Population-based case-control study of oral ketoconazole treatment for birth outcomes

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

The objective of the study presented here was to check the effect of oral ketoconazole treatment on fetal development. Ketoconazole has been given a teratogenic classification of C by the US Food and Drug Administration, but human controlled epidemiological studies of the treatment's effects have not been reported. The occurrence of ketoconazole use in the second to third months of gestation was compared between cases with congenital abnormalities and their matched controls in the large population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996. Birth weight and gestational age were evaluated in control newborn infants born to mothers with or without ketoconazole treatment. The case group comprised 22 843 cases with congenital abnormalities, while the control group contained 38 151 newborn infants without any defects. Six infants (0.03%) and 12 controls (0.03%) had mothers who had received oral ketoconazole treatment (prevalence odds ratio: with 95% confidence interval: 0.8, 0.3-2.2). No group of infants with congenital abnormalities had mothers with a higher incidence of use of the drug. The mean gestational age was somewhat longer while birth weight was somewhat larger in controls with ketoconazole treated mothers. Our study failed to demonstrate a higher rate of congenital abnormalities in infants with mothers who had received oral ketoconazole treatment during pregnancy.

Original languageEnglish
Pages (from-to)5-8
Number of pages4
JournalCongenital Anomalies
Volume45
Issue number1
DOIs
Publication statusPublished - Mar 2005

Fingerprint

Ketoconazole
Case-Control Studies
Parturition
Mothers
Population
Birth Weight
Gestational Age
Newborn Infant
Therapeutics
Pregnancy
United States Food and Drug Administration
Fetal Development
Epidemiologic Studies
Odds Ratio
Confidence Intervals
Control Groups
Incidence
Pharmaceutical Preparations

Keywords

  • Case-control study
  • Congenital abnormalities
  • Ketoconazole
  • Preterm birth
  • Teratogenic effect

ASJC Scopus subject areas

  • Developmental Biology

Cite this

Population-based case-control study of oral ketoconazole treatment for birth outcomes. / Kazy, Zoltán; Puhó, Erzsébet; Czeizel, Andrew E.

In: Congenital Anomalies, Vol. 45, No. 1, 03.2005, p. 5-8.

Research output: Contribution to journalArticle

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