Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000252516
Ethics application status
Approved
Date submitted
6/03/2001
Date registered
6/03/2001
Date last updated
10/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australasian Collaborative Trial of Magnesium Sulphate for the Prevention of Mortality and Cerebral Palsy in Infants Born Very Preterm.
Scientific title
Australasian Collaborative Trial of Magnesium Sulphate for the Prevention of Mortality and Cerebral Palsy in Infants Born Very Preterm.
Secondary ID [1] 25 0
Perinatal Trials Registry: PTR354
Universal Trial Number (UTN)
Trial acronym
ACTOMgSO4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infants born very preterm (<30 weeks) 25 0
Condition category
Condition code
Reproductive Health and Childbirth 28 28 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 29 29 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment group: Magnesium sulphate (2mmol/mL).
Dosing regimen for both groups: Loading infusion: 8 mLs over 20mins via infusion pump. Maintenance: 2mLs/hr until delivery or 24 hrs whichever is longer
Intervention code [1] 1086 0
Treatment: Drugs
Comparator / control treatment
Placebo group: Normal saline
Dosing regimen for both groups: Loading infusion: 8 mLs over 20mins via infusion pump. Maintenance: 2mLs/hr until delivery or 24 hrs whichever is longer
Control group
Placebo

Outcomes
Primary outcome [1] 55 0
Cerebral palsy
Timepoint [1] 55 0
2 years corrected age
Primary outcome [2] 56 0
Neonatal infant survival
Timepoint [2] 56 0
Up to 2 years of age
Primary outcome [3] 300711 0
Death or Cerebral Palsy
Timepoint [3] 300711 0
Early School Age
Secondary outcome [1] 80 0
Cerebroventricular haemmorhage
Timepoint [1] 80 0
Up to time of primary hospital discharge.
Secondary outcome [2] 81 0
Periventricular leukomalacia
Timepoint [2] 81 0
Up to time of primary hospital discharge.
Secondary outcome [3] 82 0
Maternal morbidity
Timepoint [3] 82 0
Up to 6 weeks postnatal.

Eligibility
Key inclusion criteria
Pregnant women <30 weeks where delivery is planned or definately expected within 24 hours.
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to magnesium sulphate; in second stage of labour; previous magnesium sulphate therapy in the pregnancy and magnesium sulphate therapy considered essential

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered Containers: packs identical in appearance, labelled with unique study number by independent third party
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified Allocation: stratified by centre and plurality (singleton. twin, higher-order multiple). Computer generated sequence with variable block sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/02/1996
Actual
29/02/1996
Date of last participant enrolment
Anticipated
Actual
15/09/2000
Date of last data collection
Anticipated
Actual
30/12/2011
Sample size
Target
1178
Accrual to date
Final
1178
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA
Recruitment outside Australia
Country [1] 8563 0
New Zealand
State/province [1] 8563 0

Funding & Sponsors
Funding source category [1] 35 0
Government body
Name [1] 35 0
National Health & Medical Research Council 5 yr Epidemiology Grant
Country [1] 35 0
Australia
Funding source category [2] 36 0
Charities/Societies/Foundations
Name [2] 36 0
Channel 7 Research Foundation of South Australia Inc
Country [2] 36 0
Australia
Funding source category [3] 37 0
Charities/Societies/Foundations
Name [3] 37 0
Queen Victoria Hospital Research Foundation
Country [3] 37 0
Australia
Primary sponsor type
Individual
Name
Prof Caroline Crowther
Address
Women's & Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 32 0
Individual
Name [1] 32 0
Prof Janet Hiller
Address [1] 32 0
University of Adelaide
North Tce, Adelaide SA 5005
Country [1] 32 0
Australia
Secondary sponsor category [2] 33 0
Individual
Name [2] 33 0
Prof Lex Doyle
Address [2] 33 0
The Royal Women's Hospital
cnr Grattan St & Flemington Rd
Parkville Vic 3052
Country [2] 33 0
Australia
Secondary sponsor category [3] 34 0
Individual
Name [3] 34 0
A/Prof Ross Haslam
Address [3] 34 0
Women's & Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country [3] 34 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308 0
Women's & Children's Hospital, Maternal Perinatal Clinical Trials Unit Adelaide University
Ethics committee address [1] 308 0
Ethics committee country [1] 308 0
Australia
Date submitted for ethics approval [1] 308 0
Approval date [1] 308 0
01/12/1995
Ethics approval number [1] 308 0

Summary
Brief summary
Infants born preterm have an increased risk of mortality and cerebral
palsy. Evidence from recent case controlled studies support animal
research that suggests maternal administration of magnesium sulphate may
reduce the risk of cerebral palsy and mortality in infants born very
preterm. It is important that these findings are tested in large
randomised controlled trials as soon as possible to assess whether
prophylactic treatment should be recommedned for clinical practice in
the case of women who are at risk of preterm delivery. Trial participants, trial research staff and all involved in clinical
care of participants were blinded.
Trial treatment packs of identical appearance, labelled only with unique
study number.
Trial website
Trial related presentations / publications
Effect of magnesium sulfate given for neuroprotection before preterm birth: a randomized controlled trial.
Crowther CA, Hiller JE, Doyle LW, Haslam RR; Australasian Collaborative Trial of Magnesium Sulphate (ACTOMg SO4) Collaborative Group..
JAMA. 2003 Nov 26;290(20):2669-76

School-age outcomes of very preterm infants after antenatal treatment with magnesium sulfate vs placebo.
Doyle LW, Anderson PJ, Haslam R, Lee KJ, Crowther C; Australasian Collaborative Trial of Magnesium Sulphate (ACTOMgSO4) Study Group..
JAMA. 2014 Sep 17;312(11):1105-13. doi: 10.1001/jama.2014.11189.
Public notes
Attachments [1] 1351 1351 0 0
/AnzctrAttachments/1335-Crowther et al. JAMA 2003 ACTOMgSO4 Trial.pdf
Attachments [2] 1352 1352 0 0
/AnzctrAttachments/1335-Doyle et al JAMA 2014.pdf

Contacts
Principal investigator
Name 35173 0
Prof Caroline Crowther
Address 35173 0
Women's & Children's Hospital
72 King William Rd
North Ade.laide SA 5006
Country 35173 0
Australia
Phone 35173 0
+61 8 8161 7619
Fax 35173 0
Email 35173 0
[email protected]
Contact person for public queries
Name 10275 0
Prof Caroline Crowther
Address 10275 0
University Obstetrics & Gynaecology
Women's & Children's Hospital
Queen Victoria Building
Level 1
72 King William Road
North Adelaide SA 5006
Country 10275 0
Australia
Phone 10275 0
+61 8 8161 7619
Fax 10275 0
+61 8 81617652
Email 10275 0
[email protected]
Contact person for scientific queries
Name 1203 0
Prof Caroline Crowther
Address 1203 0
University Obstetrics & Gynaecology
Women's & Children's Hospital
Queen Victoria Building
Level 1
72 King William Road
North Adelaide SA 5006
Country 1203 0
Australia
Phone 1203 0
+61 8 8161 7619
Fax 1203 0
+61 8 81617652
Email 1203 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseThe role of social risk in an early preventative care programme for infants born very preterm: a randomized controlled trial.2018https://dx.doi.org/10.1111/dmcn.13594
N.B. These documents automatically identified may not have been verified by the study sponsor.