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 NINDS 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 WWE have increased seizures during pregnancy and delineate the contributing factors;2) Determine if C-section rate is increased in WWE and delineate contributing factors;3) Determine if WWE 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 AED exposure on verbal intellectual abilities and other neurobehavioral outcomes in the children of WWE;5) Determine if small for gestation age and other adverse neonatal outcomes are increased in children of WWE;6) Determine if breastfeeding when taking AEDs impairs the child's verbal intellectual and other cognitive abilities. An overall goal f the proposed research is to establish the relationship between AED exposure and outcomes in the mother and child as well as describe and explain the variability in AED 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.

Public Health Relevance

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.

National Institute of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
National Institute of Neurological Disorders and Stroke Initial Review Group (NSD)
Program Officer
Fureman, Brandy E
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Emory University
Schools of Medicine
United States
Zip Code
Meador, Kimford J; Loring, David W (2016) Developmental effects of antiepileptic drugs and the need for improved regulations. Neurology 86:297-306
Gerard, Elizabeth E; Meador, Kimford J (2016) Managing Epilepsy in Women. Continuum (Minneap Minn) 22:204-26
Vélez-Ruiz, Naymeé J; Pennell, Page B (2016) Issues for Women with Epilepsy. Neurol Clin 34:411-25, ix
Pennell, Page B (2016) Use of Antiepileptic Drugs During Pregnancy: Evolving Concepts. Neurotherapeutics 13:811-820
Patel, Sima I; Pennell, Page B (2016) Management of epilepsy during pregnancy: an update. Ther Adv Neurol Disord 9:118-29
Wen, Xuerong; Meador, Kimford J; Hartzema, Abraham (2015) Antiepileptic drug use by pregnant women enrolled in Florida Medicaid. Neurology 84:944-50
Inoyama, Katherine; Meador, Kimford J (2015) Cognitive outcomes of prenatal antiepileptic drug exposure. Epilepsy Res 114:89-97
Loring, David W; Kapur, Ritu; Meador, Kimford J et al. (2015) Differential neuropsychological outcomes following targeted responsive neurostimulation for partial-onset epilepsy. Epilepsia 56:1836-44
Leeman-Markowski, B A; Smart, O L; Faught, R E et al. (2015) Cessation of gamma activity in the dorsomedial nucleus associated with loss of consciousness during focal seizures. Epilepsy Behav 51:215-20
Drane, Daniel L; Loring, David W; Voets, Natalie L et al. (2015) Better object recognition and naming outcome with MRI-guided stereotactic laser amygdalohippocampotomy for temporal lobe epilepsy. Epilepsia 56:101-13

Showing the most recent 10 out of 26 publications