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

Lee, N; Mårtensson, LB; Homer, C; Webster, J; Gibbons, K; Stapleton, H; Santos, ND; Beckmann, M; Gao, Y; Kildea, S

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

Lee, N Mårtensson, LB Homer, C

Webster, J Gibbons, K Stapleton, H Santos, ND Beckmann, M Gao, Y Kildea, S

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Publication Type:: Journal Article
Citation:: BMC Pregnancy and Childbirth, 2013, 13
Issue Date:: 2013-05-03

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Field	Value	Language
dc.contributor.author	Lee, N	en_US
dc.contributor.author	Mårtensson, LB	en_US
dc.contributor.author	Homer, C https://orcid.org/0000-0002-7454-3011	en_US
dc.contributor.author	Webster, J	en_US
dc.contributor.author	Gibbons, K	en_US
dc.contributor.author	Stapleton, H	en_US
dc.contributor.author	Santos, ND	en_US
dc.contributor.author	Beckmann, M	en_US
dc.contributor.author	Gao, Y	en_US
dc.contributor.author	Kildea, S https://orcid.org/0000-0001-8591-4968	en_US
dc.date.available	2013-04-24	en_US
dc.date.issued	2013-05-03	en_US
dc.identifier.citation	BMC Pregnancy and Childbirth, 2013, 13	en_US
dc.identifier.uri	http://hdl.handle.net/10453/30636
dc.description.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/design: 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. © 2013 Lee et al.; licensee BioMed Central Ltd.	en_US
dc.relation	http://purl.org/au-research/grants/nhmrc/APP1024872
dc.relation.ispartof	BMC Pregnancy and Childbirth	en_US
dc.relation.isbasedon	10.1186/1471-2393-13-105	en_US
dc.subject.classification	Obstetrics & Reproductive Medicine	en_US
dc.subject.mesh	Sacrococcygeal Region	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Back Pain	en_US
dc.subject.mesh	Water	en_US
dc.subject.mesh	Analgesics	en_US
dc.subject.mesh	Cesarean Section	en_US
dc.subject.mesh	Injections, Intradermal	en_US
dc.subject.mesh	Double-Blind Method	en_US
dc.subject.mesh	Pregnancy	en_US
dc.subject.mesh	Labor, Obstetric	en_US
dc.subject.mesh	Research Design	en_US
dc.subject.mesh	Adolescent	en_US
dc.subject.mesh	Adult	en_US
dc.subject.mesh	Australia	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Young Adult	en_US
dc.title	Impact on Caesarean section rates following injections of sterile water (ICARIS): A multicentre randomised controlled trial	en_US
dc.type	Journal Article
utslib.citation.volume	13	en_US
utslib.for	1110 Nursing	en_US
utslib.for	1114 Paediatrics and Reproductive Medicine	en_US
utslib.for	1117 Public Health and Health Services	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
pubs.organisational-group	/University of Technology Sydney/Strength - WHO CC
utslib.copyright.status	open_access
dcterms.license	This work is distributed under a Creative Commons Attribution license (CC BY) http://creativecommons.org/licenses/by/2.0
pubs.publication-status	Published	en_US
pubs.volume	13	en_US

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/design: 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. © 2013 Lee et al.; licensee BioMed Central Ltd.

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http://hdl.handle.net/10453/30636