Early detection of gestational diabetes using multiomics techniques
Clinical Study of a New Technology System for Early Diagnosis and Screening of GDM Based on Multiomics
Women's Hospital School Of Medicine Zhejiang University · NCT05386927
This study is trying to find a better way to detect gestational diabetes early in pregnant women by using advanced testing methods on samples taken during their first trimester.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 20 Years to 49 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05386927 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the early diagnosis of gestational diabetes mellitus (GDM) by utilizing a combination of metabolomics and lipidomics. Currently, GDM is typically diagnosed during the second and third trimesters, which may be too late for effective intervention. By analyzing biological specimens collected from pregnant women in their first trimester, the study seeks to establish a new diagnostic approach that enhances detection rates and accuracy. The ultimate goal is to develop a set of multi-omics techniques that can facilitate timely screening and intervention for GDM.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women in their first trimester planning to have routine prenatal examinations at the research center.
Not a fit: Patients with pre-existing metabolic disorders or pregnancy complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of gestational diabetes, improving health outcomes for both mothers and infants.
How similar studies have performed: While the approach of using multiomics for early diagnosis is innovative, similar studies have shown promise in other conditions, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Plan to have routine prenatal examinations and give birth in the research center * First trimester * Singleton pregnancy * Without pregnancy complications * Willing to cooperate with the hospital to follow up Exclusion Criteria: * Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc. * Fetus has a known deformity or genetic defects * Incomplete clinical data
Where this trial is running
Hangzhou, Zhejiang
- Women's Hospital School Of Medicine Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Zhaoxia Liang, Prof.
- Email: xiaozaizai@zju.edu.cn
- Phone: 86571-89992115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gestational Diabetes Mellitus