Objective: To evaluate the safety of glucocorticosteroids (GCS) in pregnancy.
Study design: The Israeli Teratogen Information Service (TIS) prospectively collected and followed 311 pregnancies counseled regarding systemic use of different GCS in the first trimester. The rate of major congenital anomalies was compared to that of 790 controls who were counseled for non-teratogenic exposure.
Results: The rate of major anomalies did not significantly differ between the groups [12/262 = 4.6% (GCS), 19/728 = 2.6% (control), [P = 0.116 ]. There was no case of oral cleft and no pattern of anomalies among the GCS exposed group. Higher rates of miscarriages (11.5% versus 7.0%, P = 0.013) and preterm births (22.7% versus 10.8%, P < 0.001 ) were observed among the GCS exposed group compared to the controls. GCS exposed infants had a lower median birth weight [3080 g versus 3290 g, P < 0.001 ] and were born at an earlier median gestational age [39 weeks versus 40, P < 0.001 ] compared to the control.
Conclusions: The present study supports that GCS do not represent a major teratogenic risk in humans. The study was powered to find a 2.5-fold increase in the overall rate of major anomalies.