| Fetal outcome following roxithromycin exposure in early pregnancy. | |
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MedLine Citation:
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PMID: 16690513 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Because very little information exists on the fetal safety of roxithromycin, we aimed to extend the knowledge on fetal outcome in pregnant women who were exposed to roxithromycin in early pregnancy. METHODS: Twenty pregnant women inadvertently exposed to roxithromycin during early pregnancy were identified and prospectively followed-up. For comparison, 170 pregnant women matched by age and gravidity, not being exposed to any potential teratogenic agent during pregnancy, were recruited as controls. All gestations were confirmed by ultrasound examination, and participants were followed-up until delivery. Newborns were examined by a neonatologist. RESULTS: Of 20 pregnant women exposed to roxithromycin during early pregnancy, information was obtained from 17 cases. The median dose of roxithromycin to which pregnant women were exposed was 300 mg/day (range 300-450 mg/day) and exposure occurred at a mean of 4.0 (range 2.8-17.6) weeks. Mean gestational age at delivery was 39.2 weeks in the exposed group and 39.4 in the controls (p = 0.6). Birth weight of babies exposed in utero to roxithromycin was not different to controls. We did not observe any major malformation in the exposed group whereas three (1.8%) occurred in the control group. CONCLUSIONS:. Despite the limitations of the study due to the small sample size, roxithromycin appears not to be a major teratogen. |
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Authors:
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Jun-Yang Chun; Jung-Yeol Han; Hyun-Kyong Ahn; June-Seek Choi; Mi-Kyoung Koong; Alejandro A Nava-Ocampo; Gideon Koren |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians Volume: 19 ISSN: 1476-7058 ISO Abbreviation: J. Matern. Fetal. Neonatal. Med. Publication Date: 2006 Mar |
Date Detail:
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Created Date: 2006-05-12 Completed Date: 2006-11-22 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101136916 Medline TA: J Matern Fetal Neonatal Med Country: United States |
Other Details:
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Languages: eng Pagination: 189-92 Citation Subset: IM |
Affiliation:
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The Korean Motherisk Program, Samsung Cheil Hospital & Women's Health-care Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Anti-Bacterial Agents / pharmacology, therapeutic use Birth Weight / drug effects Cohort Studies Female Follow-Up Studies Gestational Age Humans Infant, Newborn Pregnancy Pregnancy Complications / drug therapy Pregnancy Outcome* Pregnancy Trimester, First* Prospective Studies Roxithromycin / pharmacology*, therapeutic use |
| Chemical | |
Reg. No./Substance:
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0/Anti-Bacterial Agents; 80214-83-1/Roxithromycin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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