Pregnancy Outcome Following Maternal Exposure to Metformin: a Collaborative ENTIS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 950
- 主要终点
- Major birth defects
研究概览
简要总结
This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester exposure, as well as several other pregnancy related outcomes.
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
- •Exposed group: exposed to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)).
- •Reference group: at no time during pregnancy were exposed to metformin, insulin or any other hypoglycaemic agent.
排除标准
- •exposed to any of the following known major teratogen or major fetotoxicant: acitretin, isotretinoin, mycophenolate, thalidomide, valproic acid, angiotensin-II receptor blockers (only when used in 2nd or 3rd trimester), ACE inhibitors (only when used in 2nd or 3rd trimester), or (b) following treatment indications coded: malignancies (MedDRA code: malignant or unspecified tumors (SMQ 20000091), ICD-10: C00-D09)) or malignancy related conditions (MedDRA: SMQ 20000092), ICD-10: C00-D09).
- •lost to follow-up
研究组 & 干预措施
Pregnant patient exposed to metformin
Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)).
干预措施: metformin (Drug)
Reference group
Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to any drug not known as a major teratogen or fetotoxicant and different than metformin, insulin or any other hypoglycaemic agent.
干预措施: any drug not known as a major teratogen or major fetotoxicant (Drug)
结局指标
主要结局
Major birth defects
时间窗: within two weeks after birth or at histopathological exam in case of late spontaneous abortion or stillbirth occuring in pregnancy
Spontaneous abortion
时间窗: until 20 weeks of pregnancy
次要结局
- Minor birth defects(within two weeks after birth)
- Preterm birth(after 24 weeks of pregnancy)
- Pregnancy complications(after 12 weeks of pregnancy until delivery)
研究者
Alice Panchaud
Senior research associate
Centre Hospitalier Universitaire Vaudois