VIENNA — The use of magnesium sulfate for the treatment of preeclampsia does not appear to increase the long-term risk of death or neurosensory disability in children, Lelia Duley, M.D., reported at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.
The findings come from a follow-up study of subjects who participated in the landmark multinational Magpie (Magnesium Sulfate for Prevention of Eclampsia) Trial, in which 10,141 pregnant women with preeclampsia—from the developed and the developing world—were randomized to receive magnesium sulfate (MgSO4) or placebo. Women who received MgSO4 had a 58% lower risk of eclampsia and a 45% lower risk of death, with no clear difference in the risk of death among the newborns up until the time of hospital discharge (Lancet 2002;359:1877–90).
Now, an 18-month follow-up among 4,782 women and 4,483 children from the original trial suggests that in utero exposure to the drug is not associated with long-lasting damage. “It's very reassuring,” said Dr. Duley an obstetric epidemiologist at the Resource Center for Randomized Trials, Institute of Health Sciences, Oxford, England.
A total of 13.9% of the children of the mothers who received MgSO4 before delivery had died by the time of follow-up, not significantly different from the 12.7% in the placebo group. Approximately half from each group were stillborn, said Dr. Duley, who served as principal investigator for both parts of the trial.
Among the survivors, 1,283 children from the MgSO4 group and 1,327 whose mothers received placebo were screened using the Ages and Stages questionnaire, which assesses neurosensory function. A total of 311 MgSO4 and 325 placebo children scored positively. Of those, further assessment was conducted in 217 MgSO4 and 215 placebo subjects.
Neurosensory disability was found in 19 MgSO4 and 27 placebo children, including blindness in 3 from each group, deafness in 3 MgSO4 and 1 placebo subject, and cerebral palsy in 3 MgSO4 and 9 placebo children.
In all, death or disability occurred in 15% of the MgSO4 and 14.1% of the placebo children. None of the differences were statistically significant, Dr. Duley said.
Among the mothers, there were no significant differences in deaths before or after discharge or in serious morbidity potentially related to the preeclampsia, she reported.