Women With Epilepsy: Pregnancy Outcomes and Deliveries

Epilepsy Clinical Trial

— WEPOD  

Official title:

Women With Epilepsy: Pregnancy Outcomes and Deliveries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259310
• Other study ID #: WEPOD
• Status: Completed
• Phase: N/A
• First received: December 10, 2010
• Last updated: March 4, 2016
• Start date: November 2010
• Est. completion date: March 2015

Study information

• Verified date: March 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	Brigham and Women's Hospital, Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertility in women with epilepsy compared to healthy controls	Percentage of women who have a live birth within the time frame.	1.75 years	No
Secondary	Seizure frequency in women with epilepsy at baseline compared to during pregnancy		1.75 years	No