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Article summary:

1. This pharmacoepidemiology study uses Scandinavian birth registry data to estimate the association between modafinil use during early pregnancy and major congenital malformations among infants born in Norway and Sweden between 2005-2006 and 2016-2017.

2. Compared with pregnant women who had not taken modafinil, pregnant women who had taken modafinil were more often overweight or obese and had higher rates of smoking and diagnoses of narcolepsy, multiple sclerosis, and attention-deficit/hyperactivity disorder.

3. The number and percentage of cases of malformations after exposure or without exposure to modafinil was reported.

Article analysis:

The article is generally trustworthy as it provides a detailed description of the methods used in the study, including the data sources used, the definitions for exposure to modafinil, and the characteristics of women included in the study. The authors also provide a clear explanation of their results, which are supported by statistical analysis. However, there are some potential biases that should be noted. First, the study only includes data from two countries (Norway and Sweden), so it may not be representative of other populations or countries. Second, since this is an observational study, it is possible that there may be confounding factors that could influence the results (e.g., lifestyle factors such as smoking). Finally, since this is a retrospective study based on medical records, there may be missing information or errors in recording that could affect the accuracy of the results.