Trial Search Results

Maternal and Neurodevelopmental Outcomes of in Utero Antiepileptic Drug (AED) Exposure

Epilepsy is one of the most common neurological disorders affecting women of childbearing age. Poor pregnancy outcomes are increased in these women and their children. The proposed studies will increase our knowledge on multiple levels to improve care and reduce adverse outcomes in these mothers and children. An overall goal of this study is to establish the relationship between antiepileptic drug exposure and outcomes in the mother and child as well as describe and explain the variability in antiepileptic drug exposure and response.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Emory University

Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

Stanford Investigator(s):

Eligibility


Inclusion Criteria for All Women

   - Pregnant women with epilepsy up to 20 weeks gestation, healthy pregnant women without
   epilepsy up to 20 weeks gestation, or non-pregnant women with epilepsy.

   - Ability to maintain a daily medical diary.

   - Language skills in English or Spanish adequate to perform the cognitive tests and
   questionnaires.

   - Access to a telephone for phone contacts.

   - Age 14-45 inclusive.

Inclusion Criteria applicable for pregnant women only. -Ability for follow-up through 6
years after giving birth.

Criteria applicable for non-pregnant women with epilepsy only:

   - Minimum of 9 months post live birth, miscarriage, or elective termination.

   - Not currently breastfeeding.

Exclusion Criteria for All Women

   - Women with an expected IQ<70.

   - IV drug use in past year or any of the following since the beginning of pregnancy:
   Alcohol abuse, cocaine, or methamphetamine) or sequelae of drug/alcohol abuse.

   - History of psychogenic non-epileptic spells.

   - History of positive Syphilis test.

   - History of HIV positive test.

   - Progressive cerebral disease (e.g., multiple sclerosis, progressive brain tumor).

   - Presence of other major medical illness (e.g., diabetes, cancer).

   - Any medical, psychiatric, or other condition that, in the judgment of the
   investigator, is a contraindication to protocol participation or impairs ability to
   give informed consent.

   - Concurrent participation in an experimental drug trial.

Exclusion criteria applicable for pregnant women only.

   - Exposure to known teratogens during pregnancy, excluding AEDs.

   - Detection of fetal major congenital malformation prior to enrollment in current
   pregnancy.

   - History of a known genetic disorder in herself or a primary relative (may contact
   MONEAD team with details for possible exception).

   - Use of non-licensed midwife as primary source of natal care and/or planning home
   delivery or delivery at a stand-alone birth center, independent from a hospital.

Exclusion criteria applicable for all women with epilepsy.

-Planned surgical intervention for epilepsy that would occur during the subject's
participation in the project

Exclusion criteria applicable for pregnant women with epilepsy only. -History of switching
AEDs during pregnancy prior to enrollment. "Switching" AEDs includes changing from no AED
therapy to therapy, discontinuing a current AED therapy, or changing to a different AED
therapy.

Exclusion criteria applicable for non-pregnant women only.

   - Diagnosed by a health care professional as perimenopausal or postmenopausal.

   - History of switching AEDs within 90 days of enrollment. "Switching" AEDs includes
   changing from no AED therapy to therapy, discontinuing a current AED therapy, or
   changing to a different AED therapy.

Inclusion Criteria for Study Family Members

   - The Father must be the biological father of the child in the study.

   - The Maternal Relative must be a full biological relative or half-sibling of the mother
   chosen by the following hierarchy:

      1. st choice: Sister of closest age to the mother in the trial

      2. nd Sister of next closest age

      3. rd Brother of closest age

      4. th Brother of next closest age

      5. th Mother

      6. th Father of pregnant mother in the study

      7. th Half-Sibling if NO Primary FULL relatives are available.

      Exclusion Criteria for Study Family Members

   - Any medical, psychiatric, or other condition that, in the judgment of the
   investigator, is a contraindication to protocol participation or impairs ability to
   give informed consent.

Ages Eligible for Study

14 Years - 45 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting