NL-OMON47522招募中3 期
The SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy - SUGAR-DIP trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 810
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •- Aged 18 years or over
- •- Singleton pregnancy
- •- Diagnosis of GDM as per national guidelines
- •- Indication for pharmacological treatment of GDM
- •- Gestational age between 16 and 34 weeks
- •- Ability to understand Dutch or English
- •- Ability to provide written informed consent
排除标准
- •- Known pre-existent type 1 or type 2 diabetes mellitus
- •- Severe medical or psychiatric comorbidities
- •- Serious liver disease or kidney failure, or any other condition with
- •contraindications for the use of either metformin or glibenclamide*
- •- Pregnancy with a fetus affected by major congenital birth defects and/or
- •chromosomal abnormalities
- •* * e.g. hypersensitivity to glibenclamide / metformin or to any of the
- •excipients, hypersensitivity to other sulphonylureas, history of ketoacidosis,
- •impaired adrenal function, severe infection
研究者
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