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Introduction
Pages 1-2
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.
Introduction
Pages 1-2
The “Alert Clinician”
Pages 3-8
Animal Experiments and Adverse Drug Reaction Reports
Pages 9-16
Some Epidemiological Principles
Pages 17-24
Pregnancy Outcomes with the Exception of Congenital Malformations
Pages 25-36
Congenital Malformations
Pages 37-46
Identification of Maternal Use of Drugs
Pages 47-56
The Problem of Confounding
Pages 57-76
Statistics for Dummies
Pages 77-87
Lumping or Splitting?
Pages 89-92
Timing of Drug Use and Effects on the Embryo or Fetus
Pages 93-97
Repeated Studies and Meta-analyses
Pages 99-103
The Identification of Risks and the Information Problem
Pages 105-111
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