A Multicenter Study of Artificial Intelligence Model for Fetal Congenital Heart Disease

Beijing Anzhen Hospital

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06796127

Enrollment

10000

Registered

2025-01-28

Start date

2025-02-01

Completion date

2026-08-01

Last updated

2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence (AI), Congenital Heart Disease (CHD)

Brief summary

This study addresses congenital heart disease in fetuses, a specific birth defect, by collaborating with multicenter medical institutions across China. It prospectively collects echocardiographic screening, diagnostic images, and structured parameter data from both normal and abnormal fetuses. Cases are followed up, and artificial intelligence (AI) models are developed to extract fetal heart echocardiographic image features and analyze the data. This process allows for the analysis of the AI models' accuracy, sensitivity, and specificity, and verifies the application value of AI models in fetal heart echocardiographic screening and diagnosis.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* Single or multiple pregnancy; * Gestational age 16-40 weeks; * Fetal echocardiographic images are clear and complete; * Clinical data are complete and detailed; * Sign informed consent and be able to cooperate with follow-up

Exclusion criteria

* Fetal echocardiographic images are incomplete or of poor quality that cannot be used for research; * Refusal or loss of follow-up

Design outcomes

Primary

Measure	Time frame
Diagnostic efficiency of AI model for fetal CHD	From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.

Countries

China

Outcome results