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A New Propensity Score Matched Analysis Tool for Pregnancy: Replicating A Study of Oral Clefts following Topiramate Use during the First Trimester of Pregnancy

Basic Details
Date Posted
Status
Complete
Medical Product
topiramate
Health Outcome(s)
oral clefts
Description

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.

Deliverable(s) (3)
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 Pregnancy Sentinel Modular Program Report: A New Propensity Score Matched Analysis Tool for Pregnancy: Replicating A Study of Oral Clefts following Topiramate Use during the First Trimester of Pregnancy, Report 1 Sentinel Modular Program Report: A New Propensity Score Matched Analysis Tool for Pregnancy: Replicating A Study of Oral Clefts following Topiramate Use during the First Trimester of Pregnancy, Report 2
Information
Time Period
January 1, 2000 - September 30, 2015
Population / Cohort
Females aged 12 to 54 years
Data Source(s)
Sentinel Distributed Database (SDD)
Related Links
Related 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"
Publication: Assessing Medical Product Safety During Pregnancy using Parameterizable Tools in the Sentinel Distributed Database