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Enrolling by invitation NCT06753734

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

— Observational Gestational Diabetes

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gestational Diabetes. Basic parameters: 18 years — 55 years · Female.
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 →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Incidence of gestational diabetes mellitus [Time frame: 24-28 weeks gestation]

Eligibility criteria

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

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
Cohort

Study locations

China · 1 center
  • Tianjin Central Hospital of Gynecology Obstetrics — Tianjin

Identifiers

NCT: NCT06753734 · 2024KY081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗