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Trial registered on ANZCTR
Registration number
ACTRN12611000491965
Ethics application status
Approved
Date submitted
28/04/2011
Date registered
11/05/2011
Date last updated
24/10/2019
Date data sharing statement initially provided
20/11/2018
Date results information initially provided
20/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
MAGENTA - Magnesium Sulphate at 30 to 34 weeks' gestational age: Neuroprotection Trial
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Scientific title
Does antenatal magnesium sulphate given to women at risk of imminent preterm birth (defined as planned or definitely expected in the next 24 hours) between 30 and 34 weeks' gestation reduce the risk of death or cerebral palsy in their children at 2 years corrected age? - a randomised controlled trial
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Secondary ID [1]
259661
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
MAGENTA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Complications of preterm infant
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Neuroprotection
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Cerebral Palsy
265765
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Child health
265766
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Condition category
Condition code
Reproductive Health and Childbirth
259375
259375
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0
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Antenatal care
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Reproductive Health and Childbirth
265915
265915
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0
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Complications of newborn
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Neurological
265916
265916
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Magnesium Sulphate (8% solution)- 50 ml infusion equivalent to 4g magnesium sulphate heptahydrate (16 mmol magnesium ions) administered through a dedicated intravenous line over 30 minutes. This is administered to women at risk of preterm birth between 30 and 34 weeks' gestation when birth is imminent (defined as planned or definitely expected in the next 24 hours).
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Intervention code [1]
258089
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Treatment: Drugs
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Intervention code [2]
264509
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Prevention
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Comparator / control treatment
Isotonic sodium chloride (0.9% solution) - 50 ml infusion administered through a dedicated intravenous line over 30 minutes. This is administered to women at risk of preterm birth between 30 and 34 weeks' gestation when birth is imminent (defined as planned or definitely expected in the next 24 hours).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The incidence of death or cerebral palsy defined as stillbirth, death of live born infant before hospital discharge, or death after hospital discharge before 2 years' corrected age; or any cerebral palsy [abnormality of tone with motor dysfunction].
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Assessment method [1]
262192
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Timepoint [1]
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2 years' corrected age.
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Secondary outcome [1]
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For the infant:
Health outcomes considered to be important measures of mortality and morbidity prior to primary hospital discharge; (defined as stillbirth and death of liveborn infant before hospital discharge; intraventricular haemorrhage (IVH), severe IVH, cystic periventricular leukomalacia (PVL), neonatal encephalopathy, neonatal convulsions, proven necrotising enterocolitis, retinopathy of prematurity needing treatment, patent ductus arteriosus needing treatment, respiratory distress syndrome, severity of any neonatal lung disease, chronic lung disease (oxygen dependent at 36 weeks post-menstrual age), use of respiratory support, airleak requiring drainage, confirmed infection within the first 48 hours, infection after the first 48 hours, body size at birth (weight, length, head circumference) and at discharge home.
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Assessment method [1]
273296
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Timepoint [1]
273296
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Up to hospital discharge.
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Secondary outcome [2]
273297
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Composite serious health outcome (defined as stillbirth and death of liveborn infant before hospital discharge severe respiratory disease, severe intraventricular haemorrhage (grade 3 & 4); chronic lung disease (oxygen dependent at 36 weeks post-menstrual age); proven necrotising enterocolitis; severe retinopathy of prematurity (Stage 3 or worse in the better eye); cystic periventricular leukomalacia).
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Assessment method [2]
273297
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Timepoint [2]
273297
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Up to hospital discharge.
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Secondary outcome [3]
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Individual components of the primary outcome including severity of cerebral palsy (defined as death, cerebral palsy).
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Assessment method [3]
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Timepoint [3]
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2 years' corrected age.
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Secondary outcome [4]
273299
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Death or any neurosensory disability (death defined as stillbirth, death of live born infant before hospital discharge or death after hospital discharge; and any neurosensory disabilities that includes the neurosensory impairments of cerebral palsy, [GMFCS level 1 to 5], blindness [corrected visual acuity worse than 6/60 in the better eye], deafness [hearing loss requiring amplification or worse], and any developmental delay defined as standardised score more than 1 SD below the mean (< -1SD).
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Assessment method [4]
273299
0
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Timepoint [4]
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At 2 years' corrected age.
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Secondary outcome [5]
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Death or major neurosensory disability Major neurosensory disability includes severe and moderate disability (defined as any of: legal blindness, sensorineural deafness requiring hearing aids; moderate or severe cerebral palsy [GMFCS level 2 to 5] or developmental delay/intellectual impairment [standardised score more than two SD below the mean].
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Assessment method [5]
276175
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Timepoint [5]
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At 2 years' corrected age.
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Secondary outcome [6]
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General health of the child (including use of health services since primary hospitalisation), childhood respiratory morbidity, blood pressure (Z scores and proportions in hypertensive ranges), and behaviour as assessed by the Child Behaviour Checklist (Achenbach 1992) and Body size.
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Assessment method [6]
276176
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Timepoint [6]
276176
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At 2 years' corrected age.
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Secondary outcome [7]
276177
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Maternal serious adverse cardiovascular and/or respiratory outcome of the infusion (defined as maternal death, cardiac arrest, respiratory arrest).
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Assessment method [7]
276177
0
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Timepoint [7]
276177
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At time of trial treatment infusion.
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Secondary outcome [8]
276262
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Maternal side effects of the infusion (including nausea; vomiting; flushing, infusion arm discomfort; mouth dryness; sweating; dizziness; blurred vision; respiratory rate decreased >4 breaths per minute below baseline or <12 breaths per minute; blood pressure decreased >15 mm Hg below baseline level; whether the infusion is discontinued because of side effects).
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Assessment method [8]
276262
0
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Timepoint [8]
276262
0
At time of trial treatment infusion.
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Secondary outcome [9]
296345
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Incidence of postpartum haemorrhage, estimated blood loss at birth 500 mL or more; and major postpartum haemorrhage, estimated blood loss 1500 mL or more.
Mode of birth
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Assessment method [9]
296345
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Timepoint [9]
296345
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At time of birth.
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Eligibility
Key inclusion criteria
Women are eligible for the trial if they are at risk of preterm birth between 30 and 34 weeks’ gestation where birth is planned or definitely expected within 24 hours, have a singleton or twin pregnancy, no contraindications to the use of antenatal magnesium sulphate (myasthenia gravis, respiratory depression, hypotension, absent patellar reflexes or renal failure) and give informed, written consent.
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Minimum age
16
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Women are not eligible if they have a higher-order multiple pregnancy, have already received antenatal magnesium sulphate or if magnesium sulphate therapy is considered essential for the treatment of pre-eclampsia.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible women are counselled and give signed, informed consent prior to enrolment. Trial entry details are obtained from the woman's casenotes and eligibility is confirmed. The woman is enrolled by contacting the central telephone randomisation service at the University of Adelaide. Random assignment to one of two groups: either the 'magnesium sulphate group' or the 'placebo group'. A Study Number and a corresponding numbered treatment pack will be allocated.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will use balanced variable blocks and will be created using computerise sequence generation by researchers not involved in clinical care, recruitment, data collection and follow-up assessment. Assignment to treatment group will be stratified for collaborating centre, gestational age (30 to 31 completed weeks; 32-33 completed weeks’ gestation), and number of fetuses (1 or 2).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
30/01/2012
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Actual
31/01/2012
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Date of last participant enrolment
Anticipated
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Actual
12/02/2018
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Date of last data collection
Anticipated
30/04/2020
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Actual
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Sample size
Target
1676
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Accrual to date
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Final
1691
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment outside Australia
Country [1]
5926
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New Zealand
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State/province [1]
5926
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Funding & Sponsors
Funding source category [1]
258550
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC)
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Address [1]
258550
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Physical address:
Level 5,20 Allara Street
Canberra ACT, 2601
Postal address:
GPO Box 1421
Canberra ACT, 2601
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Country [1]
258550
0
Australia
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Funding source category [2]
295315
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Charities/Societies/Foundations
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Name [2]
295315
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Cerebral Palsy Alliance
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Address [2]
295315
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187 Allambie Rd, Allambie Heights, NSW 2100
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Country [2]
295315
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Australia
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Primary sponsor type
University
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Name
University of Adelaide
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Address
North Tce
Adelaide South Australia 5005
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Country
Australia
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Secondary sponsor category [1]
257684
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None
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Name [1]
257684
0
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Address [1]
257684
0
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Country [1]
257684
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260518
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Children, Youth & Women's Health Service (CYWHS) Human Research Ethics Committee (HREC)
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Ethics committee address [1]
260518
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Children, Youth & Women's Health Service (Women's and Children's Hospital),
72 King William Road,
North Adelaide SA 5006
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Ethics committee country [1]
260518
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Australia
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Date submitted for ethics approval [1]
260518
0
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Approval date [1]
260518
0
31/10/2011
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Ethics approval number [1]
260518
0
REC 2303/8/13
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Ethics committee name [2]
286812
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Royal Children's Hospital Health Service District HREC
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Ethics committee address [2]
286812
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Royal Children's Hospital (Brisbane)
Department of Paediatrics & Child Health
Level 3 Foundation Building
Herston Rd
Herston Qld 4029
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Ethics committee country [2]
286812
0
Australia
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Date submitted for ethics approval [2]
286812
0
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Approval date [2]
286812
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18/01/2012
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Ethics approval number [2]
286812
0
HREC 11/QRCH/181
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Ethics committee name [3]
290782
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Human Research Ethics Committee (Tasmania) Network
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Ethics committee address [3]
290782
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University of Tasmania
Private Bag 1
Hobart Tasmania 7001
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Ethics committee country [3]
290782
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Australia
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Date submitted for ethics approval [3]
290782
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14/06/2012
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Approval date [3]
290782
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12/09/2012
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Ethics approval number [3]
290782
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H0012653
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Ethics committee name [4]
290783
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Northern B Health & Disability Ethics Committee
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Ethics committee address [4]
290783
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Ministry of health
c/- MEDSAFE, Level 6 Deloitte House
10 Brandon St
Wellington 6011
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Ethics committee country [4]
290783
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New Zealand
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Date submitted for ethics approval [4]
290783
0
18/05/2012
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Approval date [4]
290783
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06/09/2012
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Ethics approval number [4]
290783
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LRS/12/06/021
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Summary
Brief summary
Antenatal magnesium sulphate is recommended prior to preterm birth at less than 30 weeks’ gestation for neuroprotection of the fetus. Whether there are benefits at later gestations is uncertain. The primary aim of this randomised placebo controlled trial is to assess whether giving magnesium sulphate compared with placebo to women immediately prior to preterm birth between 30 and 34 weeks' gestation reduces the risks of death or cerebral palsy in their children at 2 years' corrected age. years' corrected age.
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Trial website
http://www.adelaide.edu.au/arch/research/clinical_trials/magenta
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
32256
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Prof Caroline Crowther
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Address
32256
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Australian Research Centre for Health of Women and Babies (ARCH), The Robinson Research Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women's and Children's Hospital, King William Road, North Adelaide SA 5006
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Country
32256
0
Australia
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Phone
32256
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+61 8161 7619
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Fax
32256
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+61 8 8161 7652
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Email
32256
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[email protected]
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Contact person for public queries
Name
15503
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Ms Pat Ashwood
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Address
15503
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Australian Research Centre for Health of Women and Babies (ARCH), The Robinson Research Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women's and Children's Hospital, King William Road, North Adelaide SA 5006
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Country
15503
0
Australia
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Phone
15503
0
+61 8 8161 7767
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Fax
15503
0
+61 8 8161 7652
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Email
15503
0
[email protected]
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Contact person for scientific queries
Name
6431
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Prof Caroline Crowther
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Address
6431
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Australian Research Centre for Health of Women and Babies (ARCH), The Robinson Research Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women's and Children's Hospital, King William Road, North Adelaide SA 5006
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Country
6431
0
Australia
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Phone
6431
0
+61 8 8161 7619
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Fax
6431
0
+61 8 8161 7652
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Email
6431
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified data relating to published outcomes from the MAGENTA Trial.
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When will data be available (start and end dates)?
Start date October 2020, no end date determined.
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Available to whom?
Only researchers who provide a methodologically sound proposal.
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Available for what types of analyses?
Data will be available for IPD meta-analyses using an approved protocol.
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How or where can data be obtained?
Access subject to approvals from Maternal and Perinatal Research Hub at Liggins Institute. Email
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Effect of antenatal magnesium sulphate on MRI biomarkers of white matter development at term equivalent age: The magnum study.
2020
https://dx.doi.org/10.1016/j.ebiom.2020.102957
Embase
Prenatal Intravenous Magnesium at 30-34 Weeks' Gestation and Neurodevelopmental Outcomes in Offspring: The MAGENTA Randomized Clinical Trial.
2023
https://dx.doi.org/10.1001/jama.2023.12357
N.B. These documents automatically identified may not have been verified by the study sponsor.
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