Evidence map›Paper›PMID 35172876›Full record

ArticleTrials2022

Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trial.

Nigel Lee, Yu Gao, Lena B Mårtensson, Leonie Callaway, Belinda Barnett, Sue Kildea

Erratum issuedOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Nigel LeeSchool of Nursing Midwifery and Social Work, University of Queensland, Level 3 Chamberlain Building, St Lucia, Queensland, Australia. nigel.lee@uq.edu.au.ORCID http://orcid.org/0000-0002-7350-5574
Yu GaoMolly Wardaguga Research Centre, College of Nursing & Midwifery, Charles Darwin University, Level 11, East building, 410 Ann St, Brisbane, Queensland, 4000, Australia.
Lena B MårtenssonSchool of Health Sciences, University of Skovde, Box 408, SE541 28, Skövde, Sweden.
Leonie CallawayWomen's and Newborn Services, Royal Brisbane and Women's Hospital, Level 6, Ned Hanlon Building, Butterfield Street, Herston, Queensland, 4029, Australia.
Belinda BarnettSchool of Nursing Midwifery and Social Work, University of Queensland, Level 3 Chamberlain Building, St Lucia, Queensland, Australia.
Sue KildeaMolly Wardaguga Research Centre, College of Nursing & Midwifery, Charles Darwin University, 17 Grevillea Drive, Sadadeen, Alice Springs, 0870, Australia.
Charles Darwin University · AUThe University of Queensland · AURoyal Brisbane and Women's Hospital · AUUniversity of Skövde · SE

Funding

National Health and Medical Research Council APP2006488
6 · The paper itself

Abstract

backgroundUp 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.

methodsIn 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 registrationANZCTR ACTRN12621001036808 . Registered on 05 August 2021.

Indexed as

Analgesia, ObstetricalLabor, ObstetricLabor PainMaternal Health ServicesFemaleHumansInfant, NewbornPragmatic Clinical Trials as TopicPregnancyRandomized Controlled Trials as TopicWaterWaterAnalgesiaLabour painRandomised controlled trialSterile water injections

Identifiers

PMID35172876
PMCPMC8848906
OpenAlexW4212906290

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.