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Neonatal outcomes after gestational exposure to nitrofurantoin.
MedLine Citation:
PMID:  23344280     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
OBJECTIVE: : To estimate whether first-trimester exposure to nitrofurantoin is associated with increased malformation rates and, secondarily, to estimate whether exposure to nitrofurantoin is associated with increased rates of negative pregnancy outcomes and perinatal complications.
METHODS: : We conducted a population-based cohort study using the Norwegian Prescription Database linked to data on all live births, stillbirths, and induced abortions after 12 weeks of gestation from The Medical Birth Registry of Norway. The study population consisted of 180,120 pregnancies in 2004-2008. The pregnancy outcomes of women who were dispensed nitrofurantoin during pregnancy were compared with the outcomes of women who were dispensed pivmecillinam (disease comparison group) and unexposed women.
RESULTS: : In all, 5,794 (3.2%) filled prescriptions for nitrofurantoin during pregnancy, 1,334 women (0.7%) in the first trimester and 979 women (0.5%) in the last 4 weeks of pregnancy. Dispensing nitrofurantoin during the first trimester was not associated with increased risk of major malformations (31 of 1,334 [2.3%]) compared with disease controls (162 of 5,800 [2.8%], odds ratio [OR] 0.79, 95% confidence interval [CI] 0.51-1.23). No increased risk for secondary adverse pregnancy outcomes was observed when compared with the disease comparison group. Dispensing nitrofurantoin the last 30 days before delivery was associated with increased risk of neonatal jaundice (103 of 959 [10.8%]) compared with unexposed women (10,336 of 127,507 [8.1%], OR 1.31, 95% CI 1.02-1.70).
CONCLUSION: : The results from this large, population-based study suggest that the teratogenic potential of nitrofurantoin is low.
LEVEL OF EVIDENCE: : II.
Authors:
Hedvig Nordeng; Angela Lupattelli; Maria Romøren; Gideon Koren
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  121     ISSN:  1873-233X     ISO Abbreviation:  Obstet Gynecol     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  306-13     Citation Subset:  AIM; IM    
Affiliation:
School of Pharmacy, Faculty of Mathematics and Natural Sciences, and the Department of General Practice, Institute of Health and Society, Faculty of Medicine, University of Oslo, and the Department of Mental Health, Norwegian Institute of Public Health, Oslo, Norway; and The Motherisk Program, the Hospital for Sick Children, Toronto, Ontario, Canada.
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