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A population‐based case–control teratologic study of acetylsalicylic acid treatments during pregnancy
Author(s) -
Czeizel Andrew E.,
Rockenbauer Magda,
Mosonyi Attila
Publication year - 2000
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/1099-1557(200005/06)9:3<193::aid-pds498>3.0.co;2-i
Subject(s) - medicine , pregnancy , gestation , population , teratology , offspring , case control study , fetus , pediatrics , obstetrics , congenital malformations , genetics , environmental health , biology
Objective To study the human teratogenic potential of two acetylsalicylic acid (ASA) drugs ASA‐100 mg and ASA‐500 mg. Design Pair analysis of cases with congenital abnormalities and matched healthy controls. Settings The large population‐based dataset of the Hungarian Case‐Control Surveillance of Congenital Abnormalities, 1980–1996. Subjects 38,151 pregnant women who had newborn infants without any defects (population control group); 22,865 case pregnant women who had newborns or fetuses with congenital abnormalities and 812 patient controls who had offspring with Down's syndrome. Results In the case group 1073 (4.7%) and in the population control group 1505 (4.0%), while in the patient control group 52 (6.4%) of the pregnant women were treated with ASA. The ASA‐500 was the major group because 1050 (4.6%) case, 1471 (3.9%) population control and 50 (6.2%) patient control pregnant women had this treatment. The case‐control pair analysis did not indicate a higher rate of any ASA treatments during 2–3 months of gestation, i.e. in the critical period for most major congenital abnormalities. Thus all three of our analyses, i.e. — (1) in matched case‐control pairs ; (2) the comparison of medically recorded ASA use in the total control group and subjects with congenital abnormalities; (3) the comparison of the occurrence of ASA treatment between the patient control group and subjects with congenital abnormalities. Conclusion Treatment with ASA drugs studied during pregnancy did not indicate a higher teratogenic risk to the fetus. Copyright © 2000 John Wiley & Sons, Ltd.