Evidence Rating Level: 1 (Excellent)
1. There were no language ability differences among 2-year-old children of women taking epileptic medication during pregnancy compared to children of healthy women not taking medication.
2. Anti-seizure medications taken in the third trimester of pregnancy had insignificant teratogenic effects on the developing fetal brain and subsequent cognitive abilities.
While it is generally a well-known fact that teratogens are to be avoided during pregnancy to reduce risk of fetal development abnormalities, the most commonly prescribed teratogens are anti-seizure medications (ASMs). Unfortunately, there remains a lack of knowledge surrounding risks, dosage, and long-term effects of these medications taken during the 3rd trimester. Furthermore, due to ethical reasons, randomization of participants and experimental research is prohibited when studying vulnerable populations such as pregnant women and their fetuses. Risks associated with teratogens such as ASMs are dose dependent and this study aimed to better understand cognitive effects on children at 2 years of age in order to adjust dose management and future treatment plans. This prospective study began at birth, continued with an assessment at 2 years old, and will also continue for an assessment at 6 years old. The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study involved 20 epilepsy centers in the United States. This multicenter, observational cohort study included 292 children of women with epilepsy (WWE) and 90 children of healthy women (without epilepsy). The MONEAD study looked specifically at the impacts of women taking anti-seizure medications (ASM) during their 3rd trimester of pregnancy. The goal of the primary analysis was focused on assessing language domain scores in order to understand effects on cognitive abilities in children at 2 years of age. The secondary analysis investigated the other 4 domains of the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) including; motor control, cognitive, social-emotional and general adaptive. Overall, the study found there were no significant differences between children of both cohorts in all domains. Differences in cognitive abilities were attributable to confounding factors of the mother and child, but none were significantly associated with the ASMs themselves. This study highlights the lack of understanding and unknown effects of teratogens during pregnancy such as anti-seizure medications. Finally, dose management during pregnancy is challenging as the long-term effects are often unclear and further research is required including the follow up study at 6 years of age.
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