IF TOCOLYTIC MAGNESIUM-SULFATE IS ASSOCIATED WITH EXCESS TOTAL PEDIATRIC MORTALITY, WHAT IS ITS IMPACT

The Magnesium and Neurologic Endpoints Trial was a randomized controll ed trial (RCT) done to learn whether or not receiving magnesium sulfat e during preterm labor could prevent cerebral palsy. Unexpectedly, in the tocolytic arms of the trial, seven (including one set of twins) of 46 cases assigned to receive magnesium ended in total pediatric morta lity (fetal + neonatal + postneonatal), compared to none of 47 cases a ssigned to other tocolytics ending in death. The difference between th e two treatment arms is highly statistically significant (risk differe nce 15.2%; 95% confidence interval 4.8, 25.6; P = .006). If this relat ionship is confirmed by experimentation with animals or through the co nduct of a large RCT at other institutions, it is possible that tocoly tic magnesium will be found to be associated with the deaths of severa l thousand newborns in the United States annually. If the true excess total pediatric mortality is 10%, and if magnesium accounts for 40% of all tocolytics used, then tocolytic magnesium increases the absolute number of infant deaths by about 4800 every year. (Obstet Gynecol 1998 ;92:308-11. (C) 1998 by The American College of Obstetricians and Gyne cologists.).