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NCT Number: NCT06002412

Quality Control of Ultrasound Images During Early Pregnancy Via AI

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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Image quality control

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.

Primary outcomes

  1. PR curve of image quality control module

    Time frame: one month

    Using Precision-Recall curve and mean average percision as evaluating indicator of image quality control model.

Secondary outcomes

  1. The accuracy of intelligent analysis system in image quality control module

    Time frame: one month

    The agreement between the prediction outcome of intelligent analysis system and the golden standard

Study contacts

Contact information is provided by the study sponsor or research team.

Di Dong, Ph.D

CONTACT

[email protected]

+86 13811833760

Yali Zang, Ph.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • Beijing Obstetrics and Gynecology Hospital
  • Changsha Hospital for Maternal and Child Health Care
  • Peking University Third Hospital
  • Second Xiangya Hospital of Central South University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2028
First posted
Aug 21, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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