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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05940363
Other study ID # MCCDTP-CHD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date June 1, 2026

Study information

Verified date July 2023
Source Beijing Anzhen Hospital
Contact Yihua He, MD
Phone 18910778673
Email heyihuaecho@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 9000
Est. completion date June 1, 2026
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Anzhen Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The integrity rate of the multi-view acquisition The integrity rate of the multi-view acquisition From June 2023 to Oct 2023
Primary Negative coincidence rate congenital heart disease screening Negative coincidence rate congenital heart disease screening From June 2023 to Oct 2023
Primary Positive coincidence rate of congenital heart disease screening Positive coincidence rate of congenital heart disease screening From June 2023 to Oct 2023
Primary The coincidence rate of multidisciplinary consultation The coincidence rate of multidisciplinary consultation From June 2023 to Oct 2023
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