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Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth

This study has been completed.

Sponsors and Collaborators: University Hospital, Rouen
Programme hospitalier de recherche clinique
Ministry of Health, France
Information provided by: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00120588
  Purpose

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.


Condition Intervention Phase
Preterm Birth
Periventricular Leukomalacia
Brain Ischemia
Intracranial Hemorrhages
Drug: magnesium
Phase IV

Drug Information available for:   Magnesium    Magnesium sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • death up to discharge of hospital
  • severe white matter injury
  • combined death up to discharge and severe white matter injury

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   700
Study Start Date:   July 1997
Estimated Study Completion Date:   July 2005

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

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120588

Locations
France, Normandy
Charles-Nicolle hospital    
      Rouen, Normandy, France, 76031

Sponsors and Collaborators
University Hospital, Rouen
Programme hospitalier de recherche clinique
Ministry of Health, France

Investigators
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    
  More Information


Study ID Numbers:   970575
First Received:   July 11, 2005
Last Updated:   July 15, 2005
ClinicalTrials.gov Identifier:   NCT00120588
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:
brain protection  
white matter injury  
neurodevelopmental sequelae  
magnesium sulfate  
intraventricular hemorrhage  

Study placed in the following topic categories:
Pregnancy Complications
Magnesium Sulfate
Obstetric Labor, Premature
Obstetric Labor Complications
Vascular Diseases
Central Nervous System Diseases
Infant, Premature, Diseases
Intracranial Hemorrhages
Ischemia
Hemorrhage
Brain Diseases
Cerebrovascular Disorders
Leukomalacia, Periventricular
Encephalomalacia
Leukomalacia
Brain Ischemia
Infant, Newborn, Diseases
Premature Birth

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Calcium Channel Blockers
Anesthetics
Central Nervous System Depressants
Reproductive Control Agents
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Pathologic Processes
Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on October 28, 2008




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