Menu
Recruiting NCT06791343

Early Diagnosis and Prediction of Maternal and Neonatal Diseases:

Observational Pregnancy-Related and Neonatal Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-Based Diagnostic and Prognostic Model.
Who it may be relevant to
Registry conditions: Pregnancy-Related and Neonatal Disorders. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test AI-Based Diagnostic and Prognostic Model
    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 outcome measures

  • Area Under the Curve (AUC) [Time frame: 1 year]
  • F1 Score [Time frame: 1 year]
Secondary outcome measures (2)
  • Sensitivity (True Positive Rate) [Time frame: 1 year]
  • Specificity (True Negative Rate) [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 3 centers
  • Guangzhou Women and Children's Medical Center — Guangzhou
  • First Affiliated Hospital of Wenzhou Medical University — Wenzhou
  • Second Affiliated Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT06791343 · Maternal and Neonatal Diseases

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗