First trimester exposure to corticosteroids and oral clefts

Birth Defects Res A Clin Mol Teratol. 2003 Dec;67(12):968-70. doi: 10.1002/bdra.10134.


Background: The possible association between oral cleft in the newborn and maternal exposure to corticoids during pregnancy is still controversial. The aim of this study was to test this association by a case-control analysis using the large multicentric MADRE database.

Methods: The MADRE database is a collection of information on malformed infants with a history of maternal first-trimester drug exposure. Nine malformation registries participate in the data collection. Cases were defined as infants presenting with a cleft palate or cleft lip, and exposure was defined by the use of corticosteroids during the first trimester of pregnancy.

Results: After 12 years of data collection, the database includes data on 11,150 malformed infants. A slight association is observed between exposure to corticoids for systemic use and the occurrence of cleft lip with or without cleft palate (OR, 2.59; 95% CI, 1.18-5.67).

Conclusions: If the observed association is real, an interpretation is suggested, based on a likely interaction between corticosteroids and environmental dioxins. It is indeed possible that human fetuses may become sensitive to the teratogenic effect of corticosteroids when they are exposed in utero to environmental pesticides as well.

Publication types

  • Multicenter Study

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Abnormalities, Drug-Induced / etiology*
  • Adult
  • Cleft Lip / epidemiology
  • Cleft Lip / etiology*
  • Cleft Palate / epidemiology
  • Cleft Palate / etiology*
  • Female
  • Global Health
  • Glucocorticoids / adverse effects*
  • Humans
  • Infant, Newborn
  • Maternal Exposure / adverse effects*
  • Pregnancy
  • Pregnancy Trimester, First
  • Registries
  • World Health Organization


  • Glucocorticoids