Using AI to detect fetal brain anomalies during second trimester ultrasounds
Development of an Artificial Intelligence Algorithm to Recognize Abnormal Findings at Routine Fetal Brain Ultrasound. AIRFRAME (Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs)
This study is testing a new AI software to see if it can help doctors find brain problems in babies during second trimester ultrasounds.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06675266 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate an AI-based software designed to recognize fetal brain structures and identify abnormalities during second trimester ultrasound scans. The study will be conducted in two phases: a retrospective phase to train the AI algorithm using previously acquired ultrasound images, followed by a prospective phase to test the algorithm in real clinical settings. The goal is to enhance the accuracy and efficiency of fetal brain anomaly detection, ultimately improving prenatal care and management.
Who should consider this trial
Good fit: Ideal candidates for this study are women with singleton pregnancies who are undergoing ultrasound examinations between 19 and 22 weeks of gestation.
Not a fit: Patients who do not have a clear visualization of the fetal brain structures during the ultrasound or who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this AI technology could significantly improve the early detection of fetal brain anomalies, leading to better prenatal counseling and management.
How similar studies have performed: While the application of AI in medical diagnostics is gaining traction, this specific approach to fetal brain anomaly detection is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with singleton pregnancies undergoing ultrasound examination between 19+0 - 22+6 weeks of gestation Exclusion Criteria: * Women who did not have the second trimester screening scan at the settled gestational age. * Women in which a good visualization of the transventricular, transthalamic and transcerebellar plane of the fetal head was not technically possible. * Women who are not able to give the informed consent.
Where this trial is running
Rome
- Fondazione Policlinico Universitario Agostino Gemelli — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Alessandra Familiari — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Alessandra Familiari, MD
- Email: alessandra.familiari@policlinicogemelli.it
- Phone: +39 3285887422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.