Objective Economic evaluation of computerised decision-support software intended to assist in the interpretation of a cardiotocography (CTG) during birth. Design Individual patient level data from the INFANT study (an unmasked randomised controlled trial). Setting Maternity units in the UK and Ireland. Population Singleton or twin pregnancy women of 35 weeks' gestation or more and receiving continuous electronic fetal monitoring during labour. Intervention Computerised decision-support software. Methods Cost-consequence analysis presenting costs and outcomes with a time horizon of 2 years from a government healthcare perspective. Unit cost data collected from a combination of primary and secondary sources. Main outcome measures Primary clinical outcomes were (i) composite € poor neonatal outcome' and (ii) developmental assessment at age 2 years in a subset of surviving children. Mean cost per mother and infant dyad from birth to hospital discharge, and from hospital discharge to 24 months follow-up. Maternal health-related quality of life was assessed at 12 and 24 months follow-up using the EuroQol three-level health-related quality of life instrument (EQ-5D-3L). Results Data were analysed for 46 042 women and 46 614 infants. No statistically significant differences were detected between trial arms in any of the primary clinical outcomes or maternal quality of life. No statistically significant differences in costs were detected in maternal or infant costs from trial entry to hospital discharge or overall from hospital discharge to 2-year follow-up. Conclusions Decision-support software during labour is not associated with additional maternal or infant benefits and over a 2-year period the software did not lead to additional costs or savings to the National Health Service. Trial registration number ISRCTN98680152.
Archives of Disease in Childhood: Fetal and Neonatal Edition
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