Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial

Abstract

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.

Authors' reply re: Computerised analysis of intrapartum fetal heart rate patterns and adverse outcomes in the INFANT trial

“…Dr Sholapurkar has drawn attention to the remarkably low perinatal mortality and morbidity in the INFANT trial, and we agree that this may in part be due to the Hawthorne effect. The intrapartum stillbirth rate was only one in 15 538 compared with one in 2617 in the 1985 Dublin trial of CTG versus intermittent auscultation, and one in 5740 in the UK as a whole in 2015 .…”

Clinician Identification of Birth Asphyxia Using Intrapartum Cardiotocography Among Neonates With and Without Encephalopathy in New Zealand

“…22 The sensitivity of 75% is not surprising given that randomized studies of intrapartum CTGs have consistently failed to report benefit (with the exception of a reduction of neonatal seizures) and the addition of fetal blood sampling, fetal electroencephalography, fetal electrocardiogram ST segment analysis, fetal pulse oximetry, and computerized CTGs have not delivered hoped-for improvements in outcomes. 13,15,23 To summarize, even with these additional features, CTGs have not been found to improve outcomes associated with birth asphyxia. Additionally, they have been associated with increases in operative vaginal delivery and cesarean delivery.…”

Quality assurance of computer-aided detection and diagnosis in colonoscopy

“…Pregnant women (N=47,062) were randomized to fetal heart rate machine interpretation and no machine interpretation, evaluating neonatal outcomes as the primary endpoint. 75 The study was not positive for machine interpretation, though the pilot studies provided good results. 76 This study emphasizes the need for full, real-world validation of AI systems before their routine use in clinical practice.…”