TY - JOUR
T1 - Pregnancy outcome after gestational exposure to the new macrolides
T2 - A prospective multi-center observational study
AU - Bar-Oz, Benjamin
AU - Diav-Citrin, Orna
AU - Shechtman, Svetlana
AU - Tellem, Rotem
AU - Arnon, Judith
AU - Francetic, Igor
AU - Berkovitch, Matitiahu
AU - Ornoy, Asher
PY - 2008/11
Y1 - 2008/11
N2 - Objectives: To determine whether the use of the new macrolides (azithromycin, clarithromycin, roxithromycin) during the first trimester of pregnancy is associated with an increased risk of major malformations. Study design: In a prospective multi-center study, pregnancy outcome was compared between pregnant women exposed to one of the new macrolides during the first trimester of pregnancy and two comparison groups one exposed to other antibiotics and the other to other non-teratogenic medications. All women enrolled in the study called one of the three participating teratogen information services (TIS). Group 1 macrolides (n = 161), group 2 other antibiotics (n = 213) and group 3 non-teratogens (n = 740). Results: A total of 161 women exposed to the new macrolides (118 were exposed in the first trimester of pregnancy) and 953 from a comparison groups were followed up. The rate of major malformations in the study group was 4.1% compared to 2.1% in the other antibiotics exposed group (OR = 1.41, 95% CI 0.47-4.23) and 3.0% in the non-teratogens exposed group. The rate of elective terminations of pregnancy was significantly higher in the exposed group in compare to both comparison groups. Conclusion: Our study, although relatively small sized, suggests that the use of the new macrolides during the first trimester of pregnancy does not represent an increased risk for congenital malformations strong enough for an induced abortion after such an exposure. Elective terminations of pregnancy because of early exposure to these medications should be reconsidered.
AB - Objectives: To determine whether the use of the new macrolides (azithromycin, clarithromycin, roxithromycin) during the first trimester of pregnancy is associated with an increased risk of major malformations. Study design: In a prospective multi-center study, pregnancy outcome was compared between pregnant women exposed to one of the new macrolides during the first trimester of pregnancy and two comparison groups one exposed to other antibiotics and the other to other non-teratogenic medications. All women enrolled in the study called one of the three participating teratogen information services (TIS). Group 1 macrolides (n = 161), group 2 other antibiotics (n = 213) and group 3 non-teratogens (n = 740). Results: A total of 161 women exposed to the new macrolides (118 were exposed in the first trimester of pregnancy) and 953 from a comparison groups were followed up. The rate of major malformations in the study group was 4.1% compared to 2.1% in the other antibiotics exposed group (OR = 1.41, 95% CI 0.47-4.23) and 3.0% in the non-teratogens exposed group. The rate of elective terminations of pregnancy was significantly higher in the exposed group in compare to both comparison groups. Conclusion: Our study, although relatively small sized, suggests that the use of the new macrolides during the first trimester of pregnancy does not represent an increased risk for congenital malformations strong enough for an induced abortion after such an exposure. Elective terminations of pregnancy because of early exposure to these medications should be reconsidered.
KW - Azithromycin
KW - Clarithromycin
KW - Congenital malformations
KW - Macrolides
KW - Pregnancy
KW - Roxithromycin
UR - http://www.scopus.com/inward/record.url?scp=54949157934&partnerID=8YFLogxK
U2 - 10.1016/j.ejogrb.2008.07.008
DO - 10.1016/j.ejogrb.2008.07.008
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C2 - 18760873
AN - SCOPUS:54949157934
SN - 0301-2115
VL - 141
SP - 31
EP - 34
JO - European Journal of Obstetrics, Gynecology and Reproductive Biology
JF - European Journal of Obstetrics, Gynecology and Reproductive Biology
IS - 1
ER -