Women With Epilepsy: Pregnancy Outcomes and Deliveries

NCT ID: NCT01259310

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-03-31

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.

Conditions

Epilepsy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with epilepsy

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

No interventions assigned to this group

Women without epilepsy

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacqueline French, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Page Pennell, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Cynthia Harden, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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

Countries

United States

Other Identifiers

WEPOD

Identifier Type: -

Identifier Source: org_study_id