ISRCTN00928792已完成未知
Metformin in Women with Type 2 Diabetes in Pregnancy ? a randomized controlled trial
The Centre for Mother, Infant, and Child Research (CMICR) (Canada)0 个研究点目标入组 502 人开始时间: 2011年7月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 502
研究概览
简要总结
2020 results in https://pubmed.ncbi.nlm.nih.gov/32946820/ (added 29/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Women between the ages of 18-45
- •2. Women diagnosed with type 2 diabetes prior to pregnancy or women with undiagnosed type 2 diabetes diagnosed prior to 20 weeks gestation [defined as women presenting with gestational diabetes before 20 weeks gestation with an elevated glycosylated hemoglobin (HbA1c) which is 8% or more above the upper normal range (i.e. HbA1c of 6.5% if upper normal is 6.0%, or HbA1c 7% if upper normal is 6.5%) or fasting glucose >= 7.0 mmol/L]
- •3. Pregnancy gestation between 12 weeks 0 days - 22 weeks 6 days
- •4. Live singleton fetus
排除标准
- •1. Women who are not on insulin
- •2. Women who are on oral hypoglycemic agents should be switched to insulin prior to randomization
- •3. Diabetes diagnosed after 20 weeks gestation
- •4. Type 1 diabetes
- •5. Known intolerance to metformin
- •6. Contraindications to metformin use which include:
- •6.1 Renal insufficiency (defined as serum creatinine of greater than 130 umol/L or creatinine clearance < 60 ml/min
- •6.2 Moderate to severe liver dysfunction (defined as liver enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) greater than three times the upper limit of normal)
- •6.3 Shock or sepsis
- •6.4 Previous hypersensitivity to metformin
- •7. Women with significant gastrointestinal problems such as severe vomiting requiring intravenous fluids or hospitalization, or active Crohn's or colitis
- •8. Previous participation in the trial
- •9. Patients who have a fetus with a known potentially lethal anomaly will be excluded. Information regarding congenital anomalies diagnosed after randomization will be recorded.
- •10. Known higher order pregnancies (twins, triplets, etc). These women will be excluded as they have a higher rate of adverse outcomes and we want to avoid any inequalities if they are unequally distributed between the groups
- •11. Presence of acute or chronic metabolic acidosis, including diabetic ketoacidosis
- •12. History of diabetic ketoacidosis or history of lactic acidosis
- •13. Presence of excessive alcohol intake, acute or chronic
- •14. Presence of congestive heart failure or history of congestive heart failure
研究者
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