A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy

Dwight J. Rouse, Deborah G. Hirtz, Elizabeth Thom, Michael W. Varner, Catherine Y. Spong, Brian M. Mercer, Jay D. Iams, Ronald J. Wapner, Yoram Sorokin, James M. Alexander, Margaret Harper, John M. Thorp, Susan M. Ramin, Fergal D. Malone, Marshall Carpenter, Menachem Miodovnik, Atef Moawad, Mary J. O'Sullivan, Alan M. Peaceman, Gary Hankins & 3 others Oded Langer, Steve N. Caritis, James M. Roberts

Research output: Contribution to journalArticle

395 Citations (Scopus)

Abstract

BACKGROUND: Research suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy. METHODS: In this multicenter, placebo-controlled, double-blind trial, we randomly assigned women at imminent risk for delivery between 24 and 31 weeks of gestation to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour, or matching placebo. The primary outcome was the composite of stillbirth or infant death by 1 year of corrected age or moderate or severe cerebral palsy at or beyond 2 years of corrected age. RESULTS: A total of 2241 women underwent randomization. The baseline characteristics were similar in the two groups. Follow-up was achieved for 95.6% of the children. The rate of the primary outcome was not significantly different in the magnesium sulfate group and the placebo group (11.3% and 11.7%, respectively; relative risk, 0.97; 95% confidence interval [CI], 0.77 to 1.23). However, in a prespecified secondary analysis, moderate or severe cerebral palsy occurred significantly less frequently in the magnesium sulfate group (1.9% vs. 3.5%; relative risk, 0.55; 95% CI, 0.32 to 0.95). The risk of death did not differ significantly between the groups (9.5% vs. 8.5%; relative risk, 1.12; 95% CI, 0.85 to 1.47). No woman had a life-threatening event. CONCLUSIONS: Fetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate or severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. (ClinicalTrials.gov number, NCT00014989.).

Original languageEnglish (US)
Pages (from-to)895-905
Number of pages11
JournalNew England Journal of Medicine
Volume359
Issue number9
DOIs
StatePublished - Aug 28 2008

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Magnesium Sulfate
Cerebral Palsy
Randomized Controlled Trials
Placebos
Confidence Intervals
Fetal Research
Stillbirth
Premature Birth
Random Allocation
Survivors
Pregnancy
Mortality

ASJC Scopus subject areas

  • Medicine(all)

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Rouse, D. J., Hirtz, D. G., Thom, E., Varner, M. W., Spong, C. Y., Mercer, B. M., ... Roberts, J. M. (2008). A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. New England Journal of Medicine, 359(9), 895-905. https://doi.org/10.1056/NEJMoa0801187

A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. / Rouse, Dwight J.; Hirtz, Deborah G.; Thom, Elizabeth; Varner, Michael W.; Spong, Catherine Y.; Mercer, Brian M.; Iams, Jay D.; Wapner, Ronald J.; Sorokin, Yoram; Alexander, James M.; Harper, Margaret; Thorp, John M.; Ramin, Susan M.; Malone, Fergal D.; Carpenter, Marshall; Miodovnik, Menachem; Moawad, Atef; O'Sullivan, Mary J.; Peaceman, Alan M.; Hankins, Gary; Langer, Oded; Caritis, Steve N.; Roberts, James M.

In: New England Journal of Medicine, Vol. 359, No. 9, 28.08.2008, p. 895-905.

Research output: Contribution to journalArticle

Rouse, DJ, Hirtz, DG, Thom, E, Varner, MW, Spong, CY, Mercer, BM, Iams, JD, Wapner, RJ, Sorokin, Y, Alexander, JM, Harper, M, Thorp, JM, Ramin, SM, Malone, FD, Carpenter, M, Miodovnik, M, Moawad, A, O'Sullivan, MJ, Peaceman, AM, Hankins, G, Langer, O, Caritis, SN & Roberts, JM 2008, 'A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy', New England Journal of Medicine, vol. 359, no. 9, pp. 895-905. https://doi.org/10.1056/NEJMoa0801187
Rouse, Dwight J. ; Hirtz, Deborah G. ; Thom, Elizabeth ; Varner, Michael W. ; Spong, Catherine Y. ; Mercer, Brian M. ; Iams, Jay D. ; Wapner, Ronald J. ; Sorokin, Yoram ; Alexander, James M. ; Harper, Margaret ; Thorp, John M. ; Ramin, Susan M. ; Malone, Fergal D. ; Carpenter, Marshall ; Miodovnik, Menachem ; Moawad, Atef ; O'Sullivan, Mary J. ; Peaceman, Alan M. ; Hankins, Gary ; Langer, Oded ; Caritis, Steve N. ; Roberts, James M. / A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. In: New England Journal of Medicine. 2008 ; Vol. 359, No. 9. pp. 895-905.
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abstract = "BACKGROUND: Research suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy. METHODS: In this multicenter, placebo-controlled, double-blind trial, we randomly assigned women at imminent risk for delivery between 24 and 31 weeks of gestation to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour, or matching placebo. The primary outcome was the composite of stillbirth or infant death by 1 year of corrected age or moderate or severe cerebral palsy at or beyond 2 years of corrected age. RESULTS: A total of 2241 women underwent randomization. The baseline characteristics were similar in the two groups. Follow-up was achieved for 95.6{\%} of the children. The rate of the primary outcome was not significantly different in the magnesium sulfate group and the placebo group (11.3{\%} and 11.7{\%}, respectively; relative risk, 0.97; 95{\%} confidence interval [CI], 0.77 to 1.23). However, in a prespecified secondary analysis, moderate or severe cerebral palsy occurred significantly less frequently in the magnesium sulfate group (1.9{\%} vs. 3.5{\%}; relative risk, 0.55; 95{\%} CI, 0.32 to 0.95). The risk of death did not differ significantly between the groups (9.5{\%} vs. 8.5{\%}; relative risk, 1.12; 95{\%} CI, 0.85 to 1.47). No woman had a life-threatening event. CONCLUSIONS: Fetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate or severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. (ClinicalTrials.gov number, NCT00014989.).",
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T1 - A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy

AU - Rouse, Dwight J.

AU - Hirtz, Deborah G.

AU - Thom, Elizabeth

AU - Varner, Michael W.

AU - Spong, Catherine Y.

AU - Mercer, Brian M.

AU - Iams, Jay D.

AU - Wapner, Ronald J.

AU - Sorokin, Yoram

AU - Alexander, James M.

AU - Harper, Margaret

AU - Thorp, John M.

AU - Ramin, Susan M.

AU - Malone, Fergal D.

AU - Carpenter, Marshall

AU - Miodovnik, Menachem

AU - Moawad, Atef

AU - O'Sullivan, Mary J.

AU - Peaceman, Alan M.

AU - Hankins, Gary

AU - Langer, Oded

AU - Caritis, Steve N.

AU - Roberts, James M.

PY - 2008/8/28

Y1 - 2008/8/28

N2 - BACKGROUND: Research suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy. METHODS: In this multicenter, placebo-controlled, double-blind trial, we randomly assigned women at imminent risk for delivery between 24 and 31 weeks of gestation to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour, or matching placebo. The primary outcome was the composite of stillbirth or infant death by 1 year of corrected age or moderate or severe cerebral palsy at or beyond 2 years of corrected age. RESULTS: A total of 2241 women underwent randomization. The baseline characteristics were similar in the two groups. Follow-up was achieved for 95.6% of the children. The rate of the primary outcome was not significantly different in the magnesium sulfate group and the placebo group (11.3% and 11.7%, respectively; relative risk, 0.97; 95% confidence interval [CI], 0.77 to 1.23). However, in a prespecified secondary analysis, moderate or severe cerebral palsy occurred significantly less frequently in the magnesium sulfate group (1.9% vs. 3.5%; relative risk, 0.55; 95% CI, 0.32 to 0.95). The risk of death did not differ significantly between the groups (9.5% vs. 8.5%; relative risk, 1.12; 95% CI, 0.85 to 1.47). No woman had a life-threatening event. CONCLUSIONS: Fetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate or severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. (ClinicalTrials.gov number, NCT00014989.).

AB - BACKGROUND: Research suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy. METHODS: In this multicenter, placebo-controlled, double-blind trial, we randomly assigned women at imminent risk for delivery between 24 and 31 weeks of gestation to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour, or matching placebo. The primary outcome was the composite of stillbirth or infant death by 1 year of corrected age or moderate or severe cerebral palsy at or beyond 2 years of corrected age. RESULTS: A total of 2241 women underwent randomization. The baseline characteristics were similar in the two groups. Follow-up was achieved for 95.6% of the children. The rate of the primary outcome was not significantly different in the magnesium sulfate group and the placebo group (11.3% and 11.7%, respectively; relative risk, 0.97; 95% confidence interval [CI], 0.77 to 1.23). However, in a prespecified secondary analysis, moderate or severe cerebral palsy occurred significantly less frequently in the magnesium sulfate group (1.9% vs. 3.5%; relative risk, 0.55; 95% CI, 0.32 to 0.95). The risk of death did not differ significantly between the groups (9.5% vs. 8.5%; relative risk, 1.12; 95% CI, 0.85 to 1.47). No woman had a life-threatening event. CONCLUSIONS: Fetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate or severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. (ClinicalTrials.gov number, NCT00014989.).

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