SummaryBackgroundContinuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usefulness. We aimed to establish whether the addition of decision-support software to assist in the interpretation of cardiotocographs affected the number of poor neonatal outcomes.MethodsIn this unmasked randomised controlled trial, we recruited women in labour aged 16 years or older having continuous electronic fetal monitoring, with a singleton or twin pregnancy, and at 35 weeks' gestation or more at 24 maternity units in the UK and Ireland. They were randomly assigned (1:1) to decision support with the INFANT system or no decision support via a computer-generated stratified block randomisation schedule. The primary outcomes were poor neonatal outcome (intrapartum stillbirth or early neonatal death excluding lethal congenital anomalies, or neonatal encephalopathy, admission to the neonatal unit within 24 h for ≥48 h with evidence of feeding difficulties, respiratory illness, or encephalopathy with evidence of compromise at birth), and developmental assessment at age 2 years in a subset of surviving children. Analyses were done by intention to treat. This trial is completed and is registered with the ISRCTN Registry, number 98680152.FindingsBetween Jan 6, 2010, and Aug 31, 2013, 47 062 women were randomly assigned (23 515 in the decision-support group and 23 547 in the no-decision-support group) and 46 042 were analysed (22 987 in the decision-support group and 23 055 in the no-decision-support group). We noted no difference in the incidence of poor neonatal outcome between the groups—172 (0·7%) babies in the decision-support group compared with 171 (0·7%) babies in the no-decision-support group (adjusted risk ratio 1·01, 95% CI 0·82–1·25). At 2 years, no significant differences were noted in terms of developmental assessment.InterpretationUse of computerised interpretation of cardiotocographs in women who have continuous electronic fetal monitoring in labour does not improve clinical outcomes for mothers or babies.FundingNational Institute for Health Research.
Objectives To investigate 1. whether an intelligent computer system could obtain a performance in labour management comparable with experts when using cardiotocograms (CTGs), patient information, and fetal blood sampling and 2. whether experts could be consistent and agree in their management of labour. Subjects An intelligent computer system and 17 clinicians experienced in fetal monitoring from 16 centres in the UK. Design Fifty cases with complete intrapartum CTGs and clinical data were reviewed by each expert and the system independently on two occasions, at least one month apart. Each CTG was scored in 15 min segments according to a protocol and estimates of the cervical dilatation and fetal scalp blood pH were given when requested. Main outcome measures Consistency and agreement in the recorded scores, agreement and timing of cases recommended for caesarean sections, fetal blood sampling rates, intervention in cases with poor outcome and intervention in cases with good clinical outcome. Results The system: Agreed with experts well and significantly better than chance (67.33%, kappa = 0.31, P 0.001). Was highly consistent (99.16%, kappa = 0.98, P 4.0001) when used by two operators independently. Recommended no unnecessary intervention in cases with normal delivery and good condition (cord artery pH > 7.15, vein pH > 7.20, 5 min Apgar ≥ 9 and no resuscitation). This was better than all but two of the experts. Recommended delivery by caesarean section in 11 cases; at least 15 of the 17 experts in each review also recommended caesarean section delivery in these cases. The majority did so within 15 min of the system and two‐thirds did so within 30 min. Identified as many of the birth asphyxiated cases (cord arterial pH < 7.05 and BDecf ≥ 12, and Apgar score at 5 min ≤ 7 with neonatal morbidity) as the majority of experts and one more than was acted upon clinically. The experts were found to be consistent and to agree. There was good agreement in the cases and the timing of caesarean section recommendations. The majority of experts did not recommend operative intervention in cases which had a normal delivery and good outcome, but did recommend operative interventions in 10 of 12 cases delivered with cord arterial pH c 7.05. However, in one of the cases delivered with birth asphyxia, 14 of the 17 experts and the system failed to recommend intervention. Conclusions The system's performance was found to be indistinguishable from the experts' in the 50 cases examined, but it was more consistent. This demonstrates the potential for an intelligent computer system to improve the interpretation of the CTG and decrease intervention. Furthermore, the good performance of most experts in this study demonstrates the potential effectiveness of the CTG and raises important questions regarding why the CTG has fallen short of expectations in current practice.
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