Trial registered on ANZCTR


Trial ID
ACTRN12611000221954
Ethics application status
Not yet submitted
Date submitted
26/02/2011
Date registered
28/02/2011
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)
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.

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
Gender
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?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/06/2012
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
1846
Actual sample size
Recruitment status
Not yet recruiting
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3654 0
4101
Recruitment postcode(s) [2] 3655 0
4006
Recruitment postcode(s) [3] 3656 0
4305

Funding & Sponsors
Funding source category [1] 258567 0
Hospital
Name [1] 258567 0
Mater Health Services
Address [1] 258567 0
Raymond Terrace
South Brisbane
Queensland
4101
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
None
Name [1] 263717 0
Address [1] 263717 0
Country [1] 263717 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260563 0
Ethics committee address [1] 260563 0
Ethics committee country [1] 260563 0
Date submitted for ethics approval [1] 260563 0
28/02/2010
Approval date [1] 260563 0
Ethics approval number [1] 260563 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32272 0
Address 32272 0
Country 32272 0
Phone 32272 0
Fax 32272 0
Email 32272 0
Contact person for public queries
Name 15519 0
Nigel Lee
Address 15519 0
Mater Medical Research Institute
Level 3 Quarters Building
Mater Health Services
Raymond Terrace
South Brisbane
Queensland
4101
Country 15519 0
Australia
Phone 15519 0
+61 7 3163 6313
Fax 15519 0
Email 15519 0
nigel.lee@mater.org.au
Contact person for scientific queries
Name 6447 0
Nigel Lee
Address 6447 0
Mater Medical Research Institute
Level 3 Quarters Building
Mater Health Services
Raymond Terrace
South Brisbane
Queensland
4101
Country 6447 0
Australia
Phone 6447 0
+61 7 3163 6313
Fax 6447 0
Email 6447 0
nigel.lee@mater.org.au