The Early Diagnosis of Gestational Diabetes Mellitus Study

First Affiliated Hospital, Sun Yat-Sen University0 sites300 target enrollmentMay 2016

ConditionsGestational Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gestational Diabetes Mellitus
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Enrollment: 300
Primary Endpoint: Rate of GDM diagnosed in 18-20 gestational week.
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The main purpose of the study is to evaluate an OGTT at 18 to 20 gestational weeks as an early diagnosis method of GDM in low risk pregnant women. By investigating maternal and neonatal outcomes that are associated with the early OGTT and regular OGTT results, the study will provide a evidence for the most appropriate time to perform an OGTT in pregnant women.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

December 2017

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Responsible Party

Principal Investigator

Bin Liu

Dr.

First Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

•Singleton pregnant women will be invited to participate in this study if they are between 18 and 40 years of age, and have had their first prenatal visit in our center before 18 weeks 0 days of gestation.

Exclusion Criteria

•Previous history of GDM or preexisting DM
•Family history of diabetes mellitus (first degree relative with diabetes or a sister with GDM)
•Body mass index\>30 kg/m2
•Previous macrosomia (baby with birth weight \>4,000 g) or a history of stillbirth
•Polycystic ovary syndrome
•Medications: corticosteroids, antipsychotics
•Participant not willing to take OGTT twice (at 18-20 gestational weeks and 24-28 gestational weeks), or not willing to have a series of prenatal care visits and deliver in our center.