Clinical trial NCT01259310: Women With Epilepsy: Pregnancy Outcomes and Deliveries
Official title: Women With Epilepsy: Pregnancy Outcomes and Deliveries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: fertility
women
epilepsy
pregnancy
seizures
seizure frequency
ovulation
menstruation
hormones
progesterone
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Northwell Health
First posted: 2010-12-14
Enrollment: 199
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Fertility in women with epilepsy compared to healthy controls
timeFrame: 1.75 years
Secondary outcomes:
measure: Seizure frequency in women with epilepsy at baseline compared to during pregnancy
timeFrame: 1.75 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Great Neck
country: United States
facility: North Shore Long Island Jewish Health System
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Jacqueline French, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Page Pennell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwell Health
name: Cynthia Harden, MD
role: PRINCIPAL_INVESTIGATOR
References: