Status:
COMPLETED
Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth
Lead Sponsor:
University Hospital, Rouen
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Preterm Birth
Periventricular Leukomalacia
Eligibility:
All Genders
Phase:
PHASE4
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 ...
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 vascula...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 1997
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00120588
Start Date
July 1 1997
End Date
July 1 2005
Last Update
June 18 2013
Active Locations (1)
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1
Charles-Nicolle hospital
Rouen, Normandy, France, 76031