Fetal ultrasound randomised trial of AI-assisted workflow for anomaly detection with health economic assessment

INTERVENTION: Pregnant women will be recruited to participate in the trial at the time of their mid‐trimester ultrasound anomaly scan. Each participant will be randomised (1 to 1) to have the scan either with AI‐assistance (FraiyaScan), or in standard unassisted fashion. Those who have been randomised to AI‐assistance will also have an AI‐assistance secondary review of the scan (FraiyaDetect). The scan duration and detection rates of congenital anomalies between the two scanning methods will be compared. A parallel process evaluation will employ a convergent parallel design based on survey and interview data from service users (main trial service users) and the healthcare workforce (end user stakeholders). A parallel process evaluation will employ a convergent parallel design based on survey and interview data from service users (main trial service users) and the healthcare workforce (end user stakeholders). Interventional and control arms are both going to last 26 weeks from the initial participation (20 week antenatal scan) to final question about the newborn outcome at 6 weeks of age. Randomisation (1‐1) is via a digital application provided by the clinical trials unit (KCL CTU) that runs on the tablet attached to the ultrasound machine. CONDITION: Ultrasound screening of prenatal abnormalities ; Pregnancy and Childbirth PRIMARY OUTCOME: 1. Scan time in minutes (collected by the computer connected to the ultrasound machine that is recording the examination); 2. Correct diagnosis of a congenital abnormality in the newborn (confirmed by the follow up call at 6 weeks to parents by a member of the research team and recorded on to the eCRF). The initial diagnosis of an abnormality if present is recorded at the time of the scan on the eCRF by the scanning sonographer SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: 1. Pregnant 2. All cases who are due for a routine mid‐trimester (18‐22 week) antenatal scan