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Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 10, 2010
First Posted Date December 14, 2010
Last Update Posted Date March 7, 2016
Study Start Date November 2010
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2011)
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.
Original Primary Outcome Measures
 (submitted: December 13, 2010)
Fertility in women with epilepsy vs. healthy controls [ Time Frame: 1.75 years ]
Percentage of women who have a live birth within the time frame.
Change History
Current Secondary Outcome Measures
 (submitted: January 3, 2011)
Seizure frequency in women with epilepsy at baseline compared to during pregnancy [ Time Frame: 1.75 years ]
Original Secondary Outcome Measures
 (submitted: December 13, 2010)
Seizure frequency in women with epilepsy at baseline vs. during pregnancy [ Time Frame: 1.75 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Women With Epilepsy: Pregnancy Outcomes and Deliveries
Official Title Women With Epilepsy: Pregnancy Outcomes and Deliveries
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).
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Epilepsy
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 4, 2016)
199
Original Estimated Enrollment
 (submitted: December 13, 2010)
200
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01259310
Other Study ID Numbers WEPOD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party NYU Langone Health
Study Sponsor NYU Langone Health
Collaborators
  • 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
PRS Account NYU Langone Health
Verification Date March 2016