title: Impact on caesarean section rates following injections of sterile water (ICARIS): a multicentre randomised controlled trial.
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.
  
  
  METHODS
  
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  Funded by the National Health and Medical Research CouncilTrial registration:Australian New Zealand Clinical Trials Registry (No ACTRN12611000221954).
  
  
  CONCLUSIONS
  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.
authors: Mater Medical Research Institute, Mater Health Services, Brisbane, Queensland, Australia. Nigel.lee@mater.org.au
authors: Nigel
authors: N
authors: Lee
authors: Lena B
authors: LB
authors: Mårtensson
authors: Caroline
authors: C
authors: Homer
authors: Joan
authors: J
authors: Webster
authors: Kristen
authors: K
authors: Gibbons
authors: Helen
authors: H
authors: Stapleton
authors: Natalie
authors: N
authors: Dos Santos
authors: Michael
authors: M
authors: Beckmann
authors: Yu
authors: Y
authors: Gao
authors: Sue
authors: S
authors: Kildea
mesh_terms: D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage*; D001315:Australia; D001416:Back Pain / Q000188:drug therapy; D002585:Cesarean Section; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007271:Injections, Intradermal; D007743:Labor, Obstetric; D011247:Pregnancy; D012107:Research Design; D012445:Sacrococcygeal Region; D014867:Water / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D000700:Analgesics; D014867:Water
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