AutoFUSE or First-Trimester Ultrasound Scan

NCT07601191 | Not Yet Recruiting DMC

• 1 other identifier: AutoFUSE-001
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Fetus Disorder

Keywords

First-trimester ultrasound; Artificial intelligence; Standard plane; Image quality control; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• The efficiency of standard plane acquisition

  The primary outcome was measured by the time required to obtain the prespecified standard planes during the ultrasound examination.

  Day 1

Secondary Outcomes (1)

• The accuracy of standard plane acquisition

  Through study completion, an average of 6 months

Study Arms (2)

AutoFUSE-assisted ultrasound scan

EXPERIMENTAL

AutoFUSE-assisted ultrasound scanning throughout the examination.

Diagnostic Test: AutoFUSE system

Traditional ultrasound scan

ACTIVE COMPARATOR

Standard ultrasound scanning according to the standard clinical protocol.

Diagnostic Test: Traditional ultrasound scan

Interventions

AutoFUSE system DIAGNOSTIC_TEST

AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).

AutoFUSE-assisted ultrasound scan

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.

Traditional ultrasound scan

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ① Pregnant women undergoing fetal ultrasound examination.
• ② A singleton pregnancy with a live fetus between 11 and 13+6 weeks with complete outcomes.

You may not qualify if:

• Incomplete pregnancy outcome information.
• Unexplained miscarriages. ③ Fetal death.
• Pregnancies with significant maternal complications.
• Multiple pregnancies.

Sponsors & Collaborators

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

Study Sites (3)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430022, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

MeSH Terms

Conditions

Fetal Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)