CClinicalTrials.gg
Status unknownNCT05388721Updated Dec 16, 2022

Correlation Between Environmental Pollution and Gestational Diabetes Mellitus

An observational study in Gestational Diabetes Mellitus, sponsored by Women's Hospital School Of Medicine Zhejiang University. Status unknown at 1 site in China. Open to female participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-16.

Sponsored by Women's Hospital School Of Medicine Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,500
Ages
20 Years to 49 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Gestational Diabetes Mellitus
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 200 across 269 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
20 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This project intends to recruit pregnant women who go to the research center for routine prenatal examination and OGTT screening.

Inclusion criteria

  • Plan to complete OGTT and give birth in the research center
  • First trimester
  • Singleton pregnancy
  • Without diabetes before pregnancy

Exclusion criteria

Exclusion Criteria:

  • Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, 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
  • Assisted reproductive
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • GDM group

    Pregnant women with positive OGTT results at 24-28 gestational weeks

    Other: Clinical data and specimen collection

  • Control group

    Pregnant women with negative OGTT results at 24-28 gestational weeks, and had baseline data that matched those in the GDM group

    Other: Clinical data and specimen collection

Interventions

  • OtherClinical data and specimen collection

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: First trimester (9-14 gestational weeks)

  2. 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.

    Time frame: Third trimester (after 28 gestational weeks)

07

Study locations

1 of 1 sites recruiting
  • Women's Hospital School Of Medicine Zhejiang University
    Hangzhou, Zhejiang 310006, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05388721
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Responsible party
Sponsor
First posted
May 24, 2022
Start date
May 1, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Dec 16, 2022

Study contacts

Zhaoxia Liang, Prof.
Contact
xiaozaizai@zju.edu.cn
86571-89992115

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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