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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00120588
First received: July 11, 2005
Last updated: June 17, 2013
Last verified: June 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate

Resource links provided by NLM:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Charles-Nicolle hospital
Rouen, Normandy, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00120588     History of Changes
Other Study ID Numbers: 1997/575/HP
Study First Received: July 11, 2005
Last Updated: June 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Brain Ischemia
Hemorrhage
Ischemia
Leukomalacia, Periventricular
Premature Birth
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Encephalomalacia
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on July 22, 2014