AutoFUSE or First-Trimester Ultrasound Scan

May 20, 2026 updated by: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
        • Contact:
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Zhongnan Hospital of Wuhan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AutoFUSE-assisted ultrasound scan
AutoFUSE-assisted ultrasound scanning throughout the examination.
Diagnostic test: AutoFUSE system
AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).
Active Comparator: Traditional ultrasound scan
Standard ultrasound scanning according to the standard clinical protocol.
Diagnostic test: Traditional ultrasound scan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficiency of standard plane acquisition
Time Frame: Day 1
The primary outcome was measured by the time required to obtain the prespecified standard planes during the ultrasound examination.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of standard plane acquisition
Time Frame: 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.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 10, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AutoFUSE-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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