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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.
Scientific title
For women in labour with backpain does the inclusion of sterile water injections with standard care reduce the rate of caesarean sections.
Secondary ID [1] 259681 0
Nil
Universal Trial Number (UTN)
U1111-1137-9016
Trial acronym
ICARIS (Impact on CAesarean Rates following Injections of Sterile water)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Labour and birth 261251 0
Condition category
Condition code
Reproductive Health and Childbirth 259404 259404 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 258112 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 262213 0
Caesarean Section
Timepoint [1] 262213 0
At birth
Secondary outcome [1] 273341 0
effect of SWI for back pain in labour on use of other pain relief methods
Timepoint [1] 273341 0
At birth
Secondary outcome [2] 273342 0
To determine the effect of SWI for back pain in labour on mode of birth
Timepoint [2] 273342 0
At birth
Secondary outcome [3] 273343 0
To determine whether SWI for back pain in labour impacts on other maternal and infant outcomes in the short term
Timepoint [3] 273343 0
at birth through the administration of a specifically designed questionnaire at 1 day following birth and 2 months postnatal.
Secondary outcome [4] 273344 0
To determine the cost of SWI for back pain in labour compared with standard care.
Timepoint [4] 273344 0
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.
Secondary outcome [5] 328848 0
VAS of back pain prior to administration of intervention or placebo
Timepoint [5] 328848 0
At randomisation
Secondary outcome [6] 328849 0
VAS of back pain following administration of intervention or placebo
Timepoint [6] 328849 0
30 minutes after administration
Secondary outcome [7] 328850 0
VAS of back pain following administration of intervention or placebo
Timepoint [7] 328850 0
60 minutes post administration
Secondary outcome [8] 328851 0
VAS of back pain following administration of intervention or placebo
Timepoint [8] 328851 0
90 minutes post administration
Secondary outcome [9] 328852 0
Pharmacological or regional analgesia used following administration of intervention or placebo
Timepoint [9] 328852 0
90 minutes following administration of intervention or placebo and at birth
Secondary outcome [10] 328853 0
The proportion of women experiencing an at least 30% reduction in pre and post administration VAS scores
Timepoint [10] 328853 0
30 minutes post administration of intervention or placebo
Secondary outcome [11] 328854 0
The proportion of women experiencing an at least 50% reduction in pre and post administration VAS scores
Timepoint [11] 328854 0
30 minutes post administration of intervention or placebo
Secondary outcome [12] 328855 0
Fetal position prior to administration of intervention or placebo determined by abdominal, vaginal or ultrasound assessment
Timepoint [12] 328855 0
at randomisation
Secondary outcome [13] 328856 0
Non-pharmacologocal use following administration of intervention or placebo
Timepoint [13] 328856 0
90 minutes following administration and at birth
Secondary outcome [14] 328857 0
Use of pharmacological analgesia prior to administration of intervention or placebo
Timepoint [14] 328857 0
at randomisation

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
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
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.

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)
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.
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.
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
Time limit for recruitment expired
Date of first participant enrolment
Anticipated
1/06/2012
Actual
9/12/2012
Date of last participant enrolment
Anticipated
Actual
5/02/2018
Date of last data collection
Anticipated
Actual
30/04/2018
Sample size
Target
1866
Accrual to date
Final
1193
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 6870 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [2] 6871 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 6872 0
Ipswich Hospital - Ipswich
Recruitment hospital [4] 6873 0
Nambour General Hospital - Nambour
Recruitment hospital [5] 6874 0
The Townsville Hospital - Douglas
Recruitment hospital [6] 6875 0
Royal Hospital for Women - Randwick
Recruitment hospital [7] 6876 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 6877 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [9] 6878 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [10] 6879 0
Nepean Hospital - Kingswood
Recruitment hospital [11] 6880 0
St George Hospital - Kogarah
Recruitment hospital [12] 6881 0
Blacktown Hospital - Blacktown
Recruitment hospital [13] 6882 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 3654 0
4101
Recruitment postcode(s) [2] 3656 0
4305
Recruitment postcode(s) [3] 14540 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [4] 14541 0
4560 - Nambour
Recruitment postcode(s) [5] 14542 0
4814 - Douglas
Recruitment postcode(s) [6] 14543 0
2031 - Randwick
Recruitment postcode(s) [7] 14544 0
2148 - Blacktown
Recruitment postcode(s) [8] 14545 0
2148 - Blacktown
Recruitment postcode(s) [9] 14546 0
2170 - Liverpool
Recruitment postcode(s) [10] 14547 0
2170 - Liverpool
Recruitment outside Australia
Country [1] 8364 0
United Kingdom
State/province [1] 8364 0
Oxford

Funding & Sponsors
Funding source category [1] 258567 0
Government body
Name [1] 258567 0
NHMRC
Country [1] 258567 0
Australia
Primary sponsor type
Hospital
Name
Mater Health Services
Address
Raymond Terrace
South Brisbane
Queensland
4101
Country
Australia
Secondary sponsor category [1] 263717 0
University
Name [1] 263717 0
Australian Catholic University
Address [1] 263717 0
1100 Nudgee Road Banyo QLD 4014
Country [1] 263717 0
Australia
Secondary sponsor category [2] 293682 0
University
Name [2] 293682 0
University of Queensland
Address [2] 293682 0
St Lucia QLD 4072
Country [2] 293682 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260563 0
HREC - Royal Brisbane and Women's Hospital
Ethics committee address [1] 260563 0
Ethics committee country [1] 260563 0
Australia
Date submitted for ethics approval [1] 260563 0
28/02/2010
Approval date [1] 260563 0
16/04/2012
Ethics approval number [1] 260563 0
HREC/12/QRBW/52)
Ethics committee name [2] 296228 0
Women's and Children's Hospital Network Human Research Ethics Committee
Ethics committee address [2] 296228 0
Ethics committee country [2] 296228 0
Australia
Date submitted for ethics approval [2] 296228 0
22/08/2013
Approval date [2] 296228 0
10/09/2013
Ethics approval number [2] 296228 0
HREC/13/WCHN/110
Ethics committee name [3] 296229 0
South Central - Oxford B Research Ethics Committee
Ethics committee address [3] 296229 0
Ethics committee country [3] 296229 0
United Kingdom
Date submitted for ethics approval [3] 296229 0
29/09/2015
Approval date [3] 296229 0
07/10/2015
Ethics approval number [3] 296229 0
15/SC0509

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32272 0
Prof Sue Kildea
Address 32272 0
Women's Health and Newborn Services (Maternity)
Mater Health Services
Level 1, Aubigny Place, Raymond Terrace
South Brisbane, Qld. 4101.
Country 32272 0
Australia
Phone 32272 0
61 7 31636388
Fax 32272 0
Email 32272 0
[email protected]
Contact person for public queries
Name 15519 0
Nigel Lee
Address 15519 0
Mater Medical Research Institute Level 2 Aubigny Place
Annerley Road Woolloongabba Q 4102
Country 15519 0
Australia
Phone 15519 0
61 7 3163 6118
Fax 15519 0
Email 15519 0
[email protected]
Contact person for scientific queries
Name 6447 0
Nigel Lee
Address 6447 0
Mater Medical Research Institute Level 2 Aubigny Place, Raymond Terrace
South Brisbane, Qld. 4101.
Country 6447 0
Australia
Phone 6447 0
61 7 3163 6118
Fax 6447 0
Email 6447 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.