[A population-based case-control study of broncho-vaxom use during pregnancy]

To study human teratogenic potential of oral broncho-vaxom treatments during pregnancy.

Pair analysis of cases with congenital abnormalities and matched population controls without congenital abnormalities.

The large population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996.

Of 38.151 pregnant women who had babies without any defects (control group), and 22.865 pregnant women who had newborn infants or fetuses with congenital abnormalities (case group).

In the control group 58 (0,15%), while in the case group 22 (0,10%) pregnant women were treated with broncho-vaxom (OR with 95% CI: 0.6, 0.4-1.1). The case-control pair analysis concerning the use of broncho-vaxom during the second-third months of pregnancy did not show any human teratogenic potential in the different groups of congenital abnormalities. The mean gestational age was longer in control infants born to mother with broncho-vaxom treatment during pregnancy compared with the figure of control infants without this treatment (40 +/- 1.3 vs. 39.4 +/- 2.1, t = 2.28, p = 0.02).

Teratogenic risk for congenital abnormalities was not detectable in the children born to women treated with broncho-vaxom during pregnancy. The possible gestational age promoter effect of broncho-vaxom needs further studies.