Epidemiological assessment of misoprostol teratogenicity

Objective To verify if any of the 15 congenital defects already reported in association with misoprostol can be found within an epidemiological regist ry of congenital defects. Design Case-control study including case-sick and case-health controls. Methods Comparison of misoprostol exposure for each specific defect, using the exposure for the rest of defects as a reference group. Population Four thousand six hundred seventy-three consecutive newborn infa nts with malformations of unknown aetiology, in the Latin American Collabor ative Study of Congenital Malformation. Results Then was no difference in exposure rate between the malformed (34/4 673) and nonmalformed (23/4980) newborns. Four of the five more frequently cited defects in the literature were found to be in excess: constriction ri ng, terminal transverse-limb defects, hydrocephalus, and arthrogryposis. Eq uinovarus feet had a normal frequency in our study. Thirteen different defe cts not described in the literature were seen in our misoprostol exposed ca ses, but only holoprosencephaly and bladder exstrophy significantly exceede d the expected number. Conclusions The confirmation from an epidemiological registry of an associa tion for four of the five more commonly observed congenital defects among m isoprostol exposed children described in the literature seems indicative of a real teratogenic effect. The defects are of vascular disruption type. Ho wever, additional attempts to achieve abortion could not be excluded as a c oncurrent contribution.