Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)
2016年3月4日 更新者：NYU Langone Health
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).
研究概览
地位
完全的
条件
详细说明
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.
研究类型
观察性的
注册 (实际的)
199
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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New York
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Great Neck、New York、美国、11021
- North Shore Long Island Jewish Health System
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New York、New York、美国、10016
- NYU Langone Medical Center
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Women with epilepsy between 18 and 40 years of age, recruited from epilepsy clinics in New York and Boston, and control women without epilepsy between 18 and 40 years of age, recruited from Obstetrics and Gynaecology clinics, local academic institutions, and referrals from epilepsy clinic employees or patients.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Women with epilepsy
Women with epilepsy, age 18-40 years, who express a desire to conceive and have stopped or plan to stop taking birth control.
|
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Women without epilepsy
Healthy women, age 18-40 years, who express a desire to conceive and have stopped or plan to stop taking birth control.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fertility in women with epilepsy compared to healthy controls
大体时间：1.75 years
|
Percentage of women who have a live birth within the time frame.
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1.75 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Seizure frequency in women with epilepsy at baseline compared to during pregnancy
大体时间：1.75 years
|
1.75 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jacqueline French, MD、NYU School of Medicine
- 首席研究员：Page Pennell, MD、Brigham and Women's Hospital
- 首席研究员：Cynthia Harden, MD、Northwell Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年11月1日
初级完成 (实际的)
2015年3月1日
研究完成 (实际的)
2015年3月1日
研究注册日期
首次提交
2010年12月10日
首先提交符合 QC 标准的
2010年12月13日
首次发布 (估计)
2010年12月14日
研究记录更新
最后更新发布 (估计)
2016年3月7日
上次提交的符合 QC 标准的更新
2016年3月4日
最后验证
2016年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.