Women With Epilepsy: Pregnancy Outcomes and Deliveries - Full Text View

Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)

This study is currently recruiting participants.

Verified May 2012 by New York University School of Medicine

First Received on December 10, 2010. Last Updated on May 16, 2012 History of Changes

Sponsor:	New York University School of Medicine
Collaborators:	Brigham and Women's Hospital North Shore Long Island Jewish Health System
Information provided by (Responsible Party):	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01259310

Purpose

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).

Condition
Epilepsy

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Women With Epilepsy: Pregnancy Outcomes and Deliveries

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Infertility Seizures

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Fertility in women with epilepsy compared to healthy controls [ Time Frame: 1.75 years ] [ Designated as safety issue: No ]
Percentage of women who have a live birth within the time frame.

Secondary Outcome Measures:

Seizure frequency in women with epilepsy at baseline compared to during pregnancy [ Time Frame: 1.75 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	November 2010
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.
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.

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 tridirectional 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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Women with epilepsy between 18 and 40 years of age, recruited from epilepsy clinics in New York and Boston, and control women without epilepsy between 18 and 40 years of age, recruited from Obstetrics and Gynaecology clinics, local academic institutions, and referrals from epilepsy clinic employees or patients.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259310

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nichelle Llewellyn 617-732-5423 nllewellyn@partners.org
Contact: Page Pennell, MD 617-732-7547 ppennell@partners.org
Principal Investigator: Page Pennell, MD
United States, New York
North Shore Long Island Jewish Health System	Recruiting
Great Neck, New York, United States, 11021
Contact: Connie Lau, MS, CCRC 516-325-7022 cLau@nshs.edu
Contact: Cynthia Harden, MD 516-325-7060 Charden@nshs.edu
Principal Investigator: Cynthia Harden, MD
NYU Langone Medical Center	Recruiting
New York, New York, United States, 10016
Contact: Joseph Lee, MA 646-558-0843 joseph.lee2@nyumc.org
Contact: Jacqueline French, MD 646-558-0868 jacqueline.french@nyumc.org
Principal Investigator: Jacqueline French, MD

Sponsors and Collaborators

New York University School of Medicine

Brigham and Women's Hospital

North Shore Long Island Jewish Health System

Investigators

Principal Investigator:	Jacqueline French, MD	NYU School of Medicine
Principal Investigator:	Page Pennell, MD	Brigham and Women's Hospital
Principal Investigator:	Cynthia Harden, MD	North Shore - LIJ Health System

More Information

No publications provided

Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01259310 History of Changes
Other Study ID Numbers:	WEPOD
Study First Received:	December 10, 2010
Last Updated:	May 16, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

fertility
women
epilepsy
pregnancy
seizures

seizure frequency
ovulation
menstruation
hormones
progesterone

Additional relevant MeSH terms:

Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2012