The outcomes of pregnancy in women exposed to the new macrolides in the first trimester: A prospective, multicentre, observational study

被引：26

作者：

Bar-Oz B. ^{[1
]}

Weber-Schoendorfer C. ^{[2
]}

Berlin M. ^{[3
]}

Clementi M. ^{[4
]}

Di Gianantonio E. ^{[4
]}

De Vries L. ^{[5
]}

De Santis M. ^{[6
]}

Merlob P. ^{[7
]}

Stahl B. ^{[7
]}

Eleftheriou G. ^{[8
]}

Maňáková E. ^{[9
]}

Hubičková-Heringová L. ^{[9
]}

Youngster I. ^{[3
]}

Berkovitch M. ^{[3
]}

机构：

[1] Department of Neonatology, Hadassah and Hebrew University Medical Center, Jerusalem

[2] Pharmakovigilanzzentrum Embryonaltoxikologie, BBGesCharit Universittsmedizin Berlin, Berlin

[3] Clinical Pharmacology and Toxicology Unit, Assaf Harofeh Medical Center, Tel Aviv University, Zerifin

[4] Servizio Informazione Teratologica, Genetica, Clinica et Epidemiologica, University of Padova, Padova

[5] Teratology Information Service, National Institute of Public Health and Environment, Bilthoven

[6] Department of Obstetrics and Gynecology, Catholic University of Sacred Heart, Rome

[7] Beilinson Teratology Information Service, Rabin Medical Center, Tel Aviv University, Tel Aviv

[8] Centro Antiveleni-Tossicologia Clinica, Department of Clinical Pharmacology, Bergamo

[9] Center of Biomedical Sciences, Division of Histology and Embryology, Charles University, Prague

来源：

Drug Safety | 2012年 / 35卷 / 7期

关键词：

Live Birth; Clarithromycin; Azithromycin; Macrolides; Ventricular Septal Defect;

D O I：

10.2165/11630920-000000000-00000

中图分类号：

学科分类号：

摘要：

Background: Macrolides are a group of commonly prescribed antibiotics. There is some doubt surrounding the use of the newer macrolides in pregnancy. Objective: The present study aimed to compare outcomes of pregnancies exposed to the new macrolides clarithromycin, azithromycin and roxithromycin with non-teratogenic preparations. Methods: In this prospective, multinational, multicentre, controlled, observational study, information was obtained either from pregnant women or their healthcare professionals who contacted their local teratogen information services in Italy, Israel, the Czech Republic, the Netherlands and Germany seeking information after exposure to macrolides. The comparison group included women or their healthcare professional who contacted these centres with questions regarding known non-teratogenic preparations. Information on obstetric and other background parameters was collected at enrollment; after delivery, subjects or their healthcare professionals were contacted to ascertain pregnancy outcome parameters and other exposures through the remainder of the pregnancy. Results: A total of 608 women exposed to macrolides during pregnancy were enrolled; 511 of the exposures occurred during the first trimester. The comparison group comprised 773 women exposed to non-teratogenic preparations during the first trimester of pregnancy. No significant difference in the rate of major congenital malformations was found between the study group and the comparison group (3.4% vs 2.4%; p = 0.36; odds ratio (OR) 1.42; 95% CI 0.70, 2.88) or in the rate of cardiovascular malformations (1.6% vs 0.9%; p = 0.265; OR 1.91; 95% CI 0.63, 5.62). No significant differences were found between subgroups of macrolides in the rates of major congenital malformations or cardiac malformations, although for azithromycin this was of borderline significance. Conclusions: This study, in agreement with earlier smaller studies, suggests that the new macrolides do not pose a significantly increased risk of major congenital malformations or cardiac malformations. © 2012 Springer International Publishing AG. All rights reserved.

引用

页码：589 / 598

页数：9

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