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

July 2, 2023 updated by: Yihua He,MD, Beijing Anzhen Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women and physicians performing prenatal screening and diagnosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
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
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
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
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
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
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
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The integrity rate of the multi-view acquisition
Time Frame: From June 2023 to Oct 2023
The integrity rate of the multi-view acquisition
From June 2023 to Oct 2023
Negative coincidence rate congenital heart disease screening
Time Frame: 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
Time Frame: 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
Time Frame: From June 2023 to Oct 2023
The coincidence rate of multidisciplinary consultation
From June 2023 to Oct 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Anzhen Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yihua He, MD, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCCDTP-CHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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