Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Preterm Birth Periventricular Leukomalacia Brain Ischemia Intracranial Hemorrhages |
Drug: magnesium |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
| Official Title: | Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate |
- death up to discharge of hospital
- severe white matter injury
- combined death up to discharge and severe white matter injury
- 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
| Estimated Enrollment: | 700 |
| Study Start Date: | July 1997 |
| Study Completion Date: | July 2005 |
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Charles-Nicolle hospital | |
| Rouen, Normandy, France, 76031 | |
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00120588 History of Changes |
| Other Study ID Numbers: | 1997/575/HP |
| Study First Received: | July 11, 2005 |
| Last Updated: | February 14, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Rouen:
|
brain protection white matter injury neurodevelopmental sequelae magnesium sulfate intraventricular hemorrhage |
Additional relevant MeSH terms:
|
Brain Ischemia Hemorrhage Ischemia Leukomalacia, Periventricular Premature Birth Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Encephalomalacia Infant, Premature, Diseases |
Infant, Newborn, Diseases Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents |
ClinicalTrials.gov processed this record on May 21, 2013