An observational study in Gestational Diabetes Mellitus, sponsored by Women's Hospital School Of Medicine Zhejiang University. Recruiting at 1 site in China. Open to female participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Observational
Gestational diabetes mellitus (GDM) is prone to cause a variety of adverse pregnancy outcomes, and has potential harm to the short-term and long-term health of both mothers and infants. However, its diagnosis mainly relies on oral glucose tolerance test (OGTT) at 24-28 weeks of gestation, so it is often diagnosed in the second and third trimester, and may be too late to intervene. Therefore, advancing the diagnostic window period of GDM is the key to the prevention and treatment of GDM and its complications. It is urgent to establish a new technology for the early diagnosis and screening of GDM with high detection rate and accuracy. Based on literature survey and previous studies, this study found that the combined analysis of metabolomics and lipidomics may have broad clinical application prospects in the early diagnosis and screening of GDM. It is hoped that a set of new techniques based on multi-omics for early diagnosis and screening of GDM can be constructed, providing a feasible and effective tool for early detection and treatment of GDM in clinical.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 200 across 269 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This project intends to recruit pregnant women who go to the research center for routine prenatal examination and OGTT screening.
Exclusion Criteria:
Pregnant women with positive OGTT results at 24-28 gestational weeks
Other: Questionnaire survey and specimen collection
Pregnant women with negative OGTT results at 24-28 gestational weeks, and had baseline data that matched those in the GDM group
Other: Questionnaire survey and specimen collection
A questionnaire survey was conducted when pregnant women were enrolled in the first trimester, and blood, urine, saliva and other specimens were collected.
Salivary metabolomics
The differential salivary metabolism molecules in saliva were detected by the self-developed detection chip, and the markers related to GDM in early pregnancy were screened. Specimens were collected during the first trimester.
Time frame: First trimester (9-14 gestational weeks)
Serum lipidomics
The differential serum lipid molecules in serum were detected by the self-developed detection chip, and the markers related to GDM in early pregnancy were screened. Specimens were collected during the first trimester.
Time frame: First trimester (9-14 gestational weeks)
Urine metabolomics
The differential urine metabolism molecules in urine were detected by the self-developed detection chip, and the markers related to GDM in early pregnancy were screened. Specimens were collected during the first trimester.
Time frame: First trimester (9-14 gestational weeks)
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Women's Hospital School Of Medicine Zhejiang University