Fraiya study version 1
Research type
Research Study
Full title
Fetal ultrasound randomised trial of AI-assisted workflow for anomaly detection with health economic assessment
IRAS ID
355136
Contact name
Reza Razavi
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
We are researching whether computerised tools can make pregnancy ultrasound scans more efficient and better at detecting babies who may have health problems after birth.
In the UK, pregnant women are offered a detailed ultrasound scan halfway through pregnancy to check their baby’s development. Unfortunately, some serious conditions are missed, which can delay support for families and specialist care for babies. We have developed artificial intelligence (AI) tools that can analyse scans in real time to speed up the process. We’ve also created ‘smart’ tools that help independent experts review scans after they’re done. This study will test whether using both tools together improves how well problems are spotted and how smoothly clinics run.
We will carry out the study in four hospitals. Around 9,500 pregnant people will be invited to take part over one year. Half will receive the usual scan, and half will have the AI-supported scan plus expert review. We’ll compare how often conditions are correctly identified, how much the scans cost, and what patients and staff think of the new approach. We’ll use surveys and interviews to gather feedback.
A dedicated group of people with lived experience of pregnancy and healthcare will help shape the study. They’ll work alongside a group of patient-facing staff to ensure the research is relevant and respectful. A trained researcher will lead interviews and help ensure open, inclusive discussions.
At the end of the study, we’ll know whether this technology helps detect serious conditions earlier, whether it’s acceptable to patients and staff, and whether it could be affordable for the NHS. We’ll share our findings through public summaries, press releases, and scientific conferences.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
25/YH/0243
Date of REC Opinion
16 Dec 2025
REC opinion
Further Information Favourable Opinion