Quality Control of Ultrasound Images During Early Pregnancy Via AI

NCT ID: NCT06002412

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2028-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research integrates artificial intelligence to enhance early pregnancy ultrasonography quality control, focusing on specific fetal sections. In collaboration with prominent medical institutions, the investigators have amassed extensive fetal ultrasound data. The investigators aim to develop a deep learning model that can accurately identify essential anatomical areas in ultrasound images and evaluate their quality. This tool is expected to significantly decrease misdiagnoses of conditions like Down Syndrome and neural system deformities by ensuring real-time image quality assessment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This research is dedicated to integrating artificial intelligence technology to optimize the quality control process of early pregnancy ultrasonography. The ultrasound images involved primarily focus on the median sagittal section, NT section, and choroid plexus of the fetus during early pregnancy. In this regard, the investigators have collaborated with renowned medical institutions such as Beijing Obstetrics and Gynecology Hospital, Peking University Third Hospital, Changsha Hospital for Maternal and Child Health Care, and Second Xiangya Hospital of Central South University to retrospectively and prospectively collect a vast amount of early pregnancy fetal ultrasound image data. Based on this, the investigators plan to establish a model rooted in deep learning. This model will be capable of precisely identifying key anatomical regions in standard ultrasound scan images. Furthermore, by recognizing these anatomical structures, the model will determine whether the ultrasound image meets the standard scanning quality. This model is anticipated to serve as a powerful auxiliary tool in obstetric ultrasonography, enabling real-time assessment of ultrasound image quality, thereby significantly reducing the rates of missed and misdiagnosed fetal diseases such as Down Syndrome and neural system malformations.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University

Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University collects clinical information and ultrasound images of sagittal, NT and choroid plexus views of the fetus which was obtained from early pregnant women who underwent NT sweeps.

Image quality control

Intervention Type OTHER

The investigators identify the region of interest in the relevant section to give a conclusion on whether the image is standard or not, guiding clinicians to standardize the operation, and reducing the rate of misdiagnosis and underdiagnosis.

Peking University Third Hospital

Peking University Third Hospital collects clinical information and ultrasound images of sagittal, NT and choroid plexus views of the fetus which was obtained from early pregnant women who underwent NT sweeps.

Image quality control

Intervention Type OTHER

The investigators identify the region of interest in the relevant section to give a conclusion on whether the image is standard or not, guiding clinicians to standardize the operation, and reducing the rate of misdiagnosis and underdiagnosis.

Changsha Hospital for Maternal and Child Health Care

Changsha Hospital for Maternal and Child Health Care collects clinical information and ultrasound images of sagittal, NT and choroid plexus views of the fetus which was obtained from early pregnant women who underwent NT sweeps.

Image quality control

Intervention Type OTHER

The investigators identify the region of interest in the relevant section to give a conclusion on whether the image is standard or not, guiding clinicians to standardize the operation, and reducing the rate of misdiagnosis and underdiagnosis.

Second Xiangya Hospital of Central South University

Second Xiangya Hospital of Central South University collects clinical information and ultrasound images of sagittal, NT and choroid plexus views of the fetus which was obtained from early pregnant women who underwent NT sweeps.

Image quality control

Intervention Type OTHER

The investigators identify the region of interest in the relevant section to give a conclusion on whether the image is standard or not, guiding clinicians to standardize the operation, and reducing the rate of misdiagnosis and underdiagnosis.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Image quality control

The investigators identify the region of interest in the relevant section to give a conclusion on whether the image is standard or not, guiding clinicians to standardize the operation, and reducing the rate of misdiagnosis and underdiagnosis.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women in early pregnancy who have detailed personal information and ultrasound images.
* The ultrasound images should clearly show the fetus's median sagittal, NT, and choroid plexus views.

Exclusion Criteria

* Ultrasound images from women in mid to late pregnancy.
* Ultrasound images that are unclear or blurry, making evaluation difficult.
* Women who did not provide complete personal and medical information during the ultrasound scan.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

Changsha Hospital for Maternal and Child Health Care

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Di Dong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University

Beijing, , China

Site Status RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Changsha Hospital for Maternal and Child Health Care

Changsha, , China

Site Status RECRUITING

Second Xiangya Hospital of Central South University

Changsha, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Di Dong, Ph.D

Role: CONTACT

+86 13811833760

Yali Zang, Ph.D

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Di Dong

Role: primary

Di Dong

Role: primary

Di Dong

Role: primary

Di Dong

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CASMI005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.