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Sterile water injections
Review question
What is the effectiveness of injected water papules for pain relief during labour?
Introduction
Injections of sterile water have been suggested as an effective method to treat back pain for women in labour. They have the potential to provide a cheap and relatively easy method of pain relief and one that could be widely available in various birth settings, including home births and midwife led units.
There is currently little guidance available on the best approach for administering this intervention (including route of administration, site of administration, dose) and its effectiveness at relieving pain in labour. The aim of this review was to determine the effectiveness of injected water papules for pain relief during labour and to determine if they should be recommended as an intervention.
Summary of the protocol
See Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.
Table 1
Summary of the protocol (PICO table).
For further details see the review protocol in appendix A.
Methods and process
This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in appendix A and the methods document (supplementary document 1).
Declarations of interest were recorded according to NICE’s conflicts of interest policy.
Effectiveness
Included studies
Eleven studies were included for this review: 1 Cochrane systematic review (Derry 2012) included 7 randomised controlled trials (RCTs) (Ader 1990, Bahasadri 2006, Kushtagi 2009, Martensson 1999, Saxena 2009, Trolle 1991 and Wiruchpongsanon 2006), and 10 RCTs (Almassinokiani 2020, Farag 2015, Fouly 2018, Koyucu 2018, Labrecque 1999, Lee 2013, Lee 2020, Martensson 2008, Rai 2013 and Rezaie 2019).
Two RCTs compared sterile water injections to dry injections (Almassinokiani 2020, Koyucu 2018). One Cochrane systematic review (Derry 2012) and 5 RCTs compared sterile water injections to saline injections (Farag 2015, Fouly 2018, Lee 2020, Rai 2013 and Rezaie 2019). Two RCTs compared sterile water injections to non-pharmacological pain relieving strategies: transcutaneous electrical nerve stimulation (TENS) (Labrecque 1999) and acupuncture (Martensson 2008). One RCT compared a high dose of sterile water injections to a low dose of sterile water injections (Lee 2013). One RCT compared sterile water injections to standard care, which included massage, water bath and movement (Labrecque 1999). The studies were from Australia, Canada, Denmark, Egypt, India, Iran, Nepal, Sweden, Thailand, Turkey and the UK.
Routes and doses of administration varied between studies, with 9 studies using subcutaneous/subdermal administration (with individual injections of 0.1ml to 0.5ml) and 13 studies using intracutaneous/intradermal administration (with individual injections of 0.1ml to 0.5ml). Studies used a single injection or a pattern of 2-4 separate injections into the Michaelis’ rhomboid.
The included studies are summarised in Table 2.
See the literature search strategy in appendix B and study selection flow chart in appendix C.
Excluded studies
Studies not included in this review are listed, and reasons for their exclusion are provided in appendix J.
Summary of included studies
Summaries of the studies that were included in this review are presented in Table 2.
Table 2
Summary of included studies.
See the full evidence tables in appendix D and the forest plots in appendix E.
Summary of the evidence
Across comparisons with dry injections, saline injections and standard care (massage, bath and movement), the majority of the evidence showed that sterile water injections had an important benefit in terms of general labour pain, back pain during labour and satisfaction. There was no evidence to suggest a difference in mode of birth, or use of other pharmacological analgesia. There was a possible harm in the comparison with saline injections, with an increase in neonatal admissions with the sterile water, but there were concerns around the quality of the evidence.
When compared to dry injections, sterile water injections at 0.4ml and 2ml doses showed an important benefit on general labour pains and back pains during labour. This was seen from 10 minutes up to 180 minutes, with the exception of 2ml dose at 10 minutes where there was no evidence of an important difference. The quality of the evidence ranged from low to high, with most of the evidence that showed a difference of high quality. Concerns were over imprecision for some outcomes, and indirectness where risk status or whether labour was induced was not reported. Overall there was no important benefit of sterile water injections over dry injections on caesarean birth, instrumental vaginal birth or the need for epidural analgesia, with the evidence of very low to moderate quality. High quality evidence showed an important benefit of sterile water injections over dry injections for satisfaction with treatment.
Overall sterile water injections showed an important benefit over saline injections in terms of back pain during labour. The quality of the evidence ranged from very low to moderate, with similar distribution between low and moderate and slightly more outcomes rated as very low. Most of the evidence was downgraded for indirectness due to not reporting on risk status or whether labour was induced. There were also concerns for risk of bias and imprecision for some of the evidence. The majority of the evidence showed a benefit of sterile water injections over saline injections on pain outcomes at the 0.4ml dose, from 10 minutes up to 120 minutes after injections. At doses of 0.6ml, the majority of the evidence showed no important benefits of sterile water injections over saline injections, with most of the evidence of moderate quality. At the 1ml dose low to moderate quality evidence showed an important benefit of sterile water injections over saline injections in terms of pain at 45 minutes and 90 minutes after injection, but not at other time points. The data was mixed at the 2ml dose, with some of the evidence showing an important benefit on pain, but some not. Overall, the majority of the evidence showed no evidence of an important difference on mode of birth, but some evidence showed a possible increase in caesarean births with sterile water injections at 1ml, and a possible increase in instrumental vaginal births at 0.4ml. The findings were imprecise, and there were concerns around the indirectness of the population and also risk of bias. The evidence showed that women were satisfied with sterile water injections, but the quality of the evidence was very low, with the main concerns around risk of bias and indirectness of the population. When analysing by subgroup analysis, satisfaction was less apparent in high income settings. There was no evidence to suggest a difference between sterile water injections or saline in terms of the different types of rescue pharmacological analgesia, with the majority of the evidence being very low quality. The evidence showed a possible important harm of sterile water injections over saline injections on neonatal admissions, but the quality of the evidence was very low due to imprecision, risk of bias and indirectness.
Different doses of sterile water injections were compared. The evidence showed an important benefit of a high dose of sterile water injections (0.4ml) on pain outcomes, when compared to a low dose (0.1ml). The evidence was of very low quality, with imprecise findings, and concerns over the indirectness of the population, as whether the labour was induced was not reported. There were also some concerns over the risk of bias. There was no evidence of an important difference for caesarean births or instrumental vaginal births, but moderate quality evidence that showed there was no difference between the doses on spontaneous vaginal births. Very low quality evidence showed no important difference on whether women would use the same treatment again, and no evidence of an important difference for satisfaction or use of rescue pharmacological analgesia.
Subcutaneous injections of sterile water were compared to intracutaneous injections of sterile water, and overall the evidence showed no clear benefit of one technique over another on pain outcomes, mode of birth or satisfaction. Most of the evidence was rated low to very low quality, with only some of the evidence of moderate quality. Most of the concerns were around the directness of the evidence as risk status or whether labour was induced were not reported. There were some concerns over the risk of bias and also around the imprecision of some findings.
Sterile water injections were compared to other non-pharmacological pain relieving strategies. When compared to TENS, sterile water injections had an important benefit on reducing pain and reducing caesarean births, but there was no evidence of an important difference for satisfaction or use of epidural analgesia. The evidence was rated as very low quality with concerns over the risk of bias and imprecision. There were also concerns over the indirectness as some women were included between 36-37 weeks of gestation, and whether the labour was induced was not reported. When compared to acupuncture, sterile water injections had an important benefit in terms of general labour pain. The quality of the evidence was very low. There were some concerns over imprecision, but most of the concerns were around the indirectness as risk status was not reported, and risk of bias. There was no evidence of an important difference between sterile water injections and acupuncture on caesarean births or instrumental vaginal births, but moderate quality evidence showed no important difference on spontaneous vaginal births. Very low quality evidence suggested that there was no evidence of a difference between the comparators on use of other rescue analgesia.
There was no evidence reported for infection at the site of injection for any of the comparisons.
See appendix F for full GRADE tables.
Economic evidence
Included studies
A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.
Excluded studies
Economic studies not included in this review are listed, and reasons for their exclusion are provided in appendix K.
Economic model
No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.
The committee’s discussion and interpretation of the evidence
The outcomes that matter most
As the aim of the review was to determine the effectiveness of water papules as a method of analgesia, the committee agreed that pain outcomes (general labour pain and back pain) and mode of birth were critical outcomes for this review. They agreed it was important to identify between general labour pain and back pain as sterile water injections could have an effect on one type of pain but not another. They agreed that mode of birth was a critical outcome as they wanted to find out whether sterile water injections have an impact on the number of women needing an assisted vaginal birth, or a caesarean birth.
The committee agreed that it was important to find out the impact of water papules on women’s experiences of labour and birth, and so they chose this as an important outcome. The committee recognised the great importance of women’s experience, but they were aware that data on this outcome was likely to be sparse and unlikely to inform decision-making in a meaningful way, so they prioritised other outcomes as critical. They also chose the use of rescue analgesia as an important outcome, as this would provide another indication of the effectiveness of water papules. As water papules involve the use of up to 4 different injection sites, the committee agreed it was important to find out whether there was increased risk of infection due to their use. Finally, the committee chose neonatal unit admission as an important outcome to determine if the use of sterile water injections had any adverse impact on the baby.
The quality of the evidence
The quality of the evidence for outcomes was assessed with GRADE and was rated as high to very low. The main issues were around the indirectness of the evidence. Most of the studies did not report the risk status of the women or whether the labour was induced. Some of the studies included women who had been induced, and some did not report the proportion of those out of the whole sample who had been induced. Some studies did not report on whether women received parenteral analgesia before the intervention. There were concerns for many outcomes around the imprecision of the estimate of effect. There were also concerns of risk of bias for many outcomes. The main issues were around the knowledge of the intervention and the potential for this to have an influence on subjective outcomes. Other concerns over bias were around not enough information provided on missing outcome data, or removing women from the study if they used rescue analgesia.
Benefits and harms
The committee discussed the evidence around sterile water injections and agreed to make recommendations supporting the use of sterile water injections for women experiencing back pain during labour. They agreed that the evidence on sterile water injections when compared with saline and dry injections were the most informative and supported these recommendations. They discussed concerns over the quality and paucity of evidence between comparisons with standard care and other non-pharmacological pain reliving strategies and agreed that this evidence was less useful in helping them make recommendations. The committee had concerns over the quality of the evidence, and therefore agreed they could not make a strong recommendation. They discussed that women should be given the option to choose sterile water injections as a method of analgesia for back pain, and in practice they would have the option to request different analgesia if sterile water injections were not an effective pain relieving strategy for them.
The committee discussed that there was some evidence showing a benefit on general labour pains, but agreed there was not enough evidence to support a recommendation and as most of the evidence of benefit was for back pain, they agreed to recommend sterile water injection for back pain during labour only.
The committee agreed that the most useful recommendations for practice would give clear guidance to practitioners on the dose of sterile water injections, and the route of injection. The committee discussed the injection route, and agreed that, although the majority of the evidence was for intracutaneous administration, as the evidence did not show a difference between outcomes when the two techniques were compared, they would make a recommendation for either intracutaneous or subcutaneous administration. They agreed that they would make it clear in the recommendation that both techniques could be used, and agreed this would help avoid confusion in practice. The committee also discussed that most midwives would be familiar with administering injections via the subcutaneous route and did not want to limit the intervention to midwives skilled in administration via intracutaneous injection only.
The committee agreed that it was important to make women aware that injections of sterile water could be painful. This was not an outcome of the review, but from their experience the committee were aware that women experience a short-lived feeling of pain or stinging at the site of injection. The committee discussed the variation across studies regarding the time of onset of pain relief, and some contradicting data which showed a benefit in terms of pain relief at various time points in some studies, but not the same benefit at the same time points in other studies. The committee discussed that the indirect population in some studies could explain this variation if some of the women had had their labour induced, and others not as this might affect the pain onset. They also discussed that it could be due to the fact that pain is a subjective outcome and felt differently among women. Nevertheless, they agreed that it was important to inform women about when they might expect to feel pain relief and how long it may last for and so they used the evidence to include in the recommendation that pain relief was likely to be felt from 10 minutes after the injections and could last up to 3 hours.
The committee discussed the evidence, which showed mixed results for pain relief with different doses. The committee noted that there could be a number of reasons for the conflicting findings such as different ways of measuring pain: some studies recorded the pain level on a pain scale, whereas others reported number of women reporting a certain percentage of pain reduction from baseline. They also discussed that stage of labour could be a factor. Sterile water injections can be administered during the latent and active phases of the first stage of labour, and even during the second stage. The studies did not consistently report which stage of labour women were in, with some studies using cervical dilation and others the stage of labour, therefore pre-specified subgroup analysis by stage of labour could not be carried out and the committee were unable to comment on how stage of labour could have an effect on pain. However, they agreed that the larger and more recent trials using a 4 × 0.1ml dose with the intracutaneous route, showed a benefit for back pain relief. The committee also specified that a 4 × 0.5ml dose should be used with the subcutaneous route of administration, as most of the subcutaneous evidence corresponded with this dosage. The committee discussed that the majority of the evidence in terms of reduction in back pain with a 4 × 0.5ml dose showed a benefit, but that this was not universal and at some time points no difference was seen, and not of high quality, which was another reason that the committee did not make a strong recommendation. The committee recommended the site of injections to be in the Rhombus of Michaelis region, which is in line with site of administration reported in the evidence.
The committee noted that some of the evidence suggested women would choose the same treatment again in the future, and they also discussed the potential harms of sterile water injections. The evidence showed sterile water injections may be associated with more neonatal admissions. Due to the very low quality of the evidence, and borderline statistical significance, the committee were not concerned. However, the committee also noted that this method of pain relief during labour did not lead to more instrumental or caesarean births, and the lack of evidence for harms further reinforced the committee’s recommendation.
No evidence had been identified on infection at the site of injection, and although the committee noted that intracutaneous and subcutaneous injections are safe, they were aware they can rarely cause irritation at the injection site and lead to infections.
Cost effectiveness and resource use
As no economic evidence was identified and because this topic was not a high priority for economic evaluation, the committee made a qualitative assessment of the cost effectiveness. They noted that this was a low-cost intervention both in terms of consumables and staff time. The committee noted that there was evidence to suggest that water injections could be effective for back pain in labour and, although there were concerns with respect to the quality of the evidence, they reasoned that water injections could improve health-related quality of life at a cost that was acceptable to the NHS.
The committee discussed that recommending sterile water injections for back pain in labour could be a change in practice as they were not currently recommended in the guideline. They were aware that some midwives may already use them for women with back pain, but that some midwives may require additional training to allow them to administer these injections to women.
The committee agreed that the low cost of the intervention and the fact that midwives would already have the necessary skills to give subcutaneous injections meant that the recommendations would not have a great impact on NHS resources.
Recommendations supported by this evidence review
This evidence review supports recommendations 1.6.13 to 1.6.15.
References – included studies
Ader 1991
Ader, L. (1991) Injections of sterile water for labour pain. Nursing times 87: 53 [PubMed: 1825354]Almassinokiani 2020
Almassinokiani, F., Ahani, N., Akbari, P. et al. (2020) Comparative analgesic effects of intradermal and subdermal injection of sterile water on active labor pain. Anesthesiology and pain medicine 10(2) [PMC free article: PMC7352939] [PubMed: 32754431]Bahasadri 2006
Bahasadri, S., Ahmadi-Abhari, S., Dehghani-Nik, M. et al. (2006) Subcutaneous sterile water injection for labour pain: a randomised controlled trial. Australian & New Zealand journal of obstetrics & gynaecology 46(2): 102–106 [PubMed: 16638030]Derry 2012
Derry, S., Straube, S., Moore, R. A. et al. (2012) Intracutaneous or subcutaneous sterile water injection compared with blinded controls for pain management in labour. Cochrane Database of Systematic Reviews [PubMed: 22258999]Farag 2015
Farag, A; Mohammed, K; Morsy, M (2015) Intracutaneous Sterile Water Injections for Relief of Back Pain during Labor. Medical Journal of Cairo University 83(1): 401–408Fouly 2018
Fouly, Howieda, Herdan, Ragaa, Habib, Dina et al. (2018) Effectiveness of injecting lower dose subcutaneous sterile water versus saline to relief labor back pain: Randomized controlled trial. European journal of midwifery 2: 3 [PMC free article: PMC7848597] [PubMed: 33537564]Koyucu 2018
Koyucu, R. G., Demirci, N., Yumru, A. E. et al. (2018) Effects of intradermal sterile water injections in women with low back pain in labor: a randomized, controlled, clinical trial. Balkan medical journal 35(2): 148–154 [PMC free article: PMC5863252] [PubMed: 29072177]Kushtagi 2009
Kushtagi, P. and Bhanu, B. T. (2009) Effectiveness of subcutaneous injection of sterile water to the lower back for pain relief in labor. Acta obstetricia et gynecologica Scandinavica 88(2): 231–233 [PubMed: 19096945]Labrecque 1999
Labrecque, M., Nouwen, A., Bergeron, M. et al. (1999) A randomized controlled trial of nonpharmacologic approaches for relief of low back pain during labor. Journal of family practice 48(4): 259–263 [PubMed: 10229249]Lee 2013
Lee, N., Webster, J., Beckmann, M. et al. (2013) Comparison of a single vs. a four intradermal sterile water injection for relief of lower back pain for women in labour: a randomised controlled trial. Midwifery 29(6): 585–591 [PubMed: 22770818]Lee 2020
Lee, N., Gao, Y., Collins, S. L. et al. (2020) Caesarean delivery rates and analgesia effectiveness following injections of sterile water for back pain in labour: a multicentre, randomised placebo controlled trial. Eclinicalmedicine 25 [PMC free article: PMC7486301] [PubMed: 32954233]Martensson 1999
Martensson, L. and Wallin, G. (1999) Labour pain treated with cutaneous injections of sterile water: a randomised controlled trial. British journal of obstetrics and gynaecology 106(7): 633–7 [PubMed: 10428516]Martensson 2008
Martensson, Lena; Stener-Victorin, Elisabet; Wallin, Gunnar (2008) Acupuncture versus subcutaneous injections of sterile water as treatment for labour pain. Acta Obstetricia et Gynecologica Scandinavica 87(2): 171–177 [PubMed: 18231884]Rai 2014
Rai, R, Uprety, D, Pradhan, T et al. (2014) Subcutaneous Sterile Water Injection for Labor Pain: A Randomized Controlled Trial. Nepal Journal of Obstetrics and Gynaecology 8(2): 68–70Rezaie 2019
Rezaie, Mehri, Shaabani, Sanaz, Jahromi, Farzin Sabouri et al. (2019) The Effect of Subcutaneous and Intracutaneous Injections of Sterile Water and Normal Saline on Pain Intensity in Nulliparous Women: A Randomized Controlled Trial. Iranian journal of nursing and midwifery research 24(5): 365–371 [PMC free article: PMC6714122] [PubMed: 31516523]Saxena 2009
Saxena, K. N.; Nischal, H.; Batra, S. (2009) Intracutaneous injections of sterile water over the sacrum for labour analgesia. Indian journal of anaesthesia 53(2): 169–173 [PMC free article: PMC2900101] [PubMed: 20640118]Trolle 1991
Trolle, B., Moller, M., Kronborg, H. et al. (1991) The effect of sterile water blocks on low back labor pain. American Journal of Obstetrics and Gynecology 164(5i): 1277–1281 [PubMed: 2035569]Wiruchpongsanon 2006
Wiruchpongsanon, P. (2006) Relief of low back labor pain by using intracutaneous injections of sterile water: a randomized clinical trial. Chotmaihet thangphaet [Journal of the Medical Association of Thailand] 89(5): 571–576 [PubMed: 16756038]
Effectiveness
Appendices
Appendix A. Review protocols
Appendix B. Literature search strategies
Literature search strategies for review question: What is the effectiveness of injected water papules for pain relief during labour?
Review question search strategies
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Health economics search strategies
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Appendix C. Effectiveness evidence study selection
Study selection for: What is the effectiveness of injected water papules for pain relief during labour? (PDF, 185K)
Appendix D. Evidence tables
Appendix E. Forest plots
Forest plots for review question: What is the effectiveness of injected water papules for pain relief during labour?
This section includes forest plots only for outcomes that are meta-analysed. Outcomes from single studies are not presented here; the quality assessment for such outcomes is provided in the GRADE profiles in appendix F.
Comparison 1: Sterile water injections versus dry injections
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Comparison 2: Subcutaneous sterile water injections versus intracutaneous sterile water injections
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Comparison 3: Sterile water injections versus saline injections
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Appendix F. GRADE tables
Appendix G. Economic evidence study selection
Appendix H. Economic evidence tables
Economic evidence tables for review question: What is the effectiveness of injected water papules for pain relief during labour?
No evidence was identified which was applicable to this review question.
Appendix I. Economic model
Economic model for review question: What is the effectiveness of injected water papules for pain relief during labour?
No economic analysis was conducted for this review question.
Appendix J. Excluded studies
Excluded studies for review question: What is the effectiveness of injected water papules for pain relief during labour?
Excluded effectiveness studies
Table 11Excluded studies and reasons for their exclusion
Study | Reason |
---|---|
Ader, L. (1991) Injections of sterile water for labour pain. Nursing times 87: 53 [PubMed: 1825354] |
- Study design - not a randomised controlled trial Commentary on the systematic review by Ader 1990 |
Ader, L.; Hansson, B.; Wallin, G. (1990) Parturition pain treated by intracutaneous injections of sterile water. Pain 41(2): 133–138 [PubMed: 2142271] |
- Included as part of a systematic review See Derry 2012 |
Anderson, F. W. J. and Johnson, C. T. (2005) Complementary and alternative medicine in obstetrics. International Journal of Gynecology and Obstetrics 91(2): 116–124 [PubMed: 16168989] |
- Study design - not a systematic review A narrative description of the literature. No new additional studies matching our PICO identified |
Bahasadri, S., Ahmadi-Abhari, S., Dehghani-Nik, M. et al. (2006) Subcutaneous sterile water injection for labour pain: a randomised controlled trial. Australian & New Zealand journal of obstetrics & gynaecology 46(2): 102–106 [PubMed: 16638030] |
- Included as part of a systematic review See Derry 2012 |
Balsbaugh, T. A. (1999) Cutaneous injections of sterile water for the relief of labor pain. Journal of family practice 48(10): 746–747 [PubMed: 12224665] |
- Study design - not a randomised controlled trial Commentary and summary of randomised controlled trial by Martensson 1999 |
Bergmann, R. (1997) Pain management: an alternative to sterile water injections?. Jordmorbladet: 11–13 [PubMed: 9431040] | - Article not in English |
Ctri (2019) To study labour analgesia with drotavarin and water block. http://www |
- Clinical trial entry only Protocol checked and comparator does not meet PICO as it is pharmacological, therefore full results not retrieved |
Cui, J. Z., Geng, Z. S., Zhang, Y. H. et al. (2016) Effects of intracutaneous injections of sterile water in patients with acute low back pain: a randomized, controlled, clinical trial. Brazilian journal of medical and biological research = revista brasileira de pesquisas medicas e biologicas 49(3) [PMC free article: PMC4763824] [PubMed: 26840703] |
- Population not in PICO Population not pregnant women in labour |
Dahl, V. and Aarnes, T. (1991) Sterile water papulae for analgesia during labor. Tidsskrift for den Norske laegeforening 111(12): 1484–1487 [PubMed: 2042178] | - Article not in English |
Euctr, G. B. (2015) Impact on Caesarean Section Rates Following Injections of Sterile Water. http://www |
- Clinical trial entry only Full published results under Lee 2020 (ID 7401856) |
Fogarty, V. (2008) Intradermal sterile water injections for the relief of low back pain in labour-A systematic review of the literature. Women and birth 21(4): 157–163 [PubMed: 18926789] | - Study design - More recent systematic reviews with all included studies have been included |
Hosseini, L. (2010) The effects of subcutaneous injection of sterile water on labor pain. Journal of maternal-fetal & neonatal medicine 23(s1): 614 | - Conference abstract |
Hosseini, L.; Najar, S.; Haghighizadeh, M. H. (2010) Effect of Subcutaneous Injection of Sterile Water on Labor Pain, Type of Labor, and Satisfaction with Pain Management in Nulliparous Women. HAYAT 16(1): 41–48 | - Article not in English |
Huntley, Alyson L.; Coon, Joanna Thompson; Ernst, Edzard (2004) Complementary and alternative medicine for labor pain: a systematic review. American journal of obstetrics and gynecology 191(1): 36–44 [PubMed: 15295342] |
- Intervention not in PICO Systematic review, most of the included studies do not meet the intervention in our PICO. The studies that do meet the PICO have already been included |
Hutton, E. K., Kasperink, M., Rutten, M. et al. (2009) Sterile water injection for labour pain: a systematic review and meta-analysis of randomised controlled trials. BJOG : an international journal of obstetrics and gynaecology 116(9): 1158–66 [PubMed: 19459860] |
- Systematic review - more recent systematic review available Derry 2012 is a more recent Cochrane review than Hutton 2009 with almost all the same included studies. Derry 2012 has been included, and further additional references included from Hutton 2009 |
Irct20170924036365N (2019) effect of intra dermal and sub dermal injection of sterile water on active labor pain. http://www |
- Clinical trial entry only Full published results assessed under Almassinokiani 2020 (ID 7401815) |
Irct20180128038535N (2018) The effect of subcutaneous and intracutaneous injection of distilled sterilized water and normal saline on the severity of childbirth pain. http://www |
- Clinical trial entry only For published results decision see Rezaie 2019 (ID 7401882) |
Irct20181023041427N (2018) Effect of subcutaneous sterile water injection on back pain of Women with Active Phase of Labor. http://www |
- Clinical trial entry only Unable to locate full published results |
Jones, L., Othman, M., Dowswell, T. et al. (2012) Pain management for women in labour: an overview of systematic reviews. Cochrane Database of Systematic Reviews [PMC free article: PMC7132546] [PubMed: 22419342] |
- Intervention not in PICO Systematic review with most of the included studies not meeting the intervention criteria as specified in our PICO. Included studies meeting the criteria have been checked and no additional randomised controlled studies were identified |
Kushtagi, P. and Bhanu, B. T. (2009) Effectiveness of subcutaneous injection of sterile water to the lower back for pain relief in labor. Acta obstetricia et gynecologica Scandinavica 88(2): 231–233 [PubMed: 19096945] |
- Included as part of a systematic review See Derry 2012 |
Lee, N., Coxeter, P., Beckmann, M. et al. (2011) A randomised non-inferiority controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour. BMC pregnancy and childbirth 11: 21 [PMC free article: PMC3080350] [PubMed: 21429223] |
- Protocol entry only Full published results assessed under Lee 2013 (ID 7401861) |
Lee, N., Leiser, M.B., Halter-Wehrli, M.Y. et al. (2022) Two versus four sterile water injections for managing back pain in labour. Women and Birth 35(supplement1): 8 [PubMed: 35153152] | - Conference abstract |
Lee, N., Martensson, L. B., Homer, C. et al. (2013) Impact on Caesarean section rates following injections of sterile water (ICARIS): a multicentre randomised controlled trial. BMC pregnancy and childbirth 13 [PMC free article: PMC3651329] [PubMed: 23642147] |
- Protocol entry only Full published results assessed under Lee 2020 (ID 7401856) |
Martensson, L.; Nyberg, K.; Wallin, G. (2000) Subcutaneous versus intracutaneous injections of sterile water for labour analgesia: A comparison of perceived pain during administration. British Journal of Obstetrics and Gynaecology 107(10): 1248–1251 [PubMed: 11028576] |
- Population not in PICO Women were not pregnant |
Martensson, L. and Wallin, G. (1999) Labour pain treated with cutaneous injections of sterile water: a randomised controlled trial. British journal of obstetrics and gynaecology 106(7): 633–7 [PubMed: 10428516] |
- Included as part of a systematic review See Derry 2012 |
Martensson, Lena B., Hutton, Eileen K., Lee, Nigel et al. (2018) Sterile water injections for childbirth pain: An evidenced based guide to practice. Women and birth : journal of the Australian College of Midwives 31(5): 380–385 [PubMed: 29241699] |
- Study design - not a systematic review A narrative description of current literature. 2 additional studies identified and have been included (Rai 2013, Farag 2015) |
Martensson, Lena B, Gunnarsson, Britt-Marie, Karlsson, Sandra et al. (2022) Effect of topical local anaesthesia on injection pain associated with administration of sterile water injections - a randomized controlled trial. BMC anesthesiology 22(1): 35 [PMC free article: PMC8805377] [PubMed: 35105307] |
- Population not in PICO Not pregnant women |
Martensson, Lena and Wallin, Gunnar (2008) Sterile water injections as treatment for low-back pain during labour: A review. Australian and New Zealand Journal of Obstetrics and Gynaecology 48(4): 369–374 [PubMed: 18837842] |
- Study design - not a systematic review Not a systematic review but a narrative description of literature. No additional new studies matching our PICO were identified |
Nct (2012) Intracutaneous Sterile Water Injections. https://clinicaltrials.gov/show/NCT01513447 |
- Clinical trial entry only Full results not available as study stopped early due to not recruiting enough eligible participants |
Nct (2014) EMLA and Sterile Water Injections - Pain From Injections. https://clinicaltrials.gov/show/NCT02213185 |
- Clinical trial entry only Protocol checked and intervention does not meet the PICO so full published results not looked for |
Nct (2016) Sterile Water Injections For Pain Relief İn Labor. https://clinicaltrials.gov/show/NCT02697994 |
- Clinical trial entry only Full published results assessed under Koyucu 2018 (ID 7401808) |
Nct (2016) Subcutaneous Sterile Water Injection for Relief of Low Back Pain. https://clinicaltrials.gov/show/NCT02813330 |
- Clinical trial entry only Full published results assessed under Fouly 2018 (ID 7401840) |
Saxena, K. N.; Nischal, H.; Batra, S. (2009) Intracutaneous injections of sterile water over the sacrum for labour analgesia. Indian journal of anaesthesia 53(2): 169–173 [PMC free article: PMC2900101] [PubMed: 20640118] |
- Included as part of a systematic review See Derry 2012 |
Simkin, Penny P. and O’Hara, MaryAnn (2002) Nonpharmacologic relief of pain during labor: Systematic reviews of five methods. American Journal of Obstetrics and Gynecology 186(5suppl): S131–S159 [PubMed: 12011879] |
- Intervention not in PICO Most of the included studies do not match the intervention in our PICO. The studies that do have already been included |
Simkin, Penny and Bolding, April (2004) Update on nonpharmacologic approaches to relieve labor pain and prevent suffering. Journal of Midwifery and Women’s Health 49(6): 489–504 [PubMed: 15544978] |
- Study design - not a systematic review Narrative review of the literature. No new additional studies meeting our PICO were identified |
Tournaire, M. and Theau-Yonneau, A. (2007) Complementary and alternative approaches to pain relief during labor. Evidence-based complementary and alternative medicine 4(4): 409–417 [PMC free article: PMC2176140] [PubMed: 18227907] |
- Study design - not a systematic review Not a systematic review but a narrative description of literature. Most of the studies described do not match our intervention. Those that do have already been included |
Trolle, B., Moller, M., Kronborg, H. et al. (1991) The effect of sterile water blocks on low back labor pain. American Journal of Obstetrics and Gynecology 164(5i): 1277–1281 [PubMed: 2035569] |
- Included as part of a systematic review See Derry 2012 |
Trolle, G. B.; Hvidman, L. E.; Guldholt, I. S. (1986) Lumbar pain in parturient women treated with sterile water injections. Ugeskrift for laeger 148(20): 1200–1202 [PubMed: 3523908] | - Article not in English |
Wallin, G.; Martensson, L.; Nikodem, C. (2000) Cutaneous lumbosacral injections of sterile water were more effective than ‘placebo’ injections for relieving first stage labour pain. Evidence-Based Medicine 5(2): 56 |
- Study design - not a randomised controlled trial Commentary on Martensson 1999, which has been assessed separately (ID 7401866) |
Wiruchpongsanon, P. (2006) Relief of low back labor pain by using intracutaneous injections of sterile water: a randomized clinical trial. Chotmaihet thangphaet [Journal of the Medical Association of Thailand] 89(5): 571–576 [PubMed: 16756038] |
- Included as part of a systematic review See Derry 2012 |
Excluded economic studies
No economic evidence was identified for this review.
Appendix K. Research recommendations – full details
Research recommendations for review question: What is the effectiveness of injected water papules for pain relief during labour?
No research recommendations were made for this review question.
Final
Evidence reviews underpinning recommendations 1.6.13 to 1.6.15 in the NICE guideline
These evidence reviews were developed by NICE
Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.
NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.
- NLM CatalogRelated NLM Catalog Entries
- PMCPubMed Central citations
- PubMedLinks to PubMed
- Review Midwives and women's experiences of Sterile Water Injections for back pain during labour: An integrative review.[Midwifery. 2021]Review Midwives and women's experiences of Sterile Water Injections for back pain during labour: An integrative review.Stulz V, Liang X, Burns E. Midwifery. 2021 Dec; 103:103164. Epub 2021 Oct 6.
- Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trial.[Trials. 2022]Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trial.Lee N, Gao Y, Mårtensson LB, Callaway L, Barnett B, Kildea S. Trials. 2022 Feb 16; 23(1):155. Epub 2022 Feb 16.
- Review Sterile water injections as treatment for low-back pain during labour: a review.[Aust N Z J Obstet Gynaecol. 2008]Review Sterile water injections as treatment for low-back pain during labour: a review.Mårtensson L, Wallin G. Aust N Z J Obstet Gynaecol. 2008 Aug; 48(4):369-74.
- Labour pain treated with cutaneous injections of sterile water: a randomised controlled trial.[Br J Obstet Gynaecol. 1999]Labour pain treated with cutaneous injections of sterile water: a randomised controlled trial.Mårtensson L, Wallin G. Br J Obstet Gynaecol. 1999 Jul; 106(7):633-7.
- Sterile water injections for childbirth pain: An evidenced based guide to practice.[Women Birth. 2018]Sterile water injections for childbirth pain: An evidenced based guide to practice.Mårtensson LB, Hutton EK, Lee N, Kildea S, Gao Y, Bergh I. Women Birth. 2018 Oct; 31(5):380-385. Epub 2017 Dec 11.
- Evidence reviews for sterile water injectionsEvidence reviews for sterile water injections
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