Early Screening for Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,442
- 试验地点
- 1
- 主要终点
- oral glucose challenge test plasma glucose value
研究概览
简要总结
The working hypothesis of this proposal is that screening for gestational diabetes mellitus as early as the 1st trimester is efficient for detecting the forthcoming presence or absence of gestational diabetes mellitus. The investigators long-term goal is the prevention of gestational diabetes mellitus onset i.e. the prevention of progression to gestational diabetes mellitus, in order to enable delivery of appropriate counselling, diagnostics and treatment for pregnant women, as well as to improve pregnancy outcomes. Therefore, robust 1st trimester screening criteria is needed.
The overall objective of this proposal is to determine an accurate and valid 1st trimester 1h post 50g oral glucose challenge test plasma glucose cut-off value that is predictive of gestational diabetes mellitus onset.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age > 18 yrs
- •Gestational age between 6 and 13 weeks from last menstrual period,
- •Alcohol < 2 drinks/day
- •Not involved in regular high intensity physical activity
- •Singleton pregnancy
- •Otherwise good health status.
排除标准
- •Type 1 or type 2 diabetes
- •Taking drugs interfering with glucose metabolism
结局指标
主要结局
oral glucose challenge test plasma glucose value
时间窗: 6-13 weeks
the sensitivity, specificity, positive and negative predictive values of oral glucose challenge test plasma glucose \>= 7.8 mmol/L during the 1st trimester (6-13 weeks of gestation), as compared with fasting 75g glucose oral glucose tolerance test performed between the 24th and 28th weeks of gestation (the Canadian Diabetes Association - CDA gold standard).
次要结局
- oral glucose challenge test plasma glucose cut-off value(6-13 weeks)
研究者
Jean-Luc Ardilouze
Endocrinologist, researcher
Université de Sherbrooke