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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 11, 2005

Last Updated Date

July 15, 2005

Start Date ^†

July 1997

Current Primary Outcome Measures ^†

death up to discharge of hospital
severe white matter injury
combined death up to discharge and severe white matter injury

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00120588 on ClinicalTrials.gov Archive Site

Current 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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Preterm Birth
Periventricular Leukomalacia
Brain Ischemia
Intracranial Hemorrhages

Intervention ^†

Drug: magnesium

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

700

Completion Date

July 2005

Primary Completion Date

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00120588

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University Hospital, Rouen

Collaborators ^††

Programme hospitalier de recherche clinique
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

Information Provided By

University Hospital, Rouen

Verification Date

February 1997

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.