Overview

This trial is active, not recruiting.

Conditions epilepsy, pregnancy
Sponsor Emory University
Collaborator The EMMES Corporation
Start date January 2013
End date July 2017
Trial size 565 participants
Trial identifier NCT01730170, 2U01NS038455-11A1, IRB00060793

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Women in their first trimester of pregnancy who are not diagnosed with epilepsy
Women diagnosed with epilepsy and not currently pregnant.
Women in their first trimester of pregnancy and diagnosed with epilepsy

Primary Outcomes

Measure
Changes in seizure frequency over pregnancy vs. post-partum (comparable time periods for non-pregnant women with epilepsy).
time frame: Pregnant women with epilepsy:1st Trimester through 9 months post-partum; Nonpregnant women with epilepsy: Study enrollment through 18 months participation
C-section Rate
time frame: Pregnant women with epilepsy & Pregnant women without epilepsy at child's birth
Rate of Depression
time frame: Pregnant women: 1st Trimester through 9 months post partum, again when child is 2 and 3 Years of age. Nonpregnant women with epilepsy: Study enrollment through 6months participation, then 12 months until 18 months participation
Child Verbal Intellectual Ability
time frame: When child is 2, 3, 4.5 and 6 Years of age
Small for Gestational Age Rate
time frame: Child's birth
Breastfeeding Effects on verbal intellectual ability in children
time frame: Birth until the child is 2 Years of age, although we anticipate not all children will breastfeed until 2 Years

Eligibility Criteria

Female participants from 14 years up to 45 years old.

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.

Additional Information

Official title Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs
Principal investigator Kimford J Meador, M.D.
Description 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 epilepsy have increased seizures during pregnancy and delineate the contributing factors; 2. Determine if C-section rate is increased in women with epilepsy and delineate contributing factors; 3. Determine if women with epilepsy have an increased risk for depression during pregnancy and post-partum period and characterize risks factors; 4. Determine the long-term effects of in utero antiepileptic drug exposure on verbal intellectual abilities and other neurobehavioral outcomes in the children of women with epilepsy; 5. Determine if small for gestation age and other adverse neonatal outcomes are increased in children of women with epilepsy; 6. Determine if breastfeeding when taking antiepileptic drugs impairs the child's verbal intellectual and other cognitive abilities. An overall goal of the proposed research 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. Anticonvulsant blood levels (ABLs) and area-under-the-concentration-time-curves (AUCs) will be used as direct measures of drug exposure. The results will enable clinicians to prospectively calculate individual dosing regimens for the mother in order to optimize dosing and limit unnecessary drug exposure to the child. In addition, genetic samples will be collected, which will provide a valuable resource for future pharmacogenetics studies to further delineate individual variability across patients.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Emory University.