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

NCT ID: NCT05940363

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-06-01

Brief Summary

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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

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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

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Congenital Heart Disease in Pregnancy Prenatal Diagnosis Fetal Echocardiography

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Liaoning Provincial Maternal and Child Health Hospital

Liaoning Provincial Maternal and Child Health Hospital

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Shenyang Maternal and Infant Hospital

Shenyang Maternal and Infant Hospital

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Guangdong Women and Children's Hospital

Guangdong Women and Children's Hospital

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Guangzhou Women and Children's Medical Center

Guangzhou Women and Children's Medical Center

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Guangdong Provincial People's Hospital

Guangdong Provincial People's Hospital

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Shandong Maternal and Child Health Hospital

Shandong Maternal and Child Health Hospital

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Fujian Provincial Maternal and Child Health Hospital

Fujian Provincial Maternal and Child Health Hospital

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Maternal and Child Health Hospital of Hubei Province

Maternal and Child Health Hospital of Hubei Province

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Anhui Provincial Maternal and Child Health Hospital

Anhui Provincial Maternal and Child Health Hospital

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Peking University First Hospital, Ningxia Women and Children's Hospital

Peking University First Hospital, Ningxia Women and Children's Hospital

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Sichuan Maternal and Child Health Hospital

Sichuan Maternal and Child Health Hospital

Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yihua He,MD

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yihua He, MD

Role: STUDY_CHAIR

Beijing Anzhen Hospital

Central Contacts

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Yihua He, MD

Role: CONTACT

18910778673 ext. +86

Yingying Zhang, PHD

Role: CONTACT

18514752298 ext. +86

Other Identifiers

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MCCDTP-CHD

Identifier Type: -

Identifier Source: org_study_id

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