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

NCT ID: NCT00120588

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-07-31
• Study Completion Date: 2005-07-31

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.

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

Conditions

Preterm Birth; Periventricular Leukomalacia; Brain Ischemia; Intracranial Hemorrhages

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

magnesium

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephane MARRET, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

university

Stephane Marret, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Jacques Benichou, MD-PhD

Role: STUDY_DIRECTOR

University hopsital of Rouen

Locations

Charles-Nicolle hospital

Rouen, Normandy, France

Countries

France

References

Chollat C, Enser M, Houivet E, Provost D, Benichou J, Marpeau L, Marret S. School-age outcomes following a randomized controlled trial of magnesium sulfate for neuroprotection of preterm infants. J Pediatr. 2014 Aug;165(2):398-400.e3. doi: 10.1016/j.jpeds.2014.04.007. Epub 2014 May 14.

Reference Type: DERIVED

PMID: 24837863 (View on PubMed)

Other Identifiers

1997/575/HP

Identifier Type: -

Identifier Source: org_study_id