Thinking of joining a study?

Register your interest

NCT05992974 | RECRUITING | Gestational Diabetes


To Identify Urinary Biomarkers Associated With Gestational Diabetes Mellitus [GDM]
Sponsor:

Peking Union Medical College Hospital

Brief Summary:

Gestational diabetes mellitus(GDM) is one of the most common complications of pregnancy. The incidence of GDM is higher in Asian than in other regions, and GDM can increase the risk of a series of perinatal complications. The investigators has been committed to the early diagnosis of GDM, and several biomarkers in the first trimester and urinary proteomic markers that were associated with GDM have been found. Based on the previous work, the aim of this study was to verify the predictive ability of urinary proteomic markers for GDM that has been found in the previous study of the researchers. This study is a multi-center, prospective, and observational study. Urine samples will be collected twice, at 12 weeks and 24-28 weeks of gestation, respectively.

Condition or disease

Gestational Diabetes

Detailed Description:

The eligibility criteria are as follows: 1. singleton pregnant women over 18 years old; 2. gestational age less than 12 weeks; 3. regular follow-up until delivery; 4. able to understand and sign an informed consent. The exclusion criteria of pregnant women are as follows: 1. with impaired glucose tolerance or diabetes mellitus before pregnancy; 2. severe chronic diseases or infectious diseases (e.g., liver disease, urinary system disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and other diseases before pregnancy); 3. medications other than vitamins used during pregnancy; 4. inability to understand and follow-up regularly; 5. other conditions judged by the investigators to be inappropriate for participation in the study.

Study Type : OBSERVATIONAL
Estimated Enrollment : 1000 participants
Official Title : To Identify Urinary Biomarkers in the First Trimester Associated With Gestational Diabetes Mellitus [GDM] and Achieve Early Diagnosis of GDM Using Urinary Proteomic Analysis: An Observational Study
Actual Study Start Date : 2023-08-31
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Criteria
Inclusion Criteria
  • * Women of childbearing age who are in early pregnancy(gestational age less than 12 weeks);
  • * Regular prenatal examination until delivery;
  • * Older than 18 years old;
  • * Obtained informed consent from participants and/or their family members.
Exclusion Criteria
  • * Twins or multiple pregnancy;
  • * With impaired glucose tolerance or diabetes mellitus before pregnancy;
  • * With severe chronic diseases or infectious diseases (e.g., liver disease, urinary system disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and other diseases before pregnancy);
  • * Medications other than vitamins used during pregnancy;
  • * Inability to understand and follow-up regularly;
  • * Other conditions that were judged by the investigator to be ineligible for participation in the study.

To Identify Urinary Biomarkers Associated With Gestational Diabetes Mellitus [GDM]

Location Details

NCT05992974


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

China, Heilongjiang

Mudanjiang First People's Hospital

MU Egg Sauce, Heilongjiang, China,

RECRUITING

China, Heilongjiang

Mudanjiang Maternal and Child Health Hospital

MU Egg Sauce, Heilongjiang, China,

Loading...