Women With Epilepsy: Pregnancy Outcomes and Deliveries

Completed

• Conditions: Epilepsy

• Registration Number: NCT01259310
• Lead Sponsor: NYU Langone Health

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 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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 199

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fertility in women with epilepsy compared to healthy controls	1.75 years	Percentage of women who have a live birth within the time frame.

Secondary Outcome Measures

Name	Time	Method
Seizure frequency in women with epilepsy at baseline compared to during pregnancy	1.75 years

Trial Locations

Locations (3)

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