Trial registered on ANZCTR


Trial ID
ACTRN12609000964213
Ethics application status
Approved
Date submitted
7/11/2009
Date registered
9/11/2009
Type of registration
Prospectively registered

Titles & IDs
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.
Scientific title
For women in labour with back pain does the single sterile water injection technique compared to the four injection technique provide comparable pain relief
Universal Trial Number (UTN)
Trial acronym
The SWITCh Trial
Linked study record

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

Intervention/exposure
Study type
Interventional
Description 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).
Intervention code [1] 241514 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 253216 0
Decrease in pain measured by Visual Analogue Pain Scale (VAS)
Timepoint [1] 253216 0
30 minutes following injection(s)
Secondary outcome [1] 262149 0
Pain score of backpain measured by VAS
Timepoint [1] 262149 0
10 minutes following injection(s)
Secondary outcome [2] 262150 0
pain associated with procedure measured by VAS
Timepoint [2] 262150 0
10 minutes following injection(s)
Secondary outcome [3] 262151 0
Pain score of backpain measured by VAS
Timepoint [3] 262151 0
60 minutes following injection(s)
Secondary outcome [4] 262152 0
Pain score of backpain measured by VAS
Timepoint [4] 262152 0
90 minutes following injection(s)
Secondary outcome [5] 262153 0
Pain score of backpain measured by VAS
Timepoint [5] 262153 0
120 mintues following injection(s)
Secondary outcome [6] 262154 0
Patient satisfaction with analgesic effect assesed using Patient Satisfaction Questionnaire
Timepoint [6] 262154 0
postpartum
Secondary outcome [7] 262155 0
Likelihood to use again with subsequent labour assesed using Patient Satisfaction Questionnaire
Timepoint [7] 262155 0
Postpartum
Secondary outcome [8] 262156 0
Other analgesia used during labour, data taken from medical records
Timepoint [8] 262156 0
Postpartum

Eligibility
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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
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).

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)
participants are invited to enroll in the trial upon experiencing significant back pain in labour.
treatment allocation by numbered sealed opaque envelopes
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
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
11/01/2010
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
320
Actual sample size
Recruitment status
Recruiting
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243988 0
Charities/Societies/Foundations
Name [1] 243988 0
J P Kelly Foundation
Address [1] 243988 0
Aubigny Place
Mater Health Services
Raymond Terrace
South Brisbane
Qld
4101
Country [1] 243988 0
Australia
Primary sponsor type
Hospital
Name
Mater Mothers' Hospital
Address
Mater Health Services
Raymond Terrace
South Brisbane
Qld
4101
Country
Australia
Secondary sponsor category [1] 251339 0
University
Name [1] 251339 0
Australian Catholic University
Address [1] 251339 0
McAuley Campus, Qld
Australian Catholic University Limited
PO Box 456, Virginia Qld 4014
Country [1] 251339 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244094 0
Mater Human Research Ethics Committee
Ethics committee address [1] 244094 0
Mater Health Services Brisbane Limited
Raymond Terrace
South Brisbane
Qld
4101
Ethics committee country [1] 244094 0
Australia
Date submitted for ethics approval [1] 244094 0
15/09/2009
Approval date [1] 244094 0
29/10/2009
Ethics approval number [1] 244094 0
1422M

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30474 0
Address 30474 0
Country 30474 0
Phone 30474 0
Fax 30474 0
Email 30474 0
Contact person for public queries
Name 13721 0
Nigel Lee
Address 13721 0
Birth Suites
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Qld
4101
Country 13721 0
Australia
Phone 13721 0
+61 7 3163 1916
Fax 13721 0
Email 13721 0
nigel.lee@mater.org.au
Contact person for scientific queries
Name 4649 0
Nigel Lee
Address 4649 0
Birth Suites
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Qld
4101
Country 4649 0
Australia
Phone 4649 0
+61 7 3163 1916
Fax 4649 0
Email 4649 0
nigel.lee@mater.org.au