NCT05940363

The National Program for the Improvement of Management of Fetal Congenital Heart Disease in China

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease With a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies Based on Multi-center Collaboration in China

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 9,000 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

To investigate and evaluate the capacity of prenatal screening, diagnosis and counseling of congenital heart disease in medical institutions in China, in order to understand the current status and existing problems of prenatal prevention and treatment capacity of congenital heart disease in China, and to obtain corresponding baseline data, so as to provide scientific basis for further improving prenatal screening and diagnosis policies in China.

Detailed description

With the rapid development of medical imaging technology, the role of ultrasound screening and diagnosis in the prevention and treatment of birth defects is increasingly prominent. Early screening, classified diagnosis, and standardized consultation are the basis for effective prevention and treatment of congenital heart disease. Due to the uneven development of medical resources and medical service levels in the eastern, central, and western regions of China, as well as between urban and rural areas, the ability of prenatal ultrasound screening, diagnosis, and clinical consultation varies greatly, and there is a lack of relevant clinical research data, which makes it difficult to adopt effective intervention measures. This study aims to investigate and analyze the prenatal screening, diagnosis, and consultation abilities of medical personnel in different regions, evaluate the current status and problems of congenital heart disease abilities in various regions, explore a multidisciplinary transfer consultation integrated service mechanism, strengthen comprehensive prevention and control abilities, ensure maternal and infant health.

Conditions

• Congenital Heart Disease in Pregnancy
• Prenatal Diagnosis
• Fetal Echocardiography

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies	To investigate and evaluate the capacity of prenatal screening, diagnosis and counseling for fetal heart disease based on medical institutions; Improving capacity for prenatal screening, diagnosis and counselling through integrated products embedded with new technologies.

Timeline

• Start date: 2023-07-01
• Primary completion: 2023-09-01
• Completion: 2026-06-01
• First posted: 2023-07-11
• Last updated: 2023-07-11