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

NCT ID: NCT06753734

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-25

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gestational Diabetes Group

No interventions assigned to this group

control group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tianjin Central Hospital of Gynecology Obstetrics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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2024KY081

Identifier Type: -

Identifier Source: org_study_id

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