Early Diagnosis and Prediction of Maternal and Neonatal Diseases: (EDPMND)

April 16, 2025 updated by: Kang Zhang, The Eye Hospital of Wenzhou Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou Women and Children's Medical Center
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • Recruiting
        • First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wenzhou, Zhejiang, China
        • Recruiting
        • Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of pregnant women aged 18 to 45 years who have received care at participating study centers. Participants must have comprehensive electronic health records (EHRs) available, including prenatal care data, laboratory results, or imaging data. Both healthy mothers and those with pregnancy-related diseases (e.g., preeclampsia, gestational diabetes) will be included in the study to assess the AI-assisted model's diagnostic capabilities. The study will focus on patients with documented care records from the participating centers.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy Maternal and Neonatal Cohort
This group consists of pregnant mothers with no pregnancy-related diseases and their healthy newborns. Participants in this cohort will serve as the control group for comparison to the experimental group. No interventions or treatments will be administered to this cohort, as they represent the baseline of healthy pregnancies and newborns.
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.
Maternal and Neonatal Disease Cohort
This group consists of pregnant mothers who have been diagnosed with pregnancy-related diseases or their affected newborns. Participants in this cohort will serve as the experimental group for evaluating the effectiveness of the early prediction model in identifying maternal and neonatal health risks.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 year
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Eye Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Maternal and Neonatal Diseases

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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