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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

17/11/2024

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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

SATURN

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Labour pain

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Anaesthesiology

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]

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]

The mean difference in Visual Analogue Scale (VAS) scores of labour pain following water injections compared to control

Timepoint [1]

30 minutes post injection

Secondary outcome [1]

The mean difference in Visual Analogue Scale (VAS) scores of labour pain following water injections compared to control

Timepoint [1]

60 minutes post injection

Secondary outcome [2]

The mean difference in Visual Analogue Scale (VAS) scores of labour pain following water injections compared to control

Timepoint [2]

90 minutes post injection

Secondary outcome [3]

The mean difference in Visual Analogue Scale (VAS) scores of labour pain following water injections compared to control

Timepoint [3]

120 minutes post injection

Secondary outcome [4]

Number of women reporting an at least 30% reduction in self reported VAS pain scores

Timepoint [4]

60 minutes post injection

Secondary outcome [5]

Number of women reporting an at least 30% reduction self reported VAS pain scores

Timepoint [5]

90 minutes post injection

Secondary outcome [6]

Number of women reporting an at least 30% reduction self reported VAS pain scores

Timepoint [6]

120 minutes post injection

Secondary outcome [7]

Number of women reporting an at least 50% reduction in self reported VAS pain scores

Timepoint [7]

60 minutes post injection

Secondary outcome [8]

Number of women reporting an at least 50% reduction in self reported VAS pain scores

Timepoint [8]

90 minutes post injection

Secondary outcome [9]

Number of women reporting an at least 50% reduction in self reported VAS pain scores

Timepoint [9]

120 minutes post injection

Secondary outcome [10]

The mean difference in VAS scores of injection pain between water injections compared to control

Timepoint [10]

At time of injection

Secondary outcome [11]

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]

At time of birth

Secondary outcome [12]

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]

At time of birth

Secondary outcome [13]

Duration of active first stage labour. This data will be assessed via data linkage to the research sites obstetric database

Timepoint [13]

At time of birth

Secondary outcome [14]

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]

At birth

Secondary outcome [15]

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]

At birth

Secondary outcome [16]

Proportion of women experiencing a spontaneous vaginal birth. This data will be assessed via data linkage to the research sites obstetric database

Timepoint [16]

At birth

Secondary outcome [17]

Proportion of women experiencing an instrumental birth. This data will be assessed via data linkage to the research sites obstetric database

Timepoint [17]

At birth

Secondary outcome [18]

Proportion of women experiencing a caesarean section. This data will be assessed via data linkage to the research sites obstetric database

Timepoint [18]

At birth

Secondary outcome [19]

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]

At birth

Secondary outcome [20]

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]

At birth

Secondary outcome [21]

Estimated blood loss at birth. This data will be assessed via data linkage to the research sites obstetric database

Timepoint [21]

At birth

Secondary outcome [22]

Neonatal Apgar score

Timepoint [22]

one minute post birth

Secondary outcome [23]

Neonatal Apgar score

Timepoint [23]

5 mins post birth

Secondary outcome [24]

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]

At birth

Secondary outcome [25]

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]

At birth

Secondary outcome [26]

Length of stay in hospital (hours). This data will be assessed via data linkage to the research sites obstetric database

Timepoint [26]

At discharge from hospital

Secondary outcome [27]

Proportion of women fully breastfeeding at discharge. This data will be assessed via data linkage to the research sites obstetric database

Timepoint [27]

At discharge from hospital

Secondary outcome [28]

Maternal satisfaction as measured by postnatal survey designed specifically for the trial

Timepoint [28]

In the first two week following the birth of the infant

Secondary outcome [29]

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]

At discharge from hospital

Secondary outcome [30]

Number of women reporting an at least 30% reduction in self reported VAS pain scores

Timepoint [30]

at 30 minutes post injections

Secondary outcome [31]

Number of women reporting an at least 50% reduction in self reported VAS pain scores

Timepoint [31]

at 30 minutes post injection

Secondary outcome [32]

The mean difference in Visual Analogue Scale (VAS) scores of labour pain following water injections compared to control

Timepoint [32]

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

Sex

Females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

26/04/2022

Actual

30/04/2022

Date of last participant enrolment

Anticipated

31/10/2023

Actual

22/11/2023

Date of last data collection

Anticipated

30/11/2023

Actual

29/11/2023

Sample size

Target

154

Accrual to date

Final

160

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Herston

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Queensland

Address

St Lucia, Queensland 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital HREC

Ethics committee address [1]

Level 14 Block 7
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/06/2021

Approval date [1]

26/07/2021

Ethics approval number [1]

HREC/2021/QRBW/76389

Ethics committee name [2]

University of Queensland Human Ethics Committee

Ethics committee address [2]

Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

27/07/2021

Approval date [2]

27/07/2021

Ethics approval number [2]

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

Dr Nigel Lee

Address

Level 3 Chamberlain Building School of Nursing Midwifery and Social Work University of Queensland St Lucia, Queensland 4072

Country

Australia

Phone

+61 0427231390

Fax

[email protected]

Contact person for public queries

Name

Nigel Lee

Address

Level 3 Chamberlain Building School of Nursing Midwifery and Social Work University of Queensland St Lucia, Queensland 4072

Country

Australia

Phone

+61 0427231390

Fax

[email protected]

Contact person for scientific queries

Name

Nigel Lee

Address

Level 3 Chamberlain Building School of Nursing Midwifery and Social Work University of Queensland St Lucia, Queensland 4072

Country

Australia

Phone

+61 0427231390

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• May be available to researchers upon written request with a methodologically sound proposal, suitable ethical approval if applicable and a signed data sharing agreement

Conditions for requesting access:
• -

What individual participant data might be shared?

• de-identified individual participant data

What types of analyses could be done with individual participant data?

• any purpose

When can requests for individual participant data be made (start and end dates)?

From:
Three months following results publication with no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approvals by Principal Investigator [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trial.	2022	https://dx.doi.org/10.1186/s13063-022-06093-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically