NCT00120588

Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth

Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 700 (planned)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Magnesium is neuroprotective in neonatal animal models of acquired hypoxic-ischemic and/or inflammatory cerebral lesions. It is associated with a significant reduction of perinatal death and cerebral palsy in some observational studies. The objective of the study is to assess if prenatal magnesium sulfate given to women at risk of preterm birth before 33 week's gestation is neuroprotective.

Detailed description

This is a randomized controlled trial at 18 french tertiary hospitals with stratification by center and multiple births in women at risk of preterm birth before 33 week's gestation and without vascular disease of pregnancy. Women received 4 g of a 0.1 g/ml magnesium sulfate solution or isotonic serum chloride solution (0.9%). The main outcome measures are rates of mortality up to discharge, of severe white matter injury (defined by the presence of cavitations and/or intraparenchymal haemorrhages on cranial ultrasonographic studies) and of combined death and severe white matter injury. The secondary outcome measures are rates of white matter injury (defined by the presence of cavitations and/or intraparenchymal haemorrhages and persisting hypechogenicities at 15 day intervals on cranial ultrasonographic studies), follow-up at two years of age

Conditions

• Preterm Birth
• Periventricular Leukomalacia
• Brain Ischemia
• Intracranial Hemorrhages

Interventions

Type	Name	Description
DRUG	magnesium

Timeline

• Start date: 1997-07-01
• Completion: 2005-07-01
• First posted: 2005-07-18
• Last updated: 2013-06-18

Locations

1 site across 1 country: France