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Trial registered on ANZCTR


Registration number
ACTRN12621001036808
Ethics application status
Approved
Date submitted
22/06/2021
Date registered
5/08/2021
Date last updated
5/08/2021
Date data sharing statement initially provided
5/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the Ability of Sterile Water Injections to Relieve Labour Pain
Scientific title
Investigating the Ability of Sterile Water Injections to Relieve Labour Pain
Secondary ID [1] 304396 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SATURN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Labour pain 322190 0
Condition category
Condition code
Reproductive Health and Childbirth 319880 319880 0 0
Childbirth and postnatal care
Anaesthesiology 320443 320443 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women with abdominal contraction pain during stage labour, assessed by visual analogue scale as equal to or greater than 6 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. Injections can be administered by a midwife or doctor. The injection is given intradermally using of one-millilitre syringes and 23 gauge needles. One injection into six anatomical points; at the fundus, part way between the fundus an umbilicus, part way between the umbilicus and the suprapubis, laterally (left and right) of the suprapubis. Women may receive up to four repeat treatments upon request once the VAS is again equal to or greater than 6. The overall duration of the intervention is 5 treatments over the course of the woman's labour. Repeat injections will be given in the same six anatomical sites as the initial treatment. There is no minimum time required between the initial or repeat doses. The case report form will collect data on the exact number of injections given at each treatment and reasons is less or more than six. Normal saline 0.9% is being used as a placebo. As normal saline is isotonic it does not result in the same degree of injection pain as sterile water and provides little if any analgesic effect.
Intervention code [1] 320756 0
Treatment: Other
Comparator / control treatment
Women with abdominal contraction pain during stage labour, assessed by visual analogue scale as equal to or greater than 6 will receive 0.1 – 0.3 millilitres of Normal Saline 0.9%. The exact volume injected is determined by visualisation of the resulting blister or bleb by the administering clinician. Injections can be administered by a midwife or doctor. The injection is given intradermally using of one-millilitre syringes and 23 gauge needles. One injection into six anatomical points; at the fundus, part way between the fundus an umbilicus, part way between the umbilicus and the suprapubis, laterally (left and right) of the suprapubis. Women may receive up to four repeat treatments upon request once the VAS is again equal to or greater than 6. The overall duration of the intervention is 5 treatments over the course of the woman's labour. Repeat injections will be given in the same six anatomical sites as the initial treatment. There is no minimum time required between the initial or repeat doses. The case report form will collect data on the exact number of injections given at each treatment and reasons is less or more than six.
Control group
Placebo

Outcomes
Primary outcome [1] 327754 0
The mean difference in Visual Analogue Scale (VAS) scores of labour pain following water injections compared to control
Timepoint [1] 327754 0
30 minutes post injection
Secondary outcome [1] 396447 0
The mean difference in Visual Analogue Scale (VAS) scores of labour pain following water injections compared to control
Timepoint [1] 396447 0
60 minutes post injection
Secondary outcome [2] 396451 0
The mean difference in Visual Analogue Scale (VAS) scores of labour pain following water injections compared to control
Timepoint [2] 396451 0
90 minutes post injection
Secondary outcome [3] 396452 0
The mean difference in Visual Analogue Scale (VAS) scores of labour pain following water injections compared to control
Timepoint [3] 396452 0
120 minutes post injection
Secondary outcome [4] 396453 0
Number of women reporting an at least 30% reduction in self reported VAS pain scores
Timepoint [4] 396453 0
60 minutes post injection
Secondary outcome [5] 396454 0
Number of women reporting an at least 30% reduction self reported VAS pain scores
Timepoint [5] 396454 0
90 minutes post injection
Secondary outcome [6] 396455 0
Number of women reporting an at least 30% reduction self reported VAS pain scores
Timepoint [6] 396455 0
120 minutes post injection
Secondary outcome [7] 396456 0
Number of women reporting an at least 50% reduction in self reported VAS pain scores
Timepoint [7] 396456 0
60 minutes post injection
Secondary outcome [8] 396457 0
Number of women reporting an at least 50% reduction in self reported VAS pain scores
Timepoint [8] 396457 0
90 minutes post injection
Secondary outcome [9] 396458 0
Number of women reporting an at least 50% reduction in self reported VAS pain scores
Timepoint [9] 396458 0
120 minutes post injection
Secondary outcome [10] 396459 0
The mean difference in VAS scores of injection pain between water injections compared to control
Timepoint [10] 396459 0
At time of injection
Secondary outcome [11] 396460 0
Other pharmacological use prior to and after randomisation (opiods, nitrous oxide inhalation, epidurals). This data will be assessed via data linkage to the research sites obstetric database
Timepoint [11] 396460 0
At time of birth
Secondary outcome [12] 396461 0
Non-pharmacological use prior to and after randomisation (water immersion, shower, mobility, birthball, massage, hypnobirthing) This data will be assessed via data linkage to the research sites obstetric database
Timepoint [12] 396461 0
At time of birth
Secondary outcome [13] 396462 0
Duration of active first stage labour. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [13] 396462 0
At time of birth
Secondary outcome [14] 396463 0
Duration of labour from 10 cm cervical dilation to birth of infant. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [14] 396463 0
At birth
Secondary outcome [15] 396464 0
Duration of labour from birth of infant to birth of placenta. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [15] 396464 0
At birth
Secondary outcome [16] 396465 0
Proportion of women experiencing a spontaneous vaginal birth. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [16] 396465 0
At birth
Secondary outcome [17] 396466 0
Proportion of women experiencing an instrumental birth. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [17] 396466 0
At birth
Secondary outcome [18] 396467 0
Proportion of women experiencing a caesarean section. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [18] 396467 0
At birth
Secondary outcome [19] 396468 0
Proportion of women experiencing an augmentation of labour using artificial rupture of membranes. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [19] 396468 0
At birth
Secondary outcome [20] 396469 0
Proportion of women experiencing an augmentation of labour using synthetic oxytocin infusion. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [20] 396469 0
At birth
Secondary outcome [21] 396470 0
Estimated blood loss at birth. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [21] 396470 0
At birth
Secondary outcome [22] 396471 0
Neonatal Apgar score
Timepoint [22] 396471 0
one minute post birth
Secondary outcome [23] 396473 0
Neonatal Apgar score
Timepoint [23] 396473 0
5 mins post birth
Secondary outcome [24] 396474 0
Proportion of infants experiencing resuscitation (intermittent positive pressure ventilation, CPR, medications used). This data will be assessed via data linkage to the research sites obstetric database
Timepoint [24] 396474 0
At birth
Secondary outcome [25] 396476 0
Proportion of infants experiencing any SCN or ICN admission. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [25] 396476 0
At birth
Secondary outcome [26] 396477 0
Length of stay in hospital (hours). This data will be assessed via data linkage to the research sites obstetric database
Timepoint [26] 396477 0
At discharge from hospital
Secondary outcome [27] 396478 0
Proportion of women fully breastfeeding at discharge. This data will be assessed via data linkage to the research sites obstetric database
Timepoint [27] 396478 0
At discharge from hospital
Secondary outcome [28] 396479 0
Maternal satisfaction as measured by postnatal survey designed specifically for the trial
Timepoint [28] 396479 0
In the first two week following the birth of the infant
Secondary outcome [29] 396480 0
Cost of care from admission in labour until discharge from hospital. This data will be assessed via data linkage to the research sites medical coding dataset.
Timepoint [29] 396480 0
At discharge from hospital
Secondary outcome [30] 396555 0
Number of women reporting an at least 30% reduction in self reported VAS pain scores
Timepoint [30] 396555 0
at 30 minutes post injections
Secondary outcome [31] 396556 0
Number of women reporting an at least 50% reduction in self reported VAS pain scores
Timepoint [31] 396556 0
at 30 minutes post injection
Secondary outcome [32] 396557 0
The mean difference in Visual Analogue Scale (VAS) scores of labour pain following water injections compared to control
Timepoint [32] 396557 0
30 minutes post repeat injections

Eligibility
Key inclusion criteria
In labour (spontaneous or induced)
Are equal to or greater than 16 years of age
Have a term singleton pregnancy (between 37 and 42 weeks gestation)
Have a fetus in a cephalic (head down) presentation
Experience abdominal labour pain assessed by visual analogue scale VAS as equal to or greater than 6
Are able to provide informed consent
Minimum age
16 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple pregnancy
Malpresentation (breech, transverse, shoulder)
Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia
Serious medical condition of pregnancy (e.g. unstable hypertension, insulin controlled diabetes)

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)
Identical ampoules of either normal saline or sterile water will be pre-prepared by the RBWH pharmacy and packed in opaque black plastic packets and arranged based on the allocation schedule. Following confirmation of consent two midwives will remove the next ampoule in sequence and administer the injections.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedules will be prepared using computer-generated pseudo-random numbers, using varying block sizes and stratified by clinical area (Birth Centre / Birth Suite).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Randomisation and stratification should ensure that groups are equal in baseline characteristics. Relative risks with 95% confidence intervals for the primary outcome will be calculated. Secondary outcome measures of categorical data will be analysed with chi-squared tests and continuous data will be analysed with t-tests for normally distributed data and Mann-Whitney U test for parametric data. Regression will be used if necessary to adjust for any other confounding variables. All study outcomes will be analysed using a two-sided P value of < 0.05 to indicate statistical significance. The study is only powered to report the primary outcome and for secondary outcomes confidence intervals (CI) will be included as a measure of the effect size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19621 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 34254 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 308767 0
Government body
Name [1] 308767 0
National Health and Medical Research Council
Address [1] 308767 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 308767 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia, Queensland 4072
Country
Australia
Secondary sponsor category [1] 309670 0
None
Name [1] 309670 0
Address [1] 309670 0
Country [1] 309670 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308680 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 308680 0
Level 14 Block 7
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Ethics committee country [1] 308680 0
Australia
Date submitted for ethics approval [1] 308680 0
22/06/2021
Approval date [1] 308680 0
26/07/2021
Ethics approval number [1] 308680 0
HREC/2021/QRBW/76389
Ethics committee name [2] 308682 0
University of Queensland Human Ethics Committee
Ethics committee address [2] 308682 0
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia
Ethics committee country [2] 308682 0
Australia
Date submitted for ethics approval [2] 308682 0
27/07/2021
Approval date [2] 308682 0
27/07/2021
Ethics approval number [2] 308682 0
2021/HE001769

Summary
Brief summary
Access to safe, effective pain relief is a hallmark of high quality maternity care. For women in labour the pharmacological options for pain relief have changed little in over 50 years. The choices of opioids and nitrous oxide have been reported as having a limited effect on labour pain and undesirable side effects. Epidurals provide excellent analgesia, however they severely limit mobility in labour, require advanced medical skills, close monitoring of mother and baby and can increase the risk of further medical interventions in birth. This trial will test the novel, off-label use of sterile water injections (six injections of 0.1 - 0.3 millilitres each) administered into the abdominal skin of laboring women to relieve contraction pain. Our research team’s previous work has provided definitive evidence for the effectiveness of water injections to relieve back pain (not contraction pain) in labour for approximately two hours. The injections can be repeated with no side effects. However, injections given into the back have no effect on abdominal contraction labour pain. Our proposed trial will use a randomised, double blind, placebo-controlled design to test the safety and analgesic effectiveness of water injections to relieve labour contraction pain. We will conduct survey and qualitative studies to assess satisfaction, acceptability and impact on the birth experience alongside a cost-effectiveness study. If successful, our study will provide a new option for labour pain relief that is safe, effective, cost efficient, only requiring skills available to many health care providers and ideal for women wanting to avoid the side effects of other pharmacological analgesic options. The common availability of sterile water and the simplicity of administration would make the procedure useful in regional areas and settings (e.g. homebirth), where other pharmacological analgesic options such as epidurals may not be available, and women in countries with developing health systems.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111538 0
Dr Nigel Lee
Address 111538 0
Level 3 Chamberlain Building
School of Nursing Midwifery and Social Work
University of Queensland
St Lucia, Queensland 4072
Country 111538 0
Australia
Phone 111538 0
+61 0427231390
Fax 111538 0
Email 111538 0
nigel.lee@uq.edu.au
Contact person for public queries
Name 111539 0
Dr Nigel Lee
Address 111539 0
Level 3 Chamberlain Building
School of Nursing Midwifery and Social Work
University of Queensland
St Lucia, Queensland 4072
Country 111539 0
Australia
Phone 111539 0
+61 0427231390
Fax 111539 0
Email 111539 0
nigel.lee@uq.edu.au
Contact person for scientific queries
Name 111540 0
Dr Nigel Lee
Address 111540 0
Level 3 Chamberlain Building
School of Nursing Midwifery and Social Work
University of Queensland
St Lucia, Queensland 4072
Country 111540 0
Australia
Phone 111540 0
+61 0427231390
Fax 111540 0
Email 111540 0
nigel.lee@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data
When will data be available (start and end dates)?
Three months following results publication with no end date
Available to whom?
May be available to researchers upon written request with a methodologically sound proposal, suitable ethical approval if applicable and a signed data sharing agreement
Available for what types of analyses?
any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator nigel.lee@uq.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results