Measuring the impact of cardiotocograph decision support software on neonatal outcomes: A propensity score-matched observational study.

Abstract

This study follows the 2017 UK INFANT Collaborative Group RCT, which compared neonatal outcomes with and without the use of the INFANT cardiotocograph decision support system for over 46000 patients in labour. The original trial failed to demonstrate a significant improvement to neonatal outcomes; however, the study design was subject to methodological critique. This Australian retrospective cohort study aimed to report perinatal outcomes before and after the introduction of INFANT decision support software for cardiotocograph use in labour. The study cohort was divided into two equivalent 18-month epochs, before and after the introduction of INFANT-Guardian® CTG decision support system. Propensity score matching analysis was undertaken to balance pre- and post-implementation groups by baseline covariates. The matched cohort included 11154 public-funded women between November 2016 and 2019, with a singleton live fetus ≥34+0weeks, being induced or in spontaneous labour. The main outcome measures were: a composite measure of serious adverse neonatal outcome comprising of one or more of: admission to intensive care nursery >48h, Apgar <4 at 5min, cord arterial pH <7.0, hypoxic ischaemic encephalopathy grade 2 or 3, therapeutic hypothermia, neonatal death. The incidence of the composite primary outcome was significantly lower following implementation of INFANT (0.57% vs. 1.00%; OR 0.57, 95%CI 0.37-0.88; P=0.01). A significant reduction in nursery admission >48h was also observed (0.05% vs. 0.30%; OR 0.18, 95%CI 0.05-0.60; P=0.002). INFANT software is associated with a reduction in serious adverse neonatal outcomes, without increasing the rate of operative delivery.