AutoFUSE or First-Trimester Ultrasound Scan

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

Treatment groups

1,000 Participants
are divided into 2 treatment groups