Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)
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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 |
- 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.
- Seizure frequency in women with epilepsy at baseline compared to during pregnancy [ Time Frame: 1.75 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | April 2013 (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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
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| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Nichelle Llewellyn 617-732-5423 nllewellyn@partners.org | |
| Contact: Page Pennell, MD 617-732-7547 ppennell@partners.org | |
| Principal Investigator: Page Pennell, MD | |
| United States, New York | |
| North Shore Long Island Jewish Health System | Recruiting |
| Great Neck, New York, United States, 11021 | |
| Contact: Connie Lau, MS, CCRC 516-325-7022 cLau@nshs.edu | |
| Contact: Cynthia Harden, MD 516-325-7060 Charden@nshs.edu | |
| Principal Investigator: Cynthia Harden, MD | |
| NYU Langone Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Joseph Lee, MA 646-558-0843 joseph.lee2@nyumc.org | |
| Contact: Jacqueline French, MD 646-558-0868 jacqueline.french@nyumc.org | |
| Principal Investigator: Jacqueline French, MD | |
| 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 |
More Information
No publications provided
| 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: | December 14, 2012 |
| 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 May 16, 2013