Women With Epilepsy: Pregnancy Outcomes and Deliveries



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 40
Updated:4/21/2016
Start Date:November 2010
End Date:March 2015

Use our guide to learn which trials are right for you!

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).

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.

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
We found this trial at
3
sites
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Great Neck, NY
Click here to add this to my saved trials