Fetal Outcomes Following Rheumatologic Drug Exposures in PregnancyBecause the onset of many of the rheumatologic conditions is during childbearing years, issues ofreproductive health play an important role in disease management. Thus, it is critical that women and theirhealthcare providers understand effects on the developing fetus of medications used to treat rheumatologicconditions. Unfortunately, little is known about the fetal risks of many of the medications currently available totreat some of the more common rheumatologic conditions, including inflammatory arthropathies andconnective tissue disorders. Large automated databases can make critical contributions to ourunderstanding of pregnancy outcomes following exposure to rheumatologic medications. Accordingly, wepropose a series of epidemiologic studies with the following specific aims: 1) to assess the risk of majorcongenital malformations and adverse fetal outcomes following fetal exposure to NSAIDs in infants whosemothers have no evidence of an inflammatory arthropathy or connective tissue disorder; and 2) to assess therisk of congenital malformations and adverse fetal outcomes following exposure to non-NSAIDrheumatologic medications in infants whose mothers have evidence of an inflammatory arthropathy orconnective tissue disorder. A retrospective study cohort will be assembled from TennCare files and birthcertificates from 1990-2007 and will include an estimated 216,033 mother-infant pairs with completeinformation on the birth certificate and enrollment in TennCare from the year prior to pregnancy through thedate of delivery or fetal death for the mothers and for the first 90 days of life for the infants. For women inthis cohort, fetal medication exposures will be identified from filled prescriptions and adverse fetal outcomeswill be detected using TennCare encounters, birth and death certificates and confirmed through medicalrecord review. The study for Specific Aim 1 (NSAIDs) will include mothers and infants in whom there is noevidence of maternal inflammatory arthropathy or connective tissue disorder. Infants with fetal NSAIDexposure will be compared to a random sample of infants born without such exposure with respect to theproportion with cardiac malformations, other major congenital malformations, and adverse fetal outcomes.The relative risk conferred by NSAID exposure will be estimated with unconditional multivariate logisticregression. The study for Specific Aim 2 (non-NSAID rheumatologic medications in women with evidence ofinflammatory arthropathies or connective tissues disorders), will include mothers with use of studymedications during the 12 months prior to pregnancy or during pregnancy excluding women with a nonrheumatologicindication (e.g. Crohn's Disease). Comparisons will be made between infants with and withoutfetal exposures to each medication using unconditional multivariate logistic regression. These studies willprovide important safety information for medications commonly used to treat rheumatologic conditions.
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