Fetus Disorder
Conditions
Keywords
First-trimester ultrasound, Artificial intelligence, Standard plane, Image quality control, Randomized clinical trial
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.
Interventions
DIAGNOSTIC_TESTAutoFUSE system
AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).
DIAGNOSTIC_TESTTraditional 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.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed