NCT05940363

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jul 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jul 2023Jun 2026

Study Start

First participant enrolled

July 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 2, 2023

Last Update Submit

July 2, 2023

Conditions

Keywords

Congenital Heart DiseasePrenatal diagnosisFetal EchocardiographyMaternal-fetal medicineDigital health technologies

Outcome Measures

Primary Outcomes (4)

  • The integrity rate of the multi-view acquisition

    The integrity rate of the multi-view acquisition

    From June 2023 to Oct 2023

  • Negative coincidence rate congenital heart disease screening

    Negative coincidence rate congenital heart disease screening

    From June 2023 to Oct 2023

  • Positive coincidence rate of congenital heart disease screening

    Positive coincidence rate of congenital heart disease screening

    From June 2023 to Oct 2023

  • The coincidence rate of multidisciplinary consultation

    The coincidence rate of multidisciplinary consultation

    From June 2023 to Oct 2023

Study Arms (11)

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

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

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

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

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

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

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

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

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

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

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

Interventions

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 HospitalFujian Provincial Maternal and Child Health HospitalGuangdong Provincial People's HospitalGuangdong Women and Children's HospitalGuangzhou Women and Children's Medical CenterLiaoning Provincial Maternal and Child Health HospitalMaternal and Child Health Hospital of Hubei ProvincePeking University First Hospital, Ningxia Women and Children's HospitalShandong Maternal and Child Health HospitalShenyang Maternal and Infant HospitalSichuan Maternal and Child Health Hospital

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women and physicians performing prenatal screening and diagnosis

You may qualify if:

  • All pregnant women and fetuses who underwent prenatal ultrasound examination in the above hospitals were enrolled

You may not qualify if:

  • Pregnant women not willing to cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Yihua He, MD

    Beijing Anzhen Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Center for Maternal-Fetal Medicine of Fetal Heart Disease

Study Record Dates

First Submitted

July 2, 2023

First Posted

July 11, 2023

Study Start

July 1, 2023

Primary Completion

September 1, 2023

Study Completion (Estimated)

June 1, 2026

Last Updated

July 11, 2023

Record last verified: 2023-07