AutoFUSE or First-Trimester Ultrasound Scan
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AutoFUSE system, Traditional ultrasound scan.
- Who it may be relevant to
- Registry conditions: Fetus Disorder. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Validation of an AI-based Intelligent Image Quality Control System for First-Trimester Ultrasound Scan: a Stepwise, Multicenter, Randomized Clinical Trial in China
Overview
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.
Interventions
- Diagnostic test AutoFUSE system
AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS). - 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.
Primary outcome measures
- The efficiency of standard plane acquisition [Time frame: Day 1]
Secondary outcome measures (1)
- The accuracy of standard plane acquisition [Time frame: Through study completion, an average of 6 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Diagnostic
Study locations
China · 3 centers
- Wuhan Union Hospital — Wuhan
- Zhongnan Hospital of Wuhan University — Wuhan
- Renmin Hospital of Wuhan University — Wuhan
Identifiers
NCT: NCT07601191 · AutoFUSE-001