NCT07661433招募中不适用
Z 32503 - Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 5
研究概览
简要总结
Purpose: The primary objective of this study is to assess the diagnostic accuracy of an AI-enabled ultrasound tool for estimating fetal weight Participants: 1,000 pregnant individuals Procedures (methods): This prospective diagnostic accuracy study will enroll 1,000 pregnant individuals within one week of anticipated delivery. At a single visit, each participant will undergo two ultrasound assessments: (1) standardized sweeps for AI analysis (performed by both specialist and nonspecialist users), (2) specialist-performed fetal biometry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Viable intrauterine pregnancy
- •Delivery expected within one week of study procedures between 24 0/7 and 42 6/7 weeks, including participants with a scheduled induction or cesarean delivery on a known date, or those admitted in spontaneous labor
- •Ability and willingness to provide written informed consent
- •Willingness to comply with all study procedures
排除标准
- •Maternal body mass index ≥ 40 kg/m^2
- •Multiple gestation (i.e., twins or higher order)
- •Known major fetal malformation or anomaly
- •Any maternal condition (medical, psychological, or social) that, in the opinion of the study team, may interfere with study participation or data integrity.
研究组 & 干预措施
Pregnant Women within One Week of Delivery
Participants receive a standardized ultrasound sweep protocol and specialist-performed fetal biometry.
干预措施: AI ultrasound diagnostic tool for fetal weight estimation (Diagnostic Test)
研究者
研究点 (5)
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