JAC Advance Access published online on September 30, 2003
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkg438
© 2003 by The British Society for Antimicrobial Chemotherapy
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Original article
1 Department of Clinical
Epidemiology, Aarhus and Aalborg University Hospitals, DK-8000 Aarhus
C, Denmark; Department of
Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of
Songkla University, Songkhla, 90110 Thailand
* Corresponding author. E-mail: uxmeno{at}aas.nja.dk.
Received 23 May 2003
; revised 6 August 2003
; accepted 7 August 2003
Objective: To estimate the risk of
adverse birth and neonatal outcome, and miscarriage in women who
used sulfamethizole during pregnancy. Methods: The association between use of sulfamethizole
and adverse birth and neonatal outcome was investigated in a case-control
and a cohort study in Denmark. We used data from the Prescription
Database, the Birth Registry and the Hospital Discharge Registry
in North Jutland County to study any association between sulfamethizole
use and first recorded miscarriage. The cohort analysis included
3484 women who received a prescription for sulfamethizole from 30
days before conception to date of delivery, and 60 175 women
who did not use a sulphonamide-containing drug during pregnancy
or 30 days before conception. The case-control analysis
included 3347 women who had a miscarriage, of whom 90 had taken
sulfamethizole, and 22 599 primiparous controls who had
a live birth. Results: Among women who received prescriptions
for sulfamethizole, adjusted odds ratios and 95% confidence
intervals for adverse birth outcome were: malformation 1.17 (0.95-1.43);
low birth weight 0.69 (0.49-0.98); pre-term birth 1.12
(0.97-1.30); stillbirth 1.02 (0.61-1.68); neonatal
jaundice 1.14 (0.38-3.46); and for receiving a prescription
for sulfamethizole within 1 week before miscarriage 1.66 (0.92-2.99). Conclusions: We found no increased risk of congenital
malformation, stillbirth or pre-term birth, and no association between
use of sulfamethizole late in pregnancy and risk of neonatal jaundice.
There was an increased risk of miscarriage after exposure to sulfamethizole
during the week before miscarriage, but further studies are needed
to evaluate whether this increased risk is causal.
Keywords: malformation, pre-term delivery, low birth weight,
miscarriage
Adverse pregnancy outcome in users of sulfamethizole
during pregnancy: a population-based observational study
2 Department of Clinical
Epidemiology, Aarhus and Aalborg University Hospitals, DK-8000 Aarhus
C, Denmark
3 Department of Clinical Microbiology, Aalborg Hospital,
DK-9000 Aalborg, Denmark
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