\documentclass[10pt]{article}

\usepackage{fullpage}
\usepackage{setspace}
\usepackage{parskip}
\usepackage{titlesec}
\usepackage[section]{placeins}
\usepackage{xcolor}
\usepackage{breakcites}
\usepackage{lineno}
\usepackage{hyphenat}





\PassOptionsToPackage{hyphens}{url}
\usepackage[colorlinks = true,
            linkcolor = blue,
            urlcolor  = blue,
            citecolor = blue,
            anchorcolor = blue]{hyperref}
\usepackage{etoolbox}
\makeatletter
\patchcmd\@combinedblfloats{\box\@outputbox}{\unvbox\@outputbox}{}{%
  \errmessage{\noexpand\@combinedblfloats could not be patched}%
}%
\makeatother


\usepackage{natbib}




\renewenvironment{abstract}
  {{\bfseries\noindent{\abstractname}\par\nobreak}\footnotesize}
  {\bigskip}

\titlespacing{\section}{0pt}{*3}{*1}
\titlespacing{\subsection}{0pt}{*2}{*0.5}
\titlespacing{\subsubsection}{0pt}{*1.5}{0pt}


\usepackage{authblk}


\usepackage{graphicx}
\usepackage[space]{grffile}
\usepackage{latexsym}
\usepackage{textcomp}
\usepackage{longtable}
\usepackage{tabulary}
\usepackage{booktabs,array,multirow}
\usepackage{amsfonts,amsmath,amssymb}
\providecommand\citet{\cite}
\providecommand\citep{\cite}
\providecommand\citealt{\cite}
% You can conditionalize code for latexml or normal latex using this.
\newif\iflatexml\latexmlfalse
\providecommand{\tightlist}{\setlength{\itemsep}{0pt}\setlength{\parskip}{0pt}}%

\AtBeginDocument{\DeclareGraphicsExtensions{.pdf,.PDF,.eps,.EPS,.png,.PNG,.tif,.TIF,.jpg,.JPG,.jpeg,.JPEG}}

\usepackage[utf8]{inputenc}
\usepackage[ngerman,greek,english]{babel}



\usepackage{float}








\begin{document}

\title{ST analysis plus CTG compared to CTG alone for intrapartum fetal
monitoring (the START randomised controlled trial): A cost minimisation
study.}



\author[1]{Chris Wilkinson}%
\author[2]{Camille Schubert}%
\author[1]{Bronni Simpson}%
\author[3]{Sabrina Kuah}%
\author[3]{Geoffrey Matthews}%
\author[1]{Ian Symonds}%
\author[4]{Ben Mol}%
\author[5]{Amy Salter}%
\author[6]{Deborah Turnbull}%
\affil[1]{The University of Adelaide Faculty of Health and Medical Sciences}%
\affil[2]{The University of Adelaide Adelaide Health Technology Assessment}%
\affil[3]{Women's and Children's Hospital Adelaide}%
\affil[4]{Monash University}%
\affil[5]{The University of Adelaide School of Public Health}%
\affil[6]{The University of Adelaide School of Psychology}%


\vspace{-1em}



  
  \date{May 22, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
\endgroup





\selectlanguage{english}
\begin{abstract}
\textbf{Objective:} To undertake a cost minimisation study of ST
analysis (STan) plus cardiotocograpy (CTG) compared to CTG alone.
\textbf{Design:} Cost-minimisation analysis alongside a randomised
controlled trial {[}(1){]}(\#ref-0001). \textbf{Setting:} A tertiary
level maternity centre in Adelaide, South Australia.
\textbf{Population:} Women in labour [?]36 weeks gestation, with a
clinical indication for continuous electronic fetal monitoring.
\textbf{Methods:} We utlilised a health service perspective covering
randomisation to final maternal and neonatal discharge, including
readmissions. Primary analysis was intention to treat, with secondary
per protocol analysis. \emph{Post hoc} analyses were conducted by
sub-groups and after exclusion of outliers. \textbf{Main outcome
measure:} Average cost per mother/baby dyad. \textbf{Results:} Costs
were calculated for 957/968 patients (98.9\%) using hospital financial
data. There was no statistically significant evidence of difference
between the two study arms but lower costs observed in the STan arm.
Average cost per mother/baby dyad was AUD12,768 for Stan+CTG, compared
with AUD15,027 for CTG alone. Lower costs were mainly due to lower
neonatal costs, particularly for critical care. Maternal labour cost was
nearly identical in the two arms. The difference was still shown,
although with reduced magnitude, when outliers were removed and
increased with a per protocol analysis. \textbf{Conclusion:} While not
statistically significant, reduced costs were observed in the CTG+STan
arm (average reduction per mother / baby dyad = AUD2,259).%
\end{abstract}%



\sloppy


\textbf{Research Paper}

\textbf{ST analysis plus CTG compared to CTG alone for intrapartum fetal
monitoring (the START randomised controlled trial): A cost minimisation
study.}

Camille Schubert \textsuperscript{1} \textbar{} Chris
Wilkinson\textsuperscript{2,3} \textbar{} Bronni Simpson
\textsuperscript{2,3}\textbar{} Sabrina Kuah \textsuperscript{3}
\textbar{} Geoffrey Matthews\textsuperscript{3} \textbar{} Ian Symonds
\textsuperscript{2,4}\textbar{} Ben Mol \textsuperscript{5} \textbar{}
Amy Salter\textsuperscript{6} \textbar{} Deborah Turnbull
\textsuperscript{7}

\begin{enumerate}
\tightlist
\item
  \emph{University of Adelaide, Adelaide Health Technology Assessment
  (AHTA), Adelaide, SA, Australia.}
\item
  \emph{Faculty of Health and Medical Sciences, University of Adelaide,
  Adelaide, SA, Australia}
\item
  \emph{Women's and Children's Hospital, North Adelaide, SA, Australia}
\item
  \emph{International Medical University Kuala Lumpur, Malaysia}
\item
  \emph{Monash University, Clayton, Vic, Australia.}
\item
  \emph{University of Adelaide, School of Public Health, Faculty of
  Health and Medical Sciences, Adelaide, SA, Australia}
\item
  \emph{University of Adelaide, School of Psychology, Faculty of Health
  and Medical Sciences, Adelaide, SA, Australia}
\end{enumerate}

\textbf{Correspondence}

Chris Wilkinson

Faculty of Health and Medical Sciences, University of Adelaide,
Adelaide, 5000, South Australia, Australia

Telephone: (61) 4128 83336

Email: chris.wilkinson@adelaide.edu.au

\textbf{Abstract}

\textbf{Objective:} To undertake a cost minimisation study of ST
analysis (STan) plus cardiotocograpy (CTG) compared to CTG alone.

\textbf{Design:} Cost-minimisation analysis alongside a randomised
controlled trial (1).

\textbf{Setting:} A tertiary level maternity centre in Adelaide, South
Australia.

\textbf{Population:} Women in labour [?]36 weeks gestation, with a
clinical indication for continuous electronic fetal monitoring.

\textbf{Methods:} We utlilised a health service perspective covering
randomisation to final maternal and neonatal discharge, including
readmissions. Primary analysis was intention to treat, with secondary
per protocol analysis. \emph{Post hoc} analyses were conducted by
sub-groups and after exclusion of outliers.

\textbf{Main outcome measure:} Average cost per mother/baby dyad.

\textbf{Results:} Costs were calculated for 957/968 patients (98.9\%)
using hospital financial data. There was no statistically significant
evidence of difference between the two study arms but lower costs
observed in the STan arm. Average cost per mother/baby dyad was
AUD12,768 for Stan+CTG, compared with AUD15,027 for CTG alone. Lower
costs were mainly due to lower neonatal costs, particularly for critical
care. Maternal labour cost was nearly identical in the two arms. The
difference was still shown, although with reduced magnitude, when
outliers were removed and increased with a per protocol analysis.

\textbf{Conclusion:} While not statistically significant, reduced costs
were observed in the CTG+STan arm (average reduction per mother / baby
dyad = AUD2,259).

\textbf{Funding:} Australian National Health and Medical Research
Council (NH\&MRC) project grant (1129648)

\textbf{Keywords:} Cost-minimisation analysis, STAN, ST analysis, CTG,
cardiotocography



\textbf{Introduction}

In contrast to the UK's NHS Resolution organisation, Australian health
care lacks an ``arms length'' institution to manage medico legal issues.
NHS Resolution's 2021-2022 annual report (2) revealed that compensating
for harm caused by NHS maternity services costs almost three times what
the health service spends on maternity care (GBP 8.2 billion, compare to
GBP 3 billion spent on care). Cumulative maternity services' liability
has reached GBP 41.5 billion. (GBP 38.8 billion relating to cerebral
palsy).

Continuous Electronic Fetal Monitoring (CEFM) (3) aims to identify
intrapartum hypoxic stress to avoid HIE and intrapartum-related
perinatal deaths. Meta-analysis of RCTS studying both high and low risk
women (4) shows show reduced neonatal seizures, but without significant
reduction in cerebral palsy. It has been argued that such meta-analyses
still lack the power to detect significant reductions in severe adverse
fetal outcomes, given the rarity of such outcomes among all risk women
(5). It is evident that the devastating impact of cerebral palsy,
frequently associated with inadequate utilisation of fetal monitoring or
substandard staff education, has created the unsustainable situation
described above (6) .

ST analysis (STan) is an adjunct to CTG, introduced at the study
institution as a standard of care in 2015, aiming to better identifying
hypoxic stress, thus to keep babies safer. It was also anticipated in
our RCT that STan as an adjunct to CTG (CTG+STan) would reduce the
proportion of emergency caesarean sections (EmCS) from false positive
diagnoses of fetal distress (7), relative to CTG alone. However,
clinical results of our RCT (1) did not demonstrate significant evidence
of a reduction in the proportion of EmCS in women requiring CEFM in
labour, but we did show a smaller proportion of poor neonatal outcomes
in the CTG+STan arm (relative to CTG alone), although the study was
underpowered to detect a decrease in metabolic acidosis or other adverse
neonatal outcomes.

With cost-effectiveness analysis of maternity interventions being
further recognised for the allocation of health resources and strategies
of clinical care, the lack of a published economic evaluation of CEFM
may be a barrier in the implementation and provision of appropriate
intrapartum fetal surveillance. The objective of this study was to
identify the cost minimising approach, by quantifying costs in the
context of clinical equivalence in each arm of the randomised controlled
trial. Thus, we have performed a cost minimisation study, as a specific
type of cost effectiveness study (8).



\textbf{Methods}

\textbf{Clinical study}

A single-centre, RCT was conducted from January 2017 to July 2021) at
the largest tertiary care centre in South Australia (Women's and
Children's Hospital , North Adelaide) (Australian Clinical Trial
register number ACTRN12615001308583; Womens and Childrens Health Network
Human Research Ethics Committee approval (HREC/14/WCHN/145). Eligibility
for the trial included: being aged 18 years or older with a singleton
pregnancy; a fetus in cephalic presentation; a gestational age
\textgreater{}36weeks and an indication for CEFM based on RANZCOG
guidelines(9). Women were randomly allocated (1:1 ratio with
stratification for parity) to monitoring either by CTG+STan or CTG
alone(. The primary hypothesis was that the proportion of EmCS for women
on CTG+STan is not equal to that for women on CTG monitoring alone. Our
secondary hypotheses included that CTG+STan monitoring is cost-effective
compared to CTG alone (8).

For women assigned to CTG+STan, a fetal scalp electrode (FSE) was
applied to the fetal head and connected to a STAN\selectlanguage{ngerman}® fetal heart monitor
(STAN, Neoventa Medical, Mölndal, Sweden)(10), which allowed both
conventional CTG interpretation and ST analysis of the fetal ECG.
Further clinical management was made using the STan clinical guidelines
{[}STAN2007 CTG classification system{]} (11), in addition to CTG
classification and interpretation according to the RANZCOG clinical
guidelines (9). In women assigned to CTG alone, either an external
doppler transducer was utilised, or a FSE was applied to the fetal head
and a conventional fetal heart rate monitor (Philips or Neoventa) was
used. The CTG was classified and interpreted according to the RANZCOG
clinical guidelines (9) Clinical decisions were based on overall
clinical assessment combined with STan and/or CTG interpretation, as
described in further detail in the study protocol (8).

\textbf{Cost measurement and valuation of resource use}

The primary outcome of EmCS occurred in 107/482 (22.2\%) of the CTG+STan
arm and in 107/485 (22.1\%) in the CTG alone arm, adjusted relative risk
(RR) 1.02; 95\% confidence interval (0.81 to 1.27), P=0.89 (1). In
addition to observing the primary outcome, data from various clinical
feeder systems were used to identify the level of care provided and the
subsequent resource inputs for each patient. All inpatient costs were
calculated on a full absorption basis (i.e. inclusion of direct and
indirect costs) for each type of resource used. The preparation of
costing data conformed to standards required for the National Hospital
Cost Data Collection for the year of collection. This was done with the
exception of two cases where known neonatal admission cost data were
missing. After investigation, this missingness was assumed to be at
random and costs were imputed based in average neonatal admission costs
for that arm. All costs are expressed in Australian dollars (AUD) for
the financial year (FY) 2021. Costs from the FY2018 are inflated
8.3503\%; FY2019, 6.1453\%; and FY2020, 3.6229\%, based on the inflation
of the National Efficient Price (NEP) for health care services provided
by public hospitals, as determined by the The Independent Hospital
Pricing Authority (IHPA) (12).

The analysis used a health service perspective and included episode
costs for all maternal and neonatal admissions and readmissions that
occurred within a six week window from randomization.

\textbf{Statistical analyses}

The primary analysis was by intention to treat, with a secondary
analysis consistent with the main paper as per-protocol. \emph{Post
hoc}analyses were conducted of maternal and neonatal cost subgroups and
after exclusion of outliers. The economic perspective taken is that of
the Australian public hospital system with total costs incurred by the
hospital. Differences in costs between the two arms are presented with
95\% confidence intervals and evidence was considered statistically
significant if two-tailed P-values were \textless{} 0.05. All analyses
were conducted using {[}Stata/MP version 17.0{]} (13).

\textbf{Public and patient involvement}

The knowledge and attitudes of the women in a pilot study of CTG+STan
versus CTG alone were separately researched and reported (14) and
subsequently, more detailed psychosocial research was incorporated into
the study protocol (8). This more detailed work has been submitted for
publication as studies on both patient satisfaction (15) and
psychosocial outcomes (16) (unpublished observations).

In this paper, the core outcome sets have not been included.



\textbf{Results}

A total of 970 women were randomised; two women in the CTG+STan arm
withdrew after randomisation, and one in this arm was mistakenly
randomised before consent was obtained. Thus 967 women, 482 randomised
to CTG+STan and 485 women randomised to CTG alone were included in the
trial. Costs were calculated for 956 of these women (98.9\%); the final
6 women in the STan arm and the final 5 women in the CTG alone arm were
not included as their costing data was not available at the time of
analysis. The two arms were similar in baseline characteristics with
mean maternal age of 31 years, mean maternal gestation at randomisation
of 39 weeks and cervical dilation at randomisation of 3 cm
(Supplementary Table 1).

\textbf{Hospital costs}

There was no statistically significant evidence of a difference between
the two study arms in the average cost per mother/ baby dyad for the
initial ITT analysis. There were lower observed costs in the CTG+Stan
arm; mean cost of AUD12,768, compared to the CTG alone arm AUD 15,027;
difference = AUD2,260 (Table 1).

\textbf{Insert table 1 about here}

The two arms were also similar in terms of the type of costs per
mother-baby dyad. Of note however, is the non-statistically significant
reduction in critical care costs in the CTG + STan arm (AUD177, compared
with AUD1,438 in the CTG alone arm) (Table 1).

\textbf{Hospital admissions types and cost by admission type}

The differences in average costs between study arms observed in Table 1
prompted further \emph{post hoc} investigation of the admission episodes
and costs by admission type. The two arms were similar in the mean
percentage of mother/baby pairs that had any additional admissions for
either mother or baby after the initial delivery admission (CTG+STan:
40\%; CTG: 43.5\%). Almost two-thirds of pairs in both arms had no
additional admissions. The CTG+STan cohort had a nominally increased
rate of maternal readmission, however it was also associated with fewer
neonatal admissions, with particular relative reductions in neonates
requiring two or more admissions, and admissions requiring critical care
(Supplementary table 2). Critical care refers to Neonatal Intensive Care
(NICU) where a multidisciplinary team cares for babies who need 1:1
continuous observation and monitoring and will often require respiratory
support including oxygen therapy, CPAP, intubation, central line
management and critical pharmacological support

Table 2 shows total and average hospital admission and readmission costs
by the type of admission. Costs associated with delivery were similar
across arms with a marginally (approximately 1\%) higher cost in the
CTG+STan arm and costs per maternal readmission were also higher in the
CTG+STan arm (AUD5,188 vs AUD3,194), however given the overall low rate
of readmissions the average difference (AUD142 vs AUD67) over the cohort
as a whole was small (Table 2).

\textbf{Insert table 2 about here}

Conversely, the rate of neonatal admissions was lower in the CTG+STan
arm, and the average neonatal admission costs for admitted babies were
approximately half in the CTG+STan arm; AUD6,690 vs AUD13,294, which
resulted in the equivalent of a cost saving of AUD2,444 \emph{for every
mother-baby dyad in the cohort} (Table 2). While the evidence of this
difference was not statistically significant (given the large
variability in costs, and the fact that the study was not powered to
detect cost differences), the magnitude of the observed difference is
remarkable. Most of the difference in cost appears to result from
increased critical care costs for admitted neonates in the CTG alone
arm. Interestingly, the seven neonates in the CTG+STan arm admitted to
critical care had average total admission costs of about one third of
the fourteen requiring critical care in the CTG alone arm (AUD30, 650
compared with AUD94, 805 per neonatal admission incorporating a critical
care stay).

\textbf{Excluding outlier(s)}

There was an extreme outlier in the CTG alone arm (a neonatal admission
costing over AUD700,000). \emph{Post hoc} re-analysis with this dyad
excluded found the magnitude of the difference in the two arms was
reduced, however the findings still showed the same direction of cost
differences in the CTG+STan arm relative to CTG alone, including a
reduction in overall costs in the CTG+STan arm (Table 3). The direction
remained when the four most extreme cost cases (i.e. all cases with
total costs over AUD100,000; 3 CTG only cases, 1 STan case) were removed
from analysis, with the CTG+STan arm total costs on average lower by
\$393 (95\%CI -\$1,442, \$655, p = 0.2309) than the CTG alone arm, still
driven largely by reduced neonatal costs (on average \$579 lower (95\%CI
-\$1,278, \$120), p= 0.0523).

\textbf{Insert table 3 about here}

\textbf{Per protocol analysis}

When analysis was performed on the basis of treatment randomised being
the same as that received (i.e. per-protocol), the difference in
delivery costs reduced to just \$87 more using STan, and the difference
in maternal readmission rates and costs were also reduced. However, the
magnitude of the cost difference associated with neonatal admissions was
enlarged, such that difference in overall total costs increased to
\$2,824 per dyad, favouring CTG+STan. (Table 4).

\textbf{Insert table 4 about here}

\textbf{Analysis by outcome}

Analysis by both treatment arm and the primary study outcome (EmCS) also
demonstrated the cost-saving associated with CTG+STan was present in
both EmCS and non-EmCS cases, but with the finding more strongly
represented in the mothers and babies who did not experience EmCS
(Supplementary table 3).

\textbf{Discussion}

\textbf{Main findings}

The STan Australian Randomised Trial (START) is the first of its kind in
an Australian setting. Previous European trials have been conducted in
relatively low intervention environments (17-19), which, with less
clinically contentious caesarean sections being performed, we
hypothesised may have resulted in a lower likelihood of demonstrating
reduction in caesarean section. This rationale was supported by the
results of our pilot study with 162 women (7) suggesting the potential
for STan as an adjunct to CTG to reduce EmCS when implemented in a
clinical setting of high caesarean section. Our findings here, while not
significant, suggest that neonatal, but not maternal costs may be
reduced with the use of CTG+STan. The study was underpowered to detect a
difference in the main clinical outcome, EmCS (1), and the final sample
size also proved to be insufficient to make conclusive statements about
costs. Nevertheless the consistent direction of effect favouring the use
of CTG+STan warrants further research.

The average (non-statistically significant) cost reduction of about
2,000 AUD per mother-baby pair was largely explained by neonatal cost
reductions in the CTG+STan arm. STan monitoring is associated with less
complexity of neonatal care (with less requirment for higher level
neonatal care). Sizable reductions are shown for the sample overall, for
re-admissions, and for the various sensitivity analyses, both
per-protocol and with outlier exclusion.

This concurs with comparable European research. An analysis (20) based
on Individual Patient Data Meta-analysis (IPDMA) (21) incorporated data
from three European trials of STan monitoring (12,987 mother/baby
dyads). There was consistent reduction in neonatal metabolic acidosis.
Although the this reduction was not statistically significant, the
authors argued that this was not unexpected as even meta-analysis were
underpowered (requiring a over 24,000 patients before sufficient power
would determine a difference in metabolic acidosis if it existed, at \selectlanguage{greek}α \selectlanguage{english}=
0.05). The results suggested that metabolic acidosis was reduced from
1100 to 900 per 100 000 newborns if a CTG+STan-based strategy was
followed. and the cost effectiveness of CTG+STan depends on the
association between metabolic acidosis and cerebral palsy. it was
estimated that CTG+STan use could prevent one case of metabolic acidosis
at a cost of 14 509 euros, and that STan becomes a cost effective
strategy if \textgreater{} 1.0\% of the patients exposed to metabolic
acidosis developed cerebral palsy. The consistency of direction of
effect and similarity in magnitude of the reduction in our study with
regard to metabolic acidosis is comparable to published trials (absolute
difference of about 7\%).

These results suggest that STan may have a role to play in efforts to
improve quality and safety of care. Whilst the focus of improving fetal
monitoring has been directed at reducing maternal intervention,
particularly caesarean section, recent developments in the UK have
necessitated a renewed emphasis on neonatal safety (22). This
re-positioning of policy (23) is partly motivated by concerns about
costs for compensating for harm (24-26).

Neonatal costs may be a sensitive proxy for adverse neonatal outcomes. A
failure to implement, correctly interpret and appropriately act in
response to intrapartum fetal monitoring has been identified as an
important association with excessive mortality and morbidity in recent
reviews of under-performing maternity health services. The 2022 Ockenden
report (26), recommended improvements in monitoring of fetal wellbeing,
ensuring that clinicians keep abreast of developments in the field.
Earlier reviews (27) of excessive neonatal mortality in the Morecombe
Bay Report made similar recommendations, (27), as did a 2022 report by
the same author concernimg the East Kent Maternity services (24).

Reviews of excessive fetal mortality in Australia has also identified
underutilisation and misinterpretation of fetal heart rate monitoring by
``inadequately skilled'' staff and a lack of ``high quality staff
education'' as associated with preventable fetal morbidity and
mortality. It is suggested that inadequate intrapartum fetal
surveillance, and inadequate use or misinterpretation of
cardiotocography contributed to excessive mortality, and part of this
has been attributed to an inadequately skilled workforce (28, 29).

The work also goes towards redressing the dearth of published evidence
of the cost effectiveness of different techniques and technologies of
fetal monitoring. We are aware of only one published economic evaluation
of CEFM in an Australian context (30). reported on a trial of 600 women
randomised to CTG or fetal pulse oximetry (FPO), finding a non
significant 23\% relative risk reduction in operative delivery..

\textbf{Strengths and limitations}

A major strength of this research is the use of comprehensive
prospectively collected patient data within the context of a RCT, and
the concurrently provided costing data. It is also the first RCT on STan
as an adjunct to CTG in a region with a relatively higher CS rate, and
hence, if there was adequate power, differences in the primary outcome,
if they existed, were more likely to be demonstrated.

COVID-19 pandemic restrictions affected recruitment with limitations on
non-critical activity mandated from March 2020. There was reluctance of
midwives to recruit, and concerns from the women themselves, due to
perceived invasiveness of the FSE and impairment of mobility resulting
from the necessary use of a scalp clip if STan was randomised. This
resulted in women 970 women completing the study, which was only 53\% of
the planned sample size. Thus, the study was underpowered to detect
absolute differences \textless{}/= 5\% and the lack of a significant
finding in the primary outcome (caesarean section) may have been due to
a Type 2 error. Additionally, this failure to achieve the required power
for clinical outcomes would may have adversely affected the power to
detect differences in the economic outcomes.

\textbf{Interpretation}

Although no significant evidence of a reduction in maternal costs has
been demonstrated, consistent indications of reduced neonatal costs
associated with babies requiring less complex levels of care in the
Stan+CTG arm suggest that this technology warrants further Australian
and international research. As more data become available, it will be
important to undertake meta-analyses, ideally including individual
patient data, as well as updating existing reviews. These reviews will
result in a stronger evidence base that should subsequently be used to
formulate information for women about their options for fetal monitoring
so that they can make informed decisions wherever practical. In the
interim, given our previous findings of similarity in the main outcome
(EmCS) and consistent patterns of cost reduction, we suggest that the
addition of STan to CTG has the potential to be cost effective.

\textbf{Conclusion}

To conclude, the findings of reduced neonatal costs associated with the
use of CTG+STan in an Australian context (ableit non-significant) are
consistent with other studies performed elsewhere. Although no reduction
of maternal costs has been demonstrated, and with no difference in the
primary clinical outcome of emergency caesarean section, the reduced
neonatal costs and the delivery of babies requiring less critical care
suggest that the addition of STan to CTG warrants further investigation,
and may be cost effective. STan may have a role in helping to address
the significant safety challenges facing the maternity services.

\textbf{Declarations}

\textbf{Author contribution}

AS, DT, CW, IS, BM, SK, and GM conceived and designed the study and
acquired funding. BS, SK, GM, CW, IS and DT managed the trial. CS, AS,
BS, GM, SK and CW acquired the data. CS and AS analysed the data. CS,
CW, AS, and DT wrote the draft of the article, and all authors reviewed,
revised, and approved the final article.

\textbf{Funding statement}

This work was funded by a peer reviewed Australian National Health and
Medical Research Council (NH\&MRC) project grant (1129648). The NH\&MRC
had no part in the conduct, analysis or writing up the project.

\textbf{Acknowledgement}

Firstly, we would like to thank the women who participated in the study,
and the midwives and doctors who informed women about the study,
recruited the women and provided care. We also thank the START Data
Safety Monitoring Committee, Diogo Ayres-de-Campos, Scott Morris and
Katherine Lee. We also thank Dr Edwin Chandraharan, who provided
training in STan monitoring and designed and initiated the
implementation of our STAN staff training and accreditation programme.

\textbf{Ethical statement}

The study was prospectively registered with the Australian Clinical
Trials Registry (Australian Clinical Trial register number
ACTRN12615001308583;)

Ethics approval was recieved from the Womens and Childrens Health
Network Human Research Ethics Committee approval (HREC/14/WCHN/145).
(approved 20/11/2017, last amendment approved 13/03/2019)

\textbf{Disclosure of interest}

Neoventa Medical (M\selectlanguage{ngerman}ölndal, Sweden) provided training, education and
engineering support for installation and use of the Neovental S31
machines, when STan was first introduced to the WCH as a standard of
care in 2015, prior to and independent of the START RCT.

\textbf{References}

1. Kuah S, Simpson B, Salter A, Matthews G, Louise J, Bednarz J, et al.
Comparison of effect of CTG + STan with CTG alone on emergency Cesarean
section rate: STan Australian Randomized controlled Trial (START).
Ultrasound in obstetrics \& gynecology : the official journal of the
International Society of Ultrasound in Obstetrics and Gynecology.
2023;62(4):462-70.

2. NHS Resolution. NHS Resolution Annual reports and accounts 2021 / 22.
NHS Resolution, Care DoHaS; 2022 20 July 2022. Report No.: HC436
Contract No.: HC436.

3. Jauniaux E, Prefumo F. Fetal heart monitoring in labour: from pinard
to artificial intelligence. BJOG : an international journal of
obstetrics and gynaecology. 2016;123(6):870.

4. Alfirevic Z, Devane D, Gyte GM, Cuthbert A. Continuous
cardiotocography (CTG) as a form of electronic fetal monitoring (EFM)
for fetal assessment during labour. Cochrane Database Syst Rev.
2017;2:CD006066.

5. Bhide A, Chandraharan E, Acharya G. Fetal monitoring in labor:
Implications of evidence generated by new systematic review. Acta
obstetricia et gynecologica Scandinavica. 2016;85:5-8.

6. Davies.M, Lambert.G. Maternity payouts cost NHS twice the price of
care itself. London Times. 2023 Saturday April 15 2023.

7. Wilkinson. C, Kuah. S, Bryson. K, Mayes. M, Matthews. G, Mol. B, et
al. A pilot randomised trial of STan fetal monitoring compared with CTG
monitoring alone. Journal of Paediatrics and Child Health. 2017;53
3--117.

8. Turnbull D, Salter A, Simpson B, Mol BW, Chandraharan E, McPhee A, et
al. Comparing the effect of STan (cardiotocographic electronic fetal
monitoring (CTG) plus analysis of the ST segment of the fetal
electrocardiogram) with CTG alone on emergency caesarean section rates:
study protocol for the STan Australian Randomised controlled Trial
(START). Trials. 2019;20(1):539.

9. RANZCOG. Intrapartum Fetal Surveillance Clinical Guideline Clinical
guideline {[}Internet{]}. 2019 {[}cited 2022 09/05/2022{]}; (Fourth
edition). Available from:
https://ranzcog.edu.au/news/intrapartum-fetal-surveillance-clinical-guideline.

10. Rosén. KG, Lindecrantz. K. STAN--the Gothenburg model for fetal
surveillance during labour by ST analysis of the fetal
electrocardiogram. . Clin Phys Physiol Meas 1989;10 51-6.

11. Amer-Wahlin I, Arulkumaran S, Hagberg H, Marsal K, Visser GH. Fetal
electrocardiogram: ST waveform analysis in intrapartum surveillance.
BJOG : an international journal of obstetrics and gynaecology.
2007;114(10):1191-3.

12. IHACPA. National Hospital Cost Data Collection 2023 {[}Available
from:
https://www.ihacpa.gov.au/health-care/costing/national-hospital-cost-data-collection.

13. Stata Statistical Software: Release 17. In: College Station TSLS,
editor. Stata Statistical Software: Release 17. College Station, TX:
StataCorp LLC. StataCorp. 2019. ed. College Station, TX: StataCorp LLC.
StataCorp. 2019.; 2019.

14. Benton M, Salter A, Simpson B, Wilkinson C, Turnbull D. A
qualitative study of a sample of women participating in an Australian
randomised controlled trial of intrapartum fetal surveillance.
Midwifery. 2020;83:102655.

15. Benton. M, Salter. A, Wilkinson. C, Simpson.B, Turnbull. D. Women's
satisfaction with intrapartum fetal surveillance: a mixed-method study
within the STan Australian Randomised Controlled Trial (START). .
Midwifery (under review). 2023.

16. Benton. M, Salter. A, Wilkinson. C, Simpson. B, Turnbull. D.
Psychosocial outcomes of a cohort of women participating in the STan
Australian Randomised Controlled Trial (START). Birth (under review).
2023.

17. Westerhuis ME, Moons KG, van Beek E, Bijvoet SM, Drogtrop AP, van
Geijn HP, et al. A randomised clinical trial on cardiotocography plus
fetal blood sampling versus cardiotocography plus ST-analysis of the
fetal electrocardiogram (STAN) for intrapartum monitoring. BMC pregnancy
and childbirth. 2007;7:13.

18. Vayssiere C, David E, Meyer N, Haberstich R, Sebahoun V, Roth E, et
al. A French randomized controlled trial of ST-segment analysis in a
population with abnormal cardiotocograms during labor. American journal
of obstetrics and gynecology. 2007;197(3):299 e1-6.

19. Westgate J, Harris M, Curnow JSH, Greene KR. Plymouth randomized
trial of cardiotocogram only versus ST waveform plus cardiotocogram for
intrapartum monitoring in 2400 cases. American journal of obstetrics and
gynecology. 1993;169(5):1151-60.

20. van 't Hooft J, Vink M, Opmeer BC, Ensing S, Kwee A, Mol BW.
ST-analysis in electronic foetal monitoring is cost-effective from both
the maternal and neonatal perspective. The journal of maternal-fetal \&
neonatal medicine : the official journal of the European Association of
Perinatal Medicine, the Federation of Asia and Oceania Perinatal
Societies, the International Society of Perinatal Obstet.
2016;29(20):3260-5.

21. Schuit E, Amer-Wahlin I, Ojala K, Vayssiere C, Westerhuis ME, Marsal
K, et al. Effectiveness of electronic fetal monitoring with additional
ST analysis in vertex singleton pregnancies at \textgreater{}36 weeks of
gestation: an individual participant data metaanalysis. American journal
of obstetrics and gynecology. 2013;208(3):187 e1- e13.

22. E. W. Hospitals in England are told to stop using caesarean rates to
assess performance. BMJ. 2022;376:o446. BMJ. 2022;376:446.

23. Secretary of State for Health and Social Care. The Government's
response to the Health and Social Care Committee report

Safety of Maternity services in England: . HMSO; 2021.

24. Kirkup. B. Reading the signals. Maternity and Neonatal Services in
East Kent. The report of the Independant Investigation. . 2022. Report
No.: ISBN: 978-1-5286-3675-9.

25. Lintern S. Top midwife says sorry for lives lost to ``normal birth''
drive. The Sunday Times. 2022 Sunday March 6 2022;Sect. News.

26. Ockenden D. Ockenden Report Final Findings, conclusions and
essential actions from the independant review of maternity services at
the Shrewsbury and Telford Hospital NHS trust.: Her Majesties Stationery
Office; 2022. Contract No.: E02725921 13/22.

27. Kirkup. B. The Report of the Morecambe Bay Investigation. Williams
Lea Group UK: The Stationery Office; 2015. Contract No.: ID 26021502.

28. Picone. D, Pehm. K. Review of the Department of Health and Human
Services' management of a critical issue at Djerriwarrh Health Services.
Australian commission on quality and safety in health care; 2015 Nov
2015.

29. Wallace EM. Report of an investigation into perinatal outcomes at
Djerriwarrh Health Services : Professor Euan M Wallace. Melbourne,
Victoria Department of Health and Human Services; 2016. Contract No.:
4753594 (ISMN).

30. East CE, Gascoigne MB, Doran CM, Brennecke SP, King JF, Colditz PB.
A cost-effectiveness analysis of the intrapartum fetal pulse oximetry
multicentre randomised controlled trial (the FOREMOST trial). BJOG : an
international journal of obstetrics and gynaecology. 2006;113(9):1080-7.

\textbf{Table 1: Hospital costs over 6 weeks, across armsintention to
treat; ITT): total and per mother/ baby dyad}\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
\begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{Hospital Costs}\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{ITT~analysis set} (956 dyads)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{CTG+Stan} (476 dyads)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{CTG} (480 dyads)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{Cost difference} \textbf{(CI 95\%), p value}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Operating Theatre and SPS\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,241\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,250\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,232\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$17 (-\$244, \$278) p=0.45\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Ward Nursing\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$4,572\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$4,510\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$4,634\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\$124 (-\$515, \$266) p=0.27\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Ward medical\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,661\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,540\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,781\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\$241 (-\$620, \$544) p=0.06\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Pharmacy, prostheses and ward stores\textsuperscript{a}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,506\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,470\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,541\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\$72 (-\$193, \$48) p=0.12\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Critical Care\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$810\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$177\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,438\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\$1,261 (-\$3,299, \$778) p=0.11\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Imaging and/or Pathology\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$442\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$411\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$473\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\$62 (-\$155, \$31) p=0.10\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Allied Health\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$185\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$149\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$222\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\$73 (-\$181, \$36) p=0.10\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Transport\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$57\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$6\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$108\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\$102 (-\$300, \$97) p=0.16\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Other\textsuperscript{b}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$3,428\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$3,256\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$3,599\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\$343 (-\$837, \$150) p=0.09\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Total costs}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$13,289,928\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$6,077,019\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$7,212,909\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Costs per mother/baby dyad\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Costs per mother/baby dyad\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Costs per mother/baby dyad\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Costs per mother/baby dyad\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Costs per mother/baby dyad\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Mean}\\
(95\% CI)\\
25\% percentile\\
50\% percentile (median)\\
75\% percentile\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{\$13,902} (\$12,290, \$15,514) \$7,227 \$10,812 \$16,128\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{\$12,768} (\$11,968, \$13,565) \$7,176 \$10,905 \$16,060\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{\$15,027} (\$11,913, \$18,141) \$7,287 \$10,638 \$16,238\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{-\$2,260} (-\$5,482, \$962), p=0.08\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\textsuperscript{a} Pharmacy includes: pharmacy and PBS drugs,
prostheses and ward stores

\textsuperscript{b} Other includes: depreciation, hotel costs,
non-clinical costs and on-costs



\textbf{Table 2: Maternal and neonatal admissions and readmissions*,
with hospital costs}\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
\begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{ITT analysis set} n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{CTG+STan} n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{CTG~} n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{Risk difference (95\% CI), and/or test~, p value}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal admissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Number of maternal admissions (for delivery)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
956\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
476\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
480\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal readmissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal readmissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal readmissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal readmissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal readmissions}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Number of maternal readmissions\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
24\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
14\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
10\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Mothers with [?]1 admission\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
23 (2.41\%)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
13 (2.73\%)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
10 (2.08\%)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0.65\% (-1.30\%,\textbf{~}2.59\%), Fisher's exact 2 sided\textbf{~}p =
0.54\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Mothers with [?]2 admissions\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
1 (0.10\%)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
1 (0.21\%)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0 (0.00\%)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0.21\% (-0.20\%,\textbf{~}0.62\%), Fisher's exact 2-sided\textbf{~}p =
0.50\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Neonatal admissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Neonatal admissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Neonatal admissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Neonatal admissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Neonatal admissions}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Number of neonatal admissions\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
375\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
175\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
200\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Neonatal readmissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Neonates with [?]1 admission\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
331 (34.62\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
161 (33.82\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
170 (35.42\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
-1.59\% (-7.62\%. -4.44\%) Fisher's exact (2 sided)\textbf{~}p =
0.634\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Neonates with [?]2 admissions\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
34 (3.56\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
10 (2.10\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
24 (5.00\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\textbf{-2.90\% (-0.562\%, -5.24\%)} Fisher's exact (2-sided)~\textbf{p
= 0.022}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Neonates with a critical care admission\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
21 (2.20\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
7 (1.47\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
14 (2.92\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
-1.45\% (-3.30\%, 0.41\%) Fisher's exact (2 sided)\textbf{~}p =
0.184\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Total admissions recorded\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
1,355\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
665\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
690\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Delivery Admission}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Delivery Admission}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Delivery Admission}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Delivery Admission}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Delivery Admission}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Total Costs\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$9,853,438\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$4,932,482\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$4,920,956\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Average per dyad\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$10,307\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$10,362\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$10,252\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$110 (-\$527, \$747), p = 0.37\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal readmissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal readmissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal readmissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal readmissions}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Maternal readmissions}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Total maternal readmission costs (n mothers readmitted)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$99,383 (23)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$67,438 (13)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$31,945 (10)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Average cost per mother with readmission\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$4,321\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$5,188\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$3,194\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$1,993 (-\$575. \$4,562), p = 0.06\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Average maternal readmission costs per dyad in cohort\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$104\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$142\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$67\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{\$}75 (-27, \$178), p = 0.08\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

Based on costings data, not as reported in clinical analysis

\textbf{Table 3: Average costs, by admission type, excluding outlier
mother/baby dyad}\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
\begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
Admission Component\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{ITT, less outlier} (955 dyads)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{CTG+STan} 476 dyads\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{CTGalone} 479 dyads\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{Difference, (CI 95\%), p value}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Delivery cost (per dyad in cohort)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$10,309\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$10,362\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$10,257\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$106 (-\$532, \$743), p = 0.4\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Maternal readmission cost (per dyad in cohort)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$104\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$142\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$67\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$75 (-\$28, \$178), p = 0.08\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Neonatal admission cost (per dyad in cohort)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$2,748\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$2,263\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$3231\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{-\$968 (-\$2,139, \$203), p =0.053}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
Neonatal ICU cost (per dyad in cohort)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$296\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$158\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\$432\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\$274 (-\$753, \$205), p=0.13\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{Average total cost, per dyad}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{\$13,162}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{\$12,767}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{\$13,554}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-\$788 (-\$2,190, \$615), p = 0.14\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 4: Admission rates and average costs, by per-protocol (PP)
analysis}\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
& \textbf{PP* ~analysis set} & \textbf{CTG+STan} & \textbf{CTG alone} &
\textbf{Difference, (CI 95\%), p value}\tabularnewline
\midrule
\endhead
Delivery Admissions (dyads) & 872 & 393 & 479 &\tabularnewline
Mothers with readmission(s) & 19 & 9 (2.29\%) & 10 (2.09\%) & 0.20\%,
Fisher's exact, 2 sided p= 1.0\tabularnewline
Neonates with admission(s) & 296 & 126 (32.06\%) & 170 (35.49\%) &
-3.43\% Fisher's exact, 2 sided p= 0.31\tabularnewline
Neonatal ICU admissions & 16 & 2 (0.51\%) & 14 (2.92\%) &
\textbf{-2.41\% Fisher's exact,}\tabularnewline
2 sided p= 0.009 & & & &\tabularnewline
Delivery cost (per dyad in cohort) & \$10,299 & \$10,347 & \$10,260 &
\$87 (-\$578, \$752), p = 0.4\tabularnewline
Maternal readmission cost (per dyad in cohort) & \$83 & \$104 & \$67 &
\$37 (-\$50, \$124), p = 0.20\tabularnewline
Neonatal admission cost (per dyad in cohort) & \$3,405 & \$1,805 &
\$4,718 & \textbf{-\$2,913 (-\$6,332, \$506), p =0.05}\tabularnewline
Neonatal ICU cost (per dyad in cohort) & \$809 & \$39 & \$1,441 &
-\$1,402 (-\$3,643, \$840), p=0.11\tabularnewline
\textbf{Total average cost, per dyad} & \textbf{\$13,788} &
\textbf{\$12,256} & \textbf{\$15,045} & -\$2,789 (-\$6290, \$7,12), p =
0.06\tabularnewline
\bottomrule
\end{longtable}

* Includes only those participants who undertook the fetal monitoring
they were randomly assigned to receive

\textbf{Hosted file}

\verb`Table S1.docx`  available at \url{https://authorea.com/users/673433/articles/672212-st-analysis-plus-ctg-compared-to-ctg-alone-for-intrapartum-fetal-monitoring-the-start-randomised-controlled-trial-a-cost-minimisation-study}

\textbf{Hosted file}

\verb`Table S2.docx`  available at \url{https://authorea.com/users/673433/articles/672212-st-analysis-plus-ctg-compared-to-ctg-alone-for-intrapartum-fetal-monitoring-the-start-randomised-controlled-trial-a-cost-minimisation-study}

\textbf{Hosted file}

\verb`Table S3.docx`  available at \url{https://authorea.com/users/673433/articles/672212-st-analysis-plus-ctg-compared-to-ctg-alone-for-intrapartum-fetal-monitoring-the-start-randomised-controlled-trial-a-cost-minimisation-study}

\selectlanguage{english}
\FloatBarrier
\end{document}

