Trial from ANZCTR


Trial ID ACTRN12611000221954
Trial Status: Registered
Date Submitted: 26/02/2011
Date Registered: 28/02/2011
Prospectively registered

Page 1

Public title Impact on Caesarean Rates following Injections of Sterile Water (ICARIS) – A randomised controlled trial.
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format For women in labour with backpain does the inclusion of sterile water injections with standard care reduce the rate of caesarean sections.
Update:
 
Reason:
 
Secondary ID [1] 259681 0
Nil
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym ICARIS (Impact on CAesarean Rates following Injections of Sterile water)
Update:
 

Page 2

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

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Treatment: Other 258112 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Control group Placebo
Update:
 
Reason:
 

Page 4

Primary Outcome: Caesarean Section 262213 0
Update:
 
Reason:
 
Timepoint: At birth 262213 0
Update:
 
Reason:
 
Secondary Outcome: effect of SWI for back pain in labour on use of other pain relief methods 273341 0
Update:
 
Reason:
 
Timepoint: At birth 273341 0
Update:
 
Reason:
 
Secondary Outcome: To determine the effect of SWI for back pain in labour on mode of birth 273342 0
Update:
 
Reason:
 
Timepoint: At birth 273342 0
Update:
 
Reason:
 
Secondary Outcome: To determine whether SWI for back pain in labour impacts on other maternal and infant outcomes in the short term 273343 0
Update:
 
Reason:
 
Timepoint: at birth through the administration of a specifically designed questionnaire at 1 day following birth and 2 months postnatal. 273343 0
Update:
 
Reason:
 
Secondary Outcome: To determine the cost of SWI for back pain in labour compared with standard care. 273344 0
Update:
 
Reason:
 
Timepoint: 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. 273344 0
Update:
 
Reason:
 

Page 5

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
Update:
 
Reason:
 
Minimum age 18 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age 50 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Females
Update:
 
Reason:
 
Healthy volunteers? Yes
Update:
 
Reason:
 
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.
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Treatment
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Masking / blinding Blinded (masking used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Not Applicable
Update:
 
Reason:
 
Anticipated date of first participant enrolment 1/06/2012
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 1846
Update:
 
Reason:
 
Recruitment status Not yet recruiting
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 
Postcode: 4101 3654 0
Update:
 
Reason:
 
Postcode: 4006 3655 0
Update:
 
Reason:
 
Postcode: 4305 3656 0
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Hospital 258567 0
Update:
 
Reason:
 
Name: Mater Health Services 258567 0
Update:
 
Reason:
 
Address: Raymond Terrace
South Brisbane
Queensland
4101
258567 0
Update:
 
Reason:
 
Country: Australia 258567 0
Update:
 
Reason:
 
Primary Sponsor Hospital
Update:
 
Reason:
 
Name: Mater Health Services
Update:
 
Reason:
 
Address: Raymond Terrace
South Brisbane
Queensland
4101
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: None 263717 0
Update:
 
Reason:
 
Name: 263717 0
Update:
 
Reason:
 
Address: 263717 0
Update:
 
Reason:
 
Country: 263717 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? No
Update:
 
Reason:
 
Ethics Committee name: 260563 0
Update:
 
Reason:
 
Address: 260563 0
Update:
 
Reason:
 
Country: 260563 0
Update:
 
Reason:
 
Approval Date: 260563 0
Update:
 
Reason:
 
Submitted Date: 28/02/2010 260563 0
Update:
 
Reason:
 
HREC: 260563 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

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

Contact person for scientific queries
Title:
Update:
 
Reason:
 
6447 0
Name: Nigel Lee
Update:
 
Reason:
 
6447 0
Address: Mater Medical Research Institute Level 3 Quarters Building Mater Health Services Raymond Terrace South Brisbane Queensland 4101
Update:
 
Reason:
 
6447 0
Country: Australia
Update:
 
6447 0
Reason:
 
Tel: +61 7 3163 6313
Update:
 
Reason:
 
6447 0
Fax:
Update:
 
Reason:
 
6447 0
Email: nigel.lee@mater.org.au
Update:
 
Reason:
 
6447 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
24591 0
Name:
Update:
 
Reason:
 
24591 0
Address:
Update:
 
Reason:
 
24591 0
Country:
Update:
 
24591 0
Reason:
 
Tel:
Update:
 
Reason:
 
24591 0
Fax:
Update:
 
Reason:
 
24591 0
Email:
Update:
 
Reason:
 
24591 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: