Ultrasound screening of prenatal abnormalities Pregnancy and Childbirth
Conditions
Interventions
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 as
Sponsors
King's College London
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 05/06/2026: 1. Scan duration: Time (minutes) to complete 20-week anomaly scan, measured using ultrasound machine timestamps/scan logs at 20-week scan 2. Detection rate of congenital anomalies: Proportion identified on ultrasound, measured against postnatal diagnosis and/or specialist confirmation at 20-week scan and postnatal follow-up Previous primary outcomes: 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
| Measure | Time frame |
|---|---|
| Added 05/06/2026: 1. User and patient acceptability: Acceptability scores and qualitative feedback, measured using questionnaires/interviews at 20-week scan 2. Accuracy of AI-assisted anomaly detection: Proportion detected with AI vs standard assessment, measured against postnatal diagnosis and/or specialist confirmation at 20-week scan and postnatal follow-up 3. Diagnostic accuracy metrics: calculated from ultrasound findings vs reference standard (postnatal diagnosis/specialist confirmation) at 20-week scan and postnatal follow-up 4. Referral to specialist services: Proportion referred to fetal medicine/cardiology, measured from clinical records at 20-week scan and antenatal follow-up 5. Follow-up scanning (recalls): Proportion requiring additional scans post 20-week scan, measured from imaging records during pregnancy 6. Screen-positive rate: Proportion of scans indicating suspected anomalies requiring further assessment, measured from ultrasound reports at 20-week scan 7. Positive predictive value of referral: Proportion of referred cases confirmed as anomalies, measured against specialist diagnosis and/or postnatal outcomes at referral and postnatal follow-up | — |
Countries
England, United Kingdom
Contacts
Public ContactReza Razavi
Outcome results
None listed