Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 565
- 试验地点
- 20
- 主要终点
- Change in seizure frequency over pregnancy vs. post-partum (comparable time periods for non-pregnant women with epilepsy).
研究概览
简要总结
Epilepsy is one of the most common neurological disorders affecting women of childbearing age. Poor pregnancy outcomes are increased in these women and their children. The proposed studies will increase our knowledge on multiple levels to improve care and reduce adverse outcomes in these mothers and children. An overall goal of this study is to establish the relationship between antiepileptic drug exposure and outcomes in the mother and child as well as describe and explain the variability in antiepileptic drug exposure and response.
详细描述
There is a compelling need for prospective, properly controlled studies in women with epilepsy (WWE) during pregnancy to improve maternal and child outcomes. The proposed investigations are pertinent to the National Institute of Neurological Disorders and Stroke Epilepsy Research Benchmarks and will address multiple gaps in our knowledge noted by the recent American Academy of Neurology guidelines. This multicenter investigation will employ a prospective, observational, parallel-group, cohort design with an established research team.
The specific aims are to:
- Determine if women with epilepsy have increased seizures during pregnancy and delineate the contributing factors;
- Determine if C-section rate is increased in women with epilepsy and delineate contributing factors;
- Determine if women with epilepsy have an increased risk for depression during pregnancy and post-partum period and characterize risks factors;
- Determine the long-term effects of in utero antiepileptic drug exposure on verbal intellectual abilities and other neurobehavioral outcomes in the children of women with epilepsy;
- Determine if small for gestation age and other adverse neonatal outcomes are increased in children of women with epilepsy;
- Determine if breastfeeding when taking antiepileptic drugs impairs the child's verbal intellectual and other cognitive abilities.
An overall goal of the proposed research is to establish the relationship between antiepileptic drug exposure and outcomes in the mother and child as well as describe and explain the variability in antiepileptic drug exposure and response.
Anticonvulsant blood levels (ABLs) and area-under-the-concentration-time-curves (AUCs) will be used as direct measures of drug exposure. The results will enable clinicians to prospectively calculate individual dosing regimens for the mother in order to optimize dosing and limit unnecessary drug exposure to the child. In addition, genetic samples will be collected, which will provide a valuable resource for future pharmacogenetics studies to further delineate individual variability across patients.
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
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in seizure frequency over pregnancy vs. post-partum (comparable time periods for non-pregnant women with epilepsy).
时间窗: Pregnant women with epilepsy:1st Trimester through 9 months post-partum; Nonpregnant women with epilepsy: Study enrollment through 18 months participation
Change in seizure frequency during pregnancy vs postpartum as measured by subject completed daily electronic seizure diaries
Child Intellectual Ability (3 and 6 YO)
时间窗: When child is 3 and 6 Years of age
Child intellectual ability as measured by the Verbal Index Score at visit 10 (3YO) and visit 12 (6YO). All of the outcome measures for cognitive outcomes at the various ages are scale scores which are continuous with a mean of 100 and a standard deviation of 15.
Child Intellectual Ability (2YO)
时间窗: When child is 2 Years of age
Child intellectual ability as measured by the Language Scale of the Bayley Scales of Infant Development -III at visit 9 (2YO). All of the outcome measures for cognitive outcomes at the various ages are scale scores which are continuous with a mean of 100 and a standard deviation of 15.
Child Intellectual Ability (4.5 YO)
时间窗: When child is 4.5 Years of age
Child intellectual ability as measured by the Torrence Test of Creative Thinking at visit 11 (4.5YO). All of the outcome measures for cognitive outcomes at the various ages are scale scores which are continuous with a mean of 100 and a standard deviation of 15.
Rate of Depression
时间窗: Pregnant women: 1st Trimester through 9 months post partum, again when child is 2 and 3 Years of age. Nonpregnant women with epilepsy: Study enrollment through 6months participation, then 12 months until 18 months participation
Rate of depression during pregnancy in pregnant women with epilepsy vs pregnant women without epilepsy screened by the Beck Depression Inventory and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual-IV.
C-section Rate
时间窗: Pregnant women with epilepsy & Pregnant women without epilepsy at child's birth
rate of C-sections in pregnant women without epilepsy vs pregnant women with epilepsy
Small for Gestational Age Rate
时间窗: Child's birth
Rate of children considered small for gestational age (\<10%tile)born to women with epilepsy vs women without epilepsy
Breastfeeding Effects on verbal intellectual ability in children
时间窗: Birth until the child is 2 Years of age, although we anticipate not all children will breastfeed until 2 Years
Measuring difference in verbal intellectual ability in breastfed children vs non-breastfed children born to women on aeds via the Bayley Scales of Infant Development III Language scale at 2 years of age and Differential Abilities Scale III at 3, 4.5 and 6 Years of age.
次要结局
未报告次要终点
研究者
Kimford Jay Meador
Professor
Stanford University