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Clinical trial

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

ID
Name
MCCDTP-CHD
Description
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.
Trial arms
Trial start
2023-07-01
Estimated PCD
2023-09-01
Trial end
2026-06-01
Status
Not yet recruiting
Treatment
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.
Arms:
Anhui Provincial Maternal and Child Health Hospital, Fujian Provincial Maternal and Child Health Hospital, Guangdong Provincial People's Hospital, Guangdong Women and Children's Hospital, Guangzhou Women and Children's Medical Center, Liaoning Provincial Maternal and Child Health Hospital, Maternal and Child Health Hospital of Hubei Province, Peking University First Hospital, Ningxia Women and Children's Hospital, Shandong Maternal and Child Health Hospital, Shenyang Maternal and Infant Hospital, Sichuan Maternal and Child Health Hospital
Size
9000
Primary endpoint
The integrity rate of the multi-view acquisition
From June 2023 to Oct 2023
Negative coincidence rate congenital heart disease screening
From June 2023 to Oct 2023
Positive coincidence rate of congenital heart disease screening
From June 2023 to Oct 2023
The coincidence rate of multidisciplinary consultation
From June 2023 to Oct 2023
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '2 Years', 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'count': 9000, 'type': 'ESTIMATED'}}
Updated at
2023-07-11

1 organization

Organization
Beijing Anzhen Hospital