Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)

Launched by STANFORD UNIVERSITY · Nov 20, 2012

Keywords

ClinConnect Summary

There is a compelling need for prospective, properly controlled studies in women with epilepsy (WWE) during pregnancy to improve maternal and child outcomes. The proposed investigations are pertinent to the National Institute of Neurological Disorders and Stroke Epilepsy Research Benchmarks and will address multiple gaps in our knowledge noted by the recent American Academy of Neurology guidelines. This multicenter investigation will employ a prospective, observational, parallel-group, cohort design with an established research team.

The specific aims are to:

1. Determine if women with ep...

Gender

FEMALE

Eligibility criteria

• • 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.