Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120588
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2005-07-11
Brief Title:
Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Magnesium is neuroprotective in neonatal animal models of acquired hypoxic-ischemic andor 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 weeks gestation is neuroprotective
The objective of the study is to assess if prenatal magnesium sulfate given to women at risk of preterm birth before 33 weeks 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 weeks gestation and without vascular disease of pregnancy
Women received 4 g of a 01 gml magnesium sulfate solution or isotonic serum chloride solution 09
The main outcome measures are rates of mortality up to discharge of severe white matter injury defined by the presence of cavitations andor 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 andor intraparenchymal haemorrhages and persisting hypechogenicities at 15 day intervals on cranial ultrasonographic studies follow-up at two years of age
Women received 4 g of a 01 gml magnesium sulfate solution or isotonic serum chloride solution 09
The main outcome measures are rates of mortality up to discharge of severe white matter injury defined by the presence of cavitations andor 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 andor intraparenchymal haemorrhages and persisting hypechogenicities at 15 day intervals on cranial ultrasonographic studies follow-up at two years of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None