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

Sponsor
Beijing Anzhen Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05940363
Collaborator
(none)
9,000
35

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
9000 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
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
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Liaoning Provincial Maternal and Child Health Hospital

Liaoning Provincial Maternal and Child Health Hospital

Combination Product: 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.

Shenyang Maternal and Infant Hospital

Shenyang Maternal and Infant Hospital

Combination Product: 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.

Guangdong Women and Children's Hospital

Guangdong Women and Children's Hospital

Combination Product: 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.

Guangzhou Women and Children's Medical Center

Guangzhou Women and Children's Medical Center

Combination Product: 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.

Guangdong Provincial People's Hospital

Guangdong Provincial People's Hospital

Combination Product: 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.

Shandong Maternal and Child Health Hospital

Shandong Maternal and Child Health Hospital

Combination Product: 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.

Fujian Provincial Maternal and Child Health Hospital

Fujian Provincial Maternal and Child Health Hospital

Combination Product: 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.

Maternal and Child Health Hospital of Hubei Province

Maternal and Child Health Hospital of Hubei Province

Combination Product: 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.

Anhui Provincial Maternal and Child Health Hospital

Anhui Provincial Maternal and Child Health Hospital

Combination Product: 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.

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

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

Combination Product: 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.

Sichuan Maternal and Child Health Hospital

Sichuan Maternal and Child Health Hospital

Combination Product: 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.

Outcome Measures

Primary Outcome Measures

  1. The integrity rate of the multi-view acquisition [From June 2023 to Oct 2023]

    The integrity rate of the multi-view acquisition

  2. Negative coincidence rate congenital heart disease screening [From June 2023 to Oct 2023]

    Negative coincidence rate congenital heart disease screening

  3. Positive coincidence rate of congenital heart disease screening [From June 2023 to Oct 2023]

    Positive coincidence rate of congenital heart disease screening

  4. The coincidence rate of multidisciplinary consultation [From June 2023 to Oct 2023]

    The coincidence rate of multidisciplinary consultation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Beijing Anzhen Hospital

Investigators

  • Study Chair: Yihua He, MD, Beijing Anzhen Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yihua He,MD, Director of the Center for Maternal-Fetal Medicine of Fetal Heart Disease, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT05940363
Other Study ID Numbers:
  • MCCDTP-CHD
First Posted:
Jul 11, 2023
Last Update Posted:
Jul 11, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yihua He,MD, Director of the Center for Maternal-Fetal Medicine of Fetal Heart Disease, Beijing Anzhen Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2023