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Objective: To determine the rate of occurrence of major malformations in infan ts whose mothers had taken the drug valproicacid (VPA) as monotherapy during the first trimester of pregnancy and had enrolled in the North American Antiepilept ic Drug Pregnancy Registry. Methods: Data were collected from pregnant women throughout the United States and Canad a through telephone-based interviews. Each woman was interviewed at enrollment, at 7 months’gestation, and postpartum.With her written permission, the medical records of each mother and her infant were obtained. The major malformations ta bulated were those identified at or before 5 days of age. The prevalence of cong enital malformations among offspring of monotherapy VPA-exposed women was compa red with that among infants of women exposed to all other antiepileptic drugs(in ternal comparison group) and with that among newborns in the Active Malformation s Surveillance Program at Brigham and Women’s Hospital (external comparison gro up). Results:Sixteen affected cases were identified among 149 VPA-exp- osed women (proportion: 10.7%; 95%CI: 6.3 to 16.9%). The prevalence in the internal comparison group was 2.9%(95%CI:2.0 to 4.1%; odds ratio: 4.0, 95%CI : 2.1 to 7.4; p < 0.001). Assuming a 1.62%prevalence in the external comparison group, the relative risk of having an affected offspring for VPA exposed women was 7.3 (95%CI: 4.4 to 12.2; p < 0.001).Conclusion: Maternal exposure to valpro ic acid during the first trimester of pregnancy significantly increased the risk of major malformations.
Objective: To determine the rate of occurrence of major malformations in infan ts whose mothers had taken the drug valproicacid (VPA) as monotherapy during the first trimester of pregnancy and had enrolled in the North American Antiepilept ic Drug Pregnancy Registry. Methods: Data were collected from pregnant women throughout the United States and Canad a through telephone-based interviews. Each woman was interviewed at enrollment, at 7 months’gestation, and postpartum .With her written permission, the medical records of each mother and her infant were obtained. The major malformations ta bulated were those identified at or before 5 days of age. The prevalence of cong enital malformations among offspring of monotherapy VPA-exposed women was compa red with that among infants of women exposed to all other other antiepileptic drugs (in ternal comparison group) and with that among newborns in the Active Malformations Surveillance Program at Brigham and Women’s Hospital (external comparison gro up The prevalence in the internal comparison group was 2.9% (95% CI: 2.0 to 4.1%; odds ratio: 4.0, 95% CI: 2.1 to 7.4; p <0.001) Assuming a 1.62% prevalence in the external comparison group, the relative risk of having an affected offspring for VPA exposed women was 7.3 (95% CI : 4.4 to 12.2; p <0.001) .Conlusion: Maternal exposure to valpro ic acid during the first trimester of pregnancy significantly increased the risk of major malformations.