ISRCTN62685558已完成2 期
?Gestational Diabetes: Things you need to know (but maybe don't)? ?- phase II: randomised controlled trial of a DVD for women with Gestational Diabetes Mellitus
Queen's University Belfast (UK)0 个研究点目标入组 150 人开始时间: 2012年11月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
- 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28258027 (added 22/01/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Age 16 or older
- •2. Pregnant women with a recent new diagnosis of GDM (as per IADPSG criteria) ? eligible if ?YES? to one of the following criteria:
- •2.1. Fasting plasma glucose, HbA1C, or random plasma glucose at booking:
- •2.2. Fasting plasma glucose = 5.1 mmol/l (92 mg/dl) but <7.0 mmol/l (126 mg/dl)
- •3. OGTT after 24 weeks gestation:
- •3.1. FPG = 5.1 mmol/l (92 mg/dl)
- •3.2. 1-h plasma glucose = 10.0 mmol/l (180 mg/dl)
- •3.3. 2-h plasma glucose = 8.5 mmol/l (153 mg/dl)
排除标准
- •1. Diagnosed with GDM in a previous pregnancy
- •2. Deemed inappropriate for woman to take part in the RCT by their Consultant Obstetrician / Physician, for example if a poor pregnancy outcome is anticipated.
- •3. Diagnosed with type 1 or type 2 diabetes during this pregnancy
- •4.Taking part in another research study
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