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.
Report 1 does not require any duration of medical or drug coverage for mothers and infants after delivery.
Report 2 requires that mothers and infants have 90 days of medical and drug coverage after delivery.
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.