MAGPIE

Clinical Question

In women with pre-eclampsia, does administration of magnesium sulfate decrease risk of seizure, maternal death, or change rate of neonatal death?

Bottom Line

Magnesium sulfate in pre-eclampsia halves the risk of eclampsia, likely reduces risk of maternal mortality, and does not affect neonatal mortality.

Design

• Multicenter, double-blind, randomized, controlled trial
• N=
  • Magnesium sulfate (n=)
  • Placebo (n=)
  • Loading dose (4g magnesium sulfate) followed by 24 hours maintenance regimen (1 g/h magnesium sulfate)
• Setting:
• Enrollment:
• Mean follow-up:
• Analysis:
• Primary outcome: Eclampsia, death of the baby prior to discharge from the hospital including stillbirths (if randomized prior to delivery)
• Secondary outcomes (composite outcome included as main outcome):
  • Serious maternal morbidity: Respiratory depression, respiratory arrest, pneumonia, cardiac arrest, coagulopathy, renal failure, liver failure, pulmonary edema, cerebral hemorrhage
  • Toxicity: need for calcium gluconate, stopped/reduced treatment due to toxicity, stopped/reduced treatment due to side effects
  • Side effects: nausea/vomiting, flushing of the skin, drowsiness, confusion, muscle weakness, abscess
  • If randomized pre-delivery:
    • Complications of labor and delivery: induction/length of labor, cesarean section, retained placenta, blood loss, transfusion, gestation at delivery
    • Neonatal morbidity: Apgar <7 at 5 min, intubation at place of delivery, ventilation, abnormal cerebral ultrasound, convulsions, admission to special care baby unit

Population

Inclusion Criteria

• Singleton and multiple pregnancies
• Either antepartum or within 24 hours postpartum
• Pre-eclampsia defined as:
  • SBP > 140 or DBP > 90 on 2 occasions,
  • AND proteinuria of 1+ or more
• Clinical uncertainty as to whether magnesium sulfate should be used

Exclusion Criteria

• Hypersensitivity to magnesium
• Hepatic coma with risk of renal failure
• Myasthenia gravis
• Of note, oliguric women (urine output < 25 mL/h) were eligible for half-dose treatment