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临床试验/NCT02740283
NCT02740283Unknown不适用

The Early Diagnosis of Gestational Diabetes Mellitus Study

First Affiliated Hospital, Sun Yat-Sen University0 个研究点目标入组 300 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
Rate of GDM diagnosed in 18-20 gestational week.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Rate of GDM diagnosed in 18-20 gestational week.

时间窗: up to 12 months

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bin Liu

Dr.

First Affiliated Hospital, Sun Yat-Sen University

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