Trial from ANZCTR


Trial ID ACTRN12609000964213
Trial Status: Registered
Date Submitted: 7/11/2009
Date Registered: 9/11/2009
Prospectively registered

Page 1

Public title A randomised, controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour.
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format For women in labour with back pain does the single sterile water injection technique compared to the four injection technique provide comparable pain relief
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym The SWITCh Trial
Update:
 

Page 2

Health condition(s) or problem(s) studied:
Women experiencing significant back pain in labour 252138 0
 Update:
 Reason:
Condition category: Condition code:
Reproductive Health and Childbirth Childbirth and postnatal care
 Update:
 Update:
  Reason:
252345 252345 0 0

Page 3

Descriptions of intervention(s) / exposure Single intradermal injection of 0.1 ml of sterile water to the most painful point, or central to the most painful area of backpain as indicated by the woman. The injection is administered when the woman descibes the backpain during any stage of labour, as being equal to or greater than seven on a Visual analogue Scale (VAS).
Update:
 
Reason:
 
Intervention Code:
Treatment: Other 241514 0
Update:
 
Reason:
 
Comparator / control treatment Four intradermal injections of 0.1 ml of sterile water to the skin surrounding the Michaelis rhomboid. The injections are administered when the woman descibes the backpain during any stage of labour, as being equal to or greater than seven on a Visual analogue Scale (VAS). The four injections are administered during a single contraction, by two midwives.
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

Primary Outcome: Decrease in pain measured by Visual Analogue Pain Scale (VAS) 253216 0
Update:
 
Reason:
 
Timepoint: 30 minutes following injection(s) 253216 0
Update:
 
Reason:
 
Secondary Outcome: Pain score of backpain measured by VAS 262149 0
Update:
 
Reason:
 
Timepoint: 10 minutes following injection(s) 262149 0
Update:
 
Reason:
 
Secondary Outcome: pain associated with procedure measured by VAS 262150 0
Update:
 
Reason:
 
Timepoint: 10 minutes following injection(s) 262150 0
Update:
 
Reason:
 
Secondary Outcome: Pain score of backpain measured by VAS 262151 0
Update:
 
Reason:
 
Timepoint: 60 minutes following injection(s) 262151 0
Update:
 
Reason:
 
Secondary Outcome: Pain score of backpain measured by VAS 262152 0
Update:
 
Reason:
 
Timepoint: 90 minutes following injection(s) 262152 0
Update:
 
Reason:
 
Secondary Outcome: Pain score of backpain measured by VAS 262153 0
Update:
 
Reason:
 
Timepoint: 120 mintues following injection(s) 262153 0
Update:
 
Reason:
 
Secondary Outcome: Patient satisfaction with analgesic effect assesed using Patient Satisfaction Questionnaire 262154 0
Update:
 
Reason:
 
Timepoint: postpartum 262154 0
Update:
 
Reason:
 
Secondary Outcome: Likelihood to use again with subsequent labour assesed using Patient Satisfaction Questionnaire 262155 0
Update:
 
Reason:
 
Timepoint: Postpartum 262155 0
Update:
 
Reason:
 
Secondary Outcome: Other analgesia used during labour, data taken from medical records 262156 0
Update:
 
Reason:
 
Timepoint: Postpartum 262156 0
Update:
 
Reason:
 

Page 5

Key inclusion criteria Women at term (between 37 and 42 weeks)
Nulliparous or multiparous
Singleton pregnancy
Cephalic presentation
First stage labour (spontaneous or induced)
No previous analgesia
Back pain assessed by VAS as greater than or equal to 7
Ability to give informed consent.
Update:
 
Reason:
 
Minimum age 18 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Females
Update:
 
Reason:
 
Healthy volunteers? Yes
Update:
 
Reason:
 
Key exclusion criteria Gestation < 37 weeks
Multiple pregnancy
Malpresentation (Breech Transverse etc.)
Second stage labour
Pharmacological analgesia prior to Sterile Water Injections (SWI)
Back pain assessed by VAS < 7
Any complications of pregnancy or labour (bleeding, diabetes hypertension).
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) participants are invited to enroll in the trial upon experiencing significant back pain in labour.
treatment allocation by numbered sealed opaque envelopes
Update:
 
Reason:
 
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) computer generated random numbers with allocation concealed in numbered sealed opaque envelope
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 11/01/2010
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 320
Update:
 
Reason:
 
Recruitment status Recruiting
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Charities/Societies/Foundations 243988 0
Update:
 
Reason:
 
Name: J P Kelly Foundation 243988 0
Update:
 
Reason:
 
Address: Aubigny Place
Mater Health Services
Raymond Terrace
South Brisbane
Qld
4101
243988 0
Update:
 
Reason:
 
Country: Australia 243988 0
Update:
 
Reason:
 
Primary Sponsor Hospital
Update:
 
Reason:
 
Name: Mater Mothers' Hospital
Update:
 
Reason:
 
Address: Mater Health Services
Raymond Terrace
South Brisbane
Qld
4101
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: University 251339 0
Update:
 
Reason:
 
Name: Australian Catholic University 251339 0
Update:
 
Reason:
 
Address: McAuley Campus, Qld
Australian Catholic University Limited
PO Box 456, Virginia Qld 4014
251339 0
Update:
 
Reason:
 
Country: Australia 251339 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: Mater Human Research Ethics Committee 244094 0
Update:
 
Reason:
 
Address: Mater Health Services Brisbane Limited
Raymond Terrace
South Brisbane
Qld
4101
244094 0
Update:
 
Reason:
 
Country: Australia 244094 0
Update:
 
Reason:
 
Approval Date: 29/10/2009 244094 0
Update:
 
Reason:
 
Submitted Date: 15/09/2009 244094 0
Update:
 
Reason:
 
HREC: 1422M 244094 0
Update:
 
Reason:
 
Brief summary The aim of the study is to see if the single sterile water injection technique is as effective as the standard four injection technique in relieving lower back pain during labour and birth. If the difference in pain relief between the two techniques, thirty minutes after injection(s) is no greater or less than 1 centremeter on the VAS, the trial will have proven it's hypothesis
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

Principal Investigator
Title:
Update:
 
Reason:
 
30474 0
Name:
Update:
 
Reason:
 
30474 0
Address:
Update:
 
Reason:
 
30474 0
Country:
Update:
 
30474 0
Reason:
 
Tel:
Update:
 
Reason:
 
30474 0
Fax:
Update:
 
Reason:
 
30474 0
Email:
Update:
 
Reason:
 
30474 0
Contact person for public queries
Title:
Update:
 
Reason:
 
13721 0
Name: Nigel Lee
Update:
 
Reason:
 
13721 0
Address: Birth Suites Mater Mothers' Hospital Raymond Terrace South Brisbane Qld 4101
Update:
 
Reason:
 
13721 0
Country: Australia
Update:
 
13721 0
Reason:
 
Tel: +61 7 3163 1916
Update:
 
Reason:
 
13721 0
Fax:
Update:
 
Reason:
 
13721 0
Email: nigel.lee@mater.org.au
Update:
 
Reason:
 
13721 0

Contact person for scientific queries
Title:
Update:
 
Reason:
 
4649 0
Name: Nigel Lee
Update:
 
Reason:
 
4649 0
Address: Birth Suites Mater Mothers' Hospital Raymond Terrace South Brisbane Qld 4101
Update:
 
Reason:
 
4649 0
Country: Australia
Update:
 
4649 0
Reason:
 
Tel: +61 7 3163 1916
Update:
 
Reason:
 
4649 0
Fax:
Update:
 
Reason:
 
4649 0
Email: nigel.lee@mater.org.au
Update:
 
Reason:
 
4649 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
22793 0
Name: Nigel Lee
Update:
 
Reason:
 
22793 0
Address: Birth Suites Mater Mothers' Hospital Raymond Terrace South Brisbane Qld 4101
Update:
 
Reason:
 
22793 0
Country: Australia
Update:
 
22793 0
Reason:
 
Tel: +61 7 3163 1916
Update:
 
Reason:
 
22793 0
Fax:
Update:
 
Reason:
 
22793 0
Email: nigel.lee@mater.org.au
Update:
 
Reason:
 
22793 0
   

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