- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04897178
Machine Learning-based Anomaly Recognition System (MARS)
Use of Machine Learning Algorithms for Automated Detection of Fetal Anomalies
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Routine second trimester anomaly scan has become a routine part of antenatal care. Early detection of fetal anomalies permits patient counselling, consideration of termination if detected anomalies are considerable, and arrangement of delivery and immediate neonatal care if indicated. Furthermore, with the expanding role of fetal interventions, early detection of fetal anomalies may expand management options, some of which may lead superior outcomes compared to postnatal interventions.
However, fetal anatomy scan necessitates a particular level of training and expertise, either by sonographers or obstetricians. Unfortunately, availability of experienced personals may be globally limited. Furthermore, first trimester anatomy scan has been evolving rapidly as ultrasound machine continues to develop and clinical research yields more information on first trimester normal standards and abnormal ranges. Accordingly, first trimester scan is anticipated to be a part of routine care in the near future. Although this tool should provide substantial benefits to obstetric patients, this would require more providers with specific training, which is unlikely to be readily available.
Artificial intelligence has been incorporated in the medical field for more than 20 years. With the advancement of deep learning algorithms, deep learning has yielded exceptional accuracy in image recognition. In the last decade, deep learning exhibits high quality performance that may exceed human performance at times. One of the earliest and most prevalent applications of deep learning in medicine are radiology-related.
In the current study, the investigators will create a series of deep learning models that appraise and identify common fetal anomalies in a series of frames including recorded videos or real time ultrasound. Deep learning algorithms will be fed by labelled images of known normal and abnormal findings representing common fetal anomalies for both training and validation. These images will be collected retrospectively through medical records of contributing centers. Their diagnostic performance will be tested on retrospectively collected videos including normal and abnormal findings. In the second stage of the study, These models will be applied to prospectively collected videos of fetal anatomy scan for further validation.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
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Assiut, Egypte, 71515
- Assiut Faculty of Medicine - Women Health Hospital
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Aswan, Egypte, 81528
- Aswan Faculty of medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Pregnant women between 18 and 45 years
- Available ultrasound image with clear findings
- postnatal confirmation of diagnosis
Exclusion Criteria:
- Absence of research authorization on medical records
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Fetuses with normal anatomy
Fetuses with normal anatomy scan who demonstrate no structural abnormalities of different systems (CNS, chest and heart, abdomen, skeletal system)
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Routine 2 dimensional Ultrasound used to screen fetuses for congenital anomalies
|
|
Fetuses with abnormal anatomy
Fetuses with abnormal anatomy scan who demonstrate any structural abnormalities that can be detected with ultrasound
|
Routine 2 dimensional Ultrasound used to screen fetuses for congenital anomalies
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diagnostic accuracy
Délai: Fetuses between 10 weeks and 32 weeks of gestation
|
Diagnostic accuracy of deep learning models in identifying major fetal structural anomalies
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Fetuses between 10 weeks and 32 weeks of gestation
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OBG-AI21-P1
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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