MAGENTA
Trial question
What is the role of intravenous administration of magnesium sulfate in pregnant women at risk of preterm birth at 30-34 weeks of gestation?
Study design
Multi-center
Double blinded
RCT
Population
1433 female patients.
Inclusion criteria: pregnant women at risk of preterm birth between 30 to 34 weeks of gestation.
Key exclusion criteria: advanced labor; maternal stress; no informed consent.
Interventions
N=729 magnesium sulfate (4 g IV).
N=704 placebo (isotonic sodium chloride solution IV).
Primary outcome
Death or cerebral palsy in offspring of treated mothers at 2 years
3.3%
2.7%
3.3 %
2.5 %
1.6 %
0.8 %
0.0 %
Magnesium
sulfate
Placebo
No significant
difference ↔
No significant difference in death or cerebral palsy in offspring of treated mothers at 2 years (3.3% vs. 2.7%; RR 1.19, 95% CI 0.65 to 2.18).
Secondary outcomes
Significant decrease in neonatal respiratory distress during birth hospitalization (34% vs. 41%; RR 0.85, 95% CI 0.76 to 0.95).
Significant decrease in chronic lung disease in infants during birth hospitalization (5.6% vs. 8.2%; RR 0.69, 95% CI 0.48 to 0.99).
Significant decrease in Cesarean delivery (56% vs. 61%; RR 0.91, 95% CI 0.84 to 0.99).
Safety outcomes
No significant differences in postpartum hemorrhage ≥ 500 mL, blood transfusion.
Significant difference in adverse events in women because of infusion (77% vs. 20%).
Conclusion
In pregnant women at risk of preterm birth between 30 to 34 weeks of gestation, magnesium sulfate was not superior to placebo with respect to death or cerebral palsy in offspring of treated mothers at 2 years.
Reference
Caroline A Crowther, Pat Ashwood, Philippa F Middleton et al. Prenatal Intravenous Magnesium at 30-34 Weeks' Gestation and Neurodevelopmental Outcomes in Offspring: The MAGENTA Randomized Clinical Trial. JAMA. 2023 Aug 15;330(7):603-614.
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