Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01259310 |
Recruitment Status :
Completed
First Posted : December 14, 2010
Last Update Posted : March 7, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Epilepsy |
Study Type : | Observational |
Actual Enrollment : | 199 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Women With Epilepsy: Pregnancy Outcomes and Deliveries |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |

Group/Cohort |
---|
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.
|
- Fertility in women with epilepsy compared to healthy controls [ Time Frame: 1.75 years ]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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | Northwell Health |
Responsible Party: | NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT01259310 |
Other Study ID Numbers: |
WEPOD |
First Posted: | December 14, 2010 Key Record Dates |
Last Update Posted: | March 7, 2016 |
Last Verified: | March 2016 |
fertility women epilepsy pregnancy seizures |
seizure frequency ovulation menstruation hormones progesterone |
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |