The effect of antenatal hypnosis training on pharmacological analgesia use during labour and birth: A systematic review and meta-analysis.

BACKGROUND: The use of hypnosis as a means of pain management during labour is becoming increasingly popular. While recent reviews have reported on pain perception, relaxation and other psychological benefits the impact of hypnosis on the use of pharmacological analgesia use has not been specifically examined. QUESTION: For women in labour at term, does antenatal hypnosis instruction compared to no instruction result in decreased use of pharmacological analgesia and influence maternal and infant birth outcomes. METHODS: Databases such as PubMed, CINAHL, Cochrane Central Register of Controlled Trials and Embase were searched with dates ranging from 1947-2024. We included randomised controlled trials (RCTs) that compared antenatal hypnosis training to no hypnosis control groups, published in English and reported on pharmacological analgesia use. The Cochrane's Risk of Bias 2 for RCTs was used to assess design quality. Study selection, quality assessment, data extraction and analysis were undertaken by two independent researchers. FINDINGS: Six RCTs met the inclusion criteria (n=2937). The use of hypnosis did not result in a significant reduction in the risk of epidural use (RR. 0.79 95% CI 0.39-1.61) or other forms of pharmacological analgesia. Factors such as blinding of care providers to the participants allocated group may have reduced the chances of successful use of hypnosis. Variations in the presentation of hypnosis between studies may also impact on outcomes. DISCUSSION AND CONCLUSION: This review reports no effect on the use of pharmacological analgesia in women trained in hypnosis antenatally compared with those who were not. Our review does highlight several RCT design characteristics that could impact on the measurement and analysis of the use and efficacy of hypnosis.

Factors influencing midwives' intentions to facilitate normal physiological birth: A qualitative study.

BACKGROUND: Whilst most women desire to birth vaginally, research highlights reducing rates of normal physiological birth worldwide. Previous studies have focussed largely on clinical practices associated with vaginal birth however health care professionals' intentions are also known to effect behaviour; a factor not well understood within the context of midwifery and normal physiological birth. QUESTION/AIM: To explore factors influencing midwives' intentions to facilitate normal physiological birth. METHODS: A qualitative study using individual interviews was conducted. The Theory of Planned Behaviour was used to develop a semi-structured interview guide to gather perceptions, thoughts, knowledge, and experience of normal physiological birth from participants. Data were analysed thematically within the theoretical constructs: attitudes, subjective norms, and perceived behavioural control. FINDINGS: Fourteen midwives from various practice settings, models, and locations in Australia were interviewed. Major factors influencing midwives' intentions to facilitate normal physiological birth were influenced by workplace culture, values and influence of leaders, the need to prioritise collaborative interdisciplinary relationships and support autonomy in midwifery. DISCUSSION: Factors influencing the midwives' intentions of facilitating normal physiological birth were multifaceted. Some influences are more obvious and observable through practice, while others were rooted in underlying beliefs and attitudes that were hidden in the subconscious of those involved. However, all contributing influences ultimately shape midwives' intentions and the way in which they facilitate normal physiological birth. CONCLUSIONS: Midwives intend to support normal physiological birth; however multiple factors influence their intentions over time. Prioritising collaborative interdisciplinary relationships and supporting autonomy in midwifery could address known barriers.

A pre-post implementation study of a care bundle to reduce perineal trauma in unassisted births conducted by midwives.

PROBLEM: The perineal-bundle is a complex intervention widely implemented in Australian maternity care facilities. BACKGROUND: Most bundle components have limited or conflicting evidence and the implementation required many midwives to change their usual practice for preventing perineal trauma. AIM: To measure the effect of perineal bundle implementation on perineal injury for women having unassisted births with midwives. METHODS: A retrospective pre-post implementation study design to determine rates of second degree, severe perineal trauma, and episiotomy. Women who had an unassisted, singleton, cephalic vaginal birth at term between two time periods: January 2011 - November 2017 and August 2018 - August 2020 with a midwife or midwifery student accoucheur. We conducted logistic regression on the primary outcomes to control for confounding variables. FINDINGS: data from 20,155 births (pre-implementation) and 6273 (post-implementation) were analysed. After implementation, no significant difference in likelihood of severe perineal trauma was demonstrated (aOR 0.86, 95% CI 0.71-1.04, p = 0.124). Nulliparous women were more likely to receive an episiotomy (aOR 1.49 95% CI 1.31-1.70 p < 0.001) and multiparous women to suffer a second degree tear (aOR 1.18 95% CI 1.09-1.27 p < 0.001). DISCUSSION: This study adds to the growing body of literature which suggests a number of bundle components are ineffective, and some potentially harmful. Why, and how, the bundle was introduced at scale without a research framework to test efficacy and safety is a key concern. CONCLUSION: Suitably designed trials should be undertaken on all proposed individual or grouped perineal protection strategies prior to broad adoption.

Perineal repair performed by midwives in Australia: A cross-sectional survey study of education and practice.

PROBLEM: Perineal repair is generally not a widely practiced skill amongst Australian midwives, the reasons for this are uncertain and may result in technique variations. BACKGROUND: Many birthing women experience perineal tears that require suturing. As midwives attend the majority of vaginal births, they would be ideally placed to undertake perineal repair. AIM: To describe the current level of midwifery perineal repair skill acquisition, knowledge, techniques and utilization by Australian midwives. METHODS: An online survey was distributed to Australian College of Midwives members and shared via social media. Data on demographics, suturing techniques, reasons why midwives did or did not suture and barriers to skill acquisition were collected. Descriptive statistics were calculated for all variables including percentages, mean, standard deviation, median and range as appropriate. FINDINGS: 375 completed surveys were received between April and May 2023. 197 midwives indicated current suturing practice and 178 did not suture. Contributing to continuity of care was the most common motivating factor. The use of a continuous suturing technique for all layers of a perineal injury was reported by the majority of suturing midwives. There was greater variation in the management of labial tears. Low numbers of skilled midwives to support attaining competency and high workloads were the main barriers to attaining suturing skills. DISCUSSION: Australian midwives view perineal suturing as a valid midwifery skill that can contribute to continuity of care. Largely organisational barriers exist to skill development and greater utilisation. CONCLUSION: Perineal repair should be prioritised as a fundamental midwifery skill.

Monte Carlo modelling of a prototype small-body portable graphite calorimeter for ultra-high dose rate proton beams.

Background and purpose: Accurate dosimetry in Ultra-High Dose Rate (UHDR) beams is challenging because high levels of ion recombination occur within ionisation chambers used as reference dosimeters. A Small-body Portable Graphite Calorimeter (SPGC) exhibiting a dose-rate independent response was built to offer reduced uncertainty on secondary standard dosimetry in UHDR regimes. The aim of this study was to quantify the effect of the geometry and material properties of the device on the dose measurement. Materials and methods: A detailed model of the SPGC was built in the Monte Carlo code TOPAS (v3.6.1) to derive the impurity and gap correction factors, kimp and kgap. A dose conversion factor, DwMC/DgMC, was also calculated using FLUKA (v2021.2.0). These factors convert the average dose to its graphite core to the dose-to-water for a 249.7 MeV mono-energetic spot-scanned clinical proton beam. The effect of the surrounding Styrofoam on the dose measurement was examined in the simulations by substituting it for graphite. Results: The kimp and kgap correction factors were 0.9993 ± 0.0002 and 1.0000 ± 0.0001, respectively when the Styrofoam was not substituted, and 1.0037 ± 0.0002 and 0.9999 ± 0.0001, respectively when substituted for graphite. The dose conversion factor was calculated to be 1.0806 ± 0.0001. All uncertainties are Type A. Conclusions: Impurity and gap correction factors, and the dose conversion factor were calculated for the SPGC in a FLASH proton beam. Separating out the effect of scatter from Styrofoam insulation showed this as the dominating correction factor, amounting to 1.0043 ± 0.0002.

Consent during labour and birth as observed by midwifery students: A mixed methods study.

BACKGROUND: While consent is an integral part of respectful maternity care, how this is obtained during labour and birth presents conflicting understandings between midwives' and women's experiences. Midwifery students are well placed to observe interactions between women and midwives during the consent process. AIM: The purpose of this study was to explore the observations and experiences of final year midwifery students of how midwives obtain consent during labour and birth. METHODS: An online survey was distributed via universities and social media to final year midwifery students across Australia. Likert scale questions based on the principles of informed consent (indications, outcomes, risks, alternatives, and voluntariness) were posed for intrapartum care in general and for specific clinical procedures. Students could also record verbal descriptions of their observations via the survey app. Recorded responses were analysed thematically. FINDINGS: 225 students responded with 195 completed surveys; 20 students provided audio recorded data. Student's observations suggested that the consent process varied considerably depending on the clinical procedure. Discussions of risks and alternatives during labour were frequently omitted. DISCUSSION: The student's accounts suggest that in many instances during labour and birth the principles of informed consent are not being applied consistently. Presenting interventions as routine care subverted choice for women in favour of the midwives' preferences. CONCLUSIONS: Consent during labour and birth is invalidated by a lack of disclosure of risks and alternatives. Health and education institutions should include information in guidelines, theoretical and practice training on minimum consent standards for specific procedures inclusive of risks and alternatives.

Absolute dosimetry for FLASH proton pencil beam scanning radiotherapy.

A paradigm shift is occurring in clinical oncology exploiting the recent discovery that short pulses of ultra-high dose rate (UHDR) radiation-FLASH radiotherapy-can significantly spare healthy tissues whilst still being at least as effective in curing cancer as radiotherapy at conventional dose rates. These properties promise reduced post-treatment complications, whilst improving patient access to proton beam radiotherapy and reducing costs. However, accurate dosimetry at UHDR is extremely complicated. This work presents measurements performed with a primary-standard proton calorimeter and derivation of the required correction factors needed to determine absolute dose for FLASH proton beam radiotherapy with an uncertainty of 0.9% (1[Formula: see text]), in line with that of conventional treatments. The establishment of a primary standard for FLASH proton radiotherapy improves accuracy and consistency of the dose delivered and is crucial for the safe implementation of clinical trials, and beyond, for this new treatment modality.

Mutations in the transcriptional regulator MeCP2 severely impact key cellular and molecular signatures of human astrocytes during maturation.

Mutations in the MECP2 gene underlie a spectrum of neurodevelopmental disorders, most commonly Rett syndrome (RTT). We ask whether MECP2 mutations interfere with human astrocyte developmental maturation, thereby affecting their ability to support neurons. Using human-based models, we show that RTT-causing MECP2 mutations greatly impact the key role of astrocytes in regulating overall brain bioenergetics and that these metabolic aberrations are likely mediated by dysfunctional mitochondria. During post-natal maturation, astrocytes rely on neurons to induce their complex stellate morphology and transcriptional changes. While MECP2 mutations cause cell-intrinsic aberrations in the astrocyte transcriptional landscape, surprisingly, they do not affect the neuron-induced astrocyte gene expression. Notably, however, astrocytes are unable to develop complex mature morphology due to cell- and non-cell-autonomous aberrations caused by MECP2 mutations. Thus, MECP2 mutations critically impact key cellular and molecular features of human astrocytes and, hence, their ability to interact and support the structural and functional maturation of neurons.

Comparing compliance with commencement and use of two partograph designs for women in active labour: A randomised controlled trial.

BACKGROUND: Documentation and assessment of progress in labour using a partograph is recommended by the World Health Organisation to assist in the timely recognition of labour dystocia. Recent studies have tested new designs of partographs that aim to account for more variable rates of labour progress. However, other studies have suggested that poor compliance in the completion of partographs affects utility. The objective of this study was to compare two types of partographs for compliance in documentation and use for managing labour. METHODS: Low-risk nulliparous women in spontaneous labour (n = 228) were randomised to either an Action Line (control) (n = 114) or Dystocia Line partograph (intervention) (n = 114). Primary outcome was compliance with instructions for commencement of the partograph following a multifaceted training strategy. Secondary outcomes included compliance with the accompanying clinical management protocol for each partograph; and labour and birth outcomes. RESULTS: The compliance rate for commencing the Action line partograph was 43.2% compared to 67.0% (p = 0.02) for the Dystocia line partograph. Other than a reduction in artificial rupture of membranes in the Dystocia Line group there were no other differences in labour management or birth outcomes. The use of centralised electronic display of labour progress may be a contributing factor. CONCLUSIONS: Compliance with the commencement and use of either partograph was low. There was little indication that the partograph was being utilized in the assessment and management of prolonged labour. Further studies are needed to explore the current utility of partographs in labour management and the effect of centralised monitoring of progress in high resource settings.

A Comparison of the Timing of Hand Expressing of Human Milk With Breast Massage to Standard Care for Mothers of Preterm Infants: An Exploratory Pilot Using a Randomized Controlled Design.

BACKGROUND: Globally, 10% of all births are preterm. Access to human milk via manual breast expression is required to reduce the incidence of adverse outcomes related to prematurity. However, there is little evidence to recommend optimum timing to commence breast expression in mothers of preterm infants or the most effective method. RESEARCH AIMS: (1) To test feasibility of recruitment and compliance to the protocol and (2) to determine influence of using hand expressing and breast massage on milk production, engorgement, mastitis, and breastfeeding status at 3 months. METHODS: This study was an exploratory parallel two-group, pilot randomized controlled trial. Mothers of preterm infants at a metropolitan maternity hospital in Queensland Australia (N = 31) were randomized to receive either hand expressing and breast massage within the 1st hr of birth or standard care, hand expressing within 6 hr of birth, to determine the influence on milk production, engorgement, mastitis, and breastfeeding status at 3 months. RESULTS: Feasibility targets were not met; however, valuable learning from this trial uncovered barriers facing midwives in the birth suite to commencing expressing in the 1st hr of birth. There was no difference in occurrence of secondary outcomes, although trends support future study. CONCLUSIONS: Overall, unpredictability of preterm birth influenced our ability to recruit participants. Important directions for future study design would benefit from incorporating expressing times up to 6 hr with a replicable breast massage.

The impact of a perineal care bundle on women's birth experiences in Queensland, Australia: A qualitative thematic analysis.

A care bundle was introduced into 28 Australian hospitals in 2018 with the aim of reducing severe perineal tears. There has been limited research regarding the impact of this bundle on women's birth experiences. QUESTION: How does the introduction of a perineal care bundle impact on women's birth experiences in Queensland maternity hospitals? METHODS: We recruited 18 women who had birthed in five Queensland hospitals where the bundle had been implemented. Semi-structured, individual interviews were analysed using reflexive thematic analysis. FINDINGS: Three descriptive themes were generated: 1) Lack of information and consent to bundle elements, 2) Other non-consented and disrespectful treatment and 3) Recommendations for hospitals and clinicians. Two analytic themes were generated: 1) Default-position: Prioritising policies over women's autonomy and 2) Counter-position: Women asserting their rights to autonomy and respect. DISCUSSION: None of the women interviewed could recall having received information about the perineal care bundle from clinicians during pregnancy. While many women accepted that its elements were in their or their baby's best interests, this was not the case for all women. Some women reported coercive and non-consented application of bundle elements, which they found distressing. CONCLUSION: Given the broader institutional context in which the perineal bundle was implemented, the impact on information provision, informed consent and the detrimental emotional consequences for some women arising from the bundle's implementation were largely foreseeable. The potential for bundled care initiatives to impinge on women's human rights to autonomy and respectful care should be given greater preventative attention prior to implementation.

Midwife-Led Continuity of Antenatal Care and Breastfeeding Duration Beyond Postpartum Hospital Discharge: A Systematic Review.

BACKGROUND: The World Health Organization recommends that infants should be exclusively breastfed for the first 6 months of life and that breastfeeding should continue for 2 years and beyond. Most women initiate breastfeeding, but many do not continue for the recommended duration. While midwife-led continuity of antenatal care is linked to improved mother and infant outcomes, the influence on breastfeeding duration has not been previously reviewed. RESEARCH AIM: To critically analyze the literature that compared midwife-led continuity of antenatal care with other models of care where researchers have measured breastfeeding duration beyond postpartum hospital discharge. METHODS: A systematic literature review with critical analysis was used to answer the research aim. We systematically searched and screened five databases for quantitative studies where researchers had reported breastfeeding duration beyond postpartum hospital discharge after midwife-led continuity of antenatal care, compared with another model of antenatal care. Methodological quality was assessed using tools from the Cochrane Collaboration (RoB2 and ROBINS-I). In total, nine studies met the inclusion criteria. RESULTS: Clear conclusions about the association between midwife-led continuity of antenatal care and breastfeeding duration were not found. The risk of bias within non-randomized studies ranged from serious to critical, and a judgement of "some concerns" of risk of bias in the one randomized study. CONCLUSION: To date, the question of whether midwife-led continuity of antenatal care improves breastfeeding duration has not been established. There has been a lack of consistency in definitions of breastfeeding and descriptions of models of care, which has weakened the evidence-based of literature reviewed.Our review protocol was registered with PROSPERO; although due to COVID-19, this registration was not checked for eligibility by the PROSPERO team (CRD42020151276). https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020151276.

Midwives experiences of interventions to improve breast expression following preterm birth: A qualitative study.

OBJECTIVE: Preterm birth impacts approximately 10% of women globally. Midwives are often the first point of care after the birth of a preterm infant providing mothers with information and support for breast expression. However, despite guidelines that suggest expression within the first hour of birth, most first expressions occur much later. This study aimed to seek an understanding of midwives' experiences with the first expression for mothers of preterm infants, including the barriers and facilitators that midwives may face. DESIGN: A qualitative design using semi-structured interviews via focus groups. Thematic analysis was used to identify relevant themes and sub-themes. PARTICIPANTS: Participants included midwives providing care to women in preterm labour and birth at a tertiary maternity hospital in Australia (N=12). All participating midwives cared for mothers of preterm infants between 28 and 35 weeks' gestation up to six hours following birth. FINDINGS: Two major themes resulted from the data, including the changing expectations of infant feeding and the responsibility versus expectation to support a woman to express in the first hour of birth with other competing clinical and organisational tasks. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Whilst individual philosophies on the benefits of human milk were positive, expressing in the birth suite was dictated by essential clinical tasks and by the institutions value placed on expressing in the first hour. Clear objectives to undertake expressing within the first hour or within the birth suite stay, need to be included in policy and supported by management and team leaders, to increase early expressing rates.

Ultrahigh dose rate pencil beam scanning proton dosimetry using ion chambers and a calorimeter in support of first in-human FLASH clinical trial.

PURPOSE: To provide ultrahigh dose rate (UHDR) pencil beam scanning (PBS) proton dosimetry comparison of clinically used plane-parallel ion chambers, PTW (Physikalisch-Technische Werkstaetten) Advanced Markus and IBA (Ion Beam Application) PPC05, with a proton graphite calorimeter in a support of first in-human proton FLASH clinical trial. METHODS: Absolute dose measurement intercomparison of the plane-parallel plate ion chambers and the proton graphite calorimeter was performed at 5-cm water-equivalent depth using rectangular 250-MeV single-layer treatment plans designed for the first in-human FLASH clinical trial. The dose rate for each field was designed to remain above 60 Gy/s. The ion recombination effects of the plane-parallel plate ion chambers at various bias voltages were also investigated in the range of dose rates between 5 and 60 Gy/s. Two independent model-based extrapolation methods were used to calculate the ion recombination correction factors ks to compare with the two-voltage technique from most widely used clinical protocols. RESULTS: The mean measured dose to water with the proton graphite calorimeter across all the predefined fields is 7.702 ± 0.037 Gy. The average ratio over the predefined fields of the PTW Advanced Markus chamber dose to the calorimeter reference dose is 1.002 ± 0.007, whereas the IBA PPC05 chamber shows ∼3% higher reading of 1.033 ± 0.007. The relative differences in the ks values determined from between the linear and quadratic extrapolation methods and the two-voltage technique for the PTW Advanced Markus chamber are not statistically significant, and the trends of dose rate dependence are similar. The IBA PPC05 shows a flat response in terms of ion recombination effects based on the ks values calculated using the two-voltage technique. Differences in ks values for the PPC05 between the two-voltage technique and other model-based extrapolation methods are not statistically significant at FLASH dose rates. Some of the ks values for the PPC05 that were extrapolated from the three-voltage linear method and the semiempirical model were reported less than unity possibly due to the charge multiplication effect, which was negligible compared to the volume recombination effect in FLASH dose rates. CONCLUSIONS: The absolute dose measurements of both PTW Advanced Markus and IBA PPC05 chambers are in a good agreement with the National Physical Laboratory graphite calorimeter reference dose considering overall uncertainties. Both ion chambers also demonstrate good reproducibility as well as stability as reference dosimeters in UHDR PBS proton radiotherapy. The dose rate dependency of the ion recombination effects of both ion chambers in cyclotron generated PBS proton beams is acceptable and therefore, both chambers are suitable to use in clinical practice for the range of dose rates between 5 and 60 Gy/s.

Chemotherapy Coupled to Macrophage Inhibition Induces T-cell and B-cell Infiltration and Durable Regression in Triple-Negative Breast Cancer.

Immunosuppressive elements within the tumor microenvironment, such as tumor-associated macrophages (TAM), can present a barrier to successful antitumor responses by cytolytic T cells. Here we employed preclinical syngeneic p53 null mouse models of triple-negative breast cancer (TNBC) to develop a treatment regimen that harnessed the immunostimulatory effects of low-dose cyclophosphamide coupled with the pharmacologic inhibition of TAMs using either a small-molecule CSF1R inhibitor or an anti-CSF1R antibody. This therapeutic combination was effective in treating several highly aggressive TNBC murine mammary tumor and lung metastasis models. Single-cell RNA sequencing characterized tumor-infiltrating lymphocytes including Th cells and antigen-presenting B cells that were highly enriched in responders to combination therapy. In one model that exhibited long-term posttreatment tumor regression, high-dimensional imaging techniques identified the close spatial localization of B220+/CD86+-activated B cells and CD4+ T cells in tertiary lymphoid structures that were present up to 6 weeks posttreatment. The transcriptional and metabolic heterogeneity of TAMs was also characterized in two closely related claudin-low/mesenchymal subtype tumor models with differential treatment responses. A murine TAM signature derived from the T12 model was highly conserved in human claudin-low breast cancers, and high expression of the TAM signature correlated with reduced overall survival in patients with breast cancer. This TAM signature may help identify human patients with claudin-low breast cancer that will benefit from the combination of cyclophosphamide and anti-CSF1R therapy. These studies illustrate the complexity of the tumor immune microenvironment and highlight different immune responses that result from rational immunotherapy combinations. SIGNIFICANCE: Immunostimulatory chemotherapy combined with pharmacologic inhibition of TAMs results in durable treatment responses elicited by Th cells and B cells in claudin-low TNBC models.

Sterile water injections for management of renal colic pain: a systematic review.

BACKGROUND: Since the 1950s a small number of centres have used sterile water injections (SWI) to treat renal colic pain. We undertook this review to determine the efficacy of SWI to manage the pain of renal colic. METHODS: We searched the electronic databases PubMed, Cochrane Central Register, CINAHL, and Scopus from database inception to 7 November 2021 for randomized controlled trials that met the inclusion criteria. RESULTS: Six trials were included in the review (n = 894 patients). Two placebo controlled trials were included in the meta-analysis. Other trials compared SWI to Diclofenac, Morphine, or oral Paracetamol. The overall quality of the trial was low. Compared to a placebo SWI demonstrated a significant reduction in self-reported pain at 30 min (Mean difference [MD] = -4.68, 95% Confidence Interval [CI] = -5.21, -4.15. p < 0.001, I2 = 0%) and at or beyond 60 min post-injection (MD = -5.34 95% CI = -5.85, -4.82, p ≤ 0.001, I2 = 0%). Pain relief provided by SWI was significantly better than oral paracetamol and equivalent to Diclofenac and Morphine. No significant side-effects were attributed to SWI use in any trials. DISCUSSION/CONCLUSION: SWI could be a suitable alternative for management of renal colic pain where alternatives such as non-steroidal anti-inflammatory and opioid drugs are either unavailable or contraindicated. However, further research is required to establish the role of SWI in renal colic pain management.

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

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.

A comparison of two versus four sterile water injections for the relief of back pain in labour: A multicentre randomised equivalence trial.

BACKGROUND: Recent trials demonstrated the safety and efficacy of sterile water injections to provide relief from labour back pain. While four injections is the most common approach variations in technique, such as employing two injections, are also used. AIM: To determine if the analgesic effect of two sterile water injections is clinically equivalent to four. METHODS: 238 women in labour with a Visual Analogue Scale pain score (VAS) of 70 millimetres (mm) (0 = no pain; 100 = worst pain imaginable) were randomised to two or four sterile water injections. The primary outcome was pain measured on a VAS at 30 min post treatment. A priori margin of equivalence was set at ±10 mm. Secondary outcomes included the likelihood of achieving an at least 30% and 50% reduction in pain, birth and neonatal outcomes. RESULTS: At 30 min post-injection the difference in VAS scores between the techniques was -5.97 (95% Confidence Interval [CI] -13.18-1.22). As the lower end of the CI exceeds the margin of -10 mm equivalence was not demonstrated. Both techniques achieved an at least 30% reduction in pain in over 75% of participants though duration of effect was longer in the four injection group. There was no difference in other birth related secondary outcomes. CONCLUSION: Four injections provided a margin of benefit over two injections in level and duration of analgesia. DISCUSSION: Four injections remains the technique of choice though two injections still provided significant pain relief and would be suitable where it was not possible or desirable to provide four.