Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trialShow others and affiliations
2022 (English)In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 155Article in journal (Refereed) Published
Abstract [en]
Background: Up to 80% of women use some form of pharmacological analgesia during labour and birth. The side effects of pharmacological agents are often incompatible with the concurrent use of non-pharmacological pain-relieving strategies, such as water immersion, ambulation and upright positioning, or may have negative effects on both the mother and foetus. Sterile water injections given into the skin of the lumbar region have been demonstrated to reduce back pain during labour. However, the injections given for back pain have no effect on abdominal contraction pain. The analgesic efficacy of sterile water injections for abdominal pain during childbirth is unknown. The injections cause an immediate, brief but significant pain that deters some women from using the procedure. This study aims to investigate the use of water injections given intradermally into the abdomen to relieve labour contraction pain. A vapocoolant spray will be applied to the skin immediately prior to the injections to reduce the injection pain. Methods: In this pragmatic, placebo-controlled trial, 154 low-risk women in labour at term with a labour pain score ≥ 60 on a 100-ml visual analogue scale (VAS) will be randomly allocated to receive either six injections of sterile water or a sodium chloride 0.9% solution as a placebo (0.1–0.3 ml per injection). Three injections are given along the midline from the fundus to the supra-pubis and three laterally across the supra-pubis. The primary outcome will be the difference in VAS score 30 min post-injection between the groups. Secondary outcomes include VAS score of the injection pain on administration, VAS score of labour pain at 60 and 90 min and maternal and neonatal birth outcomes. Discussion: Access to effective pain relief during labour is fundamental to respectful and safe maternity care. Pharmacological analgesics should support rather than limit other non-pharmacological strategies. Sterile water injections have the potential to provide an alternative form of labour pain relief that is easy to administer in any labour and birth setting and is compatible with other non-pharmacological choices. Trial registration: ANZCTR ACTRN12621001036808. Registered on 05 August 2021.
Place, publisher, year, edition, pages
BioMed Central, 2022. Vol. 23, no 1, article id 155
Keywords [en]
Analgesia, Labour pain, Randomised controlled trial, Sterile water injections, water, adverse event, female, human, labor, labor pain, maternal health service, newborn, obstetric analgesia, pregnancy, procedures, randomized controlled trial (topic), Analgesia, Obstetrical, Humans, Infant, Newborn, Labor, Obstetric, Maternal Health Services, Randomized Controlled Trials as Topic
National Category
Obstetrics, Gynecology and Reproductive Medicine
Research subject
Family-Centred Health
Identifiers
URN: urn:nbn:se:his:diva-20950DOI: 10.1186/s13063-022-06093-3ISI: 000756801600002PubMedID: 35172876Scopus ID: 2-s2.0-85124775119OAI: oai:DiVA.org:his-20950DiVA, id: diva2:1641805
Note
CC BY 4.0
This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
© 2022, The Author(s).
Correspondence to Nigel Lee.
Springer Nature
The trial was funded by the Australian Government Department of Health Medical Research Future Fund (APP2006488)
Corrigendum in: Trials 23, Article number: 321 (2022). doi:10.1186/s13063-022-06171-6
2022-03-032022-03-032024-01-17Bibliographically approved