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

Not yet recruiting

• Conditions: Congenital Heart Disease in Pregnancy; Fetal Echocardiography; Prenatal Diagnosis

• Registration Number: NCT05940363
• Lead Sponsor: Beijing Anzhen Hospital

Brief 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.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted: 2023-07-02
• Study First Submitted QC: 2023-07-02
• Last Update Submitted: 2023-07-02
• Study First Posted: 2023-07-11
• Last Update Posted: 2023-07-11
• Primary Completion: 2023-09-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 9000

Inclusion Criteria

• All pregnant women and fetuses who underwent prenatal ultrasound examination in the above hospitals were enrolled

Exclusion Criteria

• Pregnant women not willing to cooperate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The integrity rate of the multi-view acquisition	From June 2023 to Oct 2023	The integrity rate of the multi-view acquisition
Negative coincidence rate congenital heart disease screening	From June 2023 to Oct 2023	Negative coincidence rate congenital heart disease screening
Positive coincidence rate of congenital heart disease screening	From June 2023 to Oct 2023	Positive coincidence rate of congenital heart disease screening
The coincidence rate of multidisciplinary consultation	From June 2023 to Oct 2023	The coincidence rate of multidisciplinary consultation