Trial from ANZCTR


Trial ID ACTRN12611000491965
Trial Status: Registered
Date Submitted: 28/04/2011
Date Registered: 11/05/2011
Prospectively registered

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Public title MAGENTA - Magnesium Sulphate at 30 to 34 weeks' gestational age: Neuroprotection Trial
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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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UTN
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Trial acronym MAGENTA
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Health condition(s) or problem(s) studied:
Complications of preterm infant 261230 0
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Neuroprotection 265764 0
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Cerebral Palsy 265765 0
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Child health 265766 0
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Condition category: Condition code:
Reproductive Health and Childbirth Antenatal care
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259375 259375 0 0
Reproductive Health and Childbirth Complications of newborn
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265915 265915 0 0
Neurological Other neurological disorders
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265916 265916 0 0

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Descriptions 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:
Treatment: drugs 258089 0
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Intervention Code:
Prevention 264509 0
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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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Primary Outcome: 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]. 262192 0
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Timepoint: 2 years' corrected age. 262192 0
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Secondary Outcome: 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.
273296 0
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Timepoint: Up to hospital discharge. 273296 0
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Secondary Outcome: 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). 273297 0
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Timepoint: Up to hospital discharge. 273297 0
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Secondary Outcome: Individual components of the primary outcome including severity of cerebral palsy (defined as death, cerebral palsy). 273298 0
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Timepoint: 2 years' corrected age. 273298 0
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Secondary Outcome: 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). 273299 0
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Timepoint: At 2 years' corrected age. 273299 0
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Secondary Outcome: 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]. 276175 0
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Timepoint: At 2 years' corrected age. 276175 0
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Secondary Outcome: 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. 276176 0
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Timepoint: At 2 years' corrected age. 276176 0
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Secondary Outcome: Maternal serious adverse cardiovascular and/or respiratory outcome of the infusion (defined as maternal death, cardiac arrest, respiratory arrest). 276177 0
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Timepoint: At time of trial treatment infusion. 276177 0
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Secondary Outcome: 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). 276262 0
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Timepoint: At time of trial treatment infusion. 276262 0
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Secondary Outcome: 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
296345 0
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Timepoint: At time of birth. 296345 0
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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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Gender Females
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Healthy volunteers? 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 type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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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Describe the 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 (choose all that apply) 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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Assignment Parallel
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Other design features
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Phase 3
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Anticipated date of first participant enrolment 30/01/2012
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Date of first participant enrolment 31/01/2012
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 1676
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s) NSW,QLD,SA,TAS,VIC
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Recruitment outside Australia

Country: New Zealand 5926 0
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State/Province: 5926 0
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Funding Source: Government body 258550 0
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Name: National Health and Medical Research Council (NHMRC) 258550 0
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Address: Physical address:
Level 5,20 Allara Street
Canberra ACT, 2601

Postal address:
GPO Box 1421
Canberra ACT, 2601
258550 0
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Country: Australia 258550 0
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Primary Sponsor 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: None 257684 0
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Name: 257684 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Children, Youth & Women's Health Service (CYWHS) Human Research Ethics Committee (HREC) 260518 0
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Address: Children, Youth & Women's Health Service (Women's and Children's Hospital),
72 King William Road,
North Adelaide SA 5006
260518 0
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Country: Australia 260518 0
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Approval Date: 31/10/2011 260518 0
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Submitted Date: 260518 0
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HREC: REC 2303/8/13 260518 0
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Ethics Committee name: Royal Children's Hospital Health Service District HREC 286812 0
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Address: Royal Children's Hospital (Brisbane)
Department of Paediatrics & Child Health
Level 3 Foundation Building
Herston Rd
Herston Qld 4029
286812 0
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Country: Australia 286812 0
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Approval Date: 18/01/2012 286812 0
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Submitted Date: 286812 0
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HREC: HREC 11/QRCH/181 286812 0
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Ethics Committee name: Human Research Ethics Committee (Tasmania) Network 290782 0
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Address: University of Tasmania
Private Bag 1
Hobart Tasmania 7001
290782 0
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Country: Australia 290782 0
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Approval Date: 12/09/2012 290782 0
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Submitted Date: 14/06/2012 290782 0
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HREC: H0012653 290782 0
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Ethics Committee name: Northern B Health & Disability Ethics Committee 290783 0
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Address: Ministry of health
c/- MEDSAFE, Level 6 Deloitte House
10 Brandon St
Wellington 6011
290783 0
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Country: New Zealand 290783 0
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Approval Date: 06/09/2012 290783 0
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Submitted Date: 18/05/2012 290783 0
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HREC: LRS/12/06/021 290783 0
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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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Principal Investigator
Title: Prof
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Name: Caroline Crowther
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Address: 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: Australia
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Tel: +61 8161 7619
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Fax: +61 8 8161 7652
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Email: caroline.crowther@adelaide.edu.au
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Contact person for public queries
Title: Ms
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Name: Pat Ashwood
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Address: 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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Tel: +61 8 8161 7767
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Email: pat.ashwood@adelaide.edu.au
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Contact person for scientific queries
Title: Prof
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Name: Caroline Crowther
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Address: 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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Tel: +61 8 8161 7619
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Fax: +61 8 8161 7652
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Email: caroline.crowther@adelaide.edu.au
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Contact person responsible for updating information
Title: Ms
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Name: Pat Ashwood
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Address: 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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Tel: +61 8 8161 7767
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Email: pat.ashwood@adelaide.edu.au
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Addition Cancer fields
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