"Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time.

"No decision-support" - CTGs with no additional interpretation (UK standard care),

The decision-support software to be evaluated in INFANT has been designed to run on the K2 data collection system (Guardian®). The data collection system (Guardian®) is a system for managing information from labour monitoring. It displays the CTG on a computer screen alongside other clinical data which are collected as part of routine clinical care. As such, it replaces conventional paper labour notes, the CTG machine and other recording systems for documenting care during labour.

A composite of 'poor perinatal outcome' to include (a) all deaths (intrapartum stillbirths plus neonatal deaths i.e. deaths up to 28 days after birth) except deaths due to congenital anomalies, (b) significant morbidity: neonatal encephalopathy (moderate and severe); (c) admissions to the neonatal unit within 48 hours of birth for ≥ 48 hrs with evidence of feeding difficulties, respiratory illness or encephalopathy.

PARCA-R composite score at the age of two years

• Metabolic acidosis defined as a cord-artery pH <7.05 (this is 2 standard deviations below the mean) with base deficit ≥ 12 mmol/l (this is a threshold above which the risks of neurological damage increase)

• The distribution of cord-blood gas data for cord-artery pH

• Apgar score <4 at 5 minutes

• Intrapartum stillbirth

• Neonatal death

• Seizures

• Resuscitation interventions

• Admissions to neonatal unit within 48 hours of birth for at least 48 hours

• Admissions to neonatal unit within 48 hours of birth for at least 48 hours with evidence of:

  • Encephalopathy
  • Feeding difficulties
  • Respiratory illness

• Admission to a higher level of care

• In the sub-set of 7,000 surviving children without any degree of encephalopathy and agreed to be followed-up at age 2 years:

  • PARCA-R composite score
  • Cerebral palsy - (determined by asking the parents if their child has Cerebral palsy)
  • Late deaths (after the neonatal period)
  • General health issues at 2 years