Perinatal epidemiology: Issues, challenges, and potential solutions.

Perinatal epidemiology research is concerned with identifying the effects of events during pregnancy on pregnancy outcomes that include maternal, fetal, and neonatal health outcomes. Randomized trials in perinatal research face many challenges, including randomization difficulties, ethical considerations, and inadequate statistical power due to the small number of subjects eligible for participation. For these reasons, most epidemiological studies conducted in this research field are observational and include different types of bias. This review describes the key methodological difficulties in the design and analysis of randomized and observational studies in perinatal epidemiology, and provides potential corrective approaches.