Ultrasound screening of prenatal abnormalities
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). 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.
Current inclusion criteria as of 05/06/2026: For pregnant participants: 1. Booked for routine NHS mid-trimester anatomy ultrasound scan 2. Viable singleton pregnancy 3. Appointment booked in a participating ultrasound room For healthcare workforce professionals: 1. NHS staff members at participating hospital sites and staff members at industry partner Previous inclusion criteria: 1. Pregnant 2. All cases who are due for a routine mid-trimester (18-22 week) antenatal scan
Current exclusion criteria as of 05/06/2026: For pregnant participants: 1. Under 18 years of age 2. Multiple pregnancy 3. Confirmed presence of fetal structural anomalies 4. Confirmed presence of fetal chromosomal/genetic anomaly 5. High-risk pregnancy (e.g., under care of fetal medicine/fetal cardiology) 6. Insufficient English language skills to provide informed consent (even with available translation materials) For healthcare workforce professionals: 1. Staff groups or professionals not involved in ultrasound services; IT or network security; procurement; service or industry managers. Previous exclusion criteria: 1. Any identified structural abnormality 2. Any genetic or chromosomal abnormality identified 3. Participant withdrawal 4. Refusal of consent 5. Insufficient English language skills to provide informed consent 6. Multiple pregnancies