Glycemic Objectives of Women With Gestational Diabetes Mellitus
Reevaluation of the Glycemic Objectives of Women With Gestational Diabetes Mellitus
In a previous study, the investigators established the dosage of foetal glycated hemoglobin (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and determined that newborn of women with GDM had significantly higher FGH that newborn of women without GDM.
In this study, the investigators want to compare the FGH of newborn of GDM women randomized to a group reaching the Canadian Diabetes Association recommended blood glucose objectives treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Quebec
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Sherbrooke、Quebec、加拿大、J1H5N4
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- gestational age between 15 and 32 weeks since last menstrual date,
- received education on gestational diabetes mellitus,
- able to read and understand French.
Exclusion Criteria:
- known type 1 or type 2 diabetes,
- treatment interfering woth glucose metabolism,
- deficit may hinder the understanding of the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Normal glycemic control
GDM women in this group will reach glycemic objectives recommended by the Canadian Diabetes Association: fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L.
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Use diet, physical exercise of insulins to reach normal glycemic control.
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实验性的：Low glycemic control
GDM women in this group will reach lower glycemic objectives than those recommended by the Canadian Diabetes Association: fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L.
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Use diet, physical exercise of insulins to reach low glycemic control.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Foetal glycated hemoglobin
大体时间：At delivery
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At delivery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment satisfaction
大体时间：End of pregnancy
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Evaluated by questionnaire
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End of pregnancy
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 14-160
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
妊娠糖尿病的临床试验
Normal glycemic control的临床试验
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