Congenital Heart Disease in PregnancyNCT05940363
The National Program for the Improvement of Management of Fetal Congenital Heart Disease in China
An observational study of Congenital Heart Disease in Pregnancy and Prenatal Diagnosis, run by Beijing Anzhen Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Congenital Heart Disease in Pregnancy, Prenatal Diagnosis, Fetal Echocardiography
- What is being tested?
- Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies
- How many people
- 9,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jun 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women and physicians performing prenatal screening and diagnosis
Who may be able to join
- All pregnant women and fetuses who underwent prenatal ultrasound examination in the above hospitals were enrolled
Who cannot join
- Pregnant women not willing to cooperate
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Being tested
- Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies
- Keywords
- Congenital Heart Disease, Prenatal diagnosis, Fetal Echocardiography, Maternal-fetal medicine, Digital health technologies
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New TechnologiesCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Liaoning Provincial Maternal and Child Health Hospital | Liaoning Provincial Maternal and Child Health Hospital Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies | |
| Shenyang Maternal and Infant Hospital | Shenyang Maternal and Infant Hospital Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies | |
| Guangdong Women and Children's Hospital | Guangdong Women and Children's Hospital Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies | |
| Guangzhou Women and Children's Medical Center | Guangzhou Women and Children's Medical Center Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies | |
| Guangdong Provincial People's Hospital | Guangdong Provincial People's Hospital Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies | |
| Shandong Maternal and Child Health Hospital | Shandong Maternal and Child Health Hospital Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies | |
| Fujian Provincial Maternal and Child Health Hospital | Fujian Provincial Maternal and Child Health Hospital Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies | |
| Maternal and Child Health Hospital of Hubei Province | Maternal and Child Health Hospital of Hubei Province Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies | |
| Anhui Provincial Maternal and Child Health Hospital | Anhui Provincial Maternal and Child Health Hospital Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies | |
| Peking University First Hospital, Ningxia Women and Children's Hospital | Peking University First Hospital, Ningxia Women and Children's Hospital Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies | |
| Sichuan Maternal and Child Health Hospital | Sichuan Maternal and Child Health Hospital Receives: Combination Product: Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New Technologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
The integrity rate of the multi-view acquisition
The integrity rate of the multi-view acquisition
Measured: From June 2023 to Oct 2023
Negative coincidence rate congenital heart disease screening
Negative coincidence rate congenital heart disease screening
Measured: From June 2023 to Oct 2023
Positive coincidence rate of congenital heart disease screening
Positive coincidence rate of congenital heart disease screening
Measured: From June 2023 to Oct 2023
The coincidence rate of multidisciplinary consultation
The coincidence rate of multidisciplinary consultation
Measured: From June 2023 to Oct 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in PregnancyStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 9,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yihua He,MD, Beijing Anzhen Hospital
- Investigators
- Yihua He, MD, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940363
- Sponsor's protocol ID
- MCCDTP-CHD
- Status last verified
- Jul 2023
- First submitted
- 2 Jul 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05940363
- Acronym / sponsor ID
- MCCDTP-CHD
- Keywords
- Congenital Heart Disease, Prenatal diagnosis, Fetal Echocardiography, Maternal-fetal medicine, Digital health technologies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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 TechnologiesLiaoning Provincial Maternal and Child Health 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 TechnologiesShenyang Maternal and Infant 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 TechnologiesGuangdong Women and Children's Hospital |
| 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 TechnologiesGuangzhou Women and Children's Medical Center |
| 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 TechnologiesGuangdong Provincial People's 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 TechnologiesShandong 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 TechnologiesFujian Provincial Maternal and Child Health Hospital |
| 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 TechnologiesMaternal and Child Health Hospital of Hubei Province |
| 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 TechnologiesAnhui Provincial Maternal and Child Health 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 TechnologiesPeking University First Hospital, Ningxia Women and Children's 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 TechnologiesSichuan Maternal and Child Health Hospital |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women and physicians performing prenatal screening and diagnosis
Key inclusion criteria (1 listed)
- All pregnant women and fetuses who underwent prenatal ultrasound examination in the above hospitals were enrolled
Key exclusion criteria (1 listed)
- Pregnant women not willing to cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improvement on Prenatal Screening and Treatment Capabilities for Congenital Heart Disease with a Comprehensive Diagnosis and Treatment Program Incorporating New TechnologiesTo 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. | Combination product | 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 |
Primary outcome
The integrity rate of the multi-view acquisition
Time frame: From June 2023 to Oct 2023
The integrity rate of the multi-view acquisition
Negative coincidence rate congenital heart disease screening
Time frame: From June 2023 to Oct 2023
Negative coincidence rate congenital heart disease screening
Positive coincidence rate of congenital heart disease screening
Time frame: From June 2023 to Oct 2023
Positive coincidence rate of congenital heart disease screening
The coincidence rate of multidisciplinary consultation
Time frame: From June 2023 to Oct 2023
The coincidence rate of multidisciplinary consultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Heart Disease in Pregnancy
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Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
High Risk Pregnancy, Congenital Heart Disease
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Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables
Congenital Heart Disease, Congenital Vascular Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yihua He, MD study chair
Beijing Anzhen Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease in Pregnancy and Prenatal Diagnosis, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihua He, MD (18910778673 ext. +86, heyihuaecho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The integrity rate of the multi-view acquisition (time frame: From June 2023 to Oct 2023). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.