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临床试验/NCT01130012
NCT01130012已完成不适用

Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?

Kuopio University Hospital0 个研究点目标入组 440 人开始时间: 2005年4月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
440
主要终点
Number of at risk participants developing GDM during pregnancy
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Gestational diabetes mellitus (GDM)is a major health problem

  • growing prevalence of obesity
  • the older age of pregnant women

A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.

  • feasibility of an early intervention
  • glucose tolerance at weeks 26-28

详细描述

  1. A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12

  2. voluntary women in early pregnancy (n=96)

  3. 54 high risk mothers were randomized

  • lifestyle intervention group (n=27)
  • close follow-up (n=27)
  1. An OGTT was performed again at weeks 26-28
  • the lifestyle intervention group (n=27)
  • the close follow-up group (n=27)
  • other high-risk women of the early care group (n=42)who were not randomized
  1. An OGTT was also performed at weeks 26-28 in two neighboring municipalities
  • a standard care high-risk group(n=171)who did not undergo early intervention
  1. Primary outcomes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者
是

入选标准

  • •high risk for gestational diabetes
  • •fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT <7.8 mmol/l

排除标准

  • •normal glucose tolerance at weeks 8-12
  • •gestational diabetes at weeks 8-12

结局指标

主要结局

Number of at risk participants developing GDM during pregnancy

次要结局

  • The effect of intervention on fetal growth

研究者

发起方
Kuopio University Hospital
申办方类型
Other

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