Diagnostic Trial of a Vision Transformer-Based Ultrasound AI Model for Placenta Accreta Spectrum
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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Fang He, M.D, PhD
- 电话号码：+86 13724831279
- 邮箱：Gzhefang@gzhmu.edu.cn
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510150
- 招聘中
- The Third Affiliated Hospital, Guangzhou Medical University
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接触：
- Fang He, MD, PhD
- 电话号码：+86 13724831279
- 邮箱：Gzhefang@gzhmu.edu.cn
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
取样方法
研究人群
描述
Inclusion criteria:
- 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.
Exclusion criteria:
- Failure to provide written informed consent;
- Presence of severe complications that precluded continuation of pregnancy;
- Inability to comply with study procedures for other reasons.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic performance of the end-to-end Vision Transformer (ViT)-based ultrasound AI model for placenta accreta spectrum (PAS)
大体时间：At delivery (following confirmation of PAS status by surgical and/or pathological findings)
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Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC) of the model.
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At delivery (following confirmation of PAS status by surgical and/or pathological findings)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical Feasibility of the Standardized Ultrasound Video Recording Method
大体时间：At enrollment during the ultrasound examination
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Completion Rate (Proportion of patients who successfully complete the standardized recording) and time consumption (Mean recording time)
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At enrollment during the ultrasound examination
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Consistency and Efficiency Between the AI Model and Physician Diagnosis
大体时间：At enrollment during the ultrasound examination
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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).
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At enrollment during the ultrasound examination
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Safety of the AI Model
大体时间：At delivery, when PAS status and maternal outcomes are assessed
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False Negative Rate: Proportion of missed PAS-positive patients and the impact on patient outcomes .
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At delivery, when PAS status and maternal outcomes are assessed
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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