Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)
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).
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Women With Epilepsy: Pregnancy Outcomes and Deliveries|
- Fertility in women with epilepsy compared to healthy controls [ Time Frame: 1.75 years ] [ Designated as safety issue: No ]Percentage of women who have a live birth within the time frame.
- Seizure frequency in women with epilepsy at baseline compared to during pregnancy [ Time Frame: 1.75 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259310
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|North Shore Long Island Jewish Health System|
|Great Neck, New York, United States, 11021|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Jacqueline French, MD||NYU School of Medicine|
|Principal Investigator:||Page Pennell, MD||Brigham and Women's Hospital|
|Principal Investigator:||Cynthia Harden, MD||North Shore - LIJ Health System|