Clinical trial NCT05940363: The National Program for the Improvement of Management of Fetal Congenital Heart Disease in China
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Congenital Heart Disease in Pregnancy
Prenatal Diagnosis
Fetal Echocardiography
Keywords: Congenital Heart Disease
Prenatal diagnosis
Fetal Echocardiography
Maternal-fetal medicine
Digital health technologies
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 9000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and physicians performing prenatal screening and diagnosis

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.

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

Primary outcomes:
measure: The integrity rate of the multi-view acquisition
timeFrame: From June 2023 to Oct 2023
measure: Negative coincidence rate congenital heart disease screening
timeFrame: From June 2023 to Oct 2023
measure: Positive coincidence rate of congenital heart disease screening
timeFrame: From June 2023 to Oct 2023
measure: The coincidence rate of multidisciplinary consultation
timeFrame: From June 2023 to Oct 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Anzhen Hospital
name: Yihua He, MD
role: STUDY_CHAIR
References: