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Clinical Trials/NCT05940363
NCT05940363
Not yet recruiting
Not Applicable

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

Beijing Anzhen Hospital0 sites9,000 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease in Pregnancy
Sponsor
Beijing Anzhen Hospital
Enrollment
9000
Primary Endpoint
The integrity rate of the multi-view acquisition
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
June 1, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Beijing Anzhen Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yihua He,MD

Director of the Center for Maternal-Fetal Medicine of Fetal Heart Disease

Beijing Anzhen Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

The integrity rate of the multi-view acquisition

Time Frame: From June 2023 to Oct 2023

The integrity rate of the multi-view acquisition

Negative coincidence rate congenital heart disease screening

Time Frame: From June 2023 to Oct 2023

Negative coincidence rate congenital heart disease screening

Positive coincidence rate of congenital heart disease screening

Time Frame: From June 2023 to Oct 2023

Positive coincidence rate of congenital heart disease screening

The coincidence rate of multidisciplinary consultation

Time Frame: From June 2023 to Oct 2023

The coincidence rate of multidisciplinary consultation

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