Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Diagnosis of abnormal glucose tolerance
研究概览
简要总结
Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance test (OGTT).
However, less than a quarter of these women are screened. This recommendation has failed for multiple reasons; the most important being that busy new mothers must deal with the major inconveniences of returning to a sampling center for a 2h testing session, bringing baby along or paying for a sitter, transportation, parking... A mother-friendly solution is direly needed.
The investigators hypothesize that, in these women, results of an OGTT performed after delivery on the last day of their hospital stay (OGTT-1) will predict results of the recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.
The main aim of our project is to determine the optimal cut-off value for the 2h glucose result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the gold standard), in the same woman.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 and 45 years;
- •Having a positive diagnosis of gestational diabetes mellitus (IADPSG criteria);
- •Treated with diet or insulin;
- •Have given birth to a child at term; gestational age > 37 weeks;
- •Have been followed during her pregnancy by a physician who delivers in CHUS;
- •Have signed the consent form.
排除标准
- •History of glucose intolerance or diabetes before the pregnancy;
- •Have presented another obstetrical pathology during the pregnancy;
- •Severe gestational high blood pressure with proteinuria;
- •Delayed intrauterine development syndrome;
- •Pregnancy with more than a foetus;
- •Drug addiction;
- •Had complications during the delivery such as:
- •Moderate to severe postpartum bleeding;
- •Surgery in postpartum (curettage, hysterectomy, etc.).
研究组 & 干预措施
postpartum screening
Oral glucose tolerance test 2 days post-partum
干预措施: oral glucose tolerance test 2 days post-partum (Procedure)
结局指标
主要结局
Diagnosis of abnormal glucose tolerance
时间窗: 12 weeks postpartum
Oral glucose tolerance test
次要结局
- Patient's satisfaction(12 weeks post-partum)
研究者
Jean-Luc Ardilouze
Full professor, endocrinologist, researcher
Université de Sherbrooke