NCT05388721|Unknown
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Sponsor study identifier
observational
2,500
1 country
1
Study Start
May 1, 2022
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Gestational diabetes mellitus (GDM) refers to the abnormal glucose metabolism index of pregnant women during pregnancy. At present, about 15% of pregnant women will develop GDM in the second and third trimester, which seriously affects the health of the pregnant woman and the fetus. However, the etiology of GDM remains unclear. Various pollutants in the environment may have a potential impact on pregnant women and fetuses. For example, previous studies have shown that exposure to atmospheric pollutants nitric oxide and organochlorine pesticides are associated with GDM. At present, we plan to further investigate the correlation between environmental pollutants and GDM.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2022
Actual (reported)May 15, 2022
Actual (reported)May 24, 2022
Actual (reported)December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Environmental contaminants 1
The concentrations of environmental pollutants, such as organochlorine pesticides, polychlorinated biphenyls, polycyclic aromatic hydrocarbons, polybrominated diphenyl ethers and metallic elements, in serum and urine were analyzed by gas chromatochromatograms and mass spectrometry (GC-MS/MS). Specimens were collected during the first trimester and tested when classified in the GDM or control group
First trimester (9-14 gestational weeks)
Environmental contaminants 2
The concentrations of environmental pollutants, such as organochlorine pesticides, polychlorinated biphenyls, polycyclic aromatic hydrocarbons, polybrominated diphenyl ethers and metallic elements, in serum and urine were analyzed by gas chromatochromatograms and mass spectrometry (GC-MS/MS). Specimens were collected during the third trimester.
Third trimester (after 28 gestational weeks)
Pregnant women with positive OGTT results at 24-28 gestational weeks
Pregnant women with negative OGTT results at 24-28 gestational weeks, and had baseline data that matched those in the GDM group
Questionnaire survey and clinical data was conducted when pregnant women were enrolled in the first trimester, and blood and urine were collected. Furthermore, we will follow up the pregnant women until delivery, blood and urine were collected during the third trimester (after 28 weeks), and clinical information was collected. Umbilical cord blood and placental tissue will be collected if possible.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This project intends to recruit pregnant women who go to the research center for routine prenatal examination and OGTT screening.
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006, China
Serum, urine
First Submitted
May 15, 2022
First Posted
May 24, 2022
Study Start
May 1, 2022
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
SFEE Diet Management for Gestational Diabetes Mellitus
Contact the study team to confirm eligibility.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 16, 2022
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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