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临床试验/NCT02528162
NCT02528162已完成不适用

Evaluation of Knowledge Regarding Gestational Diabetes and Evaluation of (Group) Education for Gestational Diabetes

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Evaluation of the knowledge regarding GDM with a self-designed questionnaire

研究概览

简要总结

Prospective observational cohort study of women with gestational diabetes (GDM) based on the 'International Association of Pregnancy Study Groups' (IADPSG) criteria. The overall aim is to evaluate the knowledge regarding GDM of women with GDM and to evaluate the satisfaction of women with GDM about the education they receive (given in group or individually). Normal routine care is followed and evaluated.

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

入选标准

  • Women ≥ 18 years diagnosed with GDM in the university hospital Leuven.

排除标准

  • Women who received bariatric surgery.
  • Women with pregestational diabetes or diagnosed with diabetes during early pregnancy.

结局指标

主要结局

Evaluation of the knowledge regarding GDM with a self-designed questionnaire

时间窗: over a 2-4 week period

Scale (0 to 3) with questionnaire on depression (CES-D )

时间窗: over a 2-4 week period

Evaluation of satisfaction with education and Diabetes Treatment Satisfaction Questionnaire

时间窗: over a 2-4 week period

Scale (1-4) with questionnaire on anxiety (six-item short form STAI)

时间窗: over a 2-4 week period

次要结局

  • The prevalence of GDM based on the IADPSG criteria(at 24-28 weeks of pregnancy)
  • Composite endpoint of glycaemic control, weight, gestational weight gain and pregnancy outcomes(over a period of 16 weeks)
  • The frequency of insulin therapy for GDM(over a period of 16 weeks)
  • The time between the glucose challenge test and oral glucose tolerance test(at 24-28 weeks of pregnancy)
  • The frequency of an HbA1c ≥6.5%(at 24-28 weeks of pregnancy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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