Describing Prenatal Exposures and Evaluating Maternal and Infant Outcomes in Sentinel

This presentation identifies and describes pregnancies in claims-based data sources which presents logistical and inferential challenges. FDA’s Sentinel System included data from six sites with linked infant and maternal data, and reusable, parameterizable tools to identify and describe these cohorts. These tools and the methods for identifying pregnancies are publicly available and may be used by anyone following Sentinel’s Common Data Model. In this symposium, Sentinel Operation Center presenters discuss the publicly available analytic tools and recent pharmacoepidemiologic analyses related to pregnancies and outcomes within Sentinel.

It was presented at the Society for Pediatric and Perinatal Epidemiologic Research (SPER) webinar on September 13, 2022.