NCT01511835Unknown4 期
Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women
AGUNCO Obstetrics and Gynecology Centre1 个研究点 分布在 1 个国家开始时间: 2012年1月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 试验地点
- 1
- 主要终点
- OGTT
研究概览
简要总结
The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •60 women in their first trimester of pregnancy affected by one or more of the following risk factors:
- •Glycemia levels > 92 mg/dl
- •BMI > 30
- •At least a parent or a brother (or sister)affected by diabetes
- •Pre-existing pregnancy with gestational diabetes
排除标准
- •Pregnant women affected by pregestational diabetes
- •Twin pregnancy
- •Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
- •Patients affected by chronic disorders
研究组 & 干预措施
Myo-inositol powder
Experimental
干预措施: inositol + folic acid (Dietary Supplement)
Myo-inositol soft gel capsules
Experimental
干预措施: inositol + folic acid (Dietary Supplement)
Folic acid
Placebo Comparator
干预措施: Folic Acid (Drug)
结局指标
主要结局
OGTT
The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.
次要结局
- Number of pregnant women with gestational diabetes
- Number of pregnant women requiring insulin treatment
- Weight gain at the end of pregnancy
- Number of newborn infants whose weight is more than 4000 g
- Number of newborn infants requiring Neonatal Intensive Care (NIC)
研究者
研究点 (1)
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Unknown
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