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

NCT00120588 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2013-06-18

No results posted yet for this study

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.

Conditions

  • Preterm Birth
  • Periventricular Leukomalacia
  • Brain Ischemia
  • Intracranial Hemorrhages

Interventions

DRUG

magnesium

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Stephane MARRET, MD-PhD · university

  • Stephane Marret, MD-PhD · University Hospital, Rouen

  • Jacques Benichou, MD-PhD · University hopsital of Rouen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-07-31
Completion
2005-07-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120588 on ClinicalTrials.gov