Active substances: Amoxicillin
Results The outcome of 123 pregnancies with gestational use of azithromycin was ascertained as well as 123 in each of two comparison groups.
Five women used the drug more than once, due to recurrent infections during the pregnancy. Treatment for chlamydia was with a single one-gram oral dose of azithromycin, with no further recurrences.
There were no differences in the maternal characteristics between the study group and the two comparison groups. The outcomes in the exposed group were 113 live births; 6 spontaneous abortions; 3 fetal deaths and 1 therapeutic abortion for which no anomalies were detected.
There were no significant differences in the rates of major malformations between women exposed to azithromycin 3. Of note, the three malformations in the exposed group, were in the children of mothers who were treated with azithromycin for URTI.
Statistical analysis of secondary outcomes did not detect differences among the three groups in terms of pregnancy outcome, fetal distress, preterm delivery rates, and mean birth weight.
Table 1 Table 2 Malformations Full size table Discussion To our knowledge, this is the first prospective study that evaluated the fetal safety of azithromycin use during pregnancy.
We feel that it confirms, as with the macrolides, that this drug appears to be relatively safe for use during pregnancy.
Single-dose azithromycin therapy presents a distinct advantage over multiple doses of other antibiotics, and it appears to be the most cost-effective agent for many indications.
This is particularly true in the case of adolescent patients and asymptomatic infections, where many patients are unlikely to comply with multi-dose therapy.
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