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Increased rate of major malformations in offspring exposed to valproate during pregnancy

2005· article· en· 394 citations· W2166575638 on OpenAlex· 10.1212/01.wnl.0000154516.43630.c5

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About CanadaIts subject is Canada, wherever its authors sit.

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Opus teacher head0.023
GPT teacher head0.286
Teacher spread
0.263 · how far apart the two teachers sit on this one work
Validation status
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Abstract

OBJECTIVE: To determine the rate of occurrence of major malformations in infants whose mothers had taken the drug valproic acid (VPA) as monotherapy during the first trimester of pregnancy and had enrolled in the North American Antiepileptic Drug Pregnancy Registry. METHODS: Data were collected from pregnant women throughout the United States and Canada 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 tabulated were those identified at or before 5 days of age. The prevalence of congenital malformations among offspring of monotherapy VPA-exposed women was compared with that among infants of women exposed to all other antiepileptic drugs (internal comparison group) and with that among newborns in the Active Malformations Surveillance Program at Brigham and Women's Hospital (external comparison group). RESULTS: Sixteen affected cases were identified among 149 VPA-exposed 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 valproic acid during the first trimester of pregnancy significantly increased the risk of major malformations.

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The record

Venue
Neurology
Topic
Pharmacological Effects and Toxicity Studies
Field
Medicine
Canadian institutions
Funders
European Association of Plastic SurgeonsAbbott Laboratories
Keywords
PregnancyOffspringMedicineCongenital malformationsOdds ratioGestationObstetricsMedical recordValproic AcidPediatricsTeratologyEpilepsyInternal medicinePsychiatry
Has abstract in OpenAlex
yes