Women With Epilepsy: Pregnancy Outcomes and Deliveries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 3
- 主要终点
- Fertility in women with epilepsy compared to healthy controls
研究概览
简要总结
This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE).
详细描述
This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE). The investigators will determine if pregnancy rates differ in WWE compared to WWoE. Covariates of interest include proportion of ovulatory cycles, sexual activity, and type of anti-epileptic drug (AED). The investigators will compare seizure frequency during preconception to seizure frequency during pregnancy, with analysis of covariates of interest (AED type, AED ratio-to-target concentrations, and epilepsy syndrome). The investigators will also observe interactions between seizures/epilepsy, AEDs, and sex steroid hormones during this opportune time when women are not on birth control. Patterns of seizures will be evaluated for accepted catamenial patterns with consideration of ovulatory and anovulatory cycles, AED concentrations, and epilepsy type.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •between ages 18 and 40
- •planning pregnancy
- •stopped birth control or planning to stop birth control
- •for women with epilepsy: receiving at least one AED (lamotrigine, levetiracetam, carbamazepine, phenytoin, oxcarbazepine, phenobarbital, topiramate, rufinamide). If on polytherapy, AEDs cannot include lamotrigine, levetiracetam or valproate.
排除标准
- •Use of hormonal therapies for contraception
- •demonstrated infertility with the same partner (more than 12 months of unprotected intercourse without achieving pregnancy)
- •diagnosis of infertility
- •Polycystic ovarian syndrome
- •severe endometriosis
- •currently breastfeeding
- •male factor infertility
- •surgical or medical menopause
- •smokers who have more than 10 cigarettes per day
- •untreated thyroid disease
- •hyperprolactinemia or other pituitary disease
- •recently trying to achieve pregnancy for more than 6 months with having regular vaginal sexual intercourse without contraception
结局指标
主要结局
Fertility in women with epilepsy compared to healthy controls
时间窗: 1.75 years
Percentage of women who have a live birth within the time frame.
次要结局
- Seizure frequency in women with epilepsy at baseline compared to during pregnancy(1.75 years)