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Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)

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ClinicalTrials.gov Identifier: NCT01259310
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : March 7, 2016
Sponsor:
Collaborators:
Brigham and Women's Hospital
Northwell Health
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Pregnancy

Groups and Cohorts
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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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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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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259310


Locations
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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
NYU Langone Health
Brigham and Women's Hospital
Northwell Health
Investigators
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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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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01259310    
Other Study ID Numbers: WEPOD
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016
Keywords provided by NYU Langone Health:
fertility
women
epilepsy
pregnancy
seizures
 seizure frequency
ovulation
menstruation
hormones
progesterone
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases