The Early Diagnosis of Gestational Diabetes Mellitus Study

Not Applicable

• Conditions: Gestational Diabetes Mellitus
• Interventions: Behavioral: glycemic monitoring; Dietary Supplement: dietary guide

• Registration Number: NCT02740283
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-04
• Study First Submitted: 2016-04-02
• Study First Submitted QC: 2016-04-14
• Last Update Submitted: 2016-04-14
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15
• Study Start: 2016-05
• Primary Completion: 2017-05
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women	dietary guide	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.
Pregnant women	glycemic monitoring	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.

Primary Outcome Measures

Name	Time	Method
Rate of GDM diagnosed in 18-20 gestational week.	up to 12 months