Prospective assessment of pregnancy outcomes after first-trimester exposure to fluconazole.
OBJECTIVE
Our purpose was to study prospectively the pregnancy outcome after first-trimester exposure to fluconazole, an effective antifungal agent teratogenic in animals.


METHODS
We conducted a prospective cohort study of women who contacted three Italian teratogen information services. We compared the pregnancy outcomes of 226 women exposed to fluconazole with that of 452 women exposed to nonteratogenic agents, with use of logistic regression to control for potential confounders.


RESULTS
Among the 226 pregnancies exposed to fluconazole there were 22 miscarriages, 1 stillbirth, and 7 infants with congenital anomalies. The prevalence of these outcomes and of neonatal growth parameters and the rate of neonatal complications were similar to those in the reference group. Women in the fluconazole group had a fivefold increased occurrence of induced abortions.


CONCLUSIONS
First-trimester exposure to fluconazole does not appear to increase the prevalence of miscarriages, congenital anomalies, and low birth weight.
Mastroiacovo
P
P
Birth Defects Unit, Institute of Pediatrics, Catholic University, Rome, Italy.
Mazzone
T
T
Botto
L D
LD
Serafini
M A
MA
Finardi
A
A
Caramelli
L
L
Fusco
D
D
D000328:Adult; D000935:Antifungal Agents / Q000627:therapeutic use*; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy; D015331:Cohort Studies; D005260:Female; D015725:Fluconazole / Q000627:therapeutic use*; D006801:Humans; D011247:Pregnancy; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D012044:Regression Analysis
D000935:Antifungal Agents; D015725:Fluconazole