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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AutoFUSE-assisted ultrasound scan | Experimental | AutoFUSE-assisted ultrasound scanning throughout the examination. |
|
| Traditional ultrasound scan | Active Comparator | Standard ultrasound scanning according to the standard clinical protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AutoFUSE system | Diagnostic Test | AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of standard plane acquisition | The secondary outcome was assessed by whether the prespecified standard planes are correctly obtained according to predefined imaging criteria. | Through study completion, an average of 6 months |
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Inclusion Criteria:
â‘ Pregnant women undergoing fetal ultrasound examination.
â‘¡ A singleton pregnancy with a live fetus between 11 and 13+6 weeks with complete outcomes.
Exclusion Criteria:
Incomplete pregnancy outcome information.
Unexplained miscarriages. â‘¢ Fetal death.
Pregnancies with significant maternal complications.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China |
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| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| 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. |
|
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430022 | China |
|
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
|