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Enrolling by Invitation

NCT Number: NCT06753734

Early Prediction of Gestational Diabetes in High-risk Women 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.

Enrolling by Invitation

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, China

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Incidence of gestational diabetes mellitus

    Time frame: 24-28 weeks gestation

Sponsors and collaborators

Lead sponsor

Tianjin Central Hospital of Gynecology Obstetrics

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 31, 2024
Registry last updated
May 31, 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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