Early Prediction of Gestational Diabetes in High-risk Women Based on Breath Metabolomics

May 27, 2025 updated by: Tianjin Central Hospital of Gynecology Obstetrics

A Cohort Study in Women at High Risk for Gestational Diabetes Based on Breath Metabolomics

This study aim to develope novel breath markers of gestational diabetes through a prospective high-risk population cohort study and achieve early prediction of gestational diabetes based on an interpretable machine learning model.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

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

Study Locations

  • China
      • Tianjin, China
        • Tianjin Central Hospital of Gynecology Obstetrics

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The population in this study include pregnant women aged 18-55 years and at 11-14 weeks gestation with at least one risk factor for GDM

Description

Eligibility Criteria

  • 18-55 years old
  • 11-14 weeks of pregnancy
  • at least one risk factor for GDM
  • signed a written informed consent

Exclusion Criteria:

  • Diabetes mellitus or abnormal glucose metabolism before pregnancy
  • Hyperemesis gravidarum (urine ketone positive))
  • Thyroid dysfunction
  • Asthmatic patients
  • Hypertensive diseases that are difficult to control
  • Severe hepatic and renal insufficiency or severe electrolyte disturbance
  • Malignant tumor
  • Acute inflammation
  • lung disease
  • Patients with gastritis, duodenum and other digestive system diseases
  • Those with upper respiratory or oral problems who cannot cooperate with expiratory collection
  • smoker

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
control group
Gestational Diabetes Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of gestational diabetes mellitus
Time Frame: 24-28 weeks gestation
24-28 weeks gestation

Collaborators and Investigators

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

Sponsor

Tianjin Central Hospital of Gynecology Obstetrics

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)

December 25, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024KY081

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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