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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Aug 2023

Typical duration for all trials

Geographic Reach

1 country

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

August 7, 2023

Completed

8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed

16 days until next milestone

Study Start

First participant enrolled

August 31, 2023

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed

Last Updated

October 3, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

August 7, 2023

Last Update Submit

September 30, 2023

Conditions

Gestational Diabetes

Keywords

gestational diabetesurinary proteomicsearly prediction

Outcome Measures

Primary Outcomes (1)

Number of participants with gestational diabetes
Diagnosed by 75g-OGTT at 24-28 weeks of gestation. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criterion in 2010: fasting blood glucose ≥5.1mmol/L, and/or 1-hour blood glucose ≥10.0mmol/L, and/or 2-hour blood glucose ≥8.5mmol/L
at 24-28 weeks of gestation

Eligibility Criteria

Age18 Years+

Sexfemale

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Our study population was pregnant women in early pregnancy who regularly visited the following two medical center: Mudanjiang First People's Hospital, and Mudanjiang Maternal and Child Health Care Hospital. All pregnant women within 12 gestational weeks are eligible for enrollment, and whether entry or not depends on their own preference. There were no requirements for household registration, place of residence, and other identify informations of the enrolled women.

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking Union Medical College Hospitallead
Mudanjiang First People's Hospitalcollaborator
Mudanjiang Maternal and Child Health Hospitalcollaborator

Study Sites (2)

Mudanjiang First People's Hospital

Mudanjiang, Heilongjiang, China

RECRUITING

Mudanjiang Maternal and Child Health Hospital

Mudanjiang, Heilongjiang, China

RECRUITING

Related Publications (5)

Wang X, Zhao M, Guo Z, Song S, Liu S, Yuan T, Fu Y, Dong Y, Sun H, Liu X, Zhou D, Zhao W, Sun W. Urinary proteomic analysis during pregnancy and its potential application in early prediction of gestational diabetes mellitus and spontaneous abortion. Ann Transl Med. 2022 Jul;10(13):736. doi: 10.21037/atm-21-3497.
PMID: 35957715RESULT
Song S, Duo Y, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. The Predictive Ability of Hepatic Steatosis Index for Gestational Diabetes Mellitus and Large for Gestational Age Infant Compared with Other Noninvasive Indices Among Chinese Pregnancies: A Preliminary Double-center Cohort Study. Diabetes Metab Syndr Obes. 2021 Dec 16;14:4791-4800. doi: 10.2147/DMSO.S335364. eCollection 2021.
PMID: 34938090RESULT
Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Lu Z, Liu S, Zhao T, Yuan T, Fu Y, Dong Y, Zhao W, Sun W, Wang A. HOMA-IR as a risk factor of gestational diabetes mellitus and a novel simple surrogate index in early pregnancy. Int J Gynaecol Obstet. 2022 Jun;157(3):694-701. doi: 10.1002/ijgo.13905. Epub 2021 Sep 24.
PMID: 34449903RESULT
Duo Y, Song S, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. Predictability of HOMA-IR for Gestational Diabetes Mellitus in Early Pregnancy Based on Different First Trimester BMI Values. J Pers Med. 2022 Dec 28;13(1):60. doi: 10.3390/jpm13010060.
PMID: 36675721RESULT
Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Wang A, Lu Z, Sun W, Fu Y, Dong Y, Yuan T, Zhao W. ALT/AST as an Independent Risk Factor of Gestational Diabetes Mellitus Compared with TG/HDL-C. Int J Gen Med. 2022 Jan 5;15:115-121. doi: 10.2147/IJGM.S332946. eCollection 2022.
PMID: 35023950RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Tedros Adhanom Ghebreyesus
World Health Organization
PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanbei Duo, Dr.

CONTACT

86+15561852093 duoduo15561852093@163.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 15, 2023

Study Start

August 31, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

October 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing: Will not share

Locations

CN(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations