Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)

NYU Langone Health

Status: Completed

Conditions: Epilepsy

Study type: Observational

Funder types: Other

Identifiers

NCT01259310

WEPOD

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 199 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

199 participants in 2 patient groups

Women with epilepsy

Description:

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

Description:

Healthy women, age 18-40 years, who express a desire to conceive and have stopped or plan to stop taking birth control.