The Early Diagnosis of Gestational Diabetes Mellitus Study (EDoGDM)

Sun Yat-sen University

Status: Unknown

Conditions: Gestational Diabetes Mellitus

Treatments: Dietary Supplement: dietary guide; Behavioral: glycemic monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02740283

SYSU5010-2016014

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Pregnant women

Experimental group

Description:

As a diagnostic study, the cohort will recruit 300 pregnant women who meet inclusion and exclusion criteria outlined below. OGTTs will be performed between 18 and 20 gestational weeks (early-OGTT) and 24 to 28 gestational weeks (regular-OGTT). Clinical and laboratory information of the mother and their offspring will be collected for analysis.

Treatment:

Behavioral: glycemic monitoring

Dietary Supplement: dietary guide