Status:
COMPLETED
Women With Epilepsy: Pregnancy Outcomes and Deliveries
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Brigham and Women's Hospital
Northwell Health
Conditions:
Epilepsy
Eligibility:
FEMALE
18-40 years
Brief Summary
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).
Detailed Description
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 invest...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT01259310
Start Date
November 1 2010
End Date
March 1 2015
Last Update
March 7 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
North Shore Long Island Jewish Health System
Great Neck, New York, United States, 11021
3
NYU Langone Medical Center
New York, New York, United States, 10016