AutoFUSE or First-Trimester Ultrasound Scan

NCT07601191 — Not applicable, Not yet recruiting, 1000 participants, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

Registry	NCT07601191
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, diagnostic
Enrollment	1000 (Estimated)
Sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Other)
Conditions	Fetus Disorder
Interventions	AutoFUSE system, Traditional ultrasound scan (Diagnostic test)
Dates	start 2026-06-01 (estimated), primary completion 2026-10-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-05-22, last updated 2026-05-22
Locations	3 sites in China

-Summary

The goal of this clinical trial is to validate the clinical application capabilities of AutoFUSE. The main questions it aims to answer are:

Does AutoFUSE reduce the time required to obtain standard planes in first-trimester ultrasound scan? Does AutoFUSE improve the accuracy of standard plane acquisition in first-trimester ultrasound scan? What safety outcomes occur in participants undergoing AutoFUSE-assisted ultrasound examination? Researchers will compare AutoFUSE-assisted ultrasound scan with standard clinical protocol (SCP) ultrasound scan to evaluate the efficacy and safety of AutoFUSE in clinical practice.

Participants will:

Undergo either AutoFUSE-assisted ultrasound scan or standard clinical ultrasound scan according to the study design.

Complete scheduled visits for examinations, data collection and follow-up. Provide information related to scan time, image quality and safety during the study.

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+Arms and interventions

Arm	Type	Interventions	Description
AutoFUSE-assisted ultrasound scan	Experimental	Diagnostic Test: AutoFUSE system	AutoFUSE-assisted ultrasound scanning throughout the examination.
Traditional ultrasound scan	Active comparator	Diagnostic Test: Traditional ultrasound scan	Standard ultrasound scanning according to the standard clinical protocol.

AutoFUSE system (Diagnostic test): AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).
Traditional ultrasound scan (Diagnostic test): Traditional ultrasound scan means the standard clinical ultrasound examination performed by sonographers using routine manual operation to acquire predefined standard anatomical planes, without real-time AI assistance, automatic plane recognition, or automatic image quality assessment. All plane acquisition and quality evaluation are completed manually by the operator.

+Outcome measures

Primary outcomes

The efficiency of standard plane acquisition [Day 1]: The primary outcome was measured by the time required to obtain the prespecified standard planes during the ultrasound examination.

Secondary outcomes

The accuracy of standard plane acquisition [Through study completion, an average of 6 months]: The secondary outcome was assessed by whether the prespecified standard planes are correctly obtained according to predefined imaging criteria.

+Eligibility

Sex: Female, accepts healthy volunteers

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.

+Locations (3)

Facility	City	Country
Wuhan Union Hospital	Wuhan, Hubei	China
Zhongnan Hospital of Wuhan University	Wuhan, Hubei	China
Renmin Hospital of Wuhan University	Wuhan, Hubei	China