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Trial registered on ANZCTR
Registration number
ACTRN12611000221954
Ethics application status
Approved
Date submitted
26/02/2011
Date registered
28/02/2011
Date last updated
14/01/2019
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Impact on Caesarean Rates following Injections of Sterile Water (ICARIS) – A randomised controlled trial.
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Scientific title
For women in labour with backpain does the inclusion of sterile water injections with standard care reduce the rate of caesarean sections.
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Secondary ID [1]
259681
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Nil
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Universal Trial Number (UTN)
U1111-1137-9016
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Trial acronym
ICARIS (Impact on CAesarean Rates following Injections of Sterile water)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Labour and birth
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Condition category
Condition code
Reproductive Health and Childbirth
259404
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0
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Women with back pain during first stage labour, assessed by visual analogue scale as = 7 will receive 0.1 – 0.3 millilitres of sterile water for injection. The exact volume injected is determined by visualisation of the resulting blister or bleb by the administering clinician. The injection is given using of one-millilitre syringes and 23 gauge needles, one injection into four anatomical points surrounding the Michaelis rhomboid over the sacral area: two over the posterior superior iliac spines (PSIS) and the remaining two at two centimetres posterior, and one centimetre medial, to the PSIS respectively. Women may receive repeat injections upon request once the VAS is again = 7. Repeat injections will be of Sterile Water for injection. There is no maximum amount of injections that women may receive during their labour.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
The control / placebo will be Normal Saline for injection 0.9%, 0.1 – 0.3 millilitres of sterile water for injection. The exact volume injected is determined by visualisation of the resulting blister or bleb by the administering clinician. The injection is given using of one-millilitre syringes and 23 gauge needles, one injection into four anatomical points surrounding the Michaelis rhomboid over the sacral area: two over the posterior superior iliac spines (PSIS) and the remaining two at two centimetres posterior, and one centimetre medial, to the PSIS respectively. Women may receive repeat injections upon request once the VAS is again = 7. Repeat injections will be of Sterile Water for injection. There is no maximum amount of injections that women may receive during their labour.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Caesarean Section
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Assessment method [1]
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Timepoint [1]
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At birth
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Secondary outcome [1]
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effect of SWI for back pain in labour on use of other pain relief methods
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Assessment method [1]
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Timepoint [1]
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At birth
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Secondary outcome [2]
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To determine the effect of SWI for back pain in labour on mode of birth
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Assessment method [2]
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Timepoint [2]
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At birth
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Secondary outcome [3]
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To determine whether SWI for back pain in labour impacts on other maternal and infant outcomes in the short term
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Assessment method [3]
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Timepoint [3]
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at birth through the administration of a specifically designed questionnaire at 1 day following birth and 2 months postnatal.
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Secondary outcome [4]
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To determine the cost of SWI for back pain in labour compared with standard care.
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Assessment method [4]
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Timepoint [4]
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Costing methods will be adapted from models developed by researchers from the Deakin University School of Health and Social Development and the Department of Organisation and Management at the Australian School of Business based at University of New South Wales.
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Secondary outcome [5]
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VAS of back pain prior to administration of intervention or placebo
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Assessment method [5]
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Timepoint [5]
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At randomisation
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Secondary outcome [6]
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VAS of back pain following administration of intervention or placebo
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Assessment method [6]
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Timepoint [6]
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30 minutes after administration
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Secondary outcome [7]
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VAS of back pain following administration of intervention or placebo
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Assessment method [7]
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Timepoint [7]
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60 minutes post administration
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Secondary outcome [8]
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VAS of back pain following administration of intervention or placebo
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Assessment method [8]
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Timepoint [8]
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90 minutes post administration
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Secondary outcome [9]
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Pharmacological or regional analgesia used following administration of intervention or placebo
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Assessment method [9]
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Timepoint [9]
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90 minutes following administration of intervention or placebo and at birth
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Secondary outcome [10]
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The proportion of women experiencing an at least 30% reduction in pre and post administration VAS scores
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Assessment method [10]
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Timepoint [10]
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30 minutes post administration of intervention or placebo
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Secondary outcome [11]
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The proportion of women experiencing an at least 50% reduction in pre and post administration VAS scores
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Assessment method [11]
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Timepoint [11]
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30 minutes post administration of intervention or placebo
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Secondary outcome [12]
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Fetal position prior to administration of intervention or placebo determined by abdominal, vaginal or ultrasound assessment
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Assessment method [12]
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Timepoint [12]
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at randomisation
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Secondary outcome [13]
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Non-pharmacologocal use following administration of intervention or placebo
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Assessment method [13]
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Timepoint [13]
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90 minutes following administration and at birth
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Secondary outcome [14]
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Use of pharmacological analgesia prior to administration of intervention or placebo
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Assessment method [14]
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Timepoint [14]
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at randomisation
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Eligibility
Key inclusion criteria
Term pregnancy (between 37 and 42 weeks gestation)
Singleton pregnancy
Cephalic presentation
Back pain assessed by VAS as =7 when women request analgesia for backpain
Able to give informed consent
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Multiple pregnancy
Malpresentation (breech, transverse, shoulder)
Back pain assessed by VAS < 7 when women request analgesia for backpain
Any major complications that could cause problems with bleeding at the injection site eg. thrombocytopenia or any clotting abnormality.
Standard exclusion criteria, based on clinical assessment to intradermal injections, will apply, including infection or inflammation involving the proposed injection sites.
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Study design
Purpose of the study
Treatment
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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)
Women with back pain in labour, with a pain score assessed by visual analogue sclae as being equal or greater than 7 and providing consent, will be enrolled in the trial. Identical ampuoles of Sterile Water for Injection and Normal Saline 0.9% labelled with a randomly generated study number will be available for use. Following consent two midiwves will remove an ampuole and administer the injections using the standard four injection technique. The midwife caring for the labouring woman will be absent from the room during the administration of the injections.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Identical ampuoles of Sterile Water for Injection and Normal Saline 0.9% prepared by the pharmacy will be labelled with a unique study number generated by the Mater Medical Research Institute using block randomisation.
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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
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
All women who underwent randomisation will be analysed in their allocated treatment groups (i.e., intention to treat). Randomisation and stratification should ensure that groups are equal in baseline characteristics. Relative risks with 95% confidence intervals for the primary outcome will be calcuted. Secondary outcome measures of categorical data will be analysed with chi-squared tests and continuous data will be analysed with t-tests for normally distributed data and Mann-Whitney U test for parametric data. Regression will be used if necessary to adjust for any other confounding variables. All study outcomes will be analysed using a two-sdied P value of <0.05 to indicate statistical significance. The study is only powered to report the primary outcome and for secondary outcomes confidence intervals (CI) will be included as a measure for the effect size. Differences in pre and post VAS scores will be reported in the format recommended by the recent Cochrane Review
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
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Other reasons
Time limit for recruitment expired
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Date of first participant enrolment
Anticipated
1/06/2012
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Actual
9/12/2012
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Date of last participant enrolment
Anticipated
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Actual
5/02/2018
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Date of last data collection
Anticipated
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Actual
30/04/2018
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Sample size
Target
1866
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Accrual to date
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Final
1193
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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Mater Mother's Hospital - South Brisbane
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Recruitment hospital [2]
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Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [3]
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Ipswich Hospital - Ipswich
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Recruitment hospital [4]
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Nambour General Hospital - Nambour
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Recruitment hospital [5]
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The Townsville Hospital - Douglas
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Recruitment hospital [6]
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Royal Hospital for Women - Randwick
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Recruitment hospital [7]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [8]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [9]
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Womens and Childrens Hospital - North Adelaide
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Recruitment hospital [10]
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Nepean Hospital - Kingswood
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Recruitment hospital [11]
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St George Hospital - Kogarah
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Recruitment hospital [12]
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Blacktown Hospital - Blacktown
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Recruitment hospital [13]
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Liverpool Hospital - Liverpool
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2148 - Blacktown
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Recruitment postcode(s) [3]
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2148 - Blacktown
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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2170 - Liverpool
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Recruitment postcode(s) [6]
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4029 - Royal Brisbane Hospital
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Recruitment postcode(s) [7]
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4101
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Recruitment postcode(s) [8]
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4305
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Recruitment postcode(s) [9]
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4560 - Nambour
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Recruitment postcode(s) [10]
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4814 - Douglas
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Recruitment outside Australia
Country [1]
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United Kingdom
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State/province [1]
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Oxford
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC
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Address [1]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Mater Health Services
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Address
Raymond Terrace
South Brisbane
Queensland
4101
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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Australian Catholic University
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Address [1]
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1100 Nudgee Road Banyo QLD 4014
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Country [1]
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Australia
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Secondary sponsor category [2]
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University
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Name [2]
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University of Queensland
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Address [2]
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St Lucia QLD 4072
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Country [2]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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HREC - Royal Brisbane and Women's Hospital
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Ethics committee address [1]
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Royal Brisbane and Women's Hospital University of Queensland, Centre for Clinical Research, Level 4, RBWH
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
260563
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28/02/2010
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Approval date [1]
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16/04/2012
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Ethics approval number [1]
260563
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HREC/12/QRBW/52)
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Ethics committee name [2]
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Women's and Children's Hospital Network Human Research Ethics Committee
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Ethics committee address [2]
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Level 2 Samuel Way Building 72 King William Road Adelaide
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
296228
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22/08/2013
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Approval date [2]
296228
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10/09/2013
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Ethics approval number [2]
296228
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HREC/13/WCHN/110
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Ethics committee name [3]
296229
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South Central - Oxford B Research Ethics Committee
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Ethics committee address [3]
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Whitefriars Level 3, Block B Lewin's Mead Bristol BS1 2NT
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Ethics committee country [3]
296229
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United Kingdom
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Date submitted for ethics approval [3]
296229
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29/09/2015
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Approval date [3]
296229
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07/10/2015
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Ethics approval number [3]
296229
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15/SC0509
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Summary
Brief summary
We will test to see if the addition of sterile water injections for the relief of back pain in labour to standard pharmacological (nitrous oxide gas, narcotics, epidural) and non-pharmaclogical analgesic options ( shower, water immersion, massage, heat, aromatherapy, TENS) will affect birth outcomes, specifically the rates of caesarean section.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sue Kildea
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Address
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Women's Health and Newborn Services (Maternity)
Mater Health Services
Level 1, Aubigny Place, Raymond Terrace
South Brisbane, Qld. 4101.
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Country
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Australia
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Phone
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61 7 31636388
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Fax
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Email
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sue.kildea@mater.uq.edu.au
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Contact person for public queries
Name
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Nigel Lee
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Address
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Mater Medical Research Institute Level 2 Aubigny Place
Annerley Road Woolloongabba Q 4102
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Country
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Australia
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Phone
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61 7 3163 6118
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Fax
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Email
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nigel.lee@mater.uq.edu.au
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Contact person for scientific queries
Name
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Nigel Lee
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Address
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Mater Medical Research Institute Level 2 Aubigny Place, Raymond Terrace
South Brisbane, Qld. 4101.
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Country
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Australia
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Phone
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61 7 3163 6118
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Fax
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Email
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nigel.lee@mater.uq.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
Download to PDF