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Objective To assess the effect of admission cardiotocography Results Based on 3034 women (1513 and 1521 randomised to IA
(ACTG) versus intermittent auscultation (IA) of the fetal heart and ACTG, respectively), there was no statistical difference
(FH) in low-risk pregnancy during assessment for possible labour between the groups in caesarean section [130 (8.6%) and 105
on caesarean section rates. (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
Design A parallel multicentre randomised trial.
of continuous CTG during labour, which was lower in the IA
Setting Three maternity units in the Republic of Ireland. group (RR 0.90, 95% CI 0.86–0.93).
Population Healthy, low-risk pregnant women, at term and Conclusion Our study demonstrates no differences in obstetric or
≥ 18 years old, who provided written informed consent. neonatal outcomes between IA and ACTG for women with
possible labour onset, other than an increased risk for continuous
Methods Women were randomised to receive IA of the FH or
CTG in women receiving ACTG.
20 minutes ACTG on admission for possible labour onset, using
remote telephone randomisation. Both groups received IA Keywords Admission cardiotocography, cardiotocography, fetal
during labour, with conversion to continuous CTG as clinically assessment, intermittent auscultation, labour admission test.
indicated.
Tweetable abstract No differences in outcomes between
Main outcome measures Caesarean section (primary outcome), intermittent auscultation and admission cardiotocography for
obstetric interventions (e.g. continuous CTG during labour, fetal women with possible labour onset.
blood sampling, augmentation of labour) and neonatal morbidity
Linked article This article is commented on by AM Vintzileos,
(e.g. metabolic acidosis, admission to the neonatal intensive care
p. 122 in this issue. To view this mini commentary visit https://
unit, neonatal death).
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.
the analysis was blinded to group allocation during the the antenatal ward to await further signs of possible labour
analysis process. onset. On readmission to the labour ward or labour assess-
ment room with further signs and symptoms of labour,
Intervention group women received ACTG with subsequent care in accordance
Women randomised to the intervention received IA of the with care as described above.
FH, performed by the admitting midwife, on admission for
possible labour onset, using either a Pinard stethoscope or Outcome measures
a hand-held Doppler ultrasound device. Although the cho- Although a core outcome set for intrapartum fetal assess-
sen method of IA was not recorded routinely, the likeli- ment is registered with the Core Outcome Measures in
hood was that a Doppler device was used in the majority Effectiveness Trials (COMET) database (http://www.comet-
of cases as this is the more commonly adopted method for initiative.org/studies/details/741?result=true), this core out-
IA in the trial settings. IA included abdominal palpation of come set is not yet developed. In the absence of a core out-
uterine contractions and assessment of the FHR for at least come set, our outcome measures were as follows. The
60 seconds after a uterine contraction. Conversion to CTG primary outcome measure was overall incidence of cae-
occurred where IA revealed a baseline FHR of < 110 beats/ sarean section. Maternal secondary outcome measures were
minute or > 160 beats/minute or any decelerations in the cCTG during labour (defined as cCTG for > 75% of labour
FH; or if any other risk factors developed during admis- duration), fetal blood sampling, augmentation of labour
sion, which warranted cCTG, or the clinician caring for the with oxytocin, augmentation of labour with artificial rup-
woman had any other cause for concern. Following IA, ture of membranes, duration of labour, epidural analgesia,
where the above interpretation criteria were met, subse- pethidine analgesia and mode of birth. Neonatal outcome
quent care during labour was in accordance with standard measures were metabolic acidosis (defined as an umbilical
care; that is, monitoring of the FHR by IA for 1 minute at artery blood pH < 7.0, and a base deficit of > 12.0 mmol/
least every 15 minutes in the first stage and at least every l),1 hypoxic ischaemic encephalopathy, seizures (either
5 minutes in the second stage of labour or conversion to apparent clinically or detected by electroencephalographic
cCTG if clinically indicated. Women assessed as not being recordings), neonatal Apgar scores at 1 and 5 minutes,
in established labour following randomisation were either admission to the neonatal intensive care unit (NICU),
discharged home or admitted to the antenatal ward to length of stay in NICU (in days), neonatal death, stillbirth,
await further signs and symptoms of labour. On readmis- intracranial haemorrhage (as determined by cranial ultra-
sion to the labour ward or labour assessment room, with sound/magnetic resonance imaging report), meconium
further signs and symptoms of labour, and where the trial aspiration (as determined on X-ray) and any neonatal
screening and register form criteria for low-risk continued resuscitation. The following baseline characteristics were
to be met, women received IA of the FHR, with subsequent also measured: maternal age, gestation at birth, parity,
care in accordance with the care as described above. neonatal birthweight and neonatal congenital abnormality
(undetected before birth).
Control group Public and patient involvement
Women randomised to the control group received 20-min- A maternity service user was a member of the Trial Steer-
utes of ACTG on admission to the labour ward or labour ing Committee. Pregnant women were involved as partici-
assessment room, as was standard care in the three partici- pants in the trial.
pating hospitals. If the baseline FHR was between 110 and
160 beats/minute, baseline variability was >10 beats/min- Sample size assumptions and estimates
ute, there were more than two accelerations present, and A retrospective clinical audit of 600 women was conducted
decelerations were absent then the tracing was classified as in two hospitals in 2007 to determine the number of
normal and discontinued, and the findings were docu- women who would potentially be eligible to take part in the
mented. The uterine contraction pattern was also assessed. study and to determine the incidence of caesarean section
If, following the ACTG, the above interpretation criteria in this low-risk maternity sample. The audit found that
were met, the woman’s care was in accordance with stan- 55% of women, across the two hospitals, met the eligibility
dard care; i.e. IA for monitoring of the FH during labour criteria, and the caesarean section rate was 5.2%. With 80%
or conversion to cCTG as warranted. If the interpretation power and a set at < 0.05, a sample size of 5776 women
criteria were not met on ACTG, CTG was continued and (2888 per group), allowing for a 10% attrition rate, was
interpretation of the tracing was used to inform the subse- required to detect a 30% reduction in the incidence of cae-
quent care of the woman, as was current practice. Women sarean section (i.e. from 5.2% with ACTG to 3.6% with IA)
assessed as not being in established labour following ran- allowing for a 10% attrition rate. Calculations were per-
domisation were either discharged home or admitted to formed using SAMPLE POWER.
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- A), 10.8% versus 8.7% (site B) and 5.4% versus 6.0% (site
marises reasons for admission and outcome details. C); significantly fewer caesarean sections occurred in the
ACTG group in site A (P = 0.046), but no differences were
Secondary exploratory analyses observed between the groups in site B (P = 0.27) or in site
A sensitivity analysis, excluding women who became ineli- C (P = 0.69).
gible post-randomisation, found no difference in caesarean
section between the groups (IA, n = 227, 15% and ACTG,
Discussion
n = 249, 16%; RR 1.19, 95% CI 0.86–1.65). To further
explore the difference between the groups in the primary Main findings
outcome, adjusting for mother’s age, parity and site, no The findings of our comparison of IA versus ACTG, in
significant difference between the groups in caesarean sec- over 3000 low-risk women presenting with possible labour
tion was found (adjusted RR 1.22; 95% CI 0.93–1.60, onset, provide no evidence of a significant difference in any
P = 0.16). There was no evidence of a significant site by of our measured primary and secondary outcomes other
allocation interaction in the adjusted models. The propor- than a decrease in use of cCTG associated with being ran-
tions of caesarean sections by allocation (IA versus ACTG, domised to IA. These findings, while offering, in the main,
respectively) and by study site were 9% versus 5.9% (site equivalence for choice of method, reflect current clinical
HIE, hypoxic ischaemic encephalopathy; RDS, respiratory distress syndrome; TTN, transient tachypnoea of the newborn.
guideline recommendations for IA use during labour group. However, an important difference in our study is
admission in low-risk, healthy pregnant women2,3 and con- that women were randomised before a formal diagnosis of
cur with previous studies where significantly lower rates of labour. One hypothesis is that ACTG has a different effect
cCTG use during labour were experienced by women on mode of birth for women with and without a diagnosis
receiving IA.4,5 Although our finding of no significant dif- of labour. Another possible explanation might simply be a
ference in caesarean birth between IA and ACTG is similar ‘chance’ finding. Given that our study failed to achieve tar-
to findings in other studies,4–7 our study differs whereby a get recruitment, it is reasonable to suppose that had we
higher incidence of caesarean birth, albeit statistically non- succeeded in achieving our sample size estimate, the trend
significant, was observed in the IA group compared with towards caesarean birth with IA may have become more
the ACTG (8.6% and 6.9%, respectively). Previous trials balanced between groups, or even reversed. A further
report higher rates of caesarean sections in ACTG groups; intriguing finding in our study was the high rate of acceler-
for example, for IA versus ACTG, Mires et al.4 report cae- ation of labour in both the IA (55%) and ACTG (57%)
sarean rates of 3.6% and 5.1%,4 Mitchell7 reports rates of groups, the majority of which was by artificial rupture of
7.7% and 8.7%, and Cheyne et al.6 report rates of 6.2% membranes. This finding, rather than reflecting abnormally
and 8.9%. This finding in our study is surprising given the slow labours, per se, or study sample bias, is most likely
significantly increased use of cCTG with ACTG and the because of active management of labour practices,11 which
known association between cCTG during labour and higher are common in many maternity units in Ireland.
caesarean rates in low-risk women when compared with IA
of the FHR.1 Although we performed secondary explora- Strengths and limitations
tory analyses on the outcome of caesarean section, we Over half of women eligible to participate in the ADCAR
remain uncertain as to why there was a nonsignificant trial declined to do so. Although similar rates of eligible
trend towards higher rates of caesarean birth in the IA consenting women have been found in another large
2006/55) to conduct the study. All other authors disclose admission in labour in low risk obstetric population. BMJ
no known competing interests. Full disclosure of interests 2001;322:1457–60.
5 Impey L, Reynolds M, MacQuillan K, Gates S, Murphy J, Sheil O.
available to view online as supporting information. Admission cardiotocography: a randomised controlled trial. Lancet
2003;361:465–70.
Contribution to authorship 6 Cheyne H, Dunlop A, Shields N, Mathers AM. A randomised
VS managed the day-to-day running of the trial and controlled trial of admission electronic fetal monitoring in normal
drafted the manuscript. DD conceived the idea for the trial labour. Midwifery 2003;19:221–9.
7 Mitchell K. The effect of the labour electronic fetal monitoring
and reviewed drafts of the manuscript. CB contributed admission test on operative delivery in low-risk women: a
methodological expertise and reviewed drafts of the manu- randomised controlled trial. Evid Based Midwifery 2008;6:18–22.
script. JN performed the statistical analysis and provided 8 Talaulikar VS, Arulkumaran A. Labour admission test. Int J Infertil
content in this section of the manuscript. SH, DJM, MJW, Fetal Med 2011;2:89–94.
JJM, SC and DOD provided clinical advice and site support 9 Devane D, Lalor JG, Daly S, McGuire W, Cuthbert A, Smith
V. Cardiotocography versus intermittent auscultation of fetal
during protocol development and during the conduct of heart on admission to labour ward for assessment of fetal
the trial. All authors read, contributed important intellec- wellbeing. Cochrane Database Syst Rev, 2017, Issue 1. Art. No.:
tual content to, and approved the final draft of the manu- CD005122.
script before submission. 10 Government of Ireland, Data Protection Amendment Act, 2003.
[http://www.irishstatutebook.ie/eli/2003/act/6/enacted/en/html]. Accessed
5 April 2018.
Details of ethics approval 11 O’Driscoll K, Meagher D, Robson M. Active Management of Labour,
Ethics approval to conduct the study was granted by the 4th edn. St. Louis, MO: Mosby Ltd.; 2003.
Faculty of Health Sciences, Trinity College Dublin (6-Oct- 12 Begley C, Devane D, Clarke M. An Evaluation of Midwifery-led Care
2008; Ref C.A. 149), and the Research Ethics Committees in the Health Service Executive North Eastern Area – The Report of
the MidU Study. Dublin, Ireland: School of Nursing and Midwifery,
of each of the three study sites (16-Nov-2007).
Trinity College Dublin/Health Service Executive; 2009.
13 Smith V, Begley CM, Clarke M, Devane D. Professionals’ views of
Funding fetal monitoring during labour: a systematic review and thematic
The ADCAR trial was funded by the Health Research analysis. BMC Pregnancy Childbirth 2012;12:166.
Board Ireland (ref: RP/2006/55) and supported by an 14 Smith V, Clarke M, Begley C, Devane D. SWAT-1: the effectiveness
of a ‘site visit’ intervention on recruitment rates in a multicentre
equipment grant from the Department of Health and Chil- randomised trials. Trials 2015;16:1–7.
dren (Ireland). & 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
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