INFANT

A multicentre randomised controlled trial of an intelligent system to support decision making in the management of labour using the cardiotocogram.

Trial started: 2010  Trial ended: 2015 

NPEU role: Randomisation service, statistical analysis and economic evaluation. Trial website: https://www.ucl.ac.uk/comprehensive-clinical-trials-unit/intelligent-fetal-monitoring-study

Summary

Objectives

To determine whether the addition of decision support software to assist in the interpretation of the cardiotocograph (CTG) reduced the number of poor neonatal outcomes, and whether or not it was cost-effective.

Methods

A two-arm individually randomised controlled trial conducted in labour wards in England, Scotland and the Republic of Ireland. Women in labour having continuous electronic fetal monitoring (EFM), with a singleton or twin pregnancy at ?35 weeks' gestation, were randomised to decision support or no decision support.

Outcome measures

Primary outcomes: (1) A composite of poor neonatal outcome: intrapartum stillbirth or early neonatal death (excluding lethal congenital anomalies), neonatal morbidity [defined as neonatal encephalopathy (NNE)], or admission to a neonatal unit within 48 hours for ?48 hours (with evidence of feeding difficulties, respiratory illness or NNE when there was evidence of compromise at birth); and (2) developmental assessment at the age of 2 years in a subset of surviving children.

Results

Between 6 January 2010 and 31 August 2013, 47,062 women were randomised and 46,042 were included in the primary analysis (22,987 in the decision support group and 23,055 in the no decision support group). The short-term primary outcome event rate was higher than anticipated. There was no evidence of a difference in the incidence of poor neonatal outcome between the groups: 0.7% (n = 172) of babies in the decision support group compared with 0.7% (n = 171) of babies in the no decision support group [adjusted risk ratio 1.01, 95% confidence interval (CI) 0.82 to 1.25]. There was no evidence of a difference in the long-term primary outcome of the Parent Report of Children's Abilities-Revised, with a mean score of 98.0 points [standard deviation (SD) 33.8 points] in the decision support group and 97.2 points (SD 33.4 points) in the no decision support group (mean difference 0.63 points, 95% CI –0.98 to 2.25 points). No evidence of a difference was found for health resource use and total costs. There was evidence that decision support did change practice (with increased fetal blood sampling and a lower rate of repeated alerts).

Conclusions

This trial does not support the hypothesis that the use of computerised interpretation of the CTG in women who have EFM in labour improves the clinical outcomes for mothers or babies.

Adapted from: Brocklehurst P, Field D, Greene K, et al. Computerised interpretation of the fetal heart rate during labour: a randomised controlled trial (INFANT). Health Technology Assessment. 2018;22(9). https://doi.org/10.3310/hta22090. © Queen's Printer and Controller of HMSO 2018. Adapted for presentation on this website.