Preterm Birth Clinical Trial
Official title:
Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
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