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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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


Sponsor: University Hospital, Rouen

Current Primary Outcome:

  • death up to discharge of hospital
  • severe white matter injury
  • combined death up to discharge and severe white matter injury


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • white matter injury
  • cystic periventricular leukomalacia
  • topography of cysts
  • intraventricular/intraparenchymal haemorrhages
  • side effects of magnesium sulfate in mothers and preterm newborns
  • follow-up at two years of age


Original Secondary Outcome: Same as current

Information By: University Hospital, Rouen

Dates:
Date Received: July 11, 2005
Date Started: July 1997
Date Completion:
Last Updated: June 17, 2013
Last Verified: June 2013