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NCT Number: NCT06791343

Early Diagnosis and Prediction of Maternal and Neonatal Diseases:

This is a multi-center, clinical study designed to evaluate the application and effectiveness of an AI-assisted predictive model for identifying maternal and neonatal diseases, leveraging multimodal health data.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Women and Children's Medical Center, Guangzhou, Guangdong, China

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About this study

Maternal and neonatal health significantly impact the well-being of both mothers and infants. Early screening, diagnosis, and intervention are crucial for preventing the onset and progression of pregnancy-related diseases and neonatal conditions. In clinical practice, obstetricians and pediatricians often need to integrate a wide range of patient data, including demographic information, medical history, biochemical markers such as blood glucose and lipid levels, as well as various imaging data such as ultrasounds, fetal monitoring, and laboratory test results, to make an accurate diagnosis and develop an appropriate care plan. In an era where precision and personalized medicine are at the forefront of healthcare, the early detection and diagnosis of maternal and neonatal diseases, as well as the selection of suitable diagnostic and therapeutic strategies, have become significant challenges in clinical settings. Recent advancements in medical imaging and data analysis techniques have greatly enhanced the accuracy and effectiveness of maternal and neonatal disease diagnosis. This study aims to develop an AI-assisted decision-making system by integrating multimodal data from electronic medical records, imaging, and laboratory results, in combination with deep learning techniques. The objective is to improve diagnostic accuracy, streamline clinical workflows, and provide more personalized care options for mothers and infants. Ultimately, this system seeks to enhance health outcomes and improve the overall quality of life for both mothers and their newborns.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant women aged 18 to 45 years.
  • Women who have received prenatal care at participating centers (e.g., hospitals or clinics).
  • Availability of comprehensive electronic health records, including prenatal care data, laboratory results, and imaging records.
  • Willingness to provide consent for participation in the study and the use of historical health data for analysis.

Exclusion criteria

  • Women under 18 or over 45 years old.
  • Participants with insufficient follow-up data or missing critical clinical information required for predictive modeling.

Treatment and study plan

AI-Based Diagnostic and Prognostic Model

Diagnostic Test

This intervention involves an AI system that integrates multimodal data, including maternal health records, laboratory test results, and imaging data, to predict the risk of maternal and neonatal diseases. The system uses deep learning algorithms to provide real-time, accurate predictions, enabling early identification of health complications. By analyzing historical health data, the model aims to predict potential risks for both mothers and infants, improving early intervention and outcomes.

Primary outcomes

  1. Area Under the Curve (AUC)

    Time frame: 1 year

    AUC of the ROC curve, used to quantify diagnostic accuracy. No unit (a ratio or percentage, typically expressed as a number between 0 and 1).

  2. F1 Score

    Time frame: 1 year

    The F1 score is the harmonic mean of precision and sensitivity (recall). It is a good measure of the model's ability to identify both true positives and minimize false positives, especially in cases where the classes are imbalanced (e.g., when the number of healthy cases is much higher than disease cases). The F1 score ranges from 0 to 1, with 1 indicating perfect precision and recall.

Secondary outcomes

  1. Sensitivity (True Positive Rate)

    Time frame: 1 year

    Sensitivity measures how well the AI model identifies true positive cases, such as correctly diagnosing pregnant women with complications or identifying neonatal disorders.

  2. Specificity (True Negative Rate)

    Time frame: 1 year

    Specificity measures the ability of the AI model to correctly identify cases without diseases, ensuring that healthy mothers and infants are correctly identified as negative.

Study contacts

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

Fei Liu, MD

CONTACT

[email protected]

+86 13810512704

Sponsors and collaborators

Lead sponsor

The Eye Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Early Prediction and Diagnosis of Maternal and Neonatal Diseases Using Multimodal Health Data

Acronym: EDPMND

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Apr 17, 2025

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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