Objective: To study the human teratogenic potential of tetanus vaccination
during pregnancy. Methods: Pair analysis of cases with congenital abnormali
ties and matched healthy controls was performed in the large population-bas
ed dataset of the Hungarian Case-Control Surveillance of Congenital Abnorma
lities, 1980-1994. Results: Of 35 727 pregnant women who had babies without
any defects in the study period (control group), 33 (0.09%) were vaccinate
d with tetanus. Of 21563 pregnant women who had offspring with congenital a
bnormalities, 25 (0.12%) had tetanus vaccination. This difference was not s
ignificant (P = 0.39). The case-control pair analysis confirmed the safety
of tetanus vaccination during pregnancy, particularly in the second and thi
rd months of gestation, i.e. during the critical period for congenital abno
rmalities. Conclusion: Tetanus vaccination during pregnancy appears not be
teratogenic to the fetus. Thus, there is no contraindication, if the use of
tetanus toroid is necessary during pregnancy. (C) 1999 International Feder
ation of Gynecology and Obstetrics.