This book addresses methodological aspects of epidemiological studies on maternal drug use in pregnancy. Discussing the existing sources of error and how they can produce incorrect conclusions, it examines various epidemiological techniques and assesses their strengths and weaknesses. These refer both to the identification of outcomes (with special emphasis on congenital malformations) and to the types of exposure (drug use).Further, the book discusses the problem of confounding and how to handle it, and provides a simple introduction to statistics. Special situations, e.g. different types of parental exposure, are examined. Lastly, the book discusses pharmacovigilance and the information problem, concluding with a short list of aspects to consider when one wants to evaluate a published paper in the field.Though the book is primarily intended for pharmacologists, gynecologists and obstetricians, it will benefit all doctors working in perinatal care.

Extensively discusses the research problems involved in the study of risks associated with drug use during pregnancy

Introduction.- The alert clinician.- Animal experiments and adverse drug reaction reports.- Some epidemiological principles.- Pregnancy outcomes with the exception of congenital malformations.- Congenital malformations.- Identification of maternal use of drugs.- The problem of confounding.- Statistics.- Lumping or splitting? Paternal use of drugs.- Timing of drug use and effects on the embryo or fetus.- Repeated studies and meta-analysis.- Pharmacovigilance.- Information on the risk with drug use during pregnancy.- Concluding remarks.