Prenatal diagnosis
Conditions
Interventions
Group2:Doctor + AI diagnosis was performed upon enrollment, and doctor alone diagnosis was performed after a 4-week washout period.
Group1:Individual doctor diagnosis was performed upon enrollment and AI + doctor diagnosis was performed after washout period (4 weeks)
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant women or guardians voluntarily participate in the clinical trial and sign the informed consent in person; 2. At the time of ultrasound examination, pregnant women were 11 weeks + 0 day to 32 weeks + 0 day (including 11 weeks + 0 and 32 weeks + 0 day); 3. Pregnant women suspected of fetal malformation with records (such as ultrasound diagnosis/markers of chromosomal diseases/abnormal serological tests/abnormal genetic tests/referral records, etc.); 4. Ultrasonic image data has not been used in the algorithm model training of this product.
Exclusion criteria
Exclusion criteria: 1. Twin or multiple pregnancies (except conjoined twins); 2. Fetal death in utero; 3. Participating in clinical studies of other drugs or devices during the study period; 4. Subjects deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity in the detection of specific malformations; | — |
Countries
China
Contacts
Public ContactXie HongNing
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed