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

Article Outline

• Objective
• Study design
• Results
• Conclusion
• Copyright

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Objective 

To evaluate whether maternally-administered MgSO4 lowers the risk of cerebral palsy (CP) or death in the offspring of women with anticipated early preterm delivery.

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Study design 

Randomized, double masked, placebo controlled trial in 20 centers. Non-preeclamptic women with PPROM, advanced preterm labor, or indicated delivery from 24-31 weeks’ gestation were randomly allocated to a 6 gm bolus of IV MgSO4 followed by 2 gm/hr, or placebo. The primary study outcome was the composite of moderate or severe CP at the corrected age of 2 years (as diagnosed by centrally trained examiners) or death.

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Results 

2241 women were randomized: 87% had PPROM, and 9% twins. Baseline characteristics including gestational age at randomization, risk factor for preterm birth, and proportion of twins were similar in the two study groups--overall, and in those randomized prior to 28 weeks. Follow-up was achieved for 95.6% of children. MgSO4 did not lower the combined rate of moderate to severe CP or death. However, it did significantly lower the rate of moderate to severe CP alone (Table. CP = moderate to severe. Numbers/percentages do not tally because some twin pregnancies experienced both outcomes).

Overall	Magnesium Sulfate (N = 1,041)	Placebo (N = 1,095)	RR (95% CI)
	n (%)
CP or Death	118 (11.3)	128 (11.7)	0.97 (0.77–1.23)
CP Alone	20 (1.9)	38 (3.5)	0.55 (0.32–0.95)
Death Alone	99 (9.5)	93 (8.5)	1.12 (0.85–1.47)

Randomization < 28 wks	Magnesium Sulfate (N = 442)	Placebo (N = 496)	RR (95% CI)
	n (%)
CP or Death	89 (20.1)	105 (21.2)	0.95 (0.74–1.22)
CP Alone	12 (2.7)	30 (6.1)	0.45 (0.23–0.87)
Death Alone	78 (17.7)	78 (15.7)	1.12 (0.84–1.49)

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Conclusion 

MgSO4 did not reduce the rate of the primary outcome of moderate to severe cerebral palsy or death, perhaps because death was the predominant component of the outcome. MgSO4 did, however, reduce the rate of moderate to severe cerebral palsy alone--by half.