Impact on Caesarean section rates following injections of sterile water (ICARIS): a multicentre randomised controlled trial

Lee, Nigel, Mårtensson, Lena B., Homer, Caroline, Webster, Joan, Gibbons, Kristen, Stapleton, Helen, Dos Santos, Natalie, Beckmann, Michael, Gao, Yu and Kildea, Sue (2013) Impact on Caesarean section rates following injections of sterile water (ICARIS): a multicentre randomised controlled trial. BMC Pregnancy and Childbirth, 13 May 2013: 105.1-105.10. doi:10.1186/1471-2393-13-105

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Author Lee, Nigel
Mårtensson, Lena B.
Homer, Caroline
Webster, Joan
Gibbons, Kristen
Stapleton, Helen
Dos Santos, Natalie
Beckmann, Michael
Gao, Yu
Kildea, Sue
Title Impact on Caesarean section rates following injections of sterile water (ICARIS): a multicentre randomised controlled trial
Journal name BMC Pregnancy and Childbirth   Check publisher's open access policy
ISSN 1471-2393
Publication date 2013-05-03
Year available 2013
Sub-type Article (original research)
DOI 10.1186/1471-2393-13-105
Open Access Status DOI
Volume 13
Issue May 2013
Start page 105.1
End page 105.10
Total pages 10
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2014
Language eng
Formatted abstract
Background Sterile water injections have been used as an effective intervention for the management of back pain during labour. The objective of the current research is to determine if sterile water injections, as an intervention for back pain in labour, will reduce the intrapartum caesarean section rate.

Design: A double blind randomised placebo controlled trial
Setting: Maternity hospitals in Australia
Participants: 1866 women in labour, ≥18 years of age who have a singleton pregnancy with a fetus in a cephalic presentation at term (between 37 + 0 and 41 + 6 weeks gestation), who assess their back pain as equal to or greater than seven on a visual analogue scale when requesting analgesia and able to provide informed consent.
Intervention: Participants will be randomised to receive either 0.1 to 0.3 millilitres of sterile water or a normal saline placebo via four intradermal injections into four anatomical points surrounding the Michaelis’ rhomboid over the sacral area. Two injections will be administered over the posterior superior iliac spine (PSIS) and the remaining two at two centimetres posterior, and one centimetre medial to the PSIS respectively.
Main outcome measure: Proportion of women who have a caesarean section in labour.
Randomisation: Permuted blocks stratified by research site.
Blinding (masking): Double-blind trial in which participants, clinicians and research staff blinded to group assignment.
Funding: Funded by the National Health and Medical Research Council
Trial registration:Australian New Zealand Clinical Trials Registry (No ACTRN12611000221954).

Discussion Sterile water injections, which may have a positive effect on reducing the CS rate, have been shown to be a safe and simple analgesic suitable for most maternity settings. A procedure that could reduce intervention rates without adversely affecting safety for mother and baby would benefit Australian families and taxpayers and would reduce requirements for maternal operating theatre time. Results will have external validity, as the technique may be easily applied to maternity populations outside Australia. In summary, the results of this trial will contribute High level evidence on the impact of SWI on intrapartum CS rates and provide evidence of the analgesic effect of SWI on back pain.
Keyword Sterile water injection
Caesarean section rates
Back pain
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
School of Medicine Publications
School of Nursing, Midwifery and Social Work Publications
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Created: Wed, 04 Sep 2013, 13:35:23 EST by Vicki Percival on behalf of School of Nursing, Midwifery and Social Work