AutoFUSE or First-Trimester Ultrasound Scan

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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Key information

Conditions

Fetus Disorder Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Renmin Hospital of Wuhan University, Wuhan, Hubei, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: May 22, 2026
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed