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Recruiting NCT05733195

The Study of Biomarker in Early Diagnosis of GDM by Metabolomics

Conditions: Gestational Diabetes Mellitus, Metabolomics Detection, Biomarker in Early Diagnosis

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Enrollment: 100
Sponsor: Peking Union Medical College Hospital

Location: China

Summary

Gestational Diabetes Mellitus (GDM) refers to abnormal glucose metabolism during pregnancy, in which elevated blood glucose is first found during pregnancy and meets the criteria for diabetes. In recent years, with the increase of obese women of childbearing age, the incidence of GDM has been rising, the current global average incidence is about 14%, and the incidence in China has increased from 2% in 1999 to 5%-8% at present. If one-step diagnosis is used, the rate will be between 13%-17%, which will greatly increase the social burden. Gestational diabetes mellitus (GDM) significantly increases the risk of diseases for pregnant women and infants, such as abortion and premature delivery, concurrent hypertension, concurrent infection, metabolic disorders, postpartum diabetes, macrosomia, fetal malformation, neonatal hypoglycemia, neonatal respiratory distress syndrome, and so on. It is one of the important public health problems threatening human health. Therefore, the accurate diagnosis of GDM is of great clinical significance for the timely formulation of intervention and treatment measures, reducing the risk of maternal and infant diseases and improving the level of public health.

Eligibility Criteria

Inclusion Criteria:First trimester (6-13 weeks);Pregnant women with a singleton pregnancy;Pregnant women who are registered at the hospital and have regular antenatal check-ups;Pregnant women who volunteered for the study were required to sign an informed consent formExclusion Criteria:Pregnant women with known type 1 or type 2 diabetes mellitus;Pregnant women with hyperlipidemia and hyperbilirubinemia;Pregnant women with hepatic and renal insufficiency

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05733195). StuddyBuddy aggregates publicly available trial information.