Women With Epilepsy: Pregnancy Outcomes and Deliveries

Completed

Conditions studied: Epilepsy

In brief

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).

Key facts

Study ID

NCT01259310

Run by

NYU Langone Health

People needed

199

Starts

2010-11-01

Expected to finish

2015-03-01

Last updated by the study team

2016-03-07

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• North Shore Long Island Jewish Health System — Great Neck, New York, United States
• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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