NCT01097720Unknown不适用
Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Adaptive Behavior Scores
研究概览
简要总结
This study is investigating the neurodevelopmental effects of prenatal exposure to lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The hypotheses to be tested include:
- Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with developmental delay with or without signs of autism.
- Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased rate of occurrence of major malformations.
- The child with major malformations is more likely to have developmental delay with or without signs of autism than the child who does not have major malformations.
- The occurrence of adaptive behavior outcomes will show a dose-response relationship with the dose of medication taken by the mother in the first trimester.
The study population includes children 36-83 months of age who were exposed throughout gestation to one of the three drugs of interest, as treatment for maternal seizure disorder.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 36 Months 至 83 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •36-83 months of age
- •Prenatal exposure to LTG, VPA, or CBZ monotherapy
- •AED was used by mother to suppress seizures
- •Mother was enrolled in the North American AED Pregnancy Registry
排除标准
- •Exposure during the first trimester to other known teratogens.
- •Mother with mental health issues
- •Refusal to release medical records to confirm eligibility.
结局指标
主要结局
Adaptive Behavior Scores
时间窗: 36-83 months of age
Measures of each child's Adaptive Behavior scores as assessed by the Vineland-II Adaptive Behavior Scales, collected when the child was between 36 and 83 months of age.
次要结局
- Presence/Absence of Major Malformations(36-83 months of age)
研究者
研究点 (1)
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