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Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Northwell Health
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01259310
First received: December 10, 2010
Last updated: March 4, 2016
Last verified: March 2016
History of Changes
  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
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 ]
Enrollment: 199
Study Start Date: November 2010
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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 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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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: March 4, 2016
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 September 30, 2016