ISRCTN86503951已完成未知
Metformin treatment vs a diabetes model of antenatal care in women with mild fasting hyperglycaemia diagnosed in pregnancy: a pilot study
Central Manchester University Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 40 人开始时间: 2014年1月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
2020 results in https://pubmed.ncbi.nlm.nih.gov/33243030/ (added 30/11/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Women with risk factors for GDM (NICE 2008) will be offered an oral glucose tolerance test (OGTT) at 26 weeks gestation as part of their routine antenatal care. Women will be provided with written information regarding the study at the time of the OGTT.
- •2. Women with mild fasting hyperglycaemia (5.1-5.4 mmol/L, 2 hour <8.5 mmol/L) will be invited to participate.
排除标准
- •1. Multiple pregnancy
- •2. Previous still-birth
- •3. Previous shoulder dystocia requiring obstetric manoeuvres
- •4. Age under 16
- •5. Incapacity to consent
- •6. A known hypersensitivity to metformin hydrochloride or to any of the excipients
- •7. Contra-indication to Metformin
- •8. Known abnormalities of the liver (tested at randomisation)
- •9. Renal failure or renal dysfunction
- •10. Acute conditions with the potential to alter renal function such as:
- •10.1. Dehydration
- •10.2. Severe infection
- •10.3. Shock
- •10.4. Intravascular administration of iodinated contrast agents
- •11. Acute or chronic diseases which may cause tissue hypoxia such as:
- •11.1. Cardiac or respiratory failure
- •11.2. Recent myocardial infarction
- •11.3. Shock
- •11.4. Hepatic insufficiency, acute alcohol intoxication, alcoholism
- •12. Lactation
研究者
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