Using AI to screen for fetal brain abnormalities during early pregnancy ultrasounds
Artificial Intelligence Algorithm for the Screening of Abnormal Fetal Brain Findings at First Trimester Ultrasound Scan
This study is testing a new artificial intelligence tool to see if it can help doctors find brain problems in babies during early pregnancy ultrasounds.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05790473 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate an artificial intelligence algorithm designed to enhance the screening of fetal brain abnormalities during first trimester ultrasounds. The study will be conducted in two phases: a retrospective phase where the AI will be trained using images from ten international fetal medicine centers, followed by a prospective phase that tests the AI's effectiveness in real clinical settings. The goal is to improve the accuracy and efficiency of identifying potential fetal brain malformations, which can be challenging due to the small size of fetal structures and operator dependency in ultrasound imaging.
Who should consider this trial
Good fit: Ideal candidates for this study are women with singleton pregnancies who are undergoing their first trimester ultrasound between 11 and 14 weeks of gestation.
Not a fit: Patients who do not have a clear mid-sagittal view of the fetal head 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 lead to earlier and more accurate detection of fetal brain abnormalities, improving outcomes for affected pregnancies.
How similar studies have performed: While the application of AI in obstetric ultrasound is emerging, this specific approach to screening for fetal brain abnormalities is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with single pregnancies who underwent ultrasound examination between 11+0 - 13+6 weeks of gestation or a fetal crown-rump-length between 45 - 84 mm. Exclusion Criteria: * Women who did not have the first trimester screening scan at the settled gestational age. * Women in which a good visualization of the mid-sagittal view of the fetal head was not technically possible. * Women who are not able to give the informed consent.
Where this trial is running
Rome
- FP Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Alessandra Familiari, MD — Fondazione Policlinico Agostino Gemelli
- Study coordinator: Alessandra Familiari, MD
- Email: familiari.ale@gmail.com
- Phone: 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.