About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
Incomplete pregnancy outcome information.
Unexplained miscarriages. ③ Fetal death.
Pregnancies with significant maternal complications.
Multiple pregnancies.
Trial design
Treatments tested in this trial
- AutoFUSE system
- Traditional ultrasound scan