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ISRCTN
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ISRCTN86938761
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DOI
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10.1186/ISRCTN86938761
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Magnesium sulphate for the treatment of pre-eclampsia: a trial to evaluate the effects on women and babies
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Scientific title
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Acronym
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MAGPIE trial
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Serial number at source
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G9701680
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Study hypothesis
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To determine the effect of magnesium sulphate when used for women with pre-eclampsia on the risk of eclampsia and perinatal death. In addition, to determine the effects of other measures of important morbidity and on use of health services resources.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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International
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Disease/condition/study domain
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Pre-eclampsia
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Participants - inclusion criteria
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1. Not delivered, or delivered within the last 24 hours
2. Blood pressure today is ≥90 mmHg diastolic or ≥140 mmHg systolic, on at least two occasions
3. Proteinuria of at least 1+
4. There is clinical uncertainty about whether magnesium sulphate would be beneficial (factors likely to influence this uncertainty are the presence of any of the following: hypereflexia, frontal headache, abnormal liver function or coagulation, and epigastric tenderness)
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Participants - exclusion criteria
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The woman does not wish to be randomised, for whatever reason/the attending clinician believes magnesium sulphate should either be given or withheld/hypersensitivity to magnesium/renal failure (women who have renal impairment may be randomised, but the volume of allocated treatment should be halved for each dose)/hepatic coma if risk of renal failure/myaesthenia gravis.
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Anticipated start date
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01/01/1998
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Anticipated end date
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31/01/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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10141
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Interventions
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Magnesium sulphate/placebo.
Follow-up: until discharge following delivery. Four year follow-up of the children is planned.
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Primary outcome measure(s)
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Eclampsia, death of the baby.
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Secondary outcome measure(s)
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Maternal death, serious maternal morbidity, labour and delivery outcomes, use of maternal health services, serious neonatal morbidity, use of neonatal health services
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12057549
2. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15113445
3. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17166220
4. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17166220
5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19366459
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Contact name
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Dr
Lelia
Duley
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Address
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MAGPIE Trial Co-ordinating Centre
Institute of Health Sciences
Old Road
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LF
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Country
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United Kingdom
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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01/07/2009
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Date ISRCTN assigned
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25/10/2000
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