TabsDetailsBasic DetailsDate Posted: Thursday, October 29, 2020Status: CompleteMedical Product: topiramateHealth Outcome(s): oral cleftsDescription: In this request we replicated the Hernandez-Diaz, et al. (1) study assessing risk of oral clefts with topiramate use during the first trimester of pregnancy. The replication was conducted to assess the performance of a newly developed inferential pregnancy tool for use in the Sentinel Distributed Database (SDD). The study period included data from January 1, 2000 to September 30, 2015. We distributed this request to six Sentinel Data Partners on June 19, 2020. These six Data Partners are a subset of the SDD and only include those that populate the Mother-Infant Linkage Table.The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.(1) Hernández-Díaz, S., et al. Topiramate use early in pregnancy and the risk of oral clefts: A pregnancy cohort study. Neurology. 2018; 90(4):e342-e351. Read More Deliverable(s) (1)Sentinel Analytic Package: A New Propensity Score Matched Analysis Tool for Pregnancy: Replicating A Study of Oral Clefts following Topiramate Use during the First Trimester of PregnancyAdditional InformationInformationTime Period: January 1, 2000 - September 30, 2015Population / Cohort: Females 12 to 54 years of ageData Source(s): Sentinel Distributed Database (SDD)Related LinksRelated Link(s): Oral Clefts Algorithm Defined in "A New Propensity Score Matched Analysis Tool for Pregnancy: Replicating A Study of Oral Clefts following Topiramate Use during the First Trimester of Pregnancy"