Document Detail


First-trimester exposure to amoxycillin/clavulanic acid: a prospective, controlled study.
MedLine Citation:
PMID:  15327589     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: The number of published studies on the use of amoxycillin/clavulanic acid during pregnancy is small and so is the number of pregnancies investigated in those studies. In this study we wished to investigate prospectively the safety of intrauterine exposure to amoxycillin/clavulanic acid in a relatively large cohort of women. METHODS: Women treated (n = 191) with amoxycillin/clavulanic acid during the first trimester of pregnancy were recruited from two teratogen information centres in Israel. Exposed women were matched for age, smoking habits and alcohol consumption with 191 controls exposed to amoxycillin only for similar medical indications. RESULTS: Maternal age, birth weight, gestational age at delivery, rates of live births and abortions were comparable between the two groups. Rates of major malformations in the amoxycillin/clavulanic acid group (3/158, 1.9%) did not differ significantly from controls (5/163, 3%) (P = 0.49, relative risk = 0.62, 95% confidence interval 0.15, 2.55), and were within the expected baseline risk for the general population. CONCLUSION: These data suggest that exposure to amoxycillin/clavulanic acid during pregnancy is unlikely to be associated with an increased risk of malformations.
Authors:
Matitiahu Berkovitch; Orna Diav-Citrin; Revital Greenberg; Michal Cohen; Mordechai Bulkowstein; Svetlana Shechtman; Oxana Bortnik; Judy Arnon; Asher Ornoy
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Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  58     ISSN:  0306-5251     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2004 Sep 
Date Detail:
Created Date:  2004-08-25     Completed Date:  2004-12-17     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  298-302     Citation Subset:  IM    
Affiliation:
Clinical Pharmacology and Toxicology unit, Drug Consultation Centre, Assaf Harofeh Medical Centre, Zerifin, Israel. mberkovitch@asaf.health.gov.il
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MeSH Terms
Descriptor/Qualifier:
Amoxicillin / adverse effects*
Anti-Bacterial Agents / adverse effects*
Case-Control Studies
Clavulanic Acid / adverse effects*
Cohort Studies
Female
Humans
Infant, Newborn
Pregnancy
Pregnancy Complications, Infectious / drug therapy*
Pregnancy Outcome
Pregnancy Trimester, First
Prospective Studies
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 26787-78-0/Amoxicillin; 58001-44-8/Clavulanic Acid
Comments/Corrections

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