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Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)

This study is currently recruiting participants.
Verified December 2012 by New York University School of Medicine
Sponsor:
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
First received: December 10, 2010
Last updated: December 14, 2012
Last verified: December 2012
History of Changes

December 10, 2010
December 14, 2012
November 2010
April 2013   (final data collection date for primary outcome measure)
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.
Fertility in women with epilepsy vs. healthy controls [ Time Frame: 1.75 years ] [ Designated as safety issue: No ]
Percentage of women who have a live birth within the time frame.
Complete list of historical versions of study NCT01259310 on ClinicalTrials.gov Archive Site
Seizure frequency in women with epilepsy at baseline compared to during pregnancy [ Time Frame: 1.75 years ] [ Designated as safety issue: No ]
Seizure frequency in women with epilepsy at baseline vs. during pregnancy [ Time Frame: 1.75 years ] [ Designated as safety issue: No ]
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Not Provided
 
Women With Epilepsy: Pregnancy Outcomes and Deliveries
Women With Epilepsy: Pregnancy Outcomes and Deliveries

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).

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.
Epilepsy
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
November 2013
April 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Not Provided
United States
 
NCT01259310
WEPOD
No
New York University School of Medicine
New York University School of Medicine
  • Brigham and Women's Hospital
  • North Shore Long Island Jewish Health System
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
New York University School of Medicine
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP