Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate|
- death up to discharge of hospital
- severe white matter injury
- combined death up to discharge and severe white matter injury
- 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
|Study Start Date:||July 1997|
|Study Completion Date:||July 2005|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120588
|Rouen, Normandy, France, 76031|
|Principal Investigator:||Stephane MARRET, MD-PhD||University|
|Principal Investigator:||Stephane Marret, MD-PhD||University Hospital, Rouen|
|Study Director:||Jacques Benichou, MD-PhD||University hopsital of Rouen|