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

This randomised controlled trial will evaluate whether an intelligent decision-support tool can improve interpretation of the intrapartum cardiotocograph (CTG) and therefore improve the management of labour for women who are judged to require continuous electronic heart rate monitoring for the management of labour using the CTG. The decision-support software interprets the CTG in the context of an individual woman's labour and offers advice on the management of labour. The primary outcomes being measured include: 'Poor neonatal outcome' to include (a) all perinatal deaths, except deaths due to congenital anomalies (b) significant morbidity: neonatal encephalopathy; other admissions to NICU within 48 hours of birth for 48 hrs or more, which are associated with adverse intrapartum events including respiratory symptoms and seizures. Developmental Quotient (DQ) at the age of two years. The main follow-up at the age of 2 years will be based on a questionnaire completed by the family, which includes the PARCA, a validated means of assessing neurodevelopment, and a section which focuses on general health issues. All cases of adverse neonatal outcome will undergo confidential panel review similar to that undertaken by the CEMACH to identify suboptimal care, particularly in relation to interpretation of the CTG and actions which flow from any identification of CTG abnormalities. The trial will recruit 46,000 women in labour and will the project will run for at least 6 years.