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

Abstract

BackgroundSterile 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.Methods/designDesign: A double blind randomised placebo controlled trialSetting: Maternity hospitals in AustraliaParticipants: 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 CouncilTrial registration:Australian New Zealand Clinical Trials Registry (No ACTRN12611000221954).DiscussionSterile 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.

Effects of Intradermal Sterile Water Injections in Women with Low Back Pain in Labor: A Randomized, Controlled, Clinical Trial

“…In the present study, although the C/S rates were lower in the case of SWI, this did not reach statistical significance (SWI: 10.7%; placebo: 20.1%, p=0.088). Lee et al ( 21 ) initiated the study entitled “Impact on caesarean section rates following injections of sterile water (ICARIS)”, which was planned to last between 2-3 years with a hypothesis that the positive effects of SWI might decrease the C/S rates. Although recent studies have shown that regional analgesia does not affect the C/S rate, this issue continues to be debated.…”

Caesarean delivery rates and analgesia effectiveness following injections of sterile water for back pain in labour: A multicentre, randomised placebo controlled trial

“…The study protocol was approved by Royal Brisbane and Women's Hospital Human Ethics Review Committee for the Australian sites and the South Central – Oxford B Research Ethics Committee for the UK site. The study protocol has been published previously [13] .…”

Comparative Analgesic Effects of Intradermal and Subdermal Injection of Sterile Water on Active Labor Pain

“…Thus, 0.1 - 0.3 cc sterile water or normal saline (as placebo) was injected intradermally at four sacral points. They showed a significant reduction in the cesarean section rate in the sterile water injection group ( 22 ). In another study on 100 parturient women in India, 50 women were injected with 4 cc sterile water and 50 women with 4 cc normal saline intradermally on the lumbosacral area.…”