Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000863730
Ethics application status
Approved
Date submitted
31/07/2013
Date registered
5/08/2013
Date last updated
23/06/2021
Date data sharing statement initially provided
23/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of two versus four sterile water injections for the relief of back pain in labour: A randomised controlled equivalence trial
Scientific title
For women in labour with back pain does a two sterile water injection technique compared to a four injection result is comparable levels of analgesia
Secondary ID [1] 282936 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women experiencing significant back pain in labour 289753 0
Condition category
Condition code
Reproductive Health and Childbirth 290090 290090 0 0
Childbirth and postnatal care
Anaesthesiology 290132 290132 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
two intradermal injections of 0.1 ml of sterile water over the posterior superior illiac spines. The injection is administered when the woman describes the backpain during any stage of labour, as being equal to or greater than seven on a Visual analogue Scale (VAS). The two injections are administered during a single contraction, by two midwives.
Intervention code [1] 287638 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 describes 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] 290132 0
Decrease in pain measured by Visual Analogue Pain Scale (VAS)
Timepoint [1] 290132 0
30 minutes following injections
Secondary outcome [1] 303993 0
pain associated with procedure measured by VAS
Timepoint [1] 303993 0
Immediately following injections
Secondary outcome [2] 303994 0
Pain score of backpain measured by VAS
Timepoint [2] 303994 0
30 minutes following injections
Secondary outcome [3] 303995 0
Pain score of backpain measured by VAS
Timepoint [3] 303995 0
60 minutes following injections
Secondary outcome [4] 303996 0
Pain score of backpain measured by VAS
Timepoint [4] 303996 0
90 minutes following injections
Secondary outcome [5] 303997 0
Pain score of backpain measured by VAS
Timepoint [5] 303997 0
120 mintues following injections
Secondary outcome [6] 303998 0
Patient satisfaction with analgesic effect assesed using Patient Satisfaction Questionnaire
Timepoint [6] 303998 0
Postpartum
Secondary outcome [7] 303999 0
Other analgesia used during labour, data taken from medical records
Timepoint [7] 303999 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
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Gestation < 37 weeks
Multiple pregnancy
Malpresentation (Breech Transverse etc.)
Second stage labour
Pharmacological analgesia less than 4 hours prior to Sterile Water Injections (SWI)
Back pain assessed by VAS < 7
Any medical complications of pregnancy or labour ( type 1 diabetes hypertension requiring intrapartum management).

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)
variable blocks with allocation concealed in numbered, sealed opaque envelope
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Recruitment ceased due to COVID-19 and subsequent impact on staffing restrictions
Date of first participant enrolment
Anticipated
1/02/2014
Actual
9/12/2014
Date of last participant enrolment
Anticipated
Actual
6/04/2020
Date of last data collection
Anticipated
Actual
6/04/2020
Sample size
Target
354
Accrual to date
Final
242
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1364 0
Gosford Hospital - Gosford
Recruitment hospital [2] 1365 0
Manly Hospital - Manly
Recruitment hospital [3] 1366 0
Mona Vale Hospital - Mona Vale
Recruitment hospital [4] 1367 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [5] 9572 0
Fairfield Hospital - Prairiewood
Recruitment hospital [6] 11786 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 18326 0
2176 - Prairiewood
Recruitment postcode(s) [2] 23912 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 287711 0
University
Name [1] 287711 0
Univeristy of Queensland / Midwifery Research Unit
Country [1] 287711 0
Australia
Primary sponsor type
University
Name
University of Queensland / Midwifery Research Unit
Address
Aubigny Place
Mater Health Services
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 286440 0
None
Name [1] 286440 0
Address [1] 286440 0
Country [1] 286440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289667 0
Hunter New England HREC
Ethics committee address [1] 289667 0
Ethics committee country [1] 289667 0
Australia
Date submitted for ethics approval [1] 289667 0
29/11/2013
Approval date [1] 289667 0
07/04/2015
Ethics approval number [1] 289667 0
HREC/14/HAWKE/48
Ethics committee name [2] 301388 0
Mater Misericordiae Ltd Human Research Ethics Committee [EC00332]
Ethics committee address [2] 301388 0
Ethics committee country [2] 301388 0
Australia
Date submitted for ethics approval [2] 301388 0
17/07/2018
Approval date [2] 301388 0
24/07/2018
Ethics approval number [2] 301388 0
HREC/18/MHS/109

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

Contacts
Principal investigator
Name 41830 0
Dr Nigel Lee
Address 41830 0
School of Nursing Midwifery and Social Work
University of Queensland
St Lucia
4072
Country 41830 0
Australia
Phone 41830 0
+61 0427231390
Fax 41830 0
Email 41830 0
[email protected]
Contact person for public queries
Name 41831 0
Nigel Lee
Address 41831 0
School of Nursing, Midwifery and Social Work
University of Queensland
St Lucia
4072
Country 41831 0
Australia
Phone 41831 0
+61 0427231390
Fax 41831 0
Email 41831 0
[email protected]
Contact person for scientific queries
Name 41832 0
Nigel Lee
Address 41832 0
School of Nursing Midwifery and Social work
University of Queensland
St Lucia
4072
Country 41832 0
Australia
Phone 41832 0
+61 0427231390
Fax 41832 0
Email 41832 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12204Study protocol  [email protected]



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.