units will be achieved by: (i) written/email information to all 
clinicians (doctors, midwives and ultrasonographers) in each unit about the study protocol and 
amendment of the local protocol for Reduced Fetal Movements (RFM) to that of the study 
protocol  (ii) a short web-based training package taking approximately one hour to complete for 
all clinicians in each centre and (iii) training /information sessions to run in each unit and (iv) 
posters in each unit to describe the practice change. 
Strategies for encouraging clinicians to increase pregnant women’s awareness of fetal 
movement will include all the above and also a fetal movement leaflet for pregnant women. 
Once units have begun active treatment it is not anticipated that they will return to conventional 
treatment.  
 
Units will be informed about treatment allocation as near as possible to the implementation of 
the “active” treatment. For practical purposes, we anticipate that each unit will need around 
three months’ notice before the “active” treatment is introduced, hence units will be informed of 
the timing of their treatment allocation (step) three months before the active treatment is due to 
start. 
5.5.3 
Emergency Unblinding Procedures 
The treatment allocation will not be administered blind, hence there is no need for emergency 
unblinding. 
5.5.4 
Withdrawal of Study Participants 
The nature of a cluster randomised study is such that it is not possible for the participant to 
withdraw from the “cluster” (Q1-4) unless she changes the hospital of delivery part way through 
the pregnancy. The delivery hospital will be considered to be the relevant hospital when 
calculating treatment allocation – no specific allowance will be made for those who have some 
antenatal care in one hospital and then transfer to another hospital with a different treatment 
allocation. 
We plan to collect routinely recorded anonymised data. Patents have the right to opt out of 
having their data used – if this happens their data would be withdrawn (eg under the 
Confidentiality and Security advisory Group Report 2002 and the Data Protection Act 
requirements for fair processing of data). Of note, only two individuals have ever contacted ISD 
asking for their data to be removed, with none within the last three years. 
Participants in Q5 who wish to withdraw will be allowed to do so. Their data will be retained and 
used, unless they additionally indicate that they wish to withdraw their data. 
6 
STUDY ASSESSMENTS 
6.1 
SAFETY ASSESSMENTS 
Not applicable. 
6.2 
STUDY ASSESSMENTS 

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There will be no specific study related assessments. All data in Scotland and Ireland will be 
routinely collected data. In other areas in the UK it may be necessary to collect data specifically 
for the purpose of this study. Such data will be collected from hospital patient records. No 
additional assessments will be required to collect outcome data. 
7 
DATA COLLECTION 
For Q1-4, data will be routinely collected during the clinical management of the patient. Data 
will be accessed from this routine collection. Different data sources will be used for 
different regions of the study. 
(i)  In Scotland the source data will be SMR2 and the Scottish Birth record 
(ii) In Ireland the source data will be the National Perinatal Reporting system (NRPS 
http://www.esri.ie/health_information/nprs). 
(iii) In Northern Ireland, the source data will be the Northern Ireland maternity Statistics 
database (NIMATS). 
(iv)  In England and Wales, the source data will be ONS, or other relevant body. 
 
Data will be collected retrospectively on an annual basis from all sources. We will assume that 
data unavailable four months after the woman delivered is likely to be unobtainable (but see 
note in section 3 above). Thus, data on the first year of the study will be collected at month four; 
data on the second year will be collected at month 16 etc.  
Data are routinely collected. A formal request for data access will be made at the start of the 
study. This will require (i) in Scotland - PAC approval and a formal approach to ISD (ii) in Ireland 
a formal approach to NRPS (iii) NIMATS in Northern Ireland (iv) in England and Wales a formal 
approach will be made to the relevant bodies.  
Data will then be sent to the eDRIS National Safe Haven (NHS National Services Scotland) by 
SFTP (or other similar) for storage and subsequent analysis within a secure project area (the 
AFFIRM study database). Further information on the National Safe Haven is available at 
http://www.isdscotland.org/Products-and-Services/eDRIS/Becoming-an-eDRIS-User/#NSS-
National-Safe-Haven. Briefly, the National Safe Haven is located on a secure server, in which 
trusted and authorised researchers can analyse individual level data while maintaining the 
utmost confidentiality. Researchers meeting the necessary criteria may remotely access a 
secure project area on the server where their data is held. It is not possible to download or print 
out information from the Safe Haven. Final output is only available for release after an eDRIS 
Research Coordinator has checked the output to ensure that it does not contain information 
which could be used either on its own or in conjunction with other data to breach an individual's 
privacy. It is anticipated that all study analysis will be done within the Safe Haven, using one of 
the available statistical packages (e.g. R, SPSS). 
Identifiers on Scottish data within the National Safe Haven are concealed from researchers.   
Data from outwith Scotland will be anonymised before submission to the National Safe Haven. 
Thus the trial team will not at any stage have access to identifiable patient data. We have 
carefully considered how we might maximise patient confidentiality whilst maintaining the 
integrity and the usefulness of the study.  
We propose that data submitted to the National Safe Haven will be “anonymised” by the data 
provider. This will happen automatically for Scottish data. Data from other areas will be 
anonymised before submission to the National Safe Haven. Thus data stored in the AFFIRM 
project area in the National Safe Haven will not include names, addresses or CHI (or equivalent) 
numbers. In other words, it would not be possible to use the AFFIRM project area data to 
identify individuals. However, we propose that the anonymisation link will be retained at the 
source so that it will be possible to re-link data retrospectively. Such re-link would require co-
operation by the data source (e.g. ISD for Scottish data, or other local clinicians /data guardians 
for other data), and, depending on the mechanism by which this was done, may require an 
amendment to ethics / research governance approvals. A similar strategy will be implemented 
with other data providers. 

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The rationale for retaining the ability of local data guardians to re-link data is because we believe 
that it is important to retain the possibility of identifying individual patients retrospectively. 
Examples include: (i) It is possible that some additional important data may be available at a 
late stage on individual participants – e.g. in the scenario where the woman or baby had a major 
adverse event and spent a long time in hospital before discharge or death. Given that data 
recording is linked to date of discharge from hospital, these data may not be available until 
some time after our planned four month cut off period. We may therefore have transferred a 
large block of data from ISD (or other data provider) into the AFFIRM study National Safe Haven 
database prior to information about this important individual and her/his outcomes. If it is not 
possible to retrospectively identify individual patients, it will not be possible to amend this single 
individual’s data in the AFFIRM study database. (ii) Although our protocol and outcome analysis 
does not require identifiable data, we believe this will be a ‘once in a lifetime” study, and that 
subsequent secondary analyses could yield important information for patients and for policy 
makers. If retrospective identification is not possible, this will limit further analysis. One likely 
example of future analyses is to determine the effect of the intervention on different causes of 
stillbirth. This is outwith the scope of the current protocol, but could be done relatively 
straightforwardly, by linking nationally recorded information on “cause” of stillbirth to our study 
database. We anticipate that such additional analyses would require additional ethics approval, 
but if all identifiers are stripped, it will not be possible to perform such subsequent analyses. 
We acknowledge that the nature of the data is that it may be possible for a determined and 
unscrupulous person to identify some individuals with uncommon events, e.g. from the date of 
delivery. However, the National Safe Haven has extensive processes in place to minimise 
access to datasets to prevent this happening, and we believe that date of delivery required 
facilitating analysis of important outcomes (e.g. age of the baby in cases of neonatal death). 
Given that postcode data will be used exclusively to determine deprivation score, we will convert 
postcodes into deciles of deprivation (e.g. Scottish Index of Multiple Deprivation Score) at 
source (eg ISD). 
All Investigators and study site staff involved with this study must comply with the requirements 
of the Data Protection Act 1998 (or equivalent for those outwith the UK) with regard to the 
collection, storage, processing and disclosure of personal information and will uphold the Act’s 
core principles. Published results will not contain any personal data that could allow 
identification of individual participant. 
 
In addition to the data recorded above, all centres will be asked to provide a copy of their 
guidelines around (i) maternal awareness of decreased fetal movement and (ii) management 
of women presenting with decreased fetal movement. Copies of guidelines will be sought by 
the study office (a) at the start of the study (b) immediately before initiation of the intervention 
in each specific unit and (c) six months after initiation of the intervention in each specific unit. 
 
For Q5, we will perform interviews of healthcare workers and a small nested cohort of pregnant 
women about their experiences of fetal movement and of this intervention. We shall ensure a 
diversity of age and include primi and multigravida women (n=30 in total). Ten interviews will 
be conducted with each of the following groups of health care providers:  obstetricians, 
midwives and sonographers/radiologists. The interviews will take a semi-structured format 
(sensitising and piloting interviews will be conducted prior to the commencement of the trial and 
in the first month of the nested qualitative study).  This format will ensure the same categories 
of data will be obtained from each participant but also allow individual responses to be fully 
explored. 
8 
STATISTICS AND DATA ANALYSIS 
8.1 
SAMPLE SIZE CALCULATION 
The sample size is the number of women delivering in hospitals participating in the study. 
Scotland has around 58,000 deliveries per year with 16 consultant led maternity units, 20 
smaller units each delivering less than 350 babies per year, and seven units delivering less 
than five births per year (Appendix 2). The units involved in Perinatal Ireland (an all-Ireland 
research consortium across 7 academic centres in Ireland currently funded by the Health 

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Research Board, Ireland) have 50,000 births per year with seven large centres (Appendix 2). 
Combining one or two of the smaller units and one larger unit into a single “hospital group” for 
each local area could provide 24 hospital “groups” – the details of hospital groupings will be 
reviewed and finalised immediately prior to randomisation.  
 
We calculated statistical power using the methodology for stepped wedge designs proposed in 
Hussey and Hughes (2007) (26). First, we analysed stillbirth event data from the Scottish 
Perinatal and Infant Mortality and Morbidity Report (SPIMMR) covering years 2005-2010 (4) to 
determine estimates of between- and within-unit variability in stillbirth rate.  Analysis was by 
generalized linear mixed model for binary outcomes.  The power calculation, as per equations 
(7) and (8) in (26) assumed: significance level 5%; analysis by generalized linear mixed 
model; deliveries equally distributed across hospital groupings; baseline stillbirth rate 0.438% 
(4); cluster coefficient of variation 0.333. 
 
Finally, the statistical power depends on the number of groups in which the intervention is 
implemented at each stage of the stepped wedge design and the duration of recruitment at 
each “step”.  Our study design proposes sequential introduction of the intervention into three 
hospital groups at a time at four month intervals over a 32 month period. This would give 92.4% 
power to detect a 30% relative risk reduction under the intervention and 80.7% power to detect 
a 25% reduction. A 30% risk reduction was seen in the Norwegian study; the anticipated effect 
sizes of 25% and 30% relative reduction take into account that the intervention will not have the 
power to reduce all stillbirths, since 20% of stillbirths in Ireland (5) and 15% in Scotland (4) are 
associated with congenital anomaly. 
 
The power actually achieved in the study will be slightly lower, as deliveries during the two 
month “washout” period following implementation of the intervention in a site will not be included 
in the analysis. The effect of this was explored using the Stata function steppedwedge (27), 
which showed the statistical power would become 88.2% (30% risk reduction) and 74.6% (25% 
risk reduction). It is anticipated that unavailability of data and women asking to withdraw their 
data will be less than 1%. 
8.2 
PROPOSED ANALYSES 
 
For the binary outcomes being addressed in research questions Q1-Q4, data will be analysed 
by generalized linear mixed model with a random effect for hospital group and fixed effects for 
the intervention implementation and study time period. Data will be analysed on an intention to 
treat basis (the design of the trial means it is not possible to determine individual patient 
/caregiver compliance with the intervention). There will be no imputations for missing data. 
Subgroup analyses will include those with and without congenital anomalies. No interim 
analyses will be performed other than those requested by the trial steering committee, who will 
be the only group to view the interim analyses. A full statistical analysis plan will be developed 
and signed off prior to locking of the study database.  
 
For research question Q5, the qualitative data will be audio recorded and transcribed.  The data 
will be coded thematically and an analytical framework developed to make sense of patient 
experience of fetal movement and the intervention and also health care providers’ perspectives 
and experiences.  NVivo will be utilised to support the analysis.  The RA and SCB will work 
together to ensure rigour and validity.  
 
The process outcomes being assessed in Q6 (rates of induction of labour, number of women 
presenting with decreased fetal movements, interval between perceiving fetal movements and 
presenting to hospital) will be analysed using the same methods as for Q1-Q4, with the 
exception of the continuous outcome (interval between perceiving fetal movements and 
presenting to hospital) which will be analysed in a normal linear mixed model. 
9 
ADVERSE EVENTS 
This is not a Clinical Trial of an Investigational Medicinal Product (CTIMP) so adverse events 
will not be formally reported. Stillbirth and other measures of fetal and maternal morbidity are 
outcomes of the study. The purpose of the intervention is to reduce such adverse events. If 

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required, the Trial Steering committee (TSC) may review unblinded data for the study, including 
morbidity and mortality indices. No other adverse event reporting will be undertaken. 
10.    
PREGNANCY 
Pregnancy is an inclusion criterion for participation in the trial. 
11 
TRIAL MANAGEMENT AND OVERSIGHT ARRANGEMENTS 
11.1 
TRIAL MANAGEMENT GROUP 
The trial will be coordinated by a Project Management Group, consisting of the grant holders 
and the Trial Manager (Sonia Whyte). The Chief Investigator - Prof Jane Norman will lead the 
project management group. 
The Trial Manager will oversee the study and will be accountable to the Chief Investigator.  
11.2 
TRIAL STEERING COMMITTEE 
A Trial Steering Committee (TSC) will be established to oversee the conduct and progress of 
the trial. The names and contact details of the TSC are detailed in Appendix 1; their terms of 
reference and a draft template for reporting will be ratified in one of their early meetings. 
11.3 
INSPECTION OF RECORDS 
Investigators and institutions involved in the study will permit trial related monitoring and audits 
on behalf of the sponsor, REC review, and regulatory inspection(s).  In the event of an audit or 
monitoring, the Investigator agrees to allow the representatives of the sponsor direct access to 
all study records and source documentation. In the event of regulatory inspection, the 
Investigator agrees to allow inspectors direct access to all study records and source 
documentation. 
11.4 
RISK ASSESSMENT 
An independent risk assessment will be performed by ACCORD to determine if monitoring is 
required and if so, at what level. An independent risk assessment will also be carried out by 
ACCORD to determine if an audit should be performed before/during/after the study and if so, 
at what locations and at what frequency. 
11.5 
STUDY MONITORING AND AUDIT 
An ACCORD Clinical Trials Monitor or an appointed monitor will visit the Investigator site prior 
to the start of the study and during the course of the study if required, in accordance with the 
monitoring plan if required. Investigator sites will be risk assessed by the ACCORD QA 
Manager, or designee, in order to determine if audit by the ACCORD QA group is required. 
12 
GOOD CLINICAL PRACTICE 
12.1 
ETHICAL CONDUCT 
The study will be conducted in accordance with the principles of the research governance 
framework operational in the relevant country. 
A favorable ethical opinion will be obtained from the appropriate REC and local R&D approval 
will be obtained prior to commencement of the study. 
12.2 
REGULATORY COMPLIANCE 
As this trial is not a CTIMP, there is no requirement for approval from the MHRA. 
12.3 
INVESTIGATOR RESPONSIBILITIES 
Local study investigator(s) will be appointed to each site (or, for small centres, groups of sites). 
S/he will be responsible for the overall conduct of the study at the site and compliance with the 
protocol and any protocol amendments. The following areas listed in this section are also the 
responsibility of the Investigator.  Responsibilities may be delegated to an appropriate member 
of study site staff.   

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12.3.1 
Informed Consent 
Informed consent will only be required for Q5 – the following statements apply to this part of the 
study only. 
The Investigator is responsible for ensuring informed consent is obtained before any protocol 
specific procedures are carried out.  The decision of a participant to participate in clinical 
research is voluntary and should be based on a clear understanding of what is involved. 
Participants must receive adequate oral and written information – appropriate Participant 
Information and Informed Consent Forms will be provided.  The oral explanation to the 
participant will be performed by the Investigator or qualified delegated person, and must cover 
all the elements specified in the Participant Information Sheet and Consent Form. 
The participant must be given every opportunity to clarify any points they do not understand 
and, if necessary, ask for more information.  The participant must be given sufficient time to 
consider the information provided.  It should be emphasised that the participant may withdraw 
their consent to participate at any time without loss of benefits to which they otherwise would 
be entitled. 
The participant will be informed and (if the participant is a patient) agree to their medical records 
being inspected by regulatory authorities and representatives of the sponsor(s) but understand 
that their name will not be disclosed outside the hospital. 
The Investigator or delegated member of the trial team and the participant will sign and date 
the Informed Consent Form(s) to confirm that consent has been obtained.  The participant will 
receive a copy of this document and a copy filed in the Investigator Site File (ISF) and 
participant’s medical notes. 
12.3.2 
Study Site Staff 
The local study investigator is expected to be familiar with the protocol and the study 
requirements and to publicise the study in their centre.  It is the Investigator’s responsibility to 
ensure that all staff assisting with the study are adequately informed about the protocol and 
their trial related duties. 
12.3.3 
Confidentiality 
All evaluation forms, reports, and other records must be identified in a manner designed to 
maintain participant confidentiality.  All records must be kept in a secure storage area with 
limited access. The Investigator and study site staff involved with this study may not disclose 
or use for any purpose other than performance of the study, any data, record, or other 
unpublished, confidential information disclosed to those individuals for the purpose of the study.  
Prior written agreement from the sponsor or its designee must be obtained for the disclosure of 
any said confidential information to other parties. 
12.3.4 
Data Protection 
All Investigators and study site staff involved with this study must comply with the requirements 
of the Data Protection Act 1998 with regard to the collection, storage, processing and disclosure 
of personal information and will uphold the Act’s core principles.  
Access to collated participant data will be restricted.  
Computers used to collate the data will have limited access measures via user names and 
passwords. 
Published results will not contain any personal data that could allow identification of individual 
participants. 
13 
STUDY CONDUCT RESPONSIBILITIES 
13.1 
PROTOCOL AMENDMENTS 
Any changes in research activity, except those necessary to remove an apparent, immediate 
hazard to the participant in the case of an urgent safety measure, must be reviewed and 
approved by the Chief Investigator and Sponsor.   

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Amendments to the protocol must be submitted in writing to the appropriate REC and local R&D 
for approval prior to participants being enrolled into an amended protocol. 
13.2 
PROTOCOL VIOLATIONS AND DEVIATIONS 
Investigators will not implement any deviation from the protocol without agreement from the 
Chief Investigator and appropriate REC and R&D approval except where necessary to eliminate 
an immediate hazard to trial participants. 
In the event that an Investigator needs to deviate from the protocol, the nature of and reasons 
for the deviation will be recorded.  If this necessitates a subsequent protocol amendment, this 
should be submitted to the REC, and local R&D for review and approval if appropriate. 
 
13.3 
SERIOUS BREACH REQUIREMENTS 
 
A serious breach is a breach which is likely to effect to a significant degree: 
 
(a) the safety or physical or mental integrity of the participants of the trial; or 
b) the scientific value of the trial. 
 
If a potential serious breach is identified by the Chief investigator, Principal Investigator or 
delegates, the co-sponsors (accord.seriousbreach@ed.ac.uk) must be notified within 
24 hours. It is the responsibility of the co-sponsors to assess the impact of the breach on the 
scientific value of the trial, to determine whether the incident constitutes a serious breach and, 
if so, report it to the REC. 
 
All violations will be assessed by the sponsor(s) to ascertain if they meet the criteria for a 
serious breach. If the sponsor(s) deem the incident to be a violation that does not constitute a 
serious breach from the protocol when identified, corrective and preventative actions will be 
taken where appropriate and they will be recorded in file notes, held within the TMF and ISF. 
13.4 
STUDY RECORD RETENTION 
All study documentation will be kept for a minimum of 5 years from the protocol defined end of 
study point. When the minimum retention period has elapsed, study documentation will not be 
destroyed without permission from the sponsor. 
 
13.5 
END OF STUDY 
The end of study date will be finalised in the protocol once the study starts 
The Investigators and/or the trial steering committee and/or the co-sponsor(s) have the right at 
any time to terminate the study for clinical or administrative reasons.  
The end of the study will be reported to the REC within 90 days, or 15 days if the study is 
terminated prematurely.  The Investigators will inform participants of the premature study 
closure and ensure that the appropriate follow up is arranged for all participants involved. 
A summary report of the study will be provided to the REC and Regulatory Authority within 
1 year of the end of the study. 
 
13.6 
INSURANCE AND INDEMNITY 
The co-sponsors are responsible for ensuring proper provision has been made for insurance or 
indemnity to cover their liability and the liability of the Chief Investigator and staff. 
The following arrangements are in place to fulfil the co-sponsors' responsibilities: 
 
The Protocol has been designed by the Chief Investigator and researchers employed 
by the University and collaborators.  The University has insurance in place (which 
includes no-fault compensation) for negligent harm caused by poor protocol design 
by the Chief Investigator and researchers employed by the University. 

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 
Sites participating in the study will be liable for clinical negligence and other negligent 
harm to individuals taking part in the study and covered by the duty of care owed to 
them by the sites concerned.  The co-sponsors require individual sites participating 
in the study to arrange for their own insurance or indemnity in respect of these 
liabilities. 
 
Sites which are part of the United Kingdom's Nation Health Service will have the 
benefit of NHS Indemnity. 
 
Sites out with the United Kingdom will be responsible for arranging their own 
indemnity or insurance for their participation in the study, as well as for compliance 
with local law applicable to their participation in the study. 
14 
REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS 
14.1 
AUTHORSHIP POLICY 
Ownership of the data arising from this study resides with the study team.  On completion of 
the study, the study data will be analysed and tabulated, and a clinical study report will be 
prepared in accordance with GCP guidelines.  
14.2 
PUBLICATION 
The clinical study report will be used for publication and presentation at scientific meetings. 
Investigators have the right to publish orally or in writing the results of the study. 
Summaries of results will also be made available to Investigators for dissemination within their 
clinics (where appropriate and according to their discretion). 
14.3 
PEER REVIEW 
This project has been peer reviewed internally, and was externally peer reviewed during the 
process of securing funding from the CSO. 
 
 

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15 
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Flenady V, Koopmans L, Middleton P, Froen JF, Smith GC, Gibbons K, et al. 
Major risk factors for stillbirth in high-income countries: a systematic review and meta-
analysis. Lancet. 2011 Apr 16;377(9774):1331-40. 
3. 
Flenady V, Middleton P, Smith GC, Duke W, Erwich JJ, Khong TY, et al. 
Stillbirths: the way forward in high-income countries. Lancet. 2011 Apr 13. 
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Morbidity Report 2010: Healthcare Improvement Scotland2012. 
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Lawn JE, Blencowe H, Pattinson R, Cousens S, Kumar R, Ibiebele I, et al. 
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Stacey T, Thompson JM, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan 
LM. The Auckland Stillbirth study, a case-control study exploring modifiable risk factors 
for third trimester stillbirth: methods and rationale. The Australian & New Zealand 
journal of obstetrics & gynaecology. 2011 Feb;51(1):3-8. 
8. 
Vintzileos AM, Fleming AD, Scorza WE, Wolf EJ, Balducci J, Campbell WA, et 
al. Relationship between fetal biophysical activities and umbilical cord blood gas 
values. American journal of obstetrics and gynecology. 1991 Sep;165(3):707-13. 
9. 
Warrander LK, Heazell AE. Identifying placental dysfunction in women with 
reduced fetal movements can be used to predict patients at increased risk of 
pregnancy complications. Med Hypotheses.. 2011 Jan;76(1):17-20. 
10. 
Holm Tveit JV, Saastad E, Stray-Pedersen B, Bordahl PE, Froen JF. Maternal 
characteristics and pregnancy outcomes in women presenting with decreased fetal 
movements in late pregnancy. Acta obstetricia et gynecologica Scandinavica.. 
2009;88(12):1345-51. 
11. 
Flenady V, Middleton P, Smith GC, Duke W, Erwich JJ, Khong TY, et al. 
Stillbirths: the way forward in high-income countries. Lancet.. 2011 May 
14;377(9778):1703-17. 
12. 
Saastad E, Winje BA, Stray Pedersen B, Froen JF. Fetal movement counting 
improved identification of fetal growth restriction and perinatal outcomes--a multi-
centre, randomized, controlled trial. PLoS One. 2011;6(12):e28482. 
13. 
Mangesi L, Hofmeyr GJ. Fetal movement counting for assessment of fetal 
wellbeing. Cochrane Database of Systematic Reviews.. 2007(1):CD004909. 
14. 
Grant A, Elbourne D, Valentin L, Alexander S. Routine formal fetal movement 
counting and risk of antepartum late death in normally formed singletons. Lancet.  
1989 Aug 12;2(8659):345-9. 
15. 
NICE National Collaborating Centre for Women's and Children's Health . 
Antenatal care. Routine care for the healthy pregnant woman. 2008. 
16. 
Tveit JV, Saastad E, Stray-Pedersen B, Bordahl PE, Flenady V, Fretts R, et al. 
Reduction of late stillbirth with the introduction of fetal movement information and 
guidelines - a clinical quality improvement. BMC pregnancy and childbirth. 2009;9:32. 
17. 
Royal College of Obstetricians and Gynecologists. Reduced fetal movements: 
Green-top guideline 57. London, UK 2011. 
18. 
Froen JF, Heazell AE, Tveit JV, Saastad E, Fretts RC, Flenady V. Fetal 
movement assessment. Seminars in perinatology. 2008 Aug;32(4):243-6. 
19. 
Hofmeyr GJ, Novikova N. Management of reported decreased fetal movements 
for improving pregnancy outcomes. Cochrane Database of Systematic Reviews.. 
2012;4:CD009148. 

AFFIRM 
Version 6_ 27th February, 2017 
 
Page 25 of 36 
20. 
Froen JF, Tveit JV, Saastad E, Bordahl PE, Stray-Pedersen B, Heazell AE, et 
al. Management of decreased fetal movements. Seminars in perinatology.. 2008 
Aug;32(4):307-11. 
21. 
Dutton P, Warrander LK, Roberts S, Bernatavicius G, Byrd L, Gaze D, et al. 
Predictors of poor perinatal outcome following maternal perception of reduced fetal 
movement - a prospective cohort study. PLOS One. 2012;7:e39784. 
22. 
Royal College of Obstetricians and Gynaecologists. The investigation and 
management of the small-for-gestational-age fetus. Draft guideline out for consultation. 
2012 2012. 
23. 
Saastad E, Winje BA, Israel P, Froen JF. Fetal movement counting--maternal 
concern and experiences: a multicenter, randomized, controlled trial. Birth.. 2012 
Mar;39(1):10-20. 
24. 
Saastad E, Israel P, Ahlborg T, Gunnes N, Froen JF. Fetal movement counting-
-effects on maternal-fetal attachment: a multicenter randomized controlled trial. Birth.. 
2011 Dec;38(4):282-93. 
25. 
Heazell AE, Green M, Wright C, Flenady V, Froen JF. Midwives' and 
obstetricians' knowledge and management of women presenting with decreased fetal 
movements. Acta obstetricia et gynecologica Scandinavica.. 2008;87(3):331-9. 
26. 
Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster 
randomized trials. Contemp Clin Trials. [. 2007 Feb;28(2):182-91. 
27. Hemming K, Girling A. A menu-driven facility for power and detectable-difference 
calculations in stepped-wedge cluster-randomized trials. The Stata Journal 
2014;14:363-380. 
. 
 
 
 
 

AFFIRM 
Version 6_ 27th February 2017 
 
Page 26 of 36 
APPENDIX 1: TRIAL STEERING COMMITTEE 
Chair – Prof Gordon Smith, University of Cambridge - gcss2@cam.ac.uk 
Obstetric member – Mr Kim Hinshaw, Sunderland Royal Hospital - kim.hinshaw@lineone.net 
 
Lay member – Mrs Louise Fenton - louisefenton78@icloud.com 
Sponsor’s representative – Dr Ray French – Ray.French@ed.ac.uk 
CI – Prof Jane Norman, University of Edinburgh –Jane.Norman@ed.ac.uk 
Trial Manager – Mrs Sonia Whyte – Sonia.Whyte@ed.ac.uk 
Invited members of the Trial Management Group (TMG) 
 
The Trial Steering Committee will act according to guidelines from the NIHR Clinical Trials toolkit (see 
http://www.ct-toolkit.ac.uk/glossary/trial-steering-committee-tsc). 

AFFIRM 
Version 6_ 27th February 2017 
 
Page 27 of 36 
 APPENDIX 2: PARTICIPATING SITES (UPDATED 09/01/2015) 
 
 
Maternity unit 
Births 2013 figures 
A. Large consultant led units (Scotland) 
 
New Royal Infirmary of Edinburgh 
6462 
Princess Royal Maternity Hospital, Glasgow 
6900 
Wishaw General Hospital, Lanarkshire 
5000 
Aberdeen Maternity Hospital, Grampian 
5009 
Ninewells Hospital, Tayside 
4281 
Crosshouse Hospital, Ayrshire 
3733 
Forth Park Maternity Hospital, Kirkcaldy, Fife 
4171 
Southern General Hospital, Glasgow 
6000 
Forth Valley Royal, Larbert 
3339 
Royal Alexandra Hospital, Paisley 
3700 
St. John's at Howden, Livingston 
2995 
Raigmore Hospital, Inverness 
3107 
Dumfries and Galloway Royal Infirmary, Dumfries 
1373 
Borders General Hospital, Borders 
1214 
Dr Gray's Hospital, Elgin 
1156 
 
 
B. Perinatal Ireland consortium 
 
Rotunda Hospital, Dublin  
9000 
University College Hospital, Galway 
2500 
Royal Jubilee Maternity Hospital, Belfast 
5000 
National Maternity, Dublin 
9000 
 
 
C. Large consultant led units (Wales) 
 
Ysbyty Gwynnedd Hospital 
2200 
Glan Clwyd Hospital 
2450 
Wrexham Maelor 
2650 
Nevill Hall Hospital 
2250 
Royal Gwent Hospital 
3450 
 
 
D. Large consultant led units (England) 
 
St Richard's Hospital, Chichester 
2600 
Worthing and Southlands Hospital, Chichester 
2700 
Birmingham Women's Hospital 
8000 
Leeds General Infirmary 
4800 
St George's Hospital, London 
5400 
Royal Preston Hospital  
4800 
Blackpool Victoria Hospital 
2900 
St Mary’s Hospital, Manchester 
8400 
Stepping Hill Hospital, Stockport 
3800 
Royal Albert Edward Infirmary, Wigan 
2800 
Total number of deliveries per year 
143140 
 
 

AFFIRM 
Version 6_ 27th February 2017 
 
Page 28 of 36 
APPENDIX 3: INFORMATION FOR WOMEN ABOUT FETAL MOVEMENTS 
 
 

AFFIRM 
Version 6_ 27th February 2017 
 
Page 29 of 36 
APPENDIX 4: UPDATED 09/01/2015 
SUGGESTED MANAGEMENT PLAN FOR WOMEN PRESENTING WITH REDUCED FETAL 
MOVEMENTS 
Guideline for management of women presenting with reduced fetal movements at more than 
28 weeks gestation.  
 
Suggested management plan is based on that employed in the Tveit study where an intervention was 
associated with a reduction in stillbirth rates. Given that decreased FM is a risk factor for SGA (OR 
ranging from 1.6 (1), to 3), these guidelines are also informed by the revised RCOG guidelines on 
SGA 
http://www.rcog.org.uk/files/rcog-corp/GTG31SGA23012013.pdf. The 
management plan 
described here depends very heavily on ultrasound, given data that ultrasound performs well both on 
an absolute basis and compared with other interventions (with a. ultrasound perceived as useful in 
detecting abnormalities in 11.6% of scans, b. detection of the identified abnormality being perceived 
as useful after ascertainment in 86.2% of women and c. the ultrasound being the only modality to 
detect abnormality in 71.3%.Ultrasound examinations (whether for LV or AC / EFW or umbilical artery 
Doppler) should only be performed by a trained individual (e.g. RCOG ultrasound module 2 “signed 
off”), and a formal report issued. Note there is no formal definition of decreased fetal movement – 
previous studies have suggested that the woman’s perception of decreased fetal movements are the 
most helpful criterion definition of decreased fetal movement, so that an arbitrary reference range for 
movements is not recommended). 
 
Single episode of presenting with reduced fetal movement. 
i. 37 weeks gestation or more  
Assess for risk factors. Perform CTG within 2 hours and USS for LV within 12 hours.  
 
 
If CTG abnormal or LV reduced (deepest vertical pool ≤ 2cm), arrange delivery, with input from 
senior obstetrician on timing, and certainly within 48 hours. 
 
 
If CTG and LV normal perform USS for EFW /AC next working day (+/-Dopplers as per local 
protocol).  
o If EFW/AC >10th centile, growth trajectory normal AND fetal movements have returned 
to normal, discharge back to routine care. 
o If AC or EFW ≤10th centile or there is decreased growth velocity or abnormal Doppler 
deliver with input from senior obstetrician on timing, and certainly within 48 hours. 
o If all investigations are normal but fetal movements have not returned to normal within 
24 hours follow recurrent reduced fetal movement pathway. 
 
 
If ≥ 40 weeks, consider delivery within 48 hours as an alternative to USS. 
 
 
ii If 27+0 – 36+6 weeks. 
Assess for risk factors. Perform CTG within 2 hours and USS for LV within 12 hours.  
 
 
If CTG abnormal or LV reduced (deepest vertical pool ≤ 2cm), involve senior obstetrician in 
management plan. 
 
 
If CTG and LV normal perform USS for EFW /AC next working day (+/- Dopplers as per local 
protocol).  
o If EFW/AC >10th centile, growth trajectory normal AND fetal movements have returned 
to normal discharge back to routine care.  
o If AC or EFW ≤10th centile or there is decreased growth velocity or abnormal Doppler 
review by senior obstetrician as per local protocol for suspected FGR. The revised 
RCOG 
guidelines 
for 
SGA 
http://www.rcog.org.uk/files/rcog-
corp/GTG31SGA23012013.pdf should also be consulted. Consider delivery by 37 
weeks for women with suspected fetal growth restriction. 
 

AFFIRM 
Version 6_ 27th February 2017 
 
Page 30 of 36 
o If all normal but fetal movements have not returned to normal within 24 hours, follow 
recurrent reduced fetal movement pathway. 
 
 
iii. If 24+0 – 26+6 weeks.  
Assess for risk factors. Confirm fetal viability. Perform fetal anomaly scan if not already completed. If 
risk factors or FGR and stillbirth present, arrange serial growth USS as per local policy/RCOG 
guideline.  
 
Recurrent episodes of reduced fetal movement. 
Recurrent reduced fetal movement is defined as persistent reduced fetal movement for more than 24 
hours or second or subsequent episode within 21 days of first presentation. If previous attendance ≥ 
21days ago follow single episode guidance above. 
 
iv. 37+0 weeks gestation or more  
Perform CTG within 2 hours. Offer delivery (eg induction of labour) with input from senior obstetrician 
on timing (and certainly within 48 hours) if woman wishes delivery. 
 
v. 27+0 –  36+6 weeks inclusive.  
Perform CTG within 2 hours and LV within 12 hours of presentation. Schedule repeat USS scan for 
EFW/AC  if it is ≥ 21 days after previous USS (+/- Dopplers as per local protocol) and perform twice 
weekly CTG monitoring and weekly LV until then. Thereafter, manage according to repeat scan 
results. If measurements of EFW/AC are ≤ 10th centile, or if there is decreased growth velocity, or 
abnormal Doppler review by senior obstetrician. If EFW/AC are > 10th centile, return to routine care. 
 
vi. 24+0 – 26+6 weeks inclusive.  
Assess for risk factors for stillbirth and FGR.  Confirm fetal viability.  Perform anomaly scan, if not 
already done.  If high risk of FGR arrange serial growth USS as per local policy /RCOG guideline.  
 
What would the impact of this be on the clinical service? 
In addition to a reduction in stillbirth, Tveit (1) showed that a policy of encouraging women to attend 
quickly after perception of decreased fetal movements had no significant increase in the total 
proportion of women attending with 6.2% of women presenting with decreased FM in third trimester 
prior to intervention and 6.6% of women after the intervention 
However, it had a significant decrease in the proportion of women who waited more than 48 h to come 
to hospital (49% vs 54%) significant reduction in admission for induction (4.9% vs 7%) significant 
decrease in the number of admissions (11% vs 14%) non significant increase in the proportion of 
women with no follow up (69% vs 63%) a significant increase in the proportion of consultations which 
had ultrasound (94% compared with 86%). 
In two other studies looking at the number of people attending with recurrent decreased fetal 
movements after 37 weeks, the figures were 0.2 – 0.5% of the obstetric population (2) (3). Again, Tveit 
showed that his intervention did not increase the number of women presenting, so the figure of 0.2 – 
0.5% of the obstetric population should be robust. Even assuming an increase in the proportion of 
women presenting (at worse a doubling), this would result in only a modest increase in the proportion 
of women undergoing induction of labour (at worst, 0.4 - 1% of the obstetric population). In practice, 
the majority may have abnormal growth monitoring, so may already be undergoing induction of labour.  
These data suggest that, with the exception of the need for ultrasound, these policies should not 
increase the need for service delivery. Regarding ultrasound, in the worst case scenario (assuming 
that no woman presenting with reduced FM currently has USS, but that all women will in the future, 
and assuming that 6-7% of all women will present at some point in the third trimester after the 
intervention, then a hospital with 7000 deliveries per year will do no more than 2 - 8 extra scans per 
week. For induction of labour, a hospital with 7000 women would have no more than 0.4 – 1.3 
inductions per week. 
 
 

AFFIRM 
Version 6_ 27th February 2017 
 
Page 31 of 36 
References: 
1. 
Tveit JV, Saastad E, Stray-Pedersen B, Bordahl PE, Flenady V, Fretts R, et al. Reduction of 
late stillbirth with the introduction of fetal movement information and guidelines - a clinical quality 
improvement. BMC pregnancy and childbirth. 2009;9:32. PubMed PMID: 19624847. Pubmed Central 
PMCID: 2734741. Epub 2009/07/25. eng. 
2. 
Dutton P, Warrander LK, Roberts S, Bernatavicius G, Byrd L, Gaze D, et al. Predictors of poor 
perinatal outcome following maternal perception of reduced fetal movement - a prospective cohort 
study. PLOS One. 2012;7:e39784. 
3. 
O'Sullivan O, Stephen G, Martindale E, Heazell AE. Predicting poor perinatal outcome in 
women who present with decreased fetal movements. Journal of obstetrics and gynaecology : the 
journal of the Institute of Obstetrics and Gynaecology. 2009 Nov;29(8):705-10. PubMed PMID: 
19821662. Epub 2009/10/14. eng. 
 

AFFIRM 
Version 6_ 27th February 2017 
 
Appendix 5 - Version 1, 17th July 2017  
 
APPENDIX 5: AUDIT OF COMPLIANCE ADDED 17th July 2017 
 
An audit of compliance with the affirm management protocol (appendix 4: updated 
09/01/2015) for women presenting with reduced fetal movements will be determined by two 
means: 
 
A) QUESTIONNAIRE Via Telephone or email contact with Principal Investigators at each site to 
determine which aspects of the AFFIRM protocol have been implemented effectively. 
 
This will involve email contact with Principal Investigators to alert them to the request for information, 
detailing the information required, followed by a phone call to elicit the information (unless it had 
already been supplied). Investigators will be asked which of the following elements they had 
implemented locally:  
 
 
Issuing leaflets to all pregnant women, 
 
Cardiotocography within 2 hours of presentation,  
 
Measurement of amniotic fluid volume within 12 hours of presentation,  
 
Growth scan by the next working day for all women presenting with reduced fetal 
movement (and who had not had a growth scan within the last three weeks, or who were 
not being induced within 48 hours),  
 
Induction of labour within 48 hours for women presenting with recurrent reduced fetal 
movement at or after 37 weeks gestation.  
 
Compliance (effective implementation) will be defined as 4/5 of the above management elements for 
80% or more of the time. 
 
 

AFFIRM 
Version 6_ 27th February 2017 
 
Appendix 5 - Version 1, 17th July 2017  
 
AUDIT PART A:  STAFF QUESTIONNAIRE  
 
Dear (PI Name) 
 
You very kindly agreed to answer some questions regarding your unit’s compliance with the 
AFFIRM audit. We would be most grateful to receive your views on the following: 
 
1. In your opinion, were the following aspects of the AFFIRM audit implemented at least 80% of 
the time at [Insert site name]? 
 
Unit name: 
(Hospital name) 
Yes Partially No 
If Partially or NO, What proportion of 
women do you estimate received 
these? 
 
Leaflets about RFM issued to women   
 
 
 
eLearning completed by staff 
 
 
 
 
CTG within 2 hours of presentation 
with RFM 
 
 
 
 
Growth scans for RFM (next working 
day) 
 
 
 
 
IOL for women 37 weeks and above 
with recurrent RFM  (within 48hrs) 
 
 
 
 
 
2. If you could turn back time to 1st January 2014, and (with the benefit of experience) would 
you agree to participate in the AFFIRM study again? YES/NO 
 
If NO, please could you explain why not? 
 
 
We would be most grateful to receive your answers by XX/ XXX/XXXX If you haven’t already given 
us your best address for sending out your vouchers, please don’t forget to include this. 
 
As always, thank you so much for your help with AFFIRM. 
 
Best Wishes 
 
 
 
Prof Jane Norman and Dr Sarah Stock 
On behalf of the AFFIRM Study 
 
 
NB: If you wish to print and fax your completed sheet to us, the number is 0131-242-6441 
 
 
 
 

AFFIRM 
Version 6_ 27th February 2017 
 
Appendix 5 - Version 1, 17th July 2017  
 
 
B) CLINICAL AUDIT to determine whether the perception of the site Principal Investigator is 
supported by review of actual decision making will be performed for the following elements: 
 
 
Cardiotocography within 2 hours of presentation,  
 
Measurement of amniotic fluid volume within 12 hours of presentation,  
 
Growth scan by the next working day for all women presenting with reduced fetal 
movement (and who had not had a growth scan within the last three weeks, or who were 
not being induced within 48 hours),  
 
Induction of labour within 48 hours for women presenting with recurrent reduced fetal 
movement at or after 37 weeks gestation. 
 
This will be conducted by asking sites to complete an audit of the management of all women 
presenting with reduced fetal movement over the course of one calendar month. Sites will be asked 
to complete an audit form for each participant.  
 
The audit form template (see below) has been generated by the central AFFIRM study team; 
anonymized forms will be analysed centrally. There will not be an attempt to corroborate Principal 
Investigator perception of the proportion of women who were given leaflets, nor will there be any 
attempt to incorporate the proportion of staff who had completed the e-learning package into 
analysis of whether any specific site has implemented the intervention or not.

Can Promoting Awareness of Fetal movements and Focussing Interventions Reduce Fetal Mortality - a stepped wedge cluster randomised trial? AFFIRM 
 
AFFIRM audit form final_May 2016  
 
 
 
 
 
 
 
 
 
Page 1 of 2 
AUDIT PART B: CLINICAL AUDIT FORM - One month data collection AUDIT [Month & Year] Unit name: [Name of Hospital] 
If you assess a woman with reduced fetal movements (RFM), please complete the questions below. Do not worry if the woman has been seen in other areas of the 
hospital by other staff, we would rather have multiple reports for the same woman than miss episodes of RFM. 
 
 
 
INSERT Patient Sticker (or WRITE name and CHI  /NHS number) 
AREA WHERE SEEN (CIRCLE)                
 
 Triage  / Labour ward /  Day Assessment Unit (DAU) 
 
 
Other (specify area i.e. antenatal ward):________________________________________ 
 
Date and time of 
presentation with reduced 
fetal movements. 
 
DATE: ______/_______/__________           
 
TIME  ____:____         am   /   pm 
 
GESTATION 
AND 
EDD: 
 
______________ WEEKS ___________ DAYS 
 
EDD:_____________________________________ 
 
Referred by (TICK BOX): 
 
 
Self 
 
Community 
Midwife 
 
GP 
 
ANC 
 
Triage 
 
DAU 
 
Other (specify:________________________________________ 
What was the primary 
reason for 
attending/phoning?  
(TICK BOX): 
 
Reduced Fetal Movements 
 
Other (specify: _______________________________________________________________ 
 
How many times has the 
woman attended before this 
visit, with RFM? (TICK 
BOX): 
 
None – first attendance 
 
 
Once previously 
 
Unknown 
 
Multiple times (please provide 
the gestation at each 
presentation i.e. 30+6) 
1 
2 
3 
4 
5 
 
What was the time interval from the woman first being aware of reduced fetal movements and 
attending the hospital (in hours)? 
                      
  HOURS: ________________________ 
 
Has she been given a leaflet 
“Your baby’s movements in 
pregnancy”?(TICK BOX): 
 
Yes – she already has one 
 
Yes – I have given one to her today 
 
Locally Created Leaflet Given 
 
NO 
Has this woman had a 
growth USS in this 
pregnancy? (TICK BOX): 
 
No, she has not had a growth 
scan 
Yes, within the last 3 weeks  (date of 
scan): 
 
DATE: ______/_______/__________ 
Yes, but more than 3 weeks ago (date of scan): 
 
                         DATE: ______/_______/__________ 
 

Can Promoting Awareness of Fetal movements and Focussing Interventions Reduce Fetal Mortality - a stepped wedge cluster randomised trial? AFFIRM 
 
AFFIRM audit form final_May 2016 
 
 
 
 
 
 
 
 
 
Page 2 of 2
 
 
 
 
 
 
 
CONTINUATION: NHS/ CHI NUMBER: …….……………… 
 
Are any of the following risk factors for Fetal growth restriction present (CIRCLE all that apply)? 
Age ≥40 
or ≤16 
Smoker 
≥20cpd 
 
Known or suspected 
growth restriction  
Congenital 
anomaly 
Raised BP (essential hypertension, pre-
eclampsia or pregnancy induced 
hypertension) 
Previous 
pre-
eclampsia  
Diabetes or  gestational 
diabetes 
Previous FGR or 
stillbirth 
What investigations were conducted during this episode of reduced fetal movement? 
Please record below the date and time that these investigations were completed or indicate if not performed. 
 
Please provide the results (CIRCLE): 
CTG  
 
 
            Not performed 
 
DATE: ___/___/______              TIME: _____:_____ am/pm         
 
Computerised CTG: YES  / NO     (CIRCLE)                                          
 
Normal / Suspicious / Pathological 
Liquor volume 
assessment on scan 
 
            Not performed 
 
 
DATE: ___/___/______               TIME: _____:_____ am/pm                        
 
Normal / Reduced / Increased 
Growth scan 
 
            Not performed 
 
 
DATE: ___/___/______               TIME: _____:_____ am/pm                        
Normal / EFW < 10th centile/ AC < 10th centile / EFW 
and AC < 10th centile 
Umbilical Artery 
Doppler 
 
            Not performed 
 
 
DATE: ___/___/______               TIME: _____:_____ am/pm                        
 
Normal/.> 95th centile/absent EDF/reversed EDF 
MCA Doppler 
 
            Not performed 
 
 
DATE: ___/___/______               TIME: _____:_____ am/pm                        
 
Normal/<5th centile 
DELIVERY METHOD (If available) 
Was the woman 
offered induction of 
labour  
 
 
YES    /   NO  (CIRCLE) 
 
IF Yes, please provide date, time and method of the 
induction: 
 
DATE: ________/  _______/  _______               
 
TIME:  _____:_____ am/pm    
 
Was the woman 
offered elective 
caesarean section as a 
result of the reduced 
fetal movement?  
 
YES    /   NO     (CIRCLE) 
 
IF Yes, please provide date, time and reason:         
   
 
DATE: ________/  _______/  _______               
 
TIME:  _____:_____ am/pm    
Please provide the reason for the elective Caesarean 
section: