Fructosamines and Gestational Diabetes (FRUCTO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Serum fructosamine rate
研究概览
简要总结
The prevalence of gestational diabetes is estimated at between 2 and 6%, but can be much higher in specific populations.
The specific treatment of gestational diabetes (diet, control weight gain, self monitoring glucose , insulin therapy) reduces complications severe perinatal, fetal macrosomia, and preeclampsia compared with abstention therapy, without additional risk of caesarean section.
Several early studies have shown that the determination of fructosamine is a very bad way of diagnosis for Gestational Diabetes. However, few studies have investigated the relationship between the determination of serum fructosamine and put under insulin in case of Gestational Diabetes.
The purpose of this study is to determine if serum fructosamines rate can be a predictive marker of the starting insulin at the patients suffering from Gestational Diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st Quarter performed between 10 and 14 weeks with measurement of the crown-rump length
- •Hospitalization for a GD's discovery whatever the term of pregnancy (GD is defined with nationals recommendations of CNGOF)
- •Not opposed to participate in the study
排除标准
- •Pregnancy uncertain term (absence of early ultrasound)
- •Previous diabetes to the pregnancy (type 1 or 2)
- •Multiple Pregnancy
- •No affiliation to a social security scheme
- •Woman with a measure of legal protection
结局指标
主要结局
Serum fructosamine rate
时间窗: at baseline (when gestational diabetes is diagnosed: between 24 and 28 weeks of gestation or later)
次要结局
未报告次要终点