Tending to the machine: The impact of intrapartum fetal surveillance on women in Australia.

Qualitative research about women and birthing people's experiences of fetal monitoring during labour and birth is scant. Labour and birth is often impacted by wearable or invasive monitoring devices, however, most published research about fetal monitoring is focused on the wellbeing of the fetus. This manuscript is derived from a larger mixed methods study, 'WOmen's Experiences of Monitoring Baby (The WOMB Study)', aiming to increase understanding of the experiences of women and birthing people in Australia, of being monitored; and about the information they received about fetal monitoring devices during pregnancy. We constructed a national cross-sectional survey that was distributed via social media in May and June, 2022. Responses were received from 861 participants. As far as we are aware, this is the first survey of the experiences of women and birthing people of intrapartum fetal monitoring conducted in Australia. This paper comprises the analysis of the free text survey responses, using qualitative and inductive content analysis. Two categories were constructed, Tending to the machine, which explores participants' perceptions of the way in which clinicians interacted with fetal monitoring technologies; and Impressions of the machine, which explores the direct impact of fetal monitoring devices upon the labour and birth experience of women and birthing people. The findings suggest that some clinicians need to reflect upon the information they provide to women and birthing people about monitoring. For example, freedom of movement is an important aspect of supporting the physiology of labour and managing pain. If freedom of movement is important, the physical restriction created by a wired cardiotocograph is inappropriate. Many participants noticed that clinicians focused their attention primarily on the technology. Prioritising the individual needs of the woman or birthing person is key to providing high quality woman-centred intrapartum care. Women should be provided with adequate information regarding the risks and benefits of different forms of fetal monitoring including how the form of monitoring might impact her labour experience.

Antenatal education - Putting research into practice: A guideline review.

PROBLEM: Antenatal care guidelines used in Australia are inconsistent in their recommendations for childbirth and parenting education (CBPE) classes for preparation of women and parents for pregnancy, childbirth, and early parenting. BACKGROUND: Clinical practice guidelines in maternity care are developed to assist healthcare practitioners and consumers to make decisions about appropriate care. The benefit of such guidelines relies on the translation and quality of the evidence contained within them. In the context of antenatal care guidelines, there is a potential evidence-practice gap with regard to CBPE. AIMS: This review aims to appraise the quality of Australian antenatal care guidelines in their recommendations for CBPE for women and partners. METHODS: Publicly available Australian antenatal care guidelines were identified including local health district websites and professional organisations pertaining to maternity care. Guidelines were reviewed independently, and the quality was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. FINDINGS: Five guidelines were included in the review and appraised using AGREE II. With the exception of the Department of Health Pregnancy Care Guidelines, guidelines scored poorly across all six domains. When appraised according to specific CBPE recommendations for rigour of development, presentation, and applicability; all guidelines received low scores. DISCUSSION: Prenatal services remain largely unregulated across the board, with no systematic approach to make recommendations for CBPE and guidelines lacking in rigour with regard to CBPE. CONCLUSION: Within the guidelines reviewed there was a lack of evidence-based recommendations provided for educators or consumers regarding childbirth and parenting education.

Women's experiences of changes to childbirth and parenting education in Australia during the COVID-19 pandemic: The birth in the time of COVID-19 (BITTOC) study.

OBJECTIVE: As changes to Childbirth and Parenting Education (CBPE) classes during the COVID-19 pandemic remain unexplored in Australia, our objective was to understand how changes to CBPE in Australia during the COVID-19 pandemic impacted on women's birth and postnatal experiences. METHODS: Survey responses were received from 3172 women (1343 pregnant and 1829 postnatal) for the 'Birth In The Time Of Covid-19 (BITTOC)' survey (August 2020 to February 2021) in Australia. One of the survey questions asked women if they had experienced changes to CBPE class schedules or format during the pandemic, with a follow up open ended text box inviting women to comment on the impact of these changes. The majority of women experienced changes to CBPE, with only 9 % stating they experienced no changes to classes. A content analysis was undertaken on the 929 open text responses discussing the impact these changes had on women's experience of pregnancy, birth and postpartum. RESULTS: 929 women (29 %) made 1131 comments regarding changes to CBPE classes during the pandemic. The main finding 'I felt so unprepared', highlights how women perceived the cessation or alteration of classes impacted their birth preparation, with many reporting an increased sense of isolation. Some women reported feeling 'It was good enough' with adequate provision of online classes, and others feeling 'I was let down by the system' due to communication and technological barriers. CONCLUSIONS: Results highlight the importance of ensuring continued provision of hybrid/online childbirth education models to enable versatility during times of crisis. Gaps in service provision, communication and resources for childbirth and parenting education need addressing.

The associations between women who are immigrants, refugees, or asylum seekers, access to universal healthcare, and the timely uptake of antenatal care: A systematic review.

BACKGROUND: The World Health Organization (WHO) recommends that antenatal care (ANC) commence before 12 weeks' gestation to reduce the risk of obstetric and perinatal complications. Immigrants, refugees, and asylum seekers are at higher risk for late or non-initiation of ANC, and exclusion from universal healthcare (UHC) may be a contributing factor. AIMS: The aims were to synthesise evidence regarding uptake of ANC and to examine if this is associated with inadequate access to UHC and to evaluate the link between ANC and the risk of pregnancy outcomes in the immigrant, refugee and asylum seeker population. METHODS: The review was performed according to meta-analysis of observational studies in epidemiology (MOOSE) guidelines. Five databases were systematically searched. Abstracts were screened against inclusion criteria, and eligible papers underwent data extraction by two independent reviewers per paper. The ROBINS-I tool was used to assess risk of bias. RESULTS: Twelve studies were included in the final review. All studies reported that ANC was delayed for women who were classified as immigrants, refugees, and asylum seekers as per the WHO recommendations, and this was statistically significant compared to controls in 11 of 12 studies (P < 0.05). Findings regarding ANC uptake and pregnancy complications were too heterogeneous to conclusively report an association. CONCLUSION: Immigrants, refugees and asylum seekers who are excluded from UHC present significantly later to ANC than receiving-country-born women with full access to UHC. The link between delayed ANC due to inadequate UHC access and pregnancy complications remains unclear due to the heterogeneous nature of the studies.

The AEDUCATE Collaboration. Comprehensive antenatal education birth preparation programmes to reduce the rates of caesarean section in nulliparous women. Protocol for an individual participant data prospective meta-analysis.

INTRODUCTION: Rates of medical interventions in normal labour and birth are increasing. This prospective meta-analysis (PMA) proposes to assess whether the addition of a comprehensive multicomponent birth preparation programme reduces caesarean section (CS) in nulliparous women compared with standard hospital care. Additionally, do participant characteristics, intervention components or hospital characteristics modify the effectiveness of the programme? METHODS AND ANALYSIS: Population: women with singleton vertex pregnancies, no planned caesarean section (CS) or epidural.Intervention: in addition to hospital-based standard care, a comprehensive antenatal education programme that includes multiple components for birth preparation, addressing the three objectives: preparing women and their birth partner/support person for childbirth through education on physiological/hormonal birth (knowledge and understanding); building women's confidence through psychological preparation (positive mindset) and support their ability to birth without pain relief using evidence-based tools (tools and techniques). The intervention could occur in a hospital-based or community setting.Comparator: standard care alone in hospital-based maternity units. OUTCOMES: Primary: CS.Secondary: epidural analgesia, mode of birth, perineal trauma, postpartum haemorrhage, newborn resuscitation, psychosocial well-being.Subgroup analysis: parity, model of care, maternal risk status, maternal education, maternal socio-economic status, intervention components. STUDY DESIGN: An individual participant data (IPD) prospective meta-analysis (PMA) of randomised controlled trials, including cluster design. Each trial is conducted independently but share core protocol elements to contribute data to the PMA. Participating trials are deemed eligible for the PMA if their results are not yet known outside their Data Monitoring Committees. ETHICS AND DISSEMINATION: Participants in the individual trials will consent to participation, with respective trials receiving ethical approval by their local Human Research Ethics Committees. Individual datasets remain the property of trialists, and can be published prior to the publication of final PMA results. The overall data for meta-analysis will be held, analysed and published by the collaborative group, led by the Cochrane PMA group. TRIAL REGISTRATION NUMBER: CRD42020103857.

Acupuncture or acupressure for pain management during labour.

BACKGROUND: Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined evidence about the use of acupuncture and acupressure for pain management in labour. This is an update of a review last published in 2011. OBJECTIVES: To examine the effects of acupuncture and acupressure for pain management in labour. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, (25 February 2019), the Cochrane Central Register of Controlled Trials (the Cochrane Library 2019, Issue 1), MEDLINE (1966 to February 2019), CINAHL (1980 to February 2019), ClinicalTrials.gov (February 2019), the WHO International Clinical Trials Registry Platfory (ICTRP) (February 2019) and reference lists of included studies. SELECTION CRITERIA: Published and unpublished randomised controlled trials (RCTs) comparing acupuncture or acupressure with placebo, no treatment or other non-pharmacological forms of pain management in labour. We included all women whether nulliparous or multiparous, and in spontaneous or induced labour. We included studies reported in abstract form if there was sufficient information to permit assessment of risk of bias. Trials using a cluster-RCT design were eligible for inclusion, but quasi-RCTs or cross-over studies were not. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 28 trials with data reporting on 3960 women. Thirteen trials reported on acupuncture and 15 trials reported on acupressure. No study was at a low risk of bias on all domains. Pain intensity was generally measured on a visual analogue scale (VAS) of 0 to 10 or 0 to 100 with low scores indicating less pain. Acupuncture versus sham acupuncture Acupuncture may make little or no difference to the intensity of pain felt by women when compared with sham acupuncture (mean difference (MD) -4.42, 95% confidence interval (CI) -12.94 to 4.09, 2 trials, 325 women, low-certainty evidence). Acupuncture may increase satisfaction with pain relief compared to sham acupuncture (risk ratio (RR) 2.38, 95% CI 1.78 to 3.19, 1 trial, 150 women, moderate-certainty evidence), and probably reduces the use of pharmacological analgesia (RR 0.75, 95% CI 0.63 to 0.89, 2 trials, 261 women, moderate-certainty evidence). Acupuncture may have no effect on assisted vaginal birth (very low-certainty evidence), and probably little to no effect on caesarean section (low-certainty evidence). Acupuncture compared to usual care We are uncertain if acupuncture reduces pain intensity compared to usual care because the evidence was found to be very low certainty (standardised mean difference (SMD) -1.31, 95% CI -2.14 to -0.49, 4 trials, 495 women, I2 = 93%). Acupuncture may have little to no effect on satisfaction with pain relief (low-certainty evidence). We are uncertain if acupuncture reduces the use of pharmacological analgesia because the evidence was found to be very low certainty (average RR 0.72, 95% CI 0.60 to 0.85, 6 trials, 1059 women, I2 = 70%). Acupuncture probably has little to no effect on assisted vaginal birth (low-certainty evidence) or caesarean section (low-certainty evidence). Acupuncture compared to no treatment One trial compared acupuncture to no treatment. We are uncertain if acupuncture reduces pain intensity (MD -1.16, 95% CI -1.51 to -0.81, 163 women, very low-certainty evidence), assisted vaginal birth or caesarean section because the evidence was found to be very low certainty. Acupuncture compared to sterile water injection We are uncertain if acupuncture has any effect on use of pharmacological analgesia, assisted vaginal birth or caesarean section because the evidence was found to be very low certainty. Acupressure compared to a sham control We are uncertain if acupressure reduces pain intensity in labour (MD -1.93, 95% CI -3.31 to -0.55, 6 trials, 472 women) or assisted vaginal birth because the evidence was found to be very low certainty. Acupressure may have little to no effect on use of pharmacological analgesia (low-certainty evidence). Acupressure probably reduces the caesarean section rate (RR 0.44, 95% CI 0.27 to 0.71, 4 trials, 313 women, moderate-certainty evidence). Acupressure compared to usual care We are uncertain if acupressure reduces pain intensity in labour (SMD -1.07, 95% CI -1.45 to -0.69, 8 trials, 620 women) or increases satisfaction with pain relief (MD 1.05, 95% CI 0.75 to 1.35, 1 trial, 105 women) because the evidence was found to be very low certainty. Acupressure may have little to no effect on caesarean section (low-certainty evidence). Acupressure compared to a combined control Acupressure probably slightly reduces the intensity of pain during labour compared with the combined control (measured on a scale of 0 to 10 with low scores indicating less pain) (SMD -0.42, 95% CI -0.65 to -0.18, 2 trials, 322 women, moderate-certainty evidence). We are uncertain if acupressure has any effect on the use of pharmacological analgesia (RR 0.94, 95% CI 0.71 to 1.25, 1 trial, 212 women), satisfaction with childbirth, assisted vaginal birth or caesarean section because the certainty of the evidence was all very low. No studies were found that reported on sense of control in labour and only one reported on satisfaction with the childbirth experience. AUTHORS' CONCLUSIONS: Acupuncture in comparison to sham acupuncture may increase satisfaction with pain management and reduce use of pharmacological analgesia. Acupressure in comparison to a combined control and usual care may reduce pain intensity. However, for other comparisons of acupuncture and acupressure, we are uncertain about the effects on pain intensity and satisfaction with pain relief due to very low-certainty evidence. Acupuncture may have little to no effect on the rates of caesarean or assisted vaginal birth. Acupressure probably reduces the need for caesarean section in comparison to a sham control. There is a need for further high-quality research that include sham controls and comparisons to usual care and report on the outcomes of sense of control in labour, satisfaction with the childbirth experience or satisfaction with pain relief.

Using Forbidden Points in Pregnancy: Adverse Outcomes and Quality of Evidence in Randomized Controlled Trials-A Systematic Narrative Review.

Objective: Pregnancy is a complex physical and hormonal condition. Many women experience back and pelvic pain, reflux, and headaches during pregnancy. There has been a significant rise in the popularity of acupuncture for pain conditions in pregnancy, wherein nonpharmacologic options are important. Concerns have been raised by both traditional and medical acupuncturists about using "forbidden points" during pregnancy and the risk of preterm contractions (PTC), as this could limit women's and practitioners' willingness to continue treatment during pregnancy. There is also a risk of bias introduced into clinical trials when participants are highly selected or they drop out of studies due to adverse outcomes. This review examined randomized controlled trials (RCTs) of acupuncture using forbidden points prior to 37 weeks of pregnancy to treat pain conditions, with the primary outcome of PTC. Methods: A database search identified RCTs, including trials of penetrating acupuncture that used forbidden points in their protocols to treat pregnancy-related pain conditions. STRICTA [Standards for Reporting Interventions in Clinical Trials of Acupuncture] and GRADE [Grades of Recommendation, Assessment, Development, and Evaluation] criteria were used to assess the quality of evidence. This review includes 8 RCTs reporting on 713 women. Results: Only 2 studies reported on the primary outcome of PTC, and there were insufficient data to perform a primary analysis. In these 2 studies, 6 participants withdrew due to PTC. No study was at a low risk of bias for all GRADE domains, and 3 studies were at high or unclear risk of bias in all domains. Conclusions: PTC is an important clinical outcome and should be reported routinely. The strength of evidence to date is insufficient to recommend using forbidden points prior to 37 weeks of pregnancy. Highly selected patient populations, risk of bias in study design, and participant withdrawal rates, suggest that high-quality trials are required.

Massage, reflexology and other manual methods for pain management in labour.

BACKGROUND: Many women would like to avoid pharmacological or invasive methods of pain management in labour, and this may contribute towards the popularity of complementary methods of pain management. This review examined the evidence currently available on manual methods, including massage and reflexology, for pain management in labour. This review is an update of the review first published in 2012. OBJECTIVES: To assess the effect, safety and acceptability of massage, reflexology and other manual methods to manage pain in labour. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register (30 June 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 6), MEDLINE (1966 to 30 June 2017, CINAHL (1980 to 30 June 2017), the Australian New Zealand Clinical Trials Registry (4 August 2017), Chinese Clinical Trial Registry (4 August 2017), ClinicalTrials.gov, (4 August 2017), the National Center for Complementary and Integrative Health (4 August 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (4 August 2017) and reference lists of retrieved trials. SELECTION CRITERIA: We included randomised controlled trials comparing manual methods with standard care, other non-pharmacological forms of pain management in labour, no treatment or placebo. We searched for trials of the following modalities: massage, warm packs, thermal manual methods, reflexology, chiropractic, osteopathy, musculo-skeletal manipulation, deep tissue massage, neuro-muscular therapy, shiatsu, tuina, trigger point therapy, myotherapy and zero balancing. We excluded trials for pain management relating to hypnosis, aromatherapy, acupuncture and acupressure; these are included in other Cochrane reviews. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality, extracted data and checked data for accuracy. We contacted trial authors for additional information. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: We included a total of 14 trials; 10 of these (1055 women) contributed data to meta-analysis. Four trials, involving 274 women, met our inclusion criteria but did not contribute data to the review. Over half the trials had a low risk of bias for random sequence generation and attrition bias. The majority of trials had a high risk of performance bias and detection bias, and an unclear risk of reporting bias. We found no trials examining the effectiveness of reflexology.MassageWe found low-quality evidence that massage provided a greater reduction in pain intensity (measured using self-reported pain scales) than usual care during the first stage of labour (standardised mean difference (SMD) -0.81, 95% confidence interval (CI) -1.06 to -0.56, six trials, 362 women). Two trials reported on pain intensity during the second and third stages of labour, and there was evidence of a reduction in pain scores in favour of massage (SMD -0.98, 95% CI -2.23 to 0.26, 124 women; and SMD -1.03, 95% CI -2.17 to 0.11, 122 women). There was very low-quality evidence showing no clear benefit of massage over usual care for the length of labour (in minutes) (mean difference (MD) 20.64, 95% CI -58.24 to 99.52, six trials, 514 women), and pharmacological pain relief (average risk ratio (RR) 0.81, 95% CI 0.37 to 1.74, four trials, 105 women). There was very low-quality evidence showing no clear benefit of massage for assisted vaginal birth (average RR 0.71, 95% CI 0.44 to 1.13, four trials, 368 women) and caesarean section (RR 0.75, 95% CI 0.51 to 1.09, six trials, 514 women). One trial reported less anxiety during the first stage of labour for women receiving massage (MD -16.27, 95% CI -27.03 to -5.51, 60 women). One trial found an increased sense of control from massage (MD 14.05, 95% CI 3.77 to 24.33, 124 women, low-quality evidence). Two trials examining satisfaction with the childbirth experience reported data on different scales; both found more satisfaction with massage, although the evidence was low quality in one study and very low in the other.Warm packsWe found very low-quality evidence for reduced pain (Visual Analogue Scale/VAS) in the first stage of labour (SMD -0.59, 95% CI -1.18 to -0.00, three trials, 191 women), and the second stage of labour (SMD -1.49, 95% CI -2.85 to -0.13, two trials, 128 women). Very low-quality evidence showed reduced length of labour (minutes) in the warm-pack group (MD -66.15, 95% CI -91.83 to -40.47; two trials; 128 women).Thermal manual methodsOne trial evaluated thermal manual methods versus usual care and found very low-quality evidence of reduced pain intensity during the first phase of labour for women receiving thermal methods (MD -1.44, 95% CI -2.24 to -0.65, one trial, 96 women). There was a reduction in the length of labour (minutes) (MD -78.24, 95% CI -118.75 to -37.73, one trial, 96 women, very low-quality evidence). There was no clear difference for assisted vaginal birth (very low-quality evidence). Results were similar for cold packs versus usual care, and intermittent hot and cold packs versus usual care, for pain intensity, length of labour and assisted vaginal birth.Music One trial that compared manual methods with music found very low-quality evidence of reduced pain intensity during labour in the massage group (RR 0.40, 95% CI 0.18 to 0.89, 101 women). There was no evidence of benefit for reduced use of pharmacological pain relief (RR 0.41, 95% CI 0.16 to 1.08, very low-quality evidence).Of the seven outcomes we assessed using GRADE, only pain intensity was reported in all comparisons. Satisfaction with the childbirth experience, sense of control, and caesarean section were rarely reported in any of the comparisons. AUTHORS' CONCLUSIONS: Massage, warm pack and thermal manual methods may have a role in reducing pain, reducing length of labour and improving women's sense of control and emotional experience of labour, although the quality of evidence varies from low to very low and few trials reported on the key GRADE outcomes. Few trials reported on safety as an outcome. There is a need for further research to address these outcomes and to examine the effectiveness and efficacy of these manual methods for pain management.

Relaxation techniques for pain management in labour.

BACKGROUND: Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute to the popularity of complementary methods of pain management. This review examined currently available evidence on the use of relaxation therapies for pain management in labour. This is an update of a review first published in 2011. OBJECTIVES: To examine the effects of mind-body relaxation techniques for pain management in labour on maternal and neonatal well-being during and after labour. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (9 May 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 5 2017), MEDLINE (1966 to 24 May 2017), CINAHL (1980 to 24 May 2017), the Australian New Zealand Clinical Trials Registry (18 May 2017), ClinicalTrials.gov (18 May 2017), the ISRCTN Register (18 May 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (18 May 2017), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (including quasi randomised and cluster trials) comparing relaxation methods with standard care, no treatment, other non-pharmacological forms of pain management in labour or placebo. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We attempted to contact study authors for additional information. We assessed evidence quality with GRADE methodology. MAIN RESULTS: This review update includes 19 studies (2519 women), 15 of which (1731 women) contribute data. Interventions examined included relaxation, yoga, music and mindfulness. Approximately half of the studies had a low risk of bias for random sequence generation and attrition bias. The majority of studies had a high risk of bias for performance and detection bias, and unclear risk of bias for, allocation concealment, reporting bias and other bias. We assessed the evidence from these studies as ranging from low to very low quality, and therefore the effects below should be interpreted with caution.RelaxationWe found that relaxation compared to usual care provided lowered the intensity of pain (measured on a scale of 0 to 10 with low scores indicating less pain) during the latent phase of labour (mean difference (MD) -1.25, 95% confidence interval (CI) -1.97 to -0.53, one trial, 40 women). Four trials reported pain intensity in the active phase; there was high heterogeneity between trials and very low-quality evidence suggested that there was no strong evidence that the effects were any different between groups for this outcome (MD -1.08, 95% CI -2.57 to 0.41, four trials, 271 women, random-effects analysis). Very low-quality evidence showed that women receiving relaxation reported greater satisfaction with pain relief during labour (risk ratio (RR) 8.00, 95% CI 1.10 to 58.19, one trial, 40 women), and showed no clear benefit for satisfaction with childbirth experience (assessed using different scales) (standard mean difference (SMD) -0.03, 95% CI -0.37 to 0.31, three trials, 1176 women). For safety outcomes there was very low-quality evidence of no clear reduction in assisted vaginal birth (average RR 0.61, 95% CI 0.20 to 1.84, four trials, 1122 women) or in caesarean section rates (average RR 0.73, 95% CI 0.26 to 2.01, four trials, 1122 women). Sense of control in labour, and breastfeeding were not reported under this comparison.YogaWhen comparing yoga to control interventions there was low-quality evidence that yoga lowered pain intensity (measured on a scale of 0 to 10) with low scores indicating less pain) (MD -6.12, 95% CI -11.77 to -0.47, one trial, 66 women), greater satisfaction with pain relief (MD 7.88, 95% CI 1.51 to 14.25, one trial, 66 women) and greater satisfaction with childbirth experience (MD 6.34, 95% CI 0.26 to 12.42 one trial, 66 women (assessed using the Maternal Comfort Scale with higher score indicating greater comfort). Sense of control in labour, breastfeeding, assisted vaginal birth, and caesarean section were not reported under this comparison.MusicWhen comparing music to control interventions there was evidence of lower pain intensity in the latent phase for women receiving music (measured on a scale of 0 to 10 with low scores indicating less pain) (MD -0.73, 95% CI -1.01 to -0.45, random-effects analysis, two trials, 192 women) and very low-quality evidence of no clear benefit in the active phase (MD -0.51, 95% CI -1.10 to 0.07, three trials, 217 women). Very low-quality evidence suggested no clear benefit in terms of reducing assisted vaginal birth (RR 0.41, 95% CI 0.08 to 2.05, one trial, 156 women) or caesarean section rate (RR 0.78, 95% CI 0.36 to 1.70, two trials, 216 women). Satisfaction with pain relief, sense of control in labour, satisfaction with childbirth experience, and breastfeeding were not reported under this comparison.Audio analgesiaOne trial evaluating audio analgesia versus control only reported one outcome and showed no evidence of benefit in satisfaction with pain relief.MindfulnessOne trial evaluating mindfulness versus usual care found an increase in sense of control for the mindfulness group (using the Childbirth Self-Efficacy Inventory) (MD 31.30, 95% CI 1.61 to 60.99, 26 women). There is no strong evidence that the effects were any different between groups for satisfaction in childbirth, or for caesarean section rate, need for assisted vaginal delivery or need for pharmacological pain relief. No other outcomes were reported in this trial. AUTHORS' CONCLUSIONS: Relaxation, yoga and music may have a role with reducing pain, and increasing satisfaction with pain relief, although the quality of evidence varies between very low to low. There was insufficient evidence for the role of mindfulness and audio-analgesia. The majority of trials did not report on the safety of the interventions. Further randomised controlled trials of relaxation modalities for pain management in labour are needed. Trials should be adequately powered and include clinically relevant outcomes such as those described in this review.

Cost analysis of the CTLB Study, a multitherapy antenatal education programme to reduce routine interventions in labour.

OBJECTIVE: To assess whether the multitherapy antenatal education 'CTLB' (Complementary Therapies for Labour and Birth) Study programme leads to net cost savings. DESIGN: Cost analysis of the CTLB Study, using analysis of outcomes and hospital funding data. METHODS: We take a payer perspective and use Australian Refined Diagnosis-Related Group (AR-DRG) cost data to estimate the potential savings per woman to the payer (government or private insurer). We consider scenarios in which the intervention cost is either borne by the woman or by the payer. Savings are computed as the difference in total cost between the control group and the study group. RESULTS: If the cost of the intervention is not borne by the payer, the average saving to the payer was calculated to be $A808 per woman. If the payer covers the cost of the programme, this figure reduces to $A659 since the average cost of delivering the programme was $A149 per woman. All these findings are significant at the 95% confidence level. Significantly more women in the study group experienced a normal vaginal birth, and significantly fewer women in the study group experienced a caesarean section. The main cost saving resulted from the reduced rate of caesarean section in the study group. CONCLUSION: The CTLB antenatal education programme leads to significant savings to payers that come from reduced use of hospital resources. Depending on which perspective is considered, and who is responsible for covering the cost of the programme, the net savings vary from $A659 to $A808 per woman. Compared with the average cost of birth in the control group, we conclude that the programme could lead to a reduction in birth-related healthcare costs of approximately 9%. TRIAL REGISTRATION NUMBER: ACTRN12611001126909.

Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks' gestation for improving pregnancy outcome.

BACKGROUND: Current management of preterm prelabour rupture of the membranes (PPROM) involves either initiating birth soon after PPROM or, alternatively, adopting a 'wait and see' approach (expectant management). It is unclear which strategy is most beneficial for mothers and their babies. This is an update of a Cochrane review published in 2010 (Buchanan 2010). OBJECTIVES: To assess the effect of planned early birth versus expectant management for women with preterm prelabour rupture of the membranes between 24 and 37 weeks' gestation for fetal, infant and maternal well being. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (30 September 2016), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials comparing planned early birth with expectant management for women with PPROM prior to 37 weeks' gestation. We excluded quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two review authors independently evaluated trials for inclusion into the review and for methodological quality. Two review authors independently extracted data. We checked data for accuracy. We assessed the quality of evidence using the GRADE approach. MAIN RESULTS: We included 12 trials in the review (3617 women and 3628 babies). For primary outcomes, we identified no clear differences between early birth and expectant management in neonatal sepsis (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.66 to 1.30, 12 trials, 3628 babies, evidence graded moderate), or proven neonatal infection with positive blood culture (RR 1.24, 95% CI 0.70 to 2.21, seven trials, 2925 babies). However, early birth increased the incidence of respiratory distress syndrome (RDS) (RR 1.26, 95% CI 1.05 to 1.53, 12 trials, 3622 babies, evidence graded high). Early birth was also associated with an increased rate of caesarean section (RR 1.26, 95% CI 1.11 to 1.44, 12 trials, 3620 women, evidence graded high).Assessment of secondary perinatal outcomes showed no clear differences in overall perinatal mortality (RR 1.76, 95% CI 0.89 to 3.50, 11 trials, 3319 babies), or intrauterine deaths (RR 0.45, 95% CI 0.13 to 1.57, 11 trials, 3321 babies) when comparing early birth with expectant management. However, early birth was associated with a higher rate of neonatal death (RR 2.55, 95% CI 1.17 to 5.56, 11 trials, 3316 babies) and need for ventilation (RR 1.27, 95% CI 1.02 to 1.58, seven trials, 2895 babies, evidence graded high). Babies of women randomised to early birth were delivered at a gestational age lower than those randomised to expectant management (mean difference (MD) -0.48 weeks, 95% CI -0.57 to -0.39, eight trials, 3139 babies). Admission to neonatal intensive care was more likely for those babies randomised to early birth (RR 1.16, 95% CI 1.08 to 1.24, four trials, 2691 babies, evidence graded moderate).In assessing secondary maternal outcomes, we found that early birth was associated with a decreased rate of chorioamnionitis (RR 0.50, 95% CI 0.26 to 0.95, eight trials, 1358 women, evidence graded moderate), and an increased rate of endometritis (RR 1.61, 95% CI 1.00 to 2.59, seven trials, 2980 women). As expected due to the intervention, women randomised to early birth had a higher chance of having an induction of labour (RR 2.18, 95% CI 2.01 to 2.36, four trials, 2691 women). Women randomised to early birth had a decreased total length of hospitalisation (MD -1.75 days, 95% CI -2.45 to -1.05, six trials, 2848 women, evidence graded moderate).Subgroup analyses indicated improved maternal and infant outcomes in expectant management in pregnancies greater than 34 weeks' gestation, specifically relating to RDS and maternal infections. The use of prophylactic antibiotics were shown to be effective in reducing maternal infections in women randomised to expectant management.Overall, we assessed all 12 studies as being at low or unclear risk of bias. Some studies lacked an adequate description of methods and the risk of bias could only be assessed as unclear. In five of the studies there were one and/or two domains where the risk of bias was judged as high. GRADE profiling showed the quality of evidence across all critical outcomes to be moderate to high. AUTHORS' CONCLUSIONS: With the addition of five randomised controlled trials (2927 women) to this updated review, we found no clinically important difference in the incidence of neonatal sepsis between women who birth immediately and those managed expectantly in PPROM prior to 37 weeks' gestation. Early planned birth was associated with an increase in the incidence of neonatal RDS, need for ventilation, neonatal mortality, endometritis, admission to neonatal intensive care, and the likelihood of birth by caesarean section, but a decreased incidence of chorioamnionitis. Women randomised to early birth also had an increased risk of labour induction, but a decreased length of hospital stay. Babies of women randomised to early birth were more likely to be born at a lower gestational age.In women with PPROM before 37 weeks' gestation with no contraindications to continuing the pregnancy, a policy of expectant management with careful monitoring was associated with better outcomes for the mother and baby.The direction of future research should be aimed at determining which groups of women with PPROM would not benefit from expectant management. This could be determined by analysing subgroups according to gestational age at presentation, corticosteroid usage, and abnormal vaginal microbiological colonisation. Research should also evaluate long-term neurodevelopmental outcomes of infants.

Complementary therapies for labour and birth study: a randomised controlled trial of antenatal integrative medicine for pain management in labour.

OBJECTIVE: To evaluate the effect of an antenatal integrative medicine education programme in addition to usual care for nulliparous women on intrapartum epidural use. DESIGN: Open-label, assessor blind, randomised controlled trial. SETTING: 2 public hospitals in Sydney, Australia. POPULATION: 176 nulliparous women with low-risk pregnancies, attending hospital-based antenatal clinics. METHODS AND INTERVENTION: The Complementary Therapies for Labour and Birth protocol, based on the She Births and acupressure for labour and birth courses, incorporated 6 evidence-based complementary medicine techniques: acupressure, visualisation and relaxation, breathing, massage, yoga techniques, and facilitated partner support. Randomisation occurred at 24-36 weeks' gestation, and participants attended a 2-day antenatal education programme plus standard care, or standard care alone. MAIN OUTCOME MEASURES: Rate of analgesic epidural use. Secondary: onset of labour, augmentation, mode of birth, newborn outcomes. RESULTS: There was a significant difference in epidural use between the 2 groups: study group (23.9%) standard care (68.7%; risk ratio (RR) 0.37 (95% CI 0.25 to 0.55), p≤0.001). The study group participants reported a reduced rate of augmentation (RR=0.54 (95% CI 0.38 to 0.77), p<0.0001); caesarean section (RR=0.52 (95% CI 0.31 to 0.87), p=0.017); length of second stage (mean difference=-0.32 (95% CI -0.64 to 0.002), p=0.05); any perineal trauma (0.88 (95% CI 0.78 to 0.98), p=0.02) and resuscitation of the newborn (RR=0.47 (95% CI 0.25 to 0.87), p≤0.015). There were no statistically significant differences found in spontaneous onset of labour, pethidine use, rate of postpartum haemorrhage, major perineal trauma (third and fourth degree tears/episiotomy), or admission to special care nursery/neonatal intensive care unit (p=0.25). CONCLUSIONS: The Complementary Therapies for Labour and Birth study protocol significantly reduced epidural use and caesarean section. This study provides evidence for integrative medicine as an effective adjunct to antenatal education, and contributes to the body of best practice evidence. TRIAL REGISTRATION NUMBER: ACTRN12611001126909.

Site-specific predictors of successful recruitment to a perinatal clinical trial.

BACKGROUND: With large collaborations needed to reach sample size requirements for relatively rare events, a major challenge for multi-centre clinical trials is efficiency of recruitment at individual sites. We used data from an international, multi-centre, randomised trial of preterm prelabour rupture of membranes to assess any impact on recruitment following the introduction of a new Clinical Trial Agreement and to identify site-specific predictors of recruitment to the trial for the purpose of targeting future recruitment sites and strategies. METHODS: The outcome measure was recruitment rate per 10,000 births, and according to this, an average recruitment rate was determined. Factors that were considered potentially predictive of recruitment above the average rate were classified according to three broad themes: 'ethics and regulatory requirements', 'characteristics of site investigators' and the 'research culture' at the collaborating site. Data were analysed using contingency tables and logistic regression modelling. RESULTS: At 31 January 2009, following the introduction of the Clinical Trial Agreement, 39 centres had obtained ethics approval to commence recruitment, and 38 centres had enrolled at least one woman. Time to first recruit ranged from 25 days to 584 days. Recruitment rates ranged from 0.18 to 6.0 per 10,000 births (mean 1.71/10,000 births) per month. Factors most associated with above-average recruitment rate were the following: implementation of a clearly defined 'system' of recruitment, engagement of other staff, time from ethics approval to first recruit and provision of a dedicated trial coordinator. CONCLUSION: A delay of greater than 3 months in approval of the new Clinical Trial Agreement had an effect which extended into the third year of the trial. Characteristics that were indicative of the presence of a 'system' were the best predictors of recruitment. It may be more effective to limit recruitment sites and focus resources on those sites where investigators are engaged with trial processes and have adequate resources and structures to support them.

Massage, reflexology and other manual methods for pain management in labour.

BACKGROUND: Many women would like to avoid pharmacological or invasive methods of pain management in labour, and this may contribute towards the popularity of complementary methods of pain management. This review examined currently available evidence supporting the use of manual healing methods including massage and reflexology for pain management in labour. OBJECTIVES: To examine the effects of manual healing methods including massage and reflexology for pain management in labour on maternal and perinatal morbidity. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2 of 4), MEDLINE (1966 to 30 June 2011), CINAHL (1980 to 30 June 2011), the Australian and New Zealand Clinical Trial Registry (30 June 2011), Chinese Clinical Trial Register (30 June 2011), Current Controlled Trials (30 June 2011), ClinicalTrials.gov, (30 June 2011) ISRCTN Register (30 June 2011), National Centre for Complementary and Alternative Medicine (NCCAM) (30 June 2011) and the WHO International Clinical Trials Registry Platform (30 June 2011). SELECTION CRITERIA: Randomised controlled trials comparing manual healing methods with standard care, no treatment, other non-pharmacological forms of pain management in labour or placebo. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We attempted to contact study authors for additional information. MAIN RESULTS: We included six trials, with data reporting on five trials and 326 women in the meta-analysis. We found trials for massage only. Less pain during labour was reported from massage compared with usual care during the first stage of labour (standardised mean difference (SMD) -0.82, 95% confidence interval (CI) -1.17 to -0.47), four trials, 225 women), and labour pain was reduced in one trial of massage compared with music (risk ratio (RR) 0.40, 95% CI 0.18 to 0.89, 101 women). One trial of massage compared with usual care found reduced anxiety during the first stage of labour (MD -16.27, 95% CI -27.03 to -5.51, 60 women). No trial was assessed as being at a low risk of bias for all quality domains. AUTHORS' CONCLUSIONS: Massage may have a role in reducing pain, and improving women's emotional experience of labour. However, there is a need for further research.

Relaxation techniques for pain management in labour.

BACKGROUND: Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined currently available evidence supporting the use of relaxation therapies for pain management in labour. OBJECTIVES: To examine the effects of relaxation methods for pain management in labour on maternal and perinatal morbidity. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2010), The Cochrane Complementary Medicine Field's Trials Register (November 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2010, Issue 4), MEDLINE (1966 to 30 November 2010), CINAHL (1980 to 30 November 2010), the Australian and New Zealand Clinical Trial Registry (30 November 2010), Chinese Clinical Trial Register (30 November 2010), Current Controlled Trials (30 November 2010), ClinicalTrials.gov, (30 November 2010) ISRCTN Register (30 November 2010), National Centre for Complementary and Alternative Medicine (NCCAM) (30 November 2010) and the WHO International Clinical Trials Registry Platform (30 November 2010). SELECTION CRITERIA: Randomised controlled trials comparing relaxation methods with standard care, no treatment, other non-pharmacological forms of pain management in labour or placebo. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion and extracted data. Data were checked for accuracy. Two review authors independently assessed trial quality. We attempted to contact study authors for additional information. MAIN RESULTS: We included 11 studies (1374 women) in the review. Relaxation was associated with a reduction in pain intensity during the latent phase (mean difference (MD) -1.25, 95% confidence interval (CI) -1.97 to -0.53, one trial, 40 women) and active phase of labour (MD -2.48, 95% CI -3.13 to 0.83, two trials, 74 women). There was evidence of improved outcomes from relaxation instruction with increased satisfaction with pain relief (risk ratio (RR) 8.00, 95% CI 1.10 to 58.19, one trial, 40 women) and lower assisted vaginal delivery (RR 0.07, 95% CI 0.01 to 0.50, two trials, 86 women). Yoga was associated with reduced pain (mean difference (MD) -6.12, 95% CI -11.77 to -0.47), one trial, 66 women), increased satisfaction with pain relief (MD 7.88, 95% CI 1.51 to 14.25, one trial, 66 women), satisfaction with the childbirth experience (MD) 6.34, 95% CI 0.26 to 12.42, one trial, 66 women), and reduced length of labour when compared to usual care (MD -139.91, 95% CI -252.50 to -27.32, one trial, 66 women) and when compared with supine position (MD -191.34, 95% CI -243.72 to -138.96, one trial, 83 women). Trials evaluating music and audio analgesia found no difference between groups in the primary outcomes pain intensity, satisfaction with pain relief, and caesarean delivery. The risk of bias was unclear for the majority of trials. AUTHORS' CONCLUSIONS: Relaxation and yoga may have a role with reducing pain, increasing satisfaction with pain relief and reducing the rate of assisted vaginal delivery. There was insufficient evidence for the role of music and audio-analgesia. However, there is a need for further research.

Acupuncture or acupressure for pain management in labour.

BACKGROUND: Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined evidence supporting the use of acupuncture and acupressure for pain management in labour. OBJECTIVES: To examine the effects of acupuncture and acupressure for pain management in labour. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register and The Cochrane Complementary Medicine Field's Trials Register (October 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2010, Issue 4), MEDLINE (1966 to October 2010), and CINAHL (1980 to October 2010). SELECTION CRITERIA: Published and unpublished randomised controlled trials comparing acupuncture and acupressure with placebo, no treatment or other non-pharmacological forms of pain management in labour. We included all women whether primiparous or multiparous, and in spontaneous or induced labour. DATA COLLECTION AND ANALYSIS: We performed meta-analysis using risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes. The outcome measures included pain intensity, satisfaction with pain relief, use of pharmacological pain relief, relaxation, caesarean section rate, augmentation with oxytocin, length of labour and anxiety. MAIN RESULTS: We included 13 trials with data reporting on 1986 women. Nine trials reported on acupuncture and four trials reported on acupressure. Less intense pain was found from acupuncture compared with no intervention (standardised mean difference (SMD) -1.00, 95% confidence interval (CI) -1.33 to -0.67, one trial, 163 women). One trial increased satisfaction with pain relief compared with placebo control (RR 2.38, 95% CI 1.78 to 3.19, 150 women). Reduced use of pharmacological analgesia was found in one trial of acupuncture compared with placebo (RR 0.72, 95% CI 0.58 to 0.88, 136 women), and compared with standard care, however, there was significant heterogeneity (RR 0.68, 95% CI 0.56 to 0.83, three trials, 704 women). Fewer instrumental deliveries from acupuncture were found compared with standard care (RR 0.67, 95% CI 0.46, 0.98, three trials, 704 women); however, there was significant heterogeneity. Pain intensity was reduced in the acupressure group compared with a placebo control (SMD -0.55, 95% CI -0.92 to -0.19, one trial, 120 women), and a combined control (SMD -0.42, 95% CI -0.65 to -0.18, two trials, 322 women). No trial was assessed as being at a low risk of bias for all of the quality domains. AUTHORS' CONCLUSIONS: Acupuncture and acupressure may have a role with reducing pain, increasing satisfaction with pain management and reduced use of pharmacological management. However, there is a need for further research.

Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks' gestation for improving pregnancy outcome.

BACKGROUND: Delivery after preterm prelabour rupture of the membranes (PPROM) may be initiated soon after PPROM or, alternatively, be delayed. It is unclear which strategy is most beneficial for mothers and their babies. OBJECTIVES: To assess the effect of planned early birth compared with expectant management for pregnancies complicated with PPROM prior to 37 weeks' gestation. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2009), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2009, Issue 1), MEDLINE (1996 to May 2009), EMBASE (1974 to May 2009), and reference lists of trials and other review articles. SELECTION CRITERIA: Randomised controlled trials comparing expectant management with early delivery for women with PPROM prior to 37 weeks' gestation. We excluded quasi randomised trials. DATA COLLECTION AND ANALYSIS: Two review authors independently evaluated trials for inclusion into the review and for methodological quality. MAIN RESULTS: We included seven trials (690 women) in the review. We identified no difference in the primary outcomes of neonatal sepsis (risk ratio (RR) 1.33, 95% confidence interval (CI) 0.72 to 2.47) or respiratory distress (RR 0.98, 95% CI 0.74 to 1.29). Early delivery increased the incidence of caesarean section (RR 1.51, 95% CI 1.08 to 2.10). There was no difference in the overall perinatal mortality (RR 0.98, 95% CI 0.41 to 2.36), intrauterine deaths (RR 0.26, 95% CI 0.04 to 1.52) or neonatal deaths (RR 1.59, 95% CI 0.61 to 4.16) when comparing early delivery with expectant management. There was no significant difference in measures of neonatal morbidity, including cerebroventricular haemorrhage (RR 1.90 95% CI 0.52 to 6.92), necrotising enterocolitis (RR 0.58, 95% CI 0.08 to 4.08), or duration of neonatal hospitalisation (mean difference (MD) -0.33 days, 95% CI -1.06 to 0.40 days). In assessing maternal outcomes, we found that early delivery increased endometritis (RR 2.32, 95% CI 1.33 to 4.07), but that early delivery had no effect on chorioamnionitis (RR 0.44, 95% CI 0.17 to 1.14). There was a significant reduction of early delivery on the duration of maternal hospital stay (MD -1.13 days, 95% CI -1.75 to -0.51 days). AUTHORS' CONCLUSIONS: There is insufficient evidence to guide clinical practice on the benefits and harms of immediate delivery compared with expectant management for women with PPROM. To date all of the clinical trials have had methodological weaknesses and have been underpowered to detect meaningful measures of infant and maternal morbidity.