Prescription of Valproate and Derivatives in Women of Childbearing Age: Qualitative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cause of valproate prescription in women of childbearing age
研究概览
简要总结
The prescription of valproate in women of childbearing age has decreased by 82% in France, for mood disorders. Exposure to valproate during pregnancy 60%. However, the ANSM sent an alert document in August 2022 because there are still patients on valproate. In addition, there were 32 births taking valproate to mothers with bipolar disorder in 2018. The risks of exposure during pregnancy which occur in 10% of exposure cases are: congenital malformations; neurodevelopmental disorders including autism spectrum disorders, attention deficit disorders more or less hyperactivity, language disorders, motor disorders, mental delays; reduction in social, attentional, motor and language abilities; a lower level of education.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject (≥16 years old)
- •Female gender
- •Prescription of Valproate and/or derivatives (Sodium Divalproate, Valpromide, Valproic Acid, Sodium Valproate) in an indication of psychiatric disorder for the period from January 1, 2021 to December 31, 2022,
- •Subject not opposing, after information, the reuse of their data for the purposes of this research
- •Holders of parental authority who do not object, after information, to the reuse of their child's data for the purposes of this research
- •Exclusion criteria:
- •Subject and/or holder of parental authority having expressed opposition to participating in the study
- •Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
排除标准
- 未提供
结局指标
主要结局
Cause of valproate prescription in women of childbearing age
时间窗: Up to 2 years
Calculation of percentages, mean, median, standard deviation The results will be considered significant at the 5% threshold.
次要结局
未报告次要终点