Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease
Epilepsy

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 Design

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Study Type :	Observational
Actual Enrollment :	199 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	Women With Epilepsy: Pregnancy Outcomes and Deliveries
Study Start Date :	November 2010
Actual Primary Completion Date :	March 2015
Actual Study Completion Date :	March 2015

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Fertility in women with epilepsy compared to healthy controls [ Time Frame: 1.75 years ]
   Percentage of women who have a live birth within the time frame.

Secondary Outcome Measures :

1. Seizure frequency in women with epilepsy at baseline compared to during pregnancy [ Time Frame: 1.75 years ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes 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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
North Shore Long Island Jewish Health System
Great Neck, New York, United States, 11021
NYU Langone Medical Center
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

Brigham and Women's Hospital

Northwell Health

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	Northwell Health

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01259310 History of Changes
Other Study ID Numbers:	WEPOD
First Posted:	December 14, 2010
Last Update Posted:	March 7, 2016
Last Verified:	March 2016

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