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