Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation

Z 32503 - Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.