Trial Review

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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.
Inserted
 
Reason: New mandatory section.
Updated on 4/03/2013 4:09:21 PM
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.
Updated from
Women recruited will receive magnesium sulphate infusion for 24 hours or they give birth (whichever is the shorter) and will be randomised to different rates of administration of the intravenous infusion. (4g [16 mmol] magnesium sulphate over 20 minutes followed by 1g [4 mmol] per hour versus 4g [16 mmol] magnesium sulphate over 60 minutes followed by 1g [4 mmol] per hour.  
Reason: Units removed to allow for administration as per hospital's protocol.
Updated on 4/03/2013 4:09:21 PM
Intervention code [1] 770 0
Treatment: Drugs
Updated from
None  
Reason: New mandatory section since trial registration.
Updated on 4/03/2013 4:09:21 PM
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).
Updated from
 
Reason: New mandatory section since trial registration.
Updated on 4/03/2013 4:09:21 PM
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.
Updated from
Occurrence of maternal side effects during therapy  
Reason: Minor amendment to terminology since initial registration. Further detail regarding possible adverse effects from trial protocol added.
Updated on 4/03/2013 4:09:21 PM
Timepoint [1] 1311 0
Measured at 20 minutes and 60 minutes after the start of the infusion, and at completion of the infusion.
Updated from
Measured at 20 minutes and 60 minutes after start of infusion.  
Reason: Minor amendment to protocol since initial registration.
Updated on 4/03/2013 4:09:21 PM
Deleted Outcome
W`hether medication stopped because of side effects  
Timepoint
Measured at 20 minutes and 60 minutes after start of infusion.
Reason: Amendment to protocol since initial registration. Cessation of treatment due to adverse effects is a secondary outcome.
Updated on 4/03/2013 4:09:21 PM
Secondary outcome [1] 2349 0
Magnesium concentrations in cord blood at birth for the infant.
Updated from
Infant cord blood magnesium sulphate levels at birth.  
Reason: Minor amendment to terminology since initial registration.
Updated on 4/03/2013 4:09:21 PM
Timepoint [1] 2349 0
Measured at birth.
Updated from
 
Reason: Timepoint now a mandatory field.
Updated on 4/03/2013 4:09:21 PM
Secondary outcome [2] 2350 0
Total amount of magnesium sulphate given prior to birth
Updated from
Total amount of magnesium sulphate given.  
Reason: Clarification regarding administration prior to birth.
Updated on 4/03/2013 4:09:21 PM
Timepoint [2] 2350 0
Measured prior to birth.
Updated from
 
Reason: Timepoint now a mandatory field.
Updated on 4/03/2013 4:09:21 PM
Secondary outcome [3] 301552 0
Cessation of treatment due to adverse effects attributed to the magnesium sulphate infusion.
Inserted
 
Reason: Minor amendment to protocol since trial registration (this was previously listed as a primary outcome).
Updated on 4/03/2013 4:09:21 PM
Timepoint [3] 301552 0
Measured throughout the infusion.
Inserted
 
Reason: Timepoint now a mandatory field.
Updated on 4/03/2013 4:09:21 PM
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)
Inserted
 
Reason: Further detail provided from protocol since initial registration.
Updated on 4/03/2013 4:09:21 PM
Timepoint [4] 301553 0
Measured at 20 minutes and 60 minutes after the start of the infusion, and at completion of the infusion.
Inserted
 
Reason: Further detail provided from protocol since initial registration.
Updated on 4/03/2013 4:09:21 PM

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.
Updated from
Singleton or twin pregnancy at a gestational age of less than 32 weeks where a decision has been made to deliver within 24 hours or to allow labour to progess if in preterm labour.  
Reason: Since initial trial registration, clinical practice guideline recommendations were released, recommending magnesium sulphate administration to women at risk of very preterm birth at less than 30 weeks gestation.
Updated on 4/03/2013 4:09:21 PM
Minimum age
Not stated
Maximum age
Not stated
Sex
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.
Updated from
1. Women with contraindications to magnesium sulphate.2. Women who are in the second stage of labour.3. Women who have been given magnesium sulphate therapy in this pregnancy.  
Reason: Minor amendment; further detail regarding contraindications provided from trial protocol.
Updated on 4/03/2013 4:09:21 PM

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
Updated from
 
Reason: Clarification that women will be blinded.
Updated on 4/03/2013 4:09:21 PM
Updated from
 
Reason: Clarification that the data analyses will be conducted blind.
Updated on 4/03/2013 4:09:21 PM
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Updated from
Not yet recruiting  
Reason: Trial completed.
Updated on 4/03/2013 4:09:21 PM
Date of first participant enrolment
Anticipated
1/01/2006
Actual
21/02/2006
Updated from
 
Reason: Updated
Updated on 10/01/2017 1:08:19 PM
Date of last participant enrolment
Anticipated
Actual
3/04/2012
Updated from
 
Reason: Trial completed.
Updated on 4/03/2013 4:09:21 PM
Date of last data collection
Anticipated
Actual
30/06/2012
Updated from
 
Reason: Updated as requested
Updated on 10/01/2017 1:08:19 PM
Sample size
Target
51
Accrual to date
Final
51
Updated from
140 
Reason: Sample size was based on a reduction in the experience of any adverse effects of the magnesium sulphate infusion (the primary outcome).
Updated on 4/03/2013 4:09:21 PM
Updated from
 
Reason: Updated
Updated on 10/01/2017 1:08:19 PM
Recruitment in Australia
Recruitment state(s)
SA
Updated from
 
Reason: Clarification since trial registration.
Updated on 4/03/2013 4:09:21 PM

Funding & Sponsors
Funding source category [1] 1085 0
University
Updated from
Self funded/Unfunded  
Reason: Clarification that the trial was self-funded by ARCH: Australian Research Centre for Health of Women and Babies, The Robinson Institute, The University of Adelaide
Updated on 4/03/2013 4:09:21 PM
Name [1] 1085 0
ARCH: Australian Research Centre for Health of Women and Babies, The Robinson Institute, The University of Adelaide
Updated from
 
Reason: Further detail provided since initial registration.
Updated on 4/03/2013 4:09:21 PM
Country [1] 1085 0
Australia
Updated from
 
Reason: Further detail provided since initial registration.
Updated on 4/03/2013 4:09:21 PM
Primary sponsor type
University
Updated from
Hospital  
Reason: Further clarification provided since initial registration.
Updated on 4/03/2013 4:09:21 PM
Name
ARCH: Australian Research Centre for Health of Women and Babies, The Robinson Institute, The University of Adelaide
Updated from
The Women's and Children's Hospital, Adelaide  
Reason: Further clarification provided since initial registration.
Updated on 4/03/2013 4:09:21 PM
Address
Level 1, Queen Victoria Building,
Women's and Children's Hospital,
72 King William Street,
NORTH ADELAIDE SA 5006
Updated from
 
Reason: Further clarification provided since initial registration.
Updated on 4/03/2013 4:09:21 PM
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
Updated from
Women's and Children's Hospital  
Reason:
Updated on 4/03/2013 4:09:21 PM
Ethics committee address [1] 2389 0
Ethics committee country [1] 2389 0
Australia
Date submitted for ethics approval [1] 2389 0
Approval date [1] 2389 0
01/11/2005
Updated from
 
Reason:
Updated on 10/01/2017 1:08:19 PM
Ethics approval number [1] 2389 0
1651/2/2013
Updated from
 
Reason: Further detail provided since initial registration.
Updated on 4/03/2013 4:09:21 PM

Summary
Brief summary
Updated from
 
Reason:
Updated on 4/03/2013 4:09:21 PM
Trial website
Trial related presentations / publications
Updated from
 
Reason:
Updated on 10/01/2017 1:08:19 PM
Public notes
Attachments [1] 1350 1350 0 0
/AnzctrAttachments/905-Bain_et_al-2014-BJOG-_An_International_Journal_of_Obstetrics_&_Gynaecology.pdf
Inserted
 
Reason: Updated
Updated on 10/01/2017 1:08:19 PM

Contacts
Principal investigator
Updated from
 

Updated on 4/03/2013 4:09:21 PM
Name 36340 0
Prof Caroline Crowther
Updated from
 

Updated on 4/03/2013 4:09:21 PM
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
Updated from
 

Updated on 4/03/2013 4:09:21 PM
Country 36340 0
Australia
Updated from
 

Updated on 4/03/2013 4:09:21 PM
Phone 36340 0
+61 8 81617647
Updated from
 

Updated on 4/03/2013 4:09:21 PM
Fax 36340 0
Email 36340 0
[email protected]
Updated from
 

Updated on 4/03/2013 4:09:21 PM
Contact person for public queries
Name 9959 0
Caroline Crowther
Updated from
Professor Caroline Crowther  

Updated on 4/03/2013 4:09:21 PM
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
Updated from
Department of Obstetrics and Gynaecology The University of Adelaide Women's & Children's Hospital King William Road North Adelaide SA 5006  

Updated on 4/03/2013 4:09:21 PM
Country 9959 0
Australia
Phone 9959 0
+61 8 81617647
Fax 9959 0
+61 8 81617652
Email 9959 0
[email protected]
Contact person for scientific queries
Name 887 0
Caroline Crowther
Updated from
Professor Caroline Crowther  

Updated on 4/03/2013 4:09:21 PM
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
Updated from
Department of Obstetrics and Gynaecology The University of Adelaide Women's & Children's Hospital King William Road North Adelaide SA 5006  

Updated on 4/03/2013 4:09:21 PM
Country 887 0
Australia
Phone 887 0
+61 8 81617647
Fax 887 0
+61 8 81617652
Email 887 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Documents Provided
Results publications and other study-related documents

No Study Results Provided