Diagnostic Trial of Vision Transformer-Based End-to-End Ultrasound Artificial Intelligence Model for Assisting in the Diagnosis of Placenta Accreta Spectrum Disorders: An Investigator-Initiated Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 561
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged between 18 and 45 years;
- •Gestational age between 24 and 34 weeks;
- •Pregnant women with a history of placenta previa;
- •Pregnant women with an anterior placenta;
- •Willingness to participate in the study and provision of written informed consent.
排除标准
- •Failure to provide written informed consent;
- •Presence of severe complications that precluded continuation of pregnancy;
- •Inability to comply with study procedures for other reasons.
研究者
FANG HE
Chief Physician/Professor of the Obstetrics Department
The Third Affiliated Hospital of Guangzhou Medical University