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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00120588 |
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Date of registration:
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11/07/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth
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Scientific title:
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Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate |
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Date of first enrolment:
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July 1997 |
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Target sample size:
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700 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00120588 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Stephane MARRET, MD-PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University |
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Name:
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Jacques Benichou, MD-PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University hopsital of Rouen |
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Name:
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Stephane Marret, MD-PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Rouen |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Periventricular Leukomalacia
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Brain Ischemia
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Intracranial Hemorrhages
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Preterm Birth
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Intervention(s)
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Drug: magnesium
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Primary Outcome(s)
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death up to discharge of hospital
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combined death up to discharge and severe white matter injury
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severe white matter injury
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Secondary Outcome(s)
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follow-up at two years of age
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intraventricular/intraparenchymal haemorrhages
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side effects of magnesium sulfate in mothers and preterm newborns
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topography of cysts
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cystic periventricular leukomalacia
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white matter injury
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Secondary ID(s)
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1997/575/HP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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