DOI: 10.1111/1471-0528.

15448 Intrapartum care

www.bjog.org

Admission cardiotocography versus intermittent

auscultation of the fetal heart in low-risk
pregnancy during evaluation for possible labour
admission – a multicentre randomised trial:
the ADCAR trial
V Smith,a C Begley,a J Newell,b S Higgins,c DJ Murphy,d,e MJ White,f JJ Morrison,g S Canny,g
D O’Donovan,h D Devanei,j
a
School of Nursing and Midwifery, Trinity College Dublin, Dublin, Ireland b School of Mathematics, Statistics and Applied Mathematics,
National University of Ireland, Galway, Ireland c Department of Obstetrics and Gynaecology, National Maternity Hospital, Dublin, Ireland
d
Department of Obstetrics, School of Medicine, Trinity College Dublin, Dublin, Ireland e Department of Obstetrics and Gynaecology, Coombe
Women and Infants University Hospital, Dublin 8, Ireland f Department of Neonatology/Paediatrics, Coombe Women and Infants University
Hospital, Dublin 8, Ireland g Department of Obstetrics and Gynaecology, University College Hospital Galway, Galway, Ireland h Department of
Neonatology/Paediatrics, University College Hospital Galway, Galway, Ireland i School of Nursing and Midwifery, National University of Ireland,
Galway, Ireland j Health Research Board, Trials Methodology Research Network, National University of Ireland, Galway, Ireland
Correspondence: V. Smith, School of Nursing and Midwifery, Trinity College Dublin, 24 D’Olier Street, Dublin 2, Ireland.
Email: smithv1@tcd.ie

Accepted 2 August 2018. Published Online 19 September 2018.

Objective To assess the effect of admission cardiotocography
(ACTG) versus intermittent auscultation (IA) of the fetal heart
(FH) in low-risk pregnancy during assessment for possible labour
on caesarean section rates.
Design A parallel multicentre randomised trial.
Setting Three maternity units in the Republic of Ireland.
Population Healthy, low-risk pregnant women, at term and
≥ 18 years old, who provided written informed consent.
Methods Women were randomised to receive IA of the FH or
20 minutes ACTG on admission for possible labour onset, using
remote telephone randomisation. Both groups received IA
during labour, with conversion to continuous CTG as clinically
indicated.
Main outcome measures Caesarean section (primary outcome),
obstetric interventions (e.g. continuous CTG during labour, fetal
blood sampling, augmentation of labour) and neonatal morbidity
(e.g. metabolic acidosis, admission to the neonatal intensive care
unit, neonatal death).
Results Based on 3034 women (1513 and 1521 randomised to IA
and ACTG, respectively), there was no statistical difference
between the groups in caesarean section [130 (8.6%) and 105
(6.9%) for IA and ACTG groups, respectively; relative risk (RR)
1.24; 95% CI 0.97–1.58], or in any other outcome except for use
of continuous CTG during labour, which was lower in the IA
group (RR 0.90, 95% CI 0.86–0.93).
Conclusion Our study demonstrates no differences in obstetric or
neonatal outcomes between IA and ACTG for women with
possible labour onset, other than an increased risk for continuous
CTG in women receiving ACTG.
Keywords Admission cardiotocography, cardiotocography, fetal
assessment, intermittent auscultation, labour admission test.
Tweetable abstract No differences in outcomes between
intermittent auscultation and admission cardiotocography for
women with possible labour onset.
Linked article This article is commented on by AM Vintzileos,
p. 122 in this issue. To view this mini commentary visit https://
doi.org/10.1111/1471-0528.15445.

Please cite this paper as: Smith V, Begley C, Newell J, Higgins S, Murphy DJ, White MJ, Morrison JJ, Canny S, O’Donovan D, Devane D. Admission
cardiotocography versus intermittent auscultation of the fetal heart in low-risk pregnancy during evaluation for possible labour admission – a multicentre
randomised trial: the ADCAR trial. BJOG 2019;126:114–121.

Trial registration: http://www.isrctn.com/(ISRCTN96340041).

114 ª 2018 Royal College of Obstetricians and Gynaecologists

 A randomised trial of ACTG versus IA on labour ward admission
Introduction
Monitoring of the fetal heart rate (FHR) throughout preg-
nancy, labour and birth is central to the assessment of fetal
wellbeing to optimise fetal and neonatal outcomes. A pre-
cursor to FHR monitoring during labour is an assessment
of the FHR on admission to the labour ward or labour
assessment room in women with signs and symptoms of
possible labour onset. This is usually performed by either
intermittent auscultation (IA), which involves listening to
and counting the fetal heart (FH) for one or more minutes,
or admission cardiotocography (ACTG), a screening test
consisting of an approximately 20-minute electronic
recording of the FHR and uterine activity. The rationale
for labour admission assessment of the FHR is to try to
identify those babies at greater risk of intrapartum fetal
compromise, and hence, who might benefit from continu-
ous cardiotocography (cCTG) during labour.1 However,
there is evidence of a lack of benefit supporting the use of
ACTG in low-risk pregnancy with many guidelines recom-
mending the use of IA in the absence of risk factors for
continuous monitoring of fetal wellbeing.2,3 However, pre-
vious trials informing these guidelines have evaluated the
effects of ACTG on women in the context of diagnosed
labour, either spontaneous onset or induced labour.4–7 Rec-
ommendations have called for studies to evaluate the
effects of ACTG on women admitted with signs and symp-
toms of possible labour onset, when ACTG is applied, gen-
erally, and before a formal diagnosis (e.g. following an
assessment of cervical dilatation and effacement on vaginal
examination) of spontaneous or induced labour.8,9
The objective of this paper is to report the findings of a
multicentre randomised trial that compared ACTG with IA
of the FHR in low-risk healthy pregnant women presenting
with signs and symptoms of possible labour onset, and
before confirmation of established labour, on rates of cae-
sarean section, obstetric intervention and neonatal morbid-
ity. The trial is registered with http://www.isrctn.com/
ISRCTN96340041.
Methods
Design and participants
A two-group, parallel, randomised trial was undertaken in
three maternity units in the Republic of Ireland between
May 2008 and June 2012. Two units were tertiary centres
with approximately 8000 and 3000 births per annum, and
the other unit was a regional centre with an annual birth
rate of approximately 4000. Participants were healthy low-
risk pregnant women attending any of the three study sites
with signs and symptoms of possible labour onset. Eligibil-
ity criteria included gestation between 37+0 and 40+6 com-
pleted weeks of pregnancy, age ≥ 18 years, and an ability
ª 2018 Royal College of Obstetricians and Gynaecologists
to understand study information and give written informed
consent. Women were excluded if any of the following con-
ditions applied to them: previous caesarean section, pre-
eclampsia, diabetes, gestational age greater than 40+6 or less
than 37+0 weeks, undergoing induction of labour, rupture
of membranes for longer than 24 hours, temperature
> 37.5°C on admission, body mass index > 35 kg/m2 at
antenatal booking, maternal age > 40 or < 18 years,
assisted conception in this pregnancy, previous stillbirth or
neonatal death, small-for-gestational-age (< 10th centile),
oligiohydramnios, polyhydramnios, abnormal Doppler
artery velocimetry, multiple pregnancy, breech presentation,
reduced fetal movements on two or more occasions, meco-
nium stained liquor, fetal congenital abnormality, or seri-
ous maternal medical disease (cardiac or vascular disease,
epilepsy, liver disease, hyperthyroidism, or abnormal renal
function).
Enrolment procedures
A two-stage process of consent was used. Women attending
the antenatal clinic between 32 and 40 weeks of gestation
were given written information about the study and asked
to consider participation before their admission to the hos-
pital with signs and symptoms of possible labour onset. A
sticker showing ‘ADCAR study information given’ was
placed on the front cover of their maternity notes high-
lighting that they had received the study information.
Women attending the labour ward/labour assessment unit
between 37+0 and 40+6 weeks of gestation with signs and
symptoms of possible labour onset (e.g. regular uterine
contractions, rupture of membranes, maternal report of
suspected labour), and who had received the study infor-
mation, were screened for eligibility to participate in the
trial using a trial screening and register form. Screening
was conducted by the admitting midwives, on a 24-hour
basis, as women presented. Women who were screened eli-
gible were invited to participate in the trial and sign the
study consent form. Following consent, participating
women were randomised to receive ACTG or IA (allocation
ratio of 1:1) by the admitting midwife using a remote cen-
tral telephone randomisation service (ALEA, a software
package developed to support randomisation in healthcare
research in Europe). Randomisation occurred before a for-
mal diagnosis of labour; eligible women with signs and
symptoms of possible labour onset were entered into the
trial irrespective of whether they were subsequently found
to be in established labour or not, or whether their admis-
sion was for nonreassuring FHR following assessment. The
randomisation sequence was computer generated, using
block randomisation, with random block sizes of two or
four, and stratification by study site. Due to the nature of
the intervention, blinding was not possible at participant
and clinician level; however, the biostatistician performing
115
 Smith et al.
the analysis was blinded to group allocation during the
analysis process.
Intervention group
Women randomised to the intervention received IA of the
FH, performed by the admitting midwife, on admission for
possible labour onset, using either a Pinard stethoscope or
a hand-held Doppler ultrasound device. Although the cho-
sen method of IA was not recorded routinely, the likeli-
hood was that a Doppler device was used in the majority
of cases as this is the more commonly adopted method for
IA in the trial settings. IA included abdominal palpation of
uterine contractions and assessment of the FHR for at least
60 seconds after a uterine contraction. Conversion to CTG
occurred where IA revealed a baseline FHR of < 110 beats/
minute or > 160 beats/minute or any decelerations in the
FH; or if any other risk factors developed during admis-
sion, which warranted cCTG, or the clinician caring for the
woman had any other cause for concern. Following IA,
where the above interpretation criteria were met, subse-
quent care during labour was in accordance with standard
care; that is, monitoring of the FHR by IA for 1 minute at
least every 15 minutes in the first stage and at least every
5 minutes in the second stage of labour or conversion to
cCTG if clinically indicated. Women assessed as not being
in established labour following randomisation were either
discharged home or admitted to the antenatal ward to
await further signs and symptoms of labour. On readmis-
sion to the labour ward or labour assessment room, with
further signs and symptoms of labour, and where the trial
screening and register form criteria for low-risk continued
to be met, women received IA of the FHR, with subsequent
care in accordance with the care as described above.
Control group
Women randomised to the control group received 20-min-
utes of ACTG on admission to the labour ward or labour
assessment room, as was standard care in the three partici-
pating hospitals. If the baseline FHR was between 110 and
160 beats/minute, baseline variability was >10 beats/min-
ute, there were more than two accelerations present, and
decelerations were absent then the tracing was classified as
normal and discontinued, and the findings were docu-
mented. The uterine contraction pattern was also assessed.
If, following the ACTG, the above interpretation criteria
were met, the woman’s care was in accordance with stan-
dard care; i.e. IA for monitoring of the FH during labour
or conversion to cCTG as warranted. If the interpretation
criteria were not met on ACTG, CTG was continued and
interpretation of the tracing was used to inform the subse-
quent care of the woman, as was current practice. Women
assessed as not being in established labour following ran-
domisation were either discharged home or admitted to
116
the antenatal ward to await further signs of possible labour
onset. On readmission to the labour ward or labour assess-
ment room with further signs and symptoms of labour,
women received ACTG with subsequent care in accordance
with care as described above.
Outcome measures
Although a core outcome set for intrapartum fetal assess-
ment is registered with the Core Outcome Measures in
Effectiveness Trials (COMET) database (http://www.comet-
initiative.org/studies/details/741?result=true), this core out-
come set is not yet developed. In the absence of a core out-
come set, our outcome measures were as follows. The
primary outcome measure was overall incidence of cae-
sarean section. Maternal secondary outcome measures were
cCTG during labour (defined as cCTG for > 75% of labour
duration), fetal blood sampling, augmentation of labour
with oxytocin, augmentation of labour with artificial rup-
ture of membranes, duration of labour, epidural analgesia,
pethidine analgesia and mode of birth. Neonatal outcome
measures were metabolic acidosis (defined as an umbilical
artery blood pH < 7.0, and a base deficit of > 12.0 mmol/
l),1 hypoxic ischaemic encephalopathy, seizures (either
apparent clinically or detected by electroencephalographic
recordings), neonatal Apgar scores at 1 and 5 minutes,
admission to the neonatal intensive care unit (NICU),
length of stay in NICU (in days), neonatal death, stillbirth,
intracranial haemorrhage (as determined by cranial ultra-
sound/magnetic resonance imaging report), meconium
aspiration (as determined on X-ray) and any neonatal
resuscitation. The following baseline characteristics were
also measured: maternal age, gestation at birth, parity,
neonatal birthweight and neonatal congenital abnormality
(undetected before birth).
Public and patient involvement
A maternity service user was a member of the Trial Steer-
ing Committee. Pregnant women were involved as partici-
pants in the trial.
Sample size assumptions and estimates
A retrospective clinical audit of 600 women was conducted
in two hospitals in 2007 to determine the number of
women who would potentially be eligible to take part in the
study and to determine the incidence of caesarean section
in this low-risk maternity sample. The audit found that
55% of women, across the two hospitals, met the eligibility
criteria, and the caesarean section rate was 5.2%. With 80%
power and a set at < 0.05, a sample size of 5776 women
(2888 per group), allowing for a 10% attrition rate, was
required to detect a 30% reduction in the incidence of cae-
sarean section (i.e. from 5.2% with ACTG to 3.6% with IA)
allowing for a 10% attrition rate. Calculations were per-
formed using SAMPLE POWER.
ª 2018 Royal College of Obstetricians and Gynaecologists
 A randomised trial of ACTG versus IA on labour ward admission

Data collection and statistical analysis Results

Data were extracted from the Maternity Information Sys-
tems in each hospital and from hard copy clinical notes as
required. Predesigned data extraction forms were devel-
oped, piloted and refined for collecting the relevant data.
All data were entered into SPSS (Version 16) in prepara-
tion for analysis. For dichotomous data, relative risks (RR)
with 95% CI were calculated. For continuous data, mean
differences (MD) with 95% CI were calculated. For the pri-
mary outcome, incidence of caesarean section, an unad-
justed analysis, followed by a secondary exploratory
analysis adjusting for a mother’s age, parity and site (and
possible interactions), was performed. All comparisons for
secondary outcomes were unadjusted. All analyses adhered
to ‘intention-to-treat’; however, as a number of women
were discharged home ‘not in labour’ following randomisa-
tion (see Table 1), and became ineligible subsequently, we
performed a sensitivity analysis for the primary outcome
excluding these women.
Ethical considerations
Ethical approval to conduct the study was granted by the
Faculty of Health Sciences, Trinity College Dublin, and the
Research Ethics Committees of each of the three study
sites. Participation was voluntary, and women could with-
draw from the study at any time. Written informed consent
was sought from eligible women as close as possible to the
time of randomisation. All data were collected, processed
and stored confidentially in accordance with the Data Pro-
tection (Amendment) Act (2003).10 The trial was funded
by an HRB-Ireland grant (ref: RP/2006/55) and supported
by an equipment grant from the Department of Health and
Children (Ireland).
During the study period, 14 928 women who had received
the study information were assessed for eligibility to partic-
ipate in the study. Of these, 6771 (45%) were screened eli-
gible, of whom 3045 (45%) consented and participated.
Eleven (0.4%; six ACTG, five IA) women were lost to fol-
low up, resulting in data from 3034 women available for
analysis. Table 1 presents participant characteristics by
group; no differences in baseline characteristics were found.
Figure 1 illustrates the recruitment and randomisation
process.
Primary outcomes
A total of 235 women had a caesarean section; 130 (8.6%)
in the IA group and 105 (6.9%) in the ACTG group. The
results demonstrate no significant difference between the
groups in relation to caesarean section rates observed
(unadjusted RR 1.24, 95% CI 0.97–1.59, P = 0.08). The
primary reasons for caesarean section in the IA and ACTG
groups, respectively, were caesarean section for abnormal
FHR pattern (n = 84 and n = 71), emergency caesarean
section for reasons other than abnormal FHR pattern
(n = 42 and n = 34), and elective caesarean section (n = 4,
IA group only).
Secondary outcomes
There were no statistical differences in any of the secondary
outcomes, other than the use of cCTG during labour,
which was significantly less in the IA group (RR 0.90, 95%
CI 0.86–0.93), P < 0.00001). Table 2 presents the results
for the secondary outcomes.
No fetal or neonatal deaths (up to discharge home) were
observed in the study. Ninety-six babies in total were

Table 1. Participant characteristics Total screened

14 928
Characteristic IA = 1513 ACTG =1521

Ineligible Declined Randomised

Maternal age at time 30.4 years 30.1 years 8157 3726 3045
of randomisation (mean)
Para 0 668 (44%) 654 (43%)
Para 1 533 (35%) 524 (35%) ACTG IA
Para 2+ 312 (21%) 343 (22%) 1527 1518
Ineligible post-randomisation 227 (15%) 249 (16%)
Spontaneous labour onset 1376 (91%) 1363 (91%)
Induced labour* 123 (8%) 149 (10%) Loss to follow up Loss to follow up
Not in labour caesarean section 14 (1%) 9 (1%) 6 5

*Two hundred and seventy-two women presenting with signs of

labour were randomised to the study, found not to be in labour, ACTG for analysis IA for analysis
1521 1513
and subsequently had an induction of labour for post-dates, or
other clinically relevant indications.
Figure 1. Randomisation and recruitment.

ª 2018 Royal College of Obstetricians and Gynaecologists 117

 Smith et al.

Table 2. Secondary outcomes

Outcome IA* = 1513 ACTG** = 1521 RR (95% CI) (unadjusted)

n (%) n (%)
mean (SD) mean (SD)

Spontaneous vaginal birth 1075 (71%) 1113 (73%) 0.97 (0.93–1.01)

Instrumental birth (all types) 307 (20%) 303 (20%) 1.02 (0.88–1.17)
Instrumental birth (specific sub-type)
Ventouse—prolonged second stage 74 (5%) 74 (5%) 1.01 (0.73–1.38)
Forceps—prolonged second stage 28 (2%) 45 (3%) 0.63 (0.39–1.00)
Instrumental—abnormal FHR pattern 205 (14%) 184 (12%) 1.12 (0.93–1.35)
Acceleration of labour (ARM + oxytocin) 829 (55%) 864 (57%) 0.96 (0.91–1.03)
ARM only 573 (38%) 608 (40%) 0.95 (0.87–1.04)
Oxytocin only 256 (17%) 256 (17%) 1.01 (0.86–1.18)
Pethidine during labour 271 (18%) 277 (18%) 0.98 (0.85–1.14)
Epidural during labour 658 (44%) 627 (41%) 1.05 (0.97–1.15)
cCTG during labour 1093 (72%) 1224/1520 (86%) 0.90 (0.86–0.93)
FBS during labour 99 (7%) 93 (6%) 1.07 (0.81–1.41)
Length of first stage (hours) 3.1 (2.4) 3.2 (2.5) –0.10 (–0.27–0.7)
Length of second stage (hours) 0.5 (0.5) 0.5 (0.5) –
Length of third stage (hours) 0.1 (0.4) 0.1 (0.2) –
Length of maternal hospital stay (days) 2.2 (1.2) 2.2 (1.2) 0.00 (–0.09–0.09)
Gestation at birth (weeks)*** 39.9 (0.9) 39.9. (0.9) –
Birthweight (g) 3523 (431) 3554 (442) –
Meconium-stained liquor 252 (17%) 266 (18%) 0.95 (0.81–1.11)
Paediatrician present at birth 556 (37%) 551 (56%) 1.01 (0.92–1.11)
Neonatal resuscitation (any) 381 (25%) 405 (27%) 0.95 (0.84–1.07)
Apgar score ≤ 7 at 1 minute 91 (6%) 107/1519 (7%) 0.85 (0.65–1.12)
Apgar score ≤ 7 at 5 minutes 12 (1%) 9/1519 (1%) 1.34 (0.57–3.17)
Arterial pH ≤ 7.05 14/1120 (1%) 15/1070 (1%) 0.89 (0.43–1.84)
Arterial BE ≥ 12.0 19/1098 10/1043 1.80 (0.84–3.86)
Admission to NICU/SCBU 42 (3%) 54 (4%) 0.78 (0.53–1.16)
Length of neonatal hospital stay (days) 2.3 (1.3) 2.3 (1.8) –

ARM, articifial rupture of membranes; BE, base excess; FBS, fetal blood sampling; SCBU, special-care baby unit.
*Denominator in all cases 1513 unless otherwise indicated.
**Denominator in all cases 1521 unless otherwise indicated.
***Participant’s gestation at birth was extracted from hospital records and mean gestational age was calculated for each group.
Bold text used to highlight statistically significant result.

admitted to the NICU/special-care baby unit. Table 3 sum-
marises reasons for admission and outcome details.
Secondary exploratory analyses
A sensitivity analysis, excluding women who became ineli-
gible post-randomisation, found no difference in caesarean
section between the groups (IA, n = 227, 15% and ACTG,
n = 249, 16%; RR 1.19, 95% CI 0.86–1.65). To further
explore the difference between the groups in the primary
outcome, adjusting for mother’s age, parity and site, no
significant difference between the groups in caesarean sec-
tion was found (adjusted RR 1.22; 95% CI 0.93–1.60,
P = 0.16). There was no evidence of a significant site by
allocation interaction in the adjusted models. The propor-
tions of caesarean sections by allocation (IA versus ACTG,
respectively) and by study site were 9% versus 5.9% (site
A), 10.8% versus 8.7% (site B) and 5.4% versus 6.0% (site
C); significantly fewer caesarean sections occurred in the
ACTG group in site A (P = 0.046), but no differences were
observed between the groups in site B (P = 0.27) or in site
C (P = 0.69).
Discussion
Main findings
The findings of our comparison of IA versus ACTG, in
over 3000 low-risk women presenting with possible labour
onset, provide no evidence of a significant difference in any
of our measured primary and secondary outcomes other
than a decrease in use of cCTG associated with being ran-
domised to IA. These findings, while offering, in the main,
equivalence for choice of method, reflect current clinical

118 ª 2018 Royal College of Obstetricians and Gynaecologists

 A randomised trial of ACTG versus IA on labour ward admission

Table 3. Summary details of babies admitted to NICU/SCBU

Reason IA ACTG Outcomes

N = 42 N = 54

Respiratory difficulties 11 13 All babies were discharged home

(poor respiratory effort, TTN, RDS) One baby receiving CPAP (ACTG) spent 8 days in NICU
Sepsis/infection 8 12 All babies were treated with intravenous antibiotics and discharged home
Two babies (ACTG) were diagnosed with meningitis and both
spent 17 days in NICU
One baby (ACTG) with congenital pneumonia spent 8 days in NICU
Meconium aspiration syndrome 2 3 All babies were discharged home
One baby (IA) was ventilated at birth and spent 10 days in NICU
Three babies (ACTG) spent 3, 5 and 10 days, respectively, in NICU
Jaundice 3 1 All babies required phototherapy
Observation (low Apgars, low temperature, 7 8 All babies were discharged home
grunting, etc.)
HIE I 3 1 All babies were discharged home within 1 week of birth
HIE II 1 1 Baby (IA) received anti-convulsive therapy 9 three doses and was
transferred to a national paediatric unit for follow-on care
Baby (ACTG) was ventilated and transferred
to a different NICU at 2 days
Pneumothorax 1 1 Baby (ACTG) developed Escherichia coli abscess; discharged home after
41 days in NICU
Cardiac 1 6 All babies were discharged home with plans for follow-up care
Trisomy 21 1 2 All babies were discharged home within 2 weeks
Other 4 6 Four babies (IA) and four babies (ACTG) were discharged home
One baby (ACTG) was queried with bowel obstruction and was transferred
to a national paediatric unit for further investigations
One baby (ACTG) diagnosed with subdural haematoma (ACTG) was
transferred to a national paediatric unit for follow-on care

HIE, hypoxic ischaemic encephalopathy; RDS, respiratory distress syndrome; TTN, transient tachypnoea of the newborn.

guideline recommendations for IA use during labour
admission in low-risk, healthy pregnant women2,3 and con-
cur with previous studies where significantly lower rates of
cCTG use during labour were experienced by women
receiving IA.4,5 Although our finding of no significant dif-
ference in caesarean birth between IA and ACTG is similar
to findings in other studies,4–7 our study differs whereby a
higher incidence of caesarean birth, albeit statistically non-
significant, was observed in the IA group compared with
the ACTG (8.6% and 6.9%, respectively). Previous trials
report higher rates of caesarean sections in ACTG groups;
for example, for IA versus ACTG, Mires et al.4 report cae-
sarean rates of 3.6% and 5.1%,4 Mitchell7 reports rates of
7.7% and 8.7%, and Cheyne et al.6 report rates of 6.2%
and 8.9%. This finding in our study is surprising given the
significantly increased use of cCTG with ACTG and the
known association between cCTG during labour and higher
caesarean rates in low-risk women when compared with IA
of the FHR.1 Although we performed secondary explora-
tory analyses on the outcome of caesarean section, we
remain uncertain as to why there was a nonsignificant
trend towards higher rates of caesarean birth in the IA
group. However, an important difference in our study is
that women were randomised before a formal diagnosis of
labour. One hypothesis is that ACTG has a different effect
on mode of birth for women with and without a diagnosis
of labour. Another possible explanation might simply be a
‘chance’ finding. Given that our study failed to achieve tar-
get recruitment, it is reasonable to suppose that had we
succeeded in achieving our sample size estimate, the trend
towards caesarean birth with IA may have become more
balanced between groups, or even reversed. A further
intriguing finding in our study was the high rate of acceler-
ation of labour in both the IA (55%) and ACTG (57%)
groups, the majority of which was by artificial rupture of
membranes. This finding, rather than reflecting abnormally
slow labours, per se, or study sample bias, is most likely
because of active management of labour practices,11 which
are common in many maternity units in Ireland.
Strengths and limitations
Over half of women eligible to participate in the ADCAR
trial declined to do so. Although similar rates of eligible
consenting women have been found in another large

ª 2018 Royal College of Obstetricians and Gynaecologists 119

 Smith et al.
maternity care trial in Ireland,12 timing of consent (i.e.
women presenting with signs of possible labour) and
approaches to taking consent (e.g. staff preferences for
CTG use13) may have impacted on consent rates. Failing to
recruit a significant portion of eligible women has the
potential to introduce selection bias, and this needs to be
considered when interpreting the results of the study.
Failing to recruit our sample size estimate is a further
study limitation. Our sample size of 1521 and 1513 for the
two groups achieves a power of 69.3% (based on the same
a priori sample size assumptions of a 0.05 to detect a 30%
reduction in the incidence of caesarean section from 6.9%
with ACTG identified in this study). Despite responsive
efforts to increase recruitment, including embedding a
Study Within A Trial (SWAT) (https://www.qub.ac.uk/site
s/TheNorthernIrelandNetworkforTrialsMethodologyResearc
h/SWATSWARInformation/) to assess the effectiveness of a
site visit on recruitment,14 extending the trial to a third site
(site C) and extending the time frame to conduct the trial,
achieving monthly recruitment targets was challenging,
with monthly rates rarely exceeding 50% of expected tar-
gets. Achieving target recruitment is known to challenge
almost all triallists, with evidence to suggest that < 50% of
trials will achieve their target rates within the planned time
frames.15,16 Nevertheless, recruiting less than the number of
expected participants to our study does limit the interpre-
tation of the results. Reasons for low recruitment to this
study were multi-fold, and reflect evidence that highlights
clinician preference for CTG use due to fear of litigation
and a perceived view of CTG technology assisting staff with
workload burden and staff shortages.13
Furthermore, given that the rationale for either IA or
ACTG use on labour admission is to assess fetal wellbeing,
ideally a trial of this type would be powered to detect a dif-
ference between the groups in a serious adverse neonatal
outcome, such as neonatal mortality. However, to do so
would require the recruitment of many thousands of
women (> 50 000) to the trial, and considerable resources.
In the absence of a core set of outcome measures evaluat-
ing the effects of ACTG, we measured and reported a rela-
tively large number of prespecified outcomes. We
acknowledge that this increased multiple testing and there-
fore the risk of a higher false-positive error rate.
Acknowledging these limitations, our study provides evi-
dence for FHR assessment based on a considerably large
sample of women and presents the third largest of five tri-
als examining IA and ACTG during labour admission.4–7
Furthermore, it is the first trial, that we are aware of, which
evaluates IA and ACTG use in women presenting with
signs and symptoms of possible labour onset, and before
confirmation of established labour, which is more likely to
accurately reflect how ACTG is applied in practice in many
settings.
120
Interpretation
Although the evidence from previous randomised trials,
and a systematic review, for IA use on labour admission, is
compelling,9 conflicting findings from recent non-rando-
mised studies continue to provide some clinicians with a
rationale for ACTG use. Rahman et al. for example, in a
study evaluating the role of ACTG, reported a low risk of
fetal compromise during labour for women with a reactive
ACTG compared with women with equivocal and ominous
ACTGs; 6.9%, 39.9% and 84.6%, respectively (P < 0.001).17
The incidence of thick meconium-stained liquor, admission
to NICU and neonatal mortality were also significantly
higher in the ominous and equivocal groups compared
with the reactive ACTG group and operative birth for sus-
pected fetal compromise was required in 5.5% (n = 8/145)
of women in the reactive group compared with 27.8%
(n = 5/18) in the equivocal group and 84.6% (n = 11/13)
of women in the ominous group. Bhartiva et al. also report
a significant correlation (P = 0.001) between nonreassuring
ACTG and meconium-stained liquor in low-risk women,
although statistically insignificant correlations were found
for low Apgar scores, NICU admission and mortality.18
Contrastingly, Akhavan et al., in their recent study of 425
pregnant women of whom 142 (33.4%) had abnormal
ACTGs, assert that an abnormal ACTG was predictive of
caesarean section, intrauterine growth restriction and low
Apgar scores (< 7) at birth.19
Conclusion
This trial demonstrates that outcomes were not different
between IA and ACTG for women with signs of labour
with the exception of increased cCTG use associated with
ACTG. In particular, our study presents evidence for IA
compared with ACTG in healthy pregnant women with
signs and symptoms of possible labour onset, before a for-
mal diagnosis of established labour. Further research com-
paring IA and ACTG use before the diagnosis of
spontaneous labour in selected samples of women present-
ing with signs and symptoms of possible labour is required.
Further research is also required comparing the use of IA
or the use of ACTG in women with confirmed compared
with unconfirmed labour during labour ward admission.
Acknowledgements
We thank all of the midwives, and other staff, at the three
participating study sites for supporting and assisting with
the conduct of the ADCAR trial. We thank also the thou-
sands of women who participated in the study.
Disclosure of interests
VS, DD, and CB declare being awarded a grant from the
Health Research Board (HRB) Ireland (Grant ref: (ref: RP/
ª 2018 Royal College of Obstetricians and Gynaecologists

2006/55) to conduct the study. All other authors disclose
no known competing interests. Full disclosure of interests
available to view online as supporting information.
Contribution to authorship
VS managed the day-to-day running of the trial and
drafted the manuscript. DD conceived the idea for the trial
and reviewed drafts of the manuscript. CB contributed
methodological expertise and reviewed drafts of the manu-
script. JN performed the statistical analysis and provided
content in this section of the manuscript. SH, DJM, MJW,
JJM, SC and DOD provided clinical advice and site support
during protocol development and during the conduct of
the trial. All authors read, contributed important intellec-
tual content to, and approved the final draft of the manu-
script before submission.
Details of ethics approval
Ethics approval to conduct the study was granted by the
Faculty of Health Sciences, Trinity College Dublin (6-Oct-
2008; Ref C.A. 149), and the Research Ethics Committees
of each of the three study sites (16-Nov-2007).
Funding
The ADCAR trial was funded by the Health Research
Board Ireland (ref: RP/2006/55) and supported by an
equipment grant from the Department of Health and Chil-
dren (Ireland). &
References
1 Alfirevic Z, Devane D, Gyte GML, Cuthbert A. Continuous
cardiotocography (CTG) as a form of electronic fetal monitoring
(EFM) for fetal assessment during labour. Cochrane Database Syst
Rev, 2017, Issue 2. Art. No.: CD006066.
2 Health Services Executive/Institute of Obstetricians
Gynaecologists. Clinical Practice Guideline: Intrapartum Fetal Heart
Rate Monitoring. Dublin: Royal College of Physicians of Ireland and
Health Service Executive; 2012.
3 National Institute for Health and Care Excellence (NICE). Intrapartum
care: care of healthy women and their babies during childbirth –
Clinical Guideline 190, 2014, United Kingdom.
4 Mires G, Williams F, Howie P. Randomised controlled trial of
cardiotocography versus Doppler auscultation of fetal heart at
ª 2018 Royal College of Obstetricians and Gynaecologists
A randomised trial of ACTG versus IA on labour ward admission
admission in labour in low risk obstetric population. BMJ
2001;322:1457–60.
5 Impey L, Reynolds M, MacQuillan K, Gates S, Murphy J, Sheil O.
Admission cardiotocography: a randomised controlled trial. Lancet
2003;361:465–70.
6 Cheyne H, Dunlop A, Shields N, Mathers AM. A randomised
controlled trial of admission electronic fetal monitoring in normal
labour. Midwifery 2003;19:221–9.
7 Mitchell K. The effect of the labour electronic fetal monitoring
admission test on operative delivery in low-risk women: a
randomised controlled trial. Evid Based Midwifery 2008;6:18–22.
8 Talaulikar VS, Arulkumaran A. Labour admission test. Int J Infertil
Fetal Med 2011;2:89–94.
9 Devane D, Lalor JG, Daly S, McGuire W, Cuthbert A, Smith
V. Cardiotocography versus intermittent auscultation of fetal
heart on admission to labour ward for assessment of fetal
wellbeing. Cochrane Database Syst Rev, 2017, Issue 1. Art. No.:
CD005122.
10 Government of Ireland, Data Protection Amendment Act, 2003.
[http://www.irishstatutebook.ie/eli/2003/act/6/enacted/en/html]. Accessed
5 April 2018.
11 O’Driscoll K, Meagher D, Robson M. Active Management of Labour,
4th edn. St. Louis, MO: Mosby Ltd.; 2003.
12 Begley C, Devane D, Clarke M. An Evaluation of Midwifery-led Care
in the Health Service Executive North Eastern Area – The Report of
the MidU Study. Dublin, Ireland: School of Nursing and Midwifery,
Trinity College Dublin/Health Service Executive; 2009.
13 Smith V, Begley CM, Clarke M, Devane D. Professionals’ views of
fetal monitoring during labour: a systematic review and thematic
analysis. BMC Pregnancy Childbirth 2012;12:166.
14 Smith V, Clarke M, Begley C, Devane D. SWAT-1: the effectiveness
of a ‘site visit’ intervention on recruitment rates in a multicentre
randomised trials. Trials 2015;16:1–7.
15 McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM,
Cook JA, et al. What influences recruitment to randomised
controlled trials? A review of trials funded by two UK funding
agencies. Trials 2006;7:9.
16 Gardner H, Fraser C, MacLennan G, Treweek S. A protocol for a
systematic review of non-randomised evaluations of strategies to
improve participant recruitment to randomised controlled trials. Syst
Rev 2016;5:131.
17 Rahman H, Renjhen P, Dutta S, Kar S. Admission cardiotocography:
and
its role in predicting foetal outcome in high-risk obstetric patients.
Australas Med J 2012;5:522–7.
18 Bhartiya V, Sharma R, Kumar A, Srivastava H. Admission
cardiotocography: a predictor of neonatal outcome. J Obstet
Gynaecol India 2016;66(Suppl 1):321–9.
19 Akhavan S, Lak P, Rahimi-Sharbaf F, Rahim Mohammadi S, Shirazi
M. Admission test and pregnancy outcome. Iran J Med Sci
2017;42:362–8.
121