The question of whether systemic use of corticosteroids during the fir
st trimester of pregnancy increases the risk of congenital malformatio
ns in people has still not been resolved. Here, we present the results
of a case-control study on the relationship of corticosteroids during
pregnancy and oral clefts in the newborn infant. Data are derived fro
m the Spanish Collaborative Study of Congenital Malformations (ECEMC).
Case subjects were 1,184 liveborn infants with nonsyndromic oral clef
ts. The results of the logistic regression analysis, show a relationsh
ip between exposure to corticosteroids during the first trimester of p
regnancy and an increased risk of cleft lip (with or without cleft pal
ate) in the newborn infants (OR = 6.55; CI = 1.44-29.76; P = 0.015), c
ontrolled for potential confounder factors, such as maternal smoking,
maternal hyperthermia, first-degree malformed relatives with cleft lip
with or without cleft palate, and maternal treatment with antiepilept
ics, benzodiazepines, metronidazole, or sex hormones during the first
trimester of pregnancy. Thus, we believe that the use of corticosteroi
ds during the first trimester of pregnancy, should be restricted to th
e following situations: for life-threatening situations, for those dis
eases without any other safe therapeutic alternative, or for those cas
es with replacement therapy. Teratology 58:2-5, 1998. (C) 1998 Wiley-L
iss, Inc.