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Quality Control of Ultrasound Images During Early Pregnancy Via AI

Deep Learning-based Quality Control of Ultrasound Images During Early Pregnancy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06002412
Enrollment
400
Registered
2023-08-21
Start date
2023-09-01
Completion date
2028-07-30
Last updated
2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Pregnancy

Keywords

Early Pregnancy, Ultrasound, Quality Control

Brief summary

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

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.

Interventions

OTHERImage 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.

Sponsors

Beijing Obstetrics and Gynecology Hospital
CollaboratorOTHER
Peking University Third Hospital
CollaboratorOTHER
Changsha Hospital for Maternal and Child Health Care
CollaboratorOTHER
Second Xiangya Hospital of Central South University
CollaboratorOTHER
Chinese Academy of Sciences
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
PR curve of image quality control moduleone monthUsing Precision-Recall curve and mean average percision as evaluating indicator of image quality control model.

Secondary

MeasureTime frameDescription
The accuracy of intelligent analysis system in image quality control moduleone monthThe agreement between the prediction outcome of intelligent analysis system and the golden standard

Countries

China

Contacts

Primary ContactDi Dong, Ph.D
di.dong@ia.ac.cn+86 13811833760
Backup ContactYali Zang, Ph.D
yali.zang@ia.ac.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026