Not_yet_recruitingNANCT07601191

Validation of an AI-based Intelligent Image Quality Control System for First-Trimester Ultrasound Scan: a Stepwise, Multicenter, Randomized Clinical Trial in China

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Trial Details

Condition	Fetus Disorder
Intervention	AutoFUSE system; Traditional ultrasound scan
Phase	NA
Status	Not_yet_recruiting
Participants	1,000
Est. Completion	31 Oct 2026
Last Updated	22 May 2026

Primary Outcome

The efficiency of standard plane acquisition

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: ① Pregnant women undergoing fetal ultrasound examination. ② A singleton pregnancy with a live fetus between 11 and 13+6 weeks with complete outcomes. Exclusion Criteria: * Incomplete pregnancy outcome information. * Unexplained miscarriages. ③ Fetal death. * Pregnancies with significant maternal complications. * Multiple pregnancies.

Trial Sites

Countries

China

View Registry Entry

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