Brain Ischemia, Intracranial Hemorrhages, Periventricular Leukomalacia, Preterm Birth
Conditions
Keywords
brain protection, white matter injury, neurodevelopmental sequelae, magnesium sulfate, intraventricular hemorrhage
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 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
Interventions
DRUGmagnesium
Sponsors
Ministry of Health, France
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* women pregnant with single, twin or triplet very preterm fetuses younger than 33 week's gestational age if birth was expected or planned within 24 hours
Exclusion criteria
* women with vascular disease of pregnancy * women with severe malformation or chromosomal abnormalities in the fetus * women with hypotension * renal insufficiency * cardiac rhythmic abnormalities * intake of calcium channel inhibitors * digitalis or indomethacin less than 24 hours * persistence of signs of cardiovascular toxicity or tachycardia for more than one hour after cessation of betamimetic intake * myasthenia * emergency C section
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| death up to discharge of hospital | — |
| severe white matter injury | — |
| combined death up to discharge and severe white matter injury | — |
Secondary
| Measure | Time frame |
|---|---|
| intraventricular/intraparenchymal haemorrhages | — |
| white matter injury | — |
| follow-up at two years of age | — |
| side effects of magnesium sulfate in mothers and preterm newborns | — |
| cystic periventricular leukomalacia | — |
| topography of cysts | — |
Countries
France
Outcome results
None listed