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Trial registered on ANZCTR


Registration number
ACTRN12605000765628
Ethics application status
Approved
Date submitted
22/11/2005
Date registered
25/11/2005
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised clinical trial of different infusion rates of magnesium sulphate given prenatally to women.
Scientific title
A randomised clinical trial of different infusion rates of magnesium sulphate given prenatally to women for the prevention of side effects.
Secondary ID [1] 282063 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Magnesium sulphate therapy, prior to very preterm birth. 921 0
Condition category
Condition code
Reproductive Health and Childbirth 988 988 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women recruited will receive a magnesium sulphate intravenous infusion for 24 hours or until they give birth (whichever is the shorter) and will be randomised to different rates of administration of the intravenous loading infusion. 4 g magnesium sulphate over 60 minutes followed by 1 g per hour versus 4 g magnesium sulphate over 20 minutes followed by 1 g per hour.
Intervention code [1] 770 0
Treatment: Drugs
Comparator / control treatment
Active control: 4 g magnesium sulphate administered over 20 minutes followed by 1 g per hour for 24 hours or until birth (whichever is the shorter).
Control group
Dose comparison

Outcomes
Primary outcome [1] 1311 0
Occurrence of any maternal adverse effects (clinical and self-assessed) during the magnesium sulphate infusion. This includes: arm discomfort with infusion, blurred vision, confusion/drowsiness, dizziness, headache, mild nausea/vomiting, mouth dryness, muscle weakness, palpitations, sweating, warmth/flushing, other reported side effects, tachycardia, respiratory depression.
Timepoint [1] 1311 0
Measured at 20 minutes and 60 minutes after the start of the infusion, and at completion of the infusion.
Secondary outcome [1] 2349 0
Magnesium concentrations in cord blood at birth for the infant.
Timepoint [1] 2349 0
Measured at birth.
Secondary outcome [2] 2350 0
Total amount of magnesium sulphate given prior to birth
Timepoint [2] 2350 0
Measured prior to birth.
Secondary outcome [3] 301552 0
Cessation of treatment due to adverse effects attributed to the magnesium sulphate infusion.
Timepoint [3] 301552 0
Measured throughout the infusion.
Secondary outcome [4] 301553 0
Adverse cardiorespiratory effects of the infusion (defined as a respiratory rate <16/minute, sdrop in diastolic blood pressure >15mmHg, cardiac arrest, respiratory arrest, maternal death)
Timepoint [4] 301553 0
Measured at 20 minutes and 60 minutes after the start of the infusion, and at completion of the infusion.

Eligibility
Key inclusion criteria
Women who are now recommended magnesium sulphate as per the National Clinical Practice Guidelines, and the South Australian Perinatal Practice Guidelines: a gestational age of less than 30 weeks where birth is planned or definitely expected within 24 hours. The women must have a singleton or twin pregnancy.
Minimum age
Not stated
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Women with the following contraindications to magnesium sulphate: absent patellar reflexes, hypocalcaemia, respiratory rate < 16/minute, renal failure, urine output < 100mls during the last 4 hours;
2) Women who are in the second stage of labour;
3) Women who have already been given magnesium sulphate therapy in this pregnancy.

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)
Central telephone randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 1085 0
University
Name [1] 1085 0
ARCH: Australian Research Centre for Health of Women and Babies, The Robinson Institute, The University of Adelaide
Address [1] 1085 0
Level 1, Queen Victoria Building,
Women's and Children's Hospital,
72 King William Street,
NORTH ADELAIDE SA 5006
Country [1] 1085 0
Australia
Primary sponsor type
University
Name
ARCH: Australian Research Centre for Health of Women and Babies, The Robinson Institute, The University of Adelaide
Address
Level 1, Queen Victoria Building,
Women's and Children's Hospital,
72 King William Street,
NORTH ADELAIDE SA 5006
Country
Australia
Secondary sponsor category [1] 946 0
None
Name [1] 946 0
N/A
Address [1] 946 0
Country [1] 946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2389 0
Children, Youth and Women’s Health Services Human Research Ethics Committee
Ethics committee address [1] 2389 0
Adelaide, South Australia
Ethics committee country [1] 2389 0
Australia
Date submitted for ethics approval [1] 2389 0
Approval date [1] 2389 0
01/11/2005
Ethics approval number [1] 2389 0
1651/2/2013

Summary
Brief summary
This randomised clinical trial will assess whether a slower, compared with the standard infusion rate of the loading dose of magnesium sulphate, given to women at risk of very preterm birth at less than 30 weeks gestation for fetal neuroprotection, is effective in reducing maternal adverse effects of treatment.
Trial website
Trial related presentations / publications
Maternal adverse effects with different loading infusion rates of antenatal magnesium sulphate for preterm fetal neuroprotection: the IRIS randomised trial.
Bain ES, Middleton PF, Yelland LN, Ashwood PJ, Crowther CA.
BJOG. 2014 Apr;121(5):595-603. doi: 10.1111/1471-0528.12535.
Public notes

Contacts
Principal investigator
Name 36340 0
Prof Caroline Crowther
Address 36340 0
ARCH: Australian Research Centre for Health of Women and Babies,
The Robinson Institute,
Discipline of Obstetrics and Gynaecology,
School of Paediatrics and Reproductive Health,
The University of Adelaide,
Level 1, Queen Victoria Building,
Women's and Children's Hospital,
72 King William Street,
NORTH ADELAIDE SA 5006
Country 36340 0
Australia
Phone 36340 0
+61 8 81617647
Fax 36340 0
Email 36340 0
caroline.crowther@adelaide.edu.au
Contact person for public queries
Name 9959 0
Prof Caroline Crowther
Address 9959 0
ARCH: Australian Research Centre for Health of Women and Babies,
The Robinson Institute,
Discipline of Obstetrics and Gynaecology,
School of Paediatrics and Reproductive Health,
The University of Adelaide,
Level 1, Queen Victoria Building,
Women's and Children's Hospital,
72 King William Street,
NORTH ADELAIDE SA 5006
Country 9959 0
Australia
Phone 9959 0
+61 8 81617647
Fax 9959 0
+61 8 81617652
Email 9959 0
caroline.crowther@adelaide.edu.au
Contact person for scientific queries
Name 887 0
Prof Caroline Crowther
Address 887 0
ARCH: Australian Research Centre for Health of Women and Babies,
The Robinson Institute,
Discipline of Obstetrics and Gynaecology,
School of Paediatrics and Reproductive Health,
The University of Adelaide,
Level 1, Queen Victoria Building,
Women's and Children's Hospital,
72 King William Street,
NORTH ADELAIDE SA 5006
Country 887 0
Australia
Phone 887 0
+61 8 81617647
Fax 887 0
+61 8 81617652
Email 887 0
caroline.crowther@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary