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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120588
Recruitment Status : Completed
First Posted : July 18, 2005
Last Update Posted : June 18, 2013
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Rouen

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.

Condition or disease Intervention/treatment Phase
Preterm Birth Periventricular Leukomalacia Brain Ischemia Intracranial Hemorrhages Drug: magnesium Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate
Study Start Date : July 1997
Actual Study Completion Date : July 2005

Primary Outcome Measures :
  1. death up to discharge of hospital
  2. severe white matter injury
  3. combined death up to discharge and severe white matter injury

Secondary Outcome Measures :
  1. white matter injury
  2. cystic periventricular leukomalacia
  3. topography of cysts
  4. intraventricular/intraparenchymal haemorrhages
  5. side effects of magnesium sulfate in mothers and preterm newborns
  6. follow-up at two years of age

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00120588

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Charles-Nicolle hospital
Rouen, Normandy, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Ministry of Health, France
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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen Identifier: NCT00120588     History of Changes
Other Study ID Numbers: 1997/575/HP
First Posted: July 18, 2005    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
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Premature Birth
Intracranial Hemorrhages
Brain Ischemia
Leukomalacia, Periventricular
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators