National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

MFMU Network Randomized Clinical Trial of
the Beneficial Effects of Antenatal Magnesium Sulfate

Objective

To test the hypothesis that prophylactic magnesium sulfa at 24-31 weeks gestation for whom delivery is imminent (with advanced preterm labor, with pPROM, or for whom delivery is less than 24 hours),reduces the risk of mortality and moderate to severe cerebral palsy at 2 years of age in their children.

Conclusion

MgSO4 may afford the fetus destined to be born preterm substantial protection against cerebral palsy, without increasing the risk of stillbirth or infant death.

Clinical Centers

Magee Womens, Tennessee, Alabama, Wayne State, Cincinnati, Wake Forest,Chicago, Ohio State, Miami, UT-San Antonio, UT-Dallas, UT-Galveston,UT-Houston, Utah, MCP Hahnemann, Brown University, Columbia University, UNC, Northwestern, Case Western

Major Eligibility Criteria

• 24-31 weeks gestation
• Either PTL w/intact membranes & cervix 4-8 cm OR pPROM w/cervix <8cm OR delivery planned < 24 hrs
• No MgSO₄ in previous 12 hour
• Informed consent

Groups

• Experimental = IV MgSO₄
• Placebo = Standard IV Fluid
• Sample size: Goal = 2000 (1000/group)

Management Protocols

• Coded IV:
  • Initial medication: MgSO₄ /placebo loing dose + 2 gm/hr for 12 hrs
  • Retreatment: If labor recurs/delivery anticipated

Outcome Measures

• Primary:
  • Death before 1 year or moderate to severe cerebral palsy at 24 months
• Secondary:
  • IVH/PVL
  • Maternal side effects and morbidity
  • Neonatal morbidity