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This study develops an end-to-end Vision Transformer (ViT)-based artificial intelligence system for ultrasound-based diagnosis of placenta accreta spectrum (PAS), aiming to improve the accuracy and efficiency of prenatal screening using standardized ultrasound video inputs.
Placenta accreta spectrum (PAS) is a life-threatening obstetric disorder involving abnormal placental invasion into the uterine wall, which is associated with severe maternal and neonatal complications. Despite advances in imaging, prenatal diagnosis remains challenging due to variability in ultrasound interpretation and reliance on operator expertise.
This study will establish a standardized ultrasound video acquisition protocol and develop a deep learning-based model using Vision Transformer (ViT) architecture to process dynamic ultrasound sequences. The model will be trained using clinically confirmed postpartum outcomes as reference labels.
The diagnostic performance of the system will be systematically evaluated, with the goal of improving consistency in interpretation and supporting more efficient clinical decision-making in prenatal PAS screening.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vision Transformer-Based End-to-End Ultrasound Artificial Intelligence Model | Diagnostic Test | An end-to-end ultrasound AI model based on the Vision Transformer (ViT) architecture was developed for the diagnosis of placenta accreta spectrum (PAS) using standardized ultrasound video inputs. Ultrasound Video Acquisition Protocol: With the patient in the supine position, the operator scanned the lower abdomen using a conventional grayscale probe. Video recording was performed in gray-scale mode for approximately 20-30 seconds, ensuring that the entire scanning region from the lower uterine segment to the uterine fundus was comprehensively captured. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the end-to-end Vision Transformer (ViT)-based ultrasound AI model for placenta accreta spectrum (PAS) | Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC) of the model. | At delivery (following confirmation of PAS status by surgical and/or pathological findings) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Feasibility of the Standardized Ultrasound Video Recording Method | Completion Rate (Proportion of patients who successfully complete the standardized recording) and time consumption (Mean recording time) | At enrollment during the ultrasound examination |
| Consistency and Efficiency Between the AI Model and Physician Diagnosis |
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Inclusion criteria:
Exclusion criteria:
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Pregnant women aged 18-45 years; Gestational age between 24 and 34 weeks; Pregnant women with a history of placenta previa or with an anterior placenta.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang He, M.D, PhD | Contact | +86 13724831279 | Gzhefang@gzhmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital, Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510150 | China |
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| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Diagnostic Consistency: Kappa coefficient used to evaluate the consistency between the AI model's diagnoses and those of experienced ultrasound physicians (Kappa > 0.75 indicates good agreement). |
| At enrollment during the ultrasound examination |
| Safety of the AI Model | False Negative Rate: Proportion of missed PAS-positive patients and the impact on patient outcomes . | At delivery, when PAS status and maternal outcomes are assessed |
| D010922 | Placenta Diseases |