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Book Cover
E-book
Author Källén, Bengt, author

Title Drugs during pregnancy : methodological aspects / Bengt Källén
Published Cham : Springer, [2016]
©2016
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Description 1 online resource (xi, 111 pages) : color illustrations
Contents 1. Introduction -- 2. The "Alert Clinician" -- 2.1. Thalidomide -- 2.2. Anticonvulsants -- 2.3. Warfarin -- 2.4. Drugs for Thyrotoxicosis -- 2.5. Retinoids -- 2.6. Mycophenolate Mofetil -- 3. Animal Experiments and Adverse Drug Reaction Reports -- 3.1. Animal Experiments -- 3.2. Adverse Drug Reaction Reports -- 4. Some Epidemiological Principles -- 4.1. Population Studies -- 4.2. Case-Control Studies -- 4.3. Cohort Studies -- 4.4. Comparison Between Case-Control and Cohort Studies -- 4.5. Nested Case-Control Studies -- 4.6. The Sibling Approach
5. Pregnancy Outcomes with the Exception of Congenital Malformations -- 5.1. Maternal Pregnancy Complications -- 5.1.1. Preeclampsia -- 5.1.2. Placenta Previa -- 5.1.3. Placenta Abruption -- 5.1.4. Other Pregnancy Complications -- 5.2. Spontaneous Abortion -- 5.3. Stillbirth and Infant Death -- 5.4. Gestational Duration and Birth Weight -- 5.5. Intrauterine Growth -- 5.6. Other Body Dimensions -- 5.7. Perinatal Morbidity -- 5.8. Long-Term Effects -- 6. Congenital Malformations -- 6.1. Defi nition -- 6.2. Major and Minor Malformations -- 6.3. Single and Multiple Malformations -- 6.4. Causes of Congenital Malformations -- 6.4.1. Genetics -- 6.4.2. Chromosome Anomalies -- 6.4.3. External Factors -- 6.5. Sources of Information on Malformations -- 6.6. Prenatal Diagnosis and Induced Abortion -- 6.7. Grouping of Congenital Malformations
7. Identification of Maternal Use of Drugs -- 7.1. Questionnaires or Interviews in a Case-Control Setting -- 7.2. Prospective Randomized Studies -- 7.3. Teratology Information Services (TIS) -- 7.4. Prospective Studies of Pregnant Populations -- 7.5. Pregnancy Registers -- 7.6. The Swedish Medical Birth Register -- 7.7. Prescription Registers -- 7.8. The Effect of Errors in Drug Exposure Ascertainment -- 7.9. Information on Dosage of Drugs Used -- 8. The Problem of Confounding -- 8.1. Mediating Factors Should Not Be Adjusted for -- 8.2. Some Common and Sometimes Important Confounders -- 8.2.1. Year of Birth -- 8.2.2. Maternal Age -- 8.2.3. Parity and Gravidity -- 8.2.4. Smoking -- 8.2.5. Use of Alcohol -- 8.2.6. Overweight and Obesity -- 8.2.7. Subfertility -- 8.2.8. Race/Nationality -- 8.2.9. Socioeconomic Level -- 8.2.10. Geography -- 8.2.11. Previous Reproductive History -- 8.2.12. Infant Sex -- 8.2.13. Concomitant Maternal Disease and Drug Use -- 8.2.14. Confounding by Indication -- 8.3. Interaction Between Confounders -- 8.4. Residual Confounding
9. Statistics for Dummies -- 9.1. Risk Estimates -- 9.2. Is the Odds Ratio or Risk Ratio Statistically Signifi cant? -- 9.3. The Confi dence Interval -- 9.4. Expected Numbers -- 9.5. Dealing with Confounders -- 9.5.1. Matching -- 9.5.2. Adjustment -- 9.6. Survival Analysis -- 9.7. Power Analysis -- 9.8. The p -value and Mass Signifi cance -- 10. Lumping or Splitting? -- 10.1. Lumping or Splitting of Drug Exposures -- 10.2. Lumping or Splitting of Outcomes -- 11. Timing of Drug Use and Effects on the Embryo or Fetus -- 11.1. Exposure Before Conception -- 11.2. Period of Organogenesis: First Trimester Exposure -- 11.3. Exposure After the First Trimester -- 12. Repeated Studies and Meta-analyses -- 13. The Identification of Risks and the Information Problem -- 13.1. Pharmacovigilance -- 13.2. Information on the Risk with Drug Use During Pregnancy -- 13.3. Concluding Remarks: How to Evaluate a Published Study
Summary "Since the middle of the 1960s, I have been working on problems associated with maternal drug use and the risk for the pregnancy and the offspring. During this time, the methodology has developed and today various strategies are used to study these complex problems. There is a very large literature in the field which is sometimes difficult to evaluate. The practical question, raised by the patient or her doctor, is if the use of a drug during pregnancy increases the risk for a negative outcome of the pregnancy and especially the risk of a congenital malformation. This question is often difficult to answer both for the patient and for her doctor, partly due to the complexity of the problem and therefore the possibility to draw wrong conclusions from published studies. This text tries to summarize my experiences and my views on these problems. It may be of some use notably for researchers who intend to enter the field."--Author's preface
"Extensively discusses the research problems involved in the study of risks associated with drug use during pregnancy. Based on more than 50 years' experience of research in the field. Illustrates problems with data from the literature and with some unpublished recent data from the Swedish Medical Birth Register. Written by Professor Emeritus Bengt Källén, an internationally respected expert in the field of birth defect epidemiology."--Publisher's description
"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."--Publisher's description
Bibliography Includes bibliographical references
Notes Print version record
Subject Fetus -- Effect of drugs on.
Human embryo -- Effect of drugs on.
Epidemiology -- Research -- Methodology.
Drugs -- Side effects.
Obstetrical pharmacology.
Pregnant women -- Drug use.
Female.
Humans.
Pregnancy.
Pregnancy -- drug effects.
Abnormalities, Drug-Induced -- etiology.
Drug Therapy -- contraindications.
Drug-Related Side Effects and Adverse Reactions.
Embryonic Structures -- drug effects.
Form Electronic book
ISBN 9783319406978 (electronic bk.)
3319406973 (electronic bk.)
(print)
(print)