NCT01892319已完成不适用
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,446
- 试验地点
- 1
- 主要终点
- Proportion of pregnancies (Levemir® treatment), compared to pregnancies (other basal insulin treatment regimens), resulting in none of the following events: Major congenital malformations, Perinatal death, Neonatal death
研究概览
简要总结
This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any data collection - Woman with a positive pregnancy test - Diabetes mellitus type 1 or 2, diagnosed prior to conception - Currently treated with Levemir® or other injectable antidiabetic treatment(s) - Unchanged basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception
排除标准
- •Women who have been pregnant for more than 16 weeks at baseline visit will be excluded from the study
研究组 & 干预措施
All patients
干预措施: insulin detemir (Drug)
All patients
干预措施: other injectable antidiabetic treatment regimens (Drug)
结局指标
主要结局
Proportion of pregnancies (Levemir® treatment), compared to pregnancies (other basal insulin treatment regimens), resulting in none of the following events: Major congenital malformations, Perinatal death, Neonatal death
时间窗: Assessed up to 4 weeks after delivery
次要结局
- Proportion of pregnancies complicated by pre-eclampsia(During pregnancy)
- Height(At the age of 1 year)
- Proportion of pregnancies resulting in pre-term delivery(Assessed at delivery)
- Proportion of pregnancies resulting in perinatal death(Assessed 1 week after delivery)
- Incidence of major hypoglycaemia(During pregnancy)
- Proportion of pregnancies resulting in neonatal death(Assessed 4 weeks after delivery)
- Proportion of pregnancies resulting in spontaneous abortion(Assessed at pregnancy termination)
- Weight(At the age of 1 year)
- Proportion with changes (progression/regression) of major congenital malformations(At the age of 1 year)
研究者
研究点 (1)
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