Document Detail

A follow-up study of birth outcome in users of pivampicillin during pregnancy.
MedLine Citation:
PMID:  10830765     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Pivampicillin is a prodrug which is widely used in Scandinavian countries for oral antibiotic therapy. The pivaloyl moiety has a carnitine depleting effect, which has caused doubts about the safety of administering pivampicillin during pregnancy. The aim of the study was to evaluate the risk of congenital malformations in general, preterm delivery and low birth weight in users of pivampicillin. METHODS: Seven hundred and ninety-one women who had redeemed a prescription of pivampicillin during their first pregnancy from 1 January 1991 to 31 December 1996 were identified in the North Jutland Pharmaco-Epidemiological Prescription Database. By linkage to the Danish Medical Birth Registry and Regional Hospital Discharge Registry we compared their birth outcomes (malformations, preterm delivery and low birth weight) with the outcomes in 7472 reference pregnancies on which the mother had not redeemed any prescription at all during pregnancy. RESULTS: The prevalence of malformations was 5.5% (11 cases) in offspring of 199 women who had used pivampicillin during the first trimester, and 5.6% (420 cases) in offspring of controls (OR: 0.95, 95% CI: 0.51-1.76). Furthermore, we did not find any significant risk of preterm delivery (OR: 0.75, 95% CI: 0.54-1.05) or low birth weight (OR: 0.93, 95% CI: 0.55-1.57). CONCLUSION: This study showed no increased risk of congenital malformations, preterm delivery or low birth weight in offspring of women who had redeemed a prescription for pivampicillin during pregnancy.
H Larsen; G L Nielsen; H T Sørensen; M Møller; J Olsen; H C Schønheyder
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Acta obstetricia et gynecologica Scandinavica     Volume:  79     ISSN:  0001-6349     ISO Abbreviation:  Acta Obstet Gynecol Scand     Publication Date:  2000 May 
Date Detail:
Created Date:  2000-06-12     Completed Date:  2000-06-12     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0370343     Medline TA:  Acta Obstet Gynecol Scand     Country:  DENMARK    
Other Details:
Languages:  eng     Pagination:  379-83     Citation Subset:  IM    
Department of Gynaecology and Obstetrics, Aalborg Hospital, Denmark.
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MeSH Terms
Abnormalities, Drug-Induced / epidemiology*
Denmark / epidemiology
Follow-Up Studies
Infant, Low Birth Weight
Infant, Newborn
Infant, Premature
Linear Models
Multivariate Analysis
Obstetric Labor, Premature / chemically induced
Penicillins / adverse effects*,  therapeutic use
Pivampicillin / adverse effects*,  therapeutic use
Pregnancy Outcome*
Prodrugs / adverse effects*,  therapeutic use
Reg. No./Substance:
0/Penicillins; 0/Prodrugs; 33817-20-8/Pivampicillin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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