Artificial Intelligence Algorithm for the Screening of Abnormal Fetal Brain Findings at First Trimester Ultrasound Scan
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 16, 2023
Trial Information
Current as of June 18, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to use artificial intelligence (AI) to help detect possible brain problems in unborn babies during the first trimester of pregnancy. The goal is to develop an AI program that can automatically analyze ultrasound images to identify whether the brain structures of the fetus are normal or show signs of abnormalities. This is important because finding these issues early can help in planning the best care for the baby.
To participate in this trial, women must be pregnant with a single baby and have had an ultrasound between 11 and 13 weeks of pregnancy. Participants will undergo a special ultrasound scan that focuses on the fetal brain, which can be challenging due to the small size of the structures and the baby’s movements. The researchers are looking for women who can provide informed consent and who can have clear images taken during the scan. This trial is currently recruiting participants, and it aims to improve how we assess fetal brain health early in pregnancy.
Gender
FEMALE
Eligibility 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.
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rome, Rm, Italy
Rome, , Italy
Patients applied
Trial Officials
Alessandra Familiari, MD
Principal Investigator
Fondazione Policlinico Agostino Gemelli
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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