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Completed

NCT Number: NCT00120588

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium

Drug

Primary outcomes

  1. death up to discharge of hospital

  2. severe white matter injury

  3. combined death up to discharge and severe white matter injury

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate

Important dates

Study start
1997
Study completion
2005
First posted
Jul 18, 2005
Registry last updated
Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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