PROSPECTIVE ASSESSMENT OF PREGNANCY OUTCOMES AFTER FIRST-TRIMESTER EXPOSURE TO FLUCONAZOLE

OBJECTIVE: Our purpose was to study prospectively the pregnancy outcom e after first-trimester exposure to fluconazole, an effective antifung al agent teratogenic in animals. STUDY DESIGN: We conducted a prospect ive cohort study of women who contacted three Italian teratogen inform ation services. We compared the pregnancy outcomes of 226 women expose d to fluconazole with that of 452 women exposed to nonteratogenic agen ts, with use of logistic regression to control for potential confounde rs. RESULTS: Among the 226 pregnancies exposed to fluconazole there we re 22 miscarriages, 1 stillbirth, and 7 infants with congenital anomal ies. The prevalence of these outcomes and of neonatal growth parameter s and the rate of neonatal complications were similar to those in the reference group. Women in the fluconazole group had a fivefold increas ed occurrence of induced abortions. CONCLUSIONS: First-trimester expos ure to fluconazole does not appear to increase the prevalence of misca rriages, congenital anomalies, and low birth weight.