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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120588
• Other study ID #: 1997/575/HP
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2005
• Last updated: June 17, 2013
• Start date: July 1997
• Est. completion date: July 2005

Study information

• Verified date: June 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Ischemia
• Hemorrhage
• Intracranial Hemorrhages
• Leukomalacia, Periventricular
• Periventricular Leukomalacia
• Premature Birth
• Preterm Birth

Intervention

Drug:
• magnesium

Locations

Country	Name	City	State
France	Charles-Nicolle hospital	Rouen	Normandy

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death up to discharge of hospital
Primary	severe white matter injury
Primary	combined death up to discharge and severe white matter injury
Secondary	white matter injury
Secondary	cystic periventricular leukomalacia
Secondary	topography of cysts
Secondary	intraventricular/intraparenchymal haemorrhages
Secondary	side effects of magnesium sulfate in mothers and preterm newborns
Secondary	follow-up at two years of age