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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05940363
Enrollment
9000
Registered
2023-07-11
Start date
2023-07-01
Completion date
2026-06-01
Last updated
2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease in Pregnancy, Fetal Echocardiography, Prenatal Diagnosis

Keywords

Congenital Heart Disease, Prenatal diagnosis, Fetal Echocardiography, Maternal-fetal medicine, Digital health technologies

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.

Interventions

COMBINATION_PRODUCTImprovement 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.

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The integrity rate of the multi-view acquisitionFrom June 2023 to Oct 2023The integrity rate of the multi-view acquisition
Negative coincidence rate congenital heart disease screeningFrom June 2023 to Oct 2023Negative coincidence rate congenital heart disease screening
Positive coincidence rate of congenital heart disease screeningFrom June 2023 to Oct 2023Positive coincidence rate of congenital heart disease screening
The coincidence rate of multidisciplinary consultationFrom June 2023 to Oct 2023The coincidence rate of multidisciplinary consultation

Contacts

Primary ContactYihua He, MD
heyihuaecho@hotmail.com18910778673
Backup ContactYingying Zhang, PHD
zhangyingyinghku@163.com18514752298

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026