Interpreting the pharmacoepidemiology literature in obstetrical studies: A guide for clinicians

Many prescribers are knowledgeable about randomized controlled trials (RCT), but are less familiar with pharmacoepidemiology studies; that is, observational studies in which a pharmacologic agent is the exposure of interest. To date, few clinical trials include pregnant women. With the absence of RCT data, prescribers must largely rely on the pharmacoepidemiology literature to guide prescribing decisions for pregnant patients. We describe different types of pharmacoepidemiology studies and present a flowchart and table checklist to support clinicians to assess the quality of, and thus the validity of conclusions from, pharmacoepidemiology studies. We provide illustrative examples of published observational studies examining antidepressant treatment during pregnancy and fetal and infant outcomes.