Augmentin treatment during pregnancy and the prevalence of congenital abnormalities - A population-based case-control teratologic study

Objective: To study the human teratogenic potential of augmentin (amoxicill in + clavulanic acid) treatment during pregnancy. Materials curd methods: P air analysis of cases with different congenital abnormalities and their mat ched controls in the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities, between 1991 and 1996. Results: The case group included 6935 pregnant women who had offspring with congenit al abnormalities; while the control group consisted of 10,238 pregnant wome n who had babies without any defects. The number (and rate) of pregnant wom en with augmentin treatment was 52(0.75%) and 56 (0.55%) in the case and co ntrol groups, respectively (crude odds ratio (OR) with 95% confidence inter val (CI) was 1.4, 0.9-2.0). The comparison of augmentin treatments during t he second-third months of pregnancy (i.e. in the critical period for most m ajor congenital abnormalities) in case-control pairs did not show a higher use of augmentin in any congenital abnormality group. Conclusion: Augmentin treatment of pregnant women in usual therapeutic doses is unlikely to incr ease the risk of congenital abnormalities in newborn infants: However, the number of cases and controls was limited, therefore, further multicenter-mu ltinational studies are needed for the final risk assessment. (C) 2001 Else vier Science Ireland Ltd. All rights reserved.