Return on investment from service transformation for young people experiencing mental health problems: Approach to economic evaluations in ACCESS Open Minds (Esprits ouverts), a multi-site pan-Canadian youth mental health project.

Introduction: Mental health problems are common globally, and typically have their onset in adolescence and early adulthood-making youth (aged 11-25) an optimal target for prevention and early intervention efforts. While increasing numbers of youth mental health (YMH) initiatives are now underway, thus far few have been subject to economic evaluations. Here we describe an approach to determining the return on investment of YMH service transformation via the pan-Canadian ACCESS Open Minds (AOM) project, for which a key focus is on improving access to mental health care and reducing unmet need in community settings. Approach: As a complex intervention package, it is hoped that the AOM transformation will: (i) enable early intervention through accessible, community-based services; (ii) shift care away toward these primary/community settings and away from acute hospital and emergency services; and (iii) offset at least some of the increased costs of primary care/community-based mental health services with reductions in the volume of more resource-intensive acute, emergency, hospital or specialist services utilized. Co-designed with three diverse sites that represent different Canadian contexts, a return on investment analysis will (separately at each site) compare the costs generated by the intervention, including volumes and expenditures associated with the AOM service transformation and any contemporaneous changes in acute, emergency, hospital or service utilization (vs. historical or parallel comparators). Available data from health system partners are being mobilized to assess these hypotheses. Anticipated results: Across urban, semi-urban and Indigenous sites, the additional costs of the AOM transformation and its implementation in community settings are expected to be at least partially offset by a reduction in the need for acute, emergency, hospital or specialist care. Discussion: Complex interventions such as AOM aim to shift care "upstream": away from acute, emergency, hospital and specialist services and toward community-based programming which is more easily accessible, often more appropriate for early-stage presentations, and more resource-efficient. Carrying out economic evaluations of such interventions is challenging given the constraints of available data and health system organization. Nonetheless, such analyses can advance knowledge, strengthen stakeholder engagement, and further implementation of this public health priority.

Women's preferences for antenatal care in Tanzania: a discrete choice experiment.

BACKGROUND: The stillbirth rate in Tanzania remains high. Greater engagement with antenatal care may help to reduce stillbirths. We investigated which characteristics of antenatal care clinics are preferred by pregnant women in Tanzania. METHODS: We conducted an unlabelled discrete choice experiment (DCE) with think-aloud interviews. Participants were pregnant women, regardless of parity/gestation, from the Mwanza and Manyara regions of Tanzania. We asked participants to choose which of two hypothetical antenatal clinics they would rather attend. Clinics were described in terms of transport mode, cleanliness, comfort, visit content, and staff attitude. Each participant made 12 choices during the experiment, and a purposively selected sub-set simultaneously verbalised the rationale for their choices. We analysed DCE responses using a multinomial logit model adjusted for study region, and think-aloud data using the Framework approach. RESULTS: We recruited 251 participants split evenly between the 2 geographical regions. Staff attitude was the most important attribute in clinic choice and dominated the think-aloud narratives. Other significant attributes were mode of transport (walking was preferred) and content of clinic visit (preference was stronger with each additional element of care provided). Cleanliness of the clinic was not a significant attribute overall and the think-aloud exercise identified a willingness to trade-off cleanliness and comfort for respectful care. CONCLUSION: Women would prefer to attend a clinic with kind staff which they can access easily. This study suggests that exploration of barriers to providing respectful care, and enabling staff to deliver it, are important areas for future investment. The DCE shows us what average preferences are; antenatal care that is aligned with identified preferences should increase uptake and engagement versus care which does not acknowledge them.

Identification of factors associated with stillbirth in Zimbabwe - a cross sectional study.

INTRODUCTION: 98% of the 2.6 million stillbirths per annum occur in low and middle income countries. However, understanding of risk factors for stillbirth in these settings is incomplete, hampering efforts to develop effective strategies to prevent deaths. METHODS: A cross-sectional study of eligible women on the postnatal ward at Mpilo Hospital, Zimbabwe was undertaken between 01/08/2018 and 31/03/2019 (n = 1779). Data were collected from birth records for maternal characteristics, obstetric and past medical history, antenatal care and pregnancy outcome. A directed acyclic graph was constructed with multivariable logistic regression performed to fit the corresponding model specification to data comprising singleton pregnancies, excluding neonatal deaths (n = 1734), using multiple imputation for missing data. Where possible, findings were validated against all women with births recorded in the hospital birth register (n = 1847). RESULTS: Risk factors for stillbirth included: previous stillbirth (29/1691 (2%) of livebirths and 39/43 (91%) of stillbirths, adjusted Odds Ratio (aOR) 2628.9, 95% CI 342.8 to 20,163.0), antenatal care (aOR 44.49 no antenatal care vs. > 4 antenatal care visits, 95% CI 6.80 to 291.19), maternal medical complications (aOR 7.33, 95% CI 1.99 to 26.92) and season of birth (Cold season vs. Mild aOR 14.29, 95% CI 3.09 to 66.08; Hot season vs. Mild aOR 3.39, 95% CI 0.86 to 13.27). Women who had recurrent stillbirth had a lower educational and health status (18.2% had no education vs. 10.0%) and were less likely to receive antenatal care (20.5% had no antenatal care vs. 6.6%) than women without recurrent stillbirth. CONCLUSION: The increased risk in women who have a history of stillbirth is a novel finding in Low and Middle Income Countries (LMICs) and is in agreement with findings from High Income Countries (HICs), although the estimated effect size is much greater (OR in HICs ~ 5). Developing antenatal care for this group of women offers an important opportunity for stillbirth prevention.

Reduced fetal movement intervention Trial-2 (ReMIT-2): protocol for a pilot randomised controlled trial of standard care informed by the result of a placental growth factor (PlGF) blood test versus standard care alone in women presenting with reduced fetal movement at or after 36+ 0 weeks gestation.

BACKGROUND: Forty percent of babies who are stillborn born die after 36 weeks gestation and have no lethal structural abnormality. Maternal perception of reduced fetal movement (RFM) is associated with stillbirth and is related to abnormal placental structure and function. The ultimate objective of this trial is to assess whether for women with RFM, intervention directed by measurement of placental biochemical factors in addition to standard care improves pregnancy outcome compared with standard care alone. This is the protocol for a pilot trial to determine the feasibility of a definitive trial and also provide proof of concept that informing care by measurement of placental factors improves neonatal outcomes. METHODS: ReMIT-2 is a multicentre, pilot randomised controlled trial of care informed by results of an additional placental factor blood test versus standard care alone for women presenting with RFM at or after 36+ 0 weeks gestation. Participants will be randomised 1:1 to the intervention arm where the blood test result is revealed and acted on, or to the control arm where the blood sample is not tested immediately and therefore the result cannot be acted on. All participants will be followed up six weeks after delivery to assess their health status and views of the trial, along with healthcare costs. A sub-group will be interviewed within 16 weeks after delivery to further explore their views of the trial. Outcomes to determine feasibility of a definitive trial include number of potentially eligible women, proportion lost to follow-up, clinical characteristics at randomisation, reasons for non-recruitment, compliance with the trial intervention and views of participants and clinicians about the trial. Proof of concept outcomes include: rates of induction of labour; Caesarean birth; and a composite neonatal outcome of stillbirths and deaths before discharge, 5-min Apgar score < 7, umbilical artery pH < 7.05 and admission to neonatal unit for > 48 h. DISCUSSION: Results from this pilot trial will help determine whether a large definitive trial is feasible. Such a study would provide evidence to guide management of women with RFM and reduce stillbirths. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN12067514 . Registered on 8 September 2017.

Do MOOCs encourage corporate social responsibility or are they simply a marketing opportunity?

This paper explores institutional drivers for developing MOOCs by juxtaposing them against the original drivers for generating MOOCs: to offer open access education. However, the original impetus for MOOC development may be shifting towards a business oriented model. Therefore, instead of contributing to corporate social responsibility and inclusivity agendas facilitating open access to education, MOOCs are akin to an institution's shop window allowing the pseudo 'purchaser' the opportunity to glimpse behind the scenes. Hence, we ask: are MOOCs merely a sophisticated form of window dressing, showing pseudo 'purchasers' what institutions want them to see enticing them to purchase more lucrative products? Notwithstanding the motivation for developing MOOCs participants must first access them. Therefore the paper examines what MOOCs actually offer participants who are likely to access them and concludes by examining how MOOCs can be developed to facilitate better completion rates and encourage wider participation from hard to access groups.

Effect of partograph use on outcomes for women in spontaneous labour at term and their babies.

BACKGROUND: The partograph (sometimes known as partogram) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partograph is to provide a pictorial overview of labour, and to alert midwives and obstetricians to deviations in maternal or fetal well-being and labour progress. Charts have traditionally contained pre-printed alert and action lines. An alert line, which is based on the slowest 10% of primigravid women's labours, signifies slow progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour.This review is an update of a review last published in 2013. OBJECTIVES: The primary objective was to determine the effectiveness and safety of partograph use on perinatal and maternal morbidity and mortality. The secondary objective was to determine which partograph design is most effective for perinatal and maternal morbidity and mortality outcomes. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (31 August 2017) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised, cluster-randomised, and quasi-randomised controlled trials involving a comparison of partograph use with no partograph, or comparison between different partograph designs. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining review authors assessed the studies independently. We assessed the evidence using the GRADE approach. MAIN RESULTS: We have included 11 studies, involving 9475 women in this review; three studies assessed partograph use versus no partograph, seven assessed different partograph designs, and one assessed partograph use versus labour scale. Risk of bias varied in all studies. It was infeasible to blind staff or women to the intervention. Two studies did not adequately conceal allocation. Loss to follow-up was low in all studies. We assessed the evidence for partograph use versus no partograph using the GRADE approach; downgrading decisions were due to study design, inconsistency, indirectness, and imprecision of effect estimates.Most trials reported caesarean section rates and Apgar scores less than 7 at five minutes; all other outcomes were not consistently reported (e.g. duration of first stage of labour and maternal experience of childbirth).Partograph versus no partograph (3 trials, 1813 women)It is uncertain whether there is any clear difference between partograph use and no partograph in caesarean section rates (average risk ratio (RR) 0.77, 95% confidence interval (CI) 0.40 to 1.46; n = 1813; 3 trials; I² = 87%; very low-quality evidence); oxytocin augmentation (RR 1.02, 95% CI 0.95 to 1.10; n = 1156; 1 trial; moderate-quality evidence); duration of first stage of labour (mean difference (MD) 0.80 hours, 95% CI -0.06 to 1.66; n = 1156; 1 trial; low-quality evidence); or Apgar score less than 7 at five minutes (RR 0.76, 95% CI 0.29 to 2.03; n = 1596; 2 trials; I² = 87%; very low-quality evidence).Partograph with different placement of action lines (4 trials, 5051 women)When compared to a four-hour action line, women in the two-hour action line group were more likely to receive oxytocin augmentation (average RR 2.44, 95% CI 1.36 to 4.35; n = 4749; 4 trials; I² = 96%). There was no clear difference in caesarean section rates (RR 1.06, 95% CI 0.88 to 1.28; n = 4749; 4 trials); duration of first stage of labour (RR 0.81 hours, 95% CI 0.32 to 2.04; n = 948; 1 trial); maternal experience of childbirth (average RR 0.61, 95% CI 0.28 to 1.35; n = 2269; 2 trials; I² = 83%); or Apgar score less than 7 at five minutes (RR 0.93, 95% CI 0.61 to 1.42; n = 4749; 4 trials) between the two- and four-hour action line.The following comparisons only include data from single studies. Fewer women reported negative childbirth experiences in the two-hour action line group compared to the three-hour action line group (RR 0.49, 95% CI 0.27 to 0.90; n = 348; 1 trial). When we compared the three- and four-hour action line groups, the caesarean section rate was higher in the three-hour action line group (RR 1.70, 95% CI 1.07 to 2.70; n = 613; 1 trial). We did not observe any clear differences in any of the other outcomes in these comparisons.Partograph with alert line only versus partograph with alert and action line (1 trial, 694 women)The caesarean section rate was lower in the alert line only group (RR 0.68, 95% CI 0.50 to 0.93). There were no clear differences between groups for oxytocin augmentation, low Apgar score, instrumental vaginal birth and perinatal death.Partograph with latent phase (composite) versus partograph without latent phase (modified) (1 trial, 743 women)The caesarean section and oxytocin augmentation rates were higher in the partograph with a latent phase (RR 2.45, 95% CI 1.72 to 3.50; and RR 2.18, 95% CI 1.67 to 2.83, respectively). There were no clear differences between groups for oxytocin augmentation, and Apgar score less than 7 at five minutes.Partograph with two-hour action line versus partograph with stepped dystocia line (1 trial, 99 women)Fewer women received oxytocin augmentation in the dystocia line group (RR 0.62, 95% CI 0.39 to 0.98). We did not observe any clear differences in any of the other primary outcomes in this comparison.Partograph versus labour scale (1 trial, 122 women)The use of the partograph compared with the labour scale resulted in fewer women receiving oxytocin augmentation (RR 0.32, 95% CI 0.18 to 0.54), but did not produce any clear differences for any of the other primary outcomes. AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot be certain of the effects of routine use of the partograph as part of standard labour management and care, or which design, if any, are most effective. Further trial evidence is required to establish the efficacy of partograph use per se and its optimum design.

Epidural versus non-epidural or no analgesia for pain management in labour.

BACKGROUND: Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain, and is widely used as a form of pain relief in labour. However, there are concerns about unintended adverse effects on the mother and infant. This is an update of an existing Cochrane Review (Epidural versus non-epidural or no analgesia in labour), last published in 2011. OBJECTIVES: To assess the effectiveness and safety of all types of epidural analgesia, including combined-spinal-epidural (CSE) on the mother and the baby, when compared with non-epidural or no pain relief during labour. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (ClinicalTrials.gov), the WHO International Clinical Trials Registry Platform (ICTRP) (30 April 2017), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials comparing all types of epidural with any form of pain relief not involving regional blockade, or no pain relief in labour. We have not included cluster-randomised or quasi-randomised trials in this update. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risks of bias, extracted data and checked them for accuracy. We assessed selected outcomes using the GRADE approach. MAIN RESULTS: Fifty-two trials met the inclusion criteria and we have included data from 40 trials, involving over 11,000 women. Four trials included more than two arms. Thirty-four trials compared epidural with opioids, seven compared epidural with no analgesia, one trial compared epidural with acu-stimulation, one trial compared epidural with inhaled analgesia, and one trial compared epidural with continuous midwifery support and other analgesia. Risks of bias varied throughout the included studies; six out of 40 studies were at high or unclear risk of bias for every bias domain, while most studies were at high or unclear risk of detection bias. Quality of the evidence assessed using GRADE ranged from moderate to low quality.Pain intensity as measured using pain scores was lower in women with epidural analgesia when compared to women who received opioids (standardised mean difference -2.64, 95% confidence interval (CI) -4.56 to -0.73; 1133 women; studies = 5; I2 = 98%; low-quality evidence) and a higher proportion were satisfied with their pain relief, reporting it to be "excellent or very good" (average risk ratio (RR) 1.47, 95% CI 1.03 to 2.08; 1911 women; studies = 7; I2 = 97%; low-quality evidence). There was substantial statistical heterogeneity in both these outcomes. There was a substantial decrease in the need for additional pain relief in women receiving epidural analgesia compared with opioid analgesia (average RR 0.10, 95% CI 0.04 to 0.25; 5099 women; studies = 16; I2 = 73%; Tau2 = 1.89; Chi2 = 52.07 (P < 0.00001)). More women in the epidural group experienced assisted vaginal birth (RR 1.44, 95% CI 1.29 to 1.60; 9948 women; studies = 30; low-quality evidence). A post hoc subgroup analysis of trials conducted after 2005 showed that this effect is negated when trials before 2005 are excluded from this analysis (RR 1.19, 95% CI 0.97 to 1.46). There was no difference between caesarean section rates (RR 1.07, 95% CI 0.96 to 1.18; 10,350 women; studies = 33; moderate-quality evidence), and maternal long-term backache (RR 1.00, 95% CI 0.89 to 1.12; 814 women; studies = 2; moderate-quality evidence). There were also no clear differences between groups for the neonatal outcomes, admission to neonatal intensive care unit (RR 1.03, 95% CI 0.95 to 1.12; 4488 babies; studies = 8; moderate-quality evidence) and Apgar score less than seven at five minutes (RR 0.73, 95% CI 0.52 to 1.02; 8752 babies; studies = 22; low-quality evidence). We downgraded the evidence for study design limitations, inconsistency, imprecision in effect estimates, and possible publication bias.Side effects were reported in both epidural and opioid groups. Women with epidural experienced more hypotension, motor blockade, fever, and urinary retention. They also had longer first and second stages of labour, and were more likely to have oxytocin augmentation than the women in the opioid group. Women receiving epidurals had less risk of respiratory depression requiring oxygen, and were less likely to experience nausea and vomiting than women receiving opioids. Babies born to women in the epidural group were less likely to have received naloxone. There was no clear difference between groups for postnatal depression, headache, itching, shivering, or drowsiness. Maternal morbidity and long-term neonatal outcomes were not reported.Epidural analgesia resulted in less reported pain when compared with placebo or no treatment, and with acu-stimulation. Pain intensity was not reported in the trials that compared epidural with inhaled analgesia, or continuous support. Few trials reported on serious maternal side effects. AUTHORS' CONCLUSIONS: Low-quality evidence shows that epidural analgesia may be more effective in reducing pain during labour and increasing maternal satisfaction with pain relief than non-epidural methods. Although overall there appears to be an increase in assisted vaginal birth when women have epidural analgesia, a post hoc subgroup analysis showed this effect is not seen in recent studies (after 2005), suggesting that modern approaches to epidural analgesia in labour do not affect this outcome. Epidural analgesia had no impact on the risk of caesarean section or long-term backache, and did not appear to have an immediate effect on neonatal status as determined by Apgar scores or in admissions to neonatal intensive care. Further research may be helpful to evaluate rare but potentially severe adverse effects of epidural analgesia and non-epidural analgesia on women in labour and long-term neonatal outcomes.

Different insulin types and regimens for pregnant women with pre-existing diabetes.

BACKGROUND: Insulin requirements may change during pregnancy, and the optimal treatment for pre-existing diabetes is unclear. There are several insulin regimens (e.g. via syringe, pen) and types of insulin (e.g. fast-acting insulin, human insulin). OBJECTIVES: To assess the effects of different insulin types and different insulin regimens in pregnant women with pre-existing type 1 or type 2 diabetes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 October 2016), ClinicalTrials.gov (17 October 2016), the WHO International Clinical Trials Registry Platform (ICTRP; 17 October 2016), and the reference lists of retrieved studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared different insulin types and regimens in pregnant women with pre-existing diabetes.We had planned to include cluster-RCTs, but none were identified. We excluded quasi-randomised controlled trials and cross-over trials. We included studies published in abstract form and contacted the authors for further details when applicable. Conference abstracts were superseded by full publications. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, conducted data extraction, assessed risk of bias, and checked for accuracy. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: The findings in this review were based on very low-quality evidence, from single, small sample sized trial estimates, with wide confidence intervals (CI), some of which crossed the line of no effect; many of the prespecified outcomes were not reported. Therefore, they should be interpreted with caution. We included five trials that included 554 women and babies (four open-label, multi-centre, two-arm trials; one single centre, four-arm RCT). All five trials were at a high or unclear risk of bias due to lack of blinding, unclear methods of randomisation, and selective reporting of outcomes. Pooling of data from the trials was not possible, as each trial looked at a different comparison.1. One trial (N = 33 women) compared Lispro insulin with regular insulin and provided very low-quality evidence for the outcomes. There were seven episodes of pre-eclampsia in the Lispro group and nine in the regular insulin group, with no clear difference between the two groups (risk ratio (RR) 0.68, 95% CI 0.35 to 1.30). There were five caesarean sections in the Lispro group and nine in the regular insulin group, with no clear difference between the two groups (RR 0.59, 95% CI 0.25 to 1.39). There were no cases of fetal anomaly in the Lispro group and one in the regular insulin group, with no clear difference between the groups (RR 0.35, 95% CI 0.02 to 8.08). Macrosomia, perinatal deaths, episodes of birth trauma including shoulder dystocia, nerve palsy, and fracture, and the composite outcome measure of neonatal morbidity were not reported.2. One trial (N = 42 women) compared human insulin to animal insulin, and provided very low-quality evidence for the outcomes. There were no cases of macrosomia in the human insulin group and two in the animal insulin group, with no clear difference between the groups (RR 0.22, 95% CI 0.01 to 4.30). Perinatal death, pre-eclampsia, caesarean section, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy and fracture and the composite outcome measure of neonatal morbidity were not reported.3. One trial (N = 93 women) compared pre-mixed insulin (70 NPH/30 REG) to self-mixed, split-dose insulin and provided very low-quality evidence to support the outcomes. Two cases of macrosomia were reported in the pre-mixed insulin group and four in the self-mixed insulin group, with no clear difference between the two groups (RR 0.49, 95% CI 0.09 to 2.54). There were seven cases of caesarean section (for cephalo-pelvic disproportion) in the pre-mixed insulin group and 12 in the self-mixed insulin group, with no clear difference between groups (RR 0.57, 95% CI 0.25 to 1.32). Perinatal death, pre-eclampsia, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy, or fracture and the composite outcome measure of neonatal morbidity were not reported.4. In the same trial (N = 93 women), insulin injected with a Novolin pen was compared to insulin injected with a conventional needle (syringe), which provided very low-quality evidence to support the outcomes. There was one case of macrosomia in the pen group and five in the needle group, with no clear difference between the different insulin regimens (RR 0.21, 95% CI 0.03 to 1.76). There were five deliveries by caesarean section in the pen group compared with 14 in the needle group; women were less likely to deliver via caesarean section when insulin was injected with a pen compared to a conventional needle (RR 0.38, 95% CI 0.15 to 0.97). Perinatal death, pre-eclampsia, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy, or fracture, and the composite outcome measure of neonatal morbidity were not reported.5. One trial (N = 223 women) comparing insulin Aspart with human insulin reported none of the review's primary outcomes: macrosomia, perinatal death, pre-eclampsia, caesarean section, fetal anomaly, birth trauma including shoulder dystocia. nerve palsy, or fracture, or the composite outcome measure of neonatal morbidity.6. One trial (N = 162 women) compared insulin Detemir with NPH insulin, and supported the outcomes with very low-quality evidence. There were three cases of major fetal anomalies in the insulin Detemir group and one in the NPH insulin group, with no clear difference between the groups (RR 3.15, 95% CI 0.33 to 29.67). Macrosomia, perinatal death, pre-eclampsia, caesarean section, birth trauma including shoulder dystocia, nerve palsy, or fracture and the composite outcome of neonatal morbidity were not reported. AUTHORS' CONCLUSIONS: With limited evidence and no meta-analyses, as each trial looked at a different comparison, no firm conclusions could be made about different insulin types and regimens in pregnant women with pre-existing type 1 or 2 diabetes. Further research is warranted to determine who has an increased risk of adverse pregnancy outcome. This would include larger trials, incorporating adequate randomisation and blinding, and key outcomes that include macrosomia, pregnancy loss, pre-eclampsia, caesarean section, fetal anomalies, and birth trauma.

The Influence of Exotic Lady Beetle (Coleoptera: Coccinellidae) Establishment on the Species Composition of the Native Lady Beetle Community in Missouri.

The diversity and abundance of native lady beetles (Coccinellidae) in North America has declined in recent decades. This decline is often correlated with the introduction and establishment of exotic lady beetle species, including Coccinella septempunctata L. and Harmonia axyridis Pallas, suggesting that exotic species precipitated the decline of native lady beetles. We examined species records of native coccinellids in Missouri over 118 yr and asked whether the species composition of the community experienced a shift following the establishment of the exotic species. We found that the contemporary native coccinellid community is different from the community that was present nearly a century ago. However, there was no evidence for a recent abrupt shift in composition triggered by the establishment of exotic species. Instead, our data suggest that the native lady beetle community has been undergoing consistent and gradual change over time, with some species decreasing in abundance and others increasing. While not excluding exotic species as a factor contributing to the decline of native lady beetle species, our findings suggest that other continuous factors, like land use change, may have played a more influential role in determining the composition of the native coccinellid communities within our region.

Interventions for varicose veins and leg oedema in pregnancy.

BACKGROUND: Pregnancy is presumed to be a major contributory factor in the increased incidence of varicose veins in women, which can in turn lead to venous insufficiency and leg oedema. The most common symptom of varicose veins and oedema is the substantial pain experienced, as well as night cramps, numbness, tingling, the legs may feel heavy, achy, and possibly be unsightly. Treatments for varicose veins are usually divided into three main groups: surgery, pharmacological and non-pharmacological treatments. Treatments of leg oedema comprise mostly symptom reduction rather than cure and use of pharmacological and non-pharmacological approaches. OBJECTIVES: To assess any form of intervention used to relieve the symptoms associated with varicose veins and leg oedema in pregnancy. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials of treatments for varicose veins or leg oedema, or both, in pregnancy. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. MAIN RESULTS: We included seven trials (involving 326 women). The trials were largely unclear for selection bias and high risk for performance and detection bias.Two studies were placebo-controlled trials. The first one compared a phlebotonic (rutoside) with placebo for the reduction in symptoms of varicose veins; the second study evaluated the efficacy of troxerutin in comparison to placebo among 30 pregnant women in their second trimester with symptomatic vulvar varicosities and venous insufficiency in their lower extremities. Data from this study were not in useable format, so were not included in the analysis. Two trials compared either compression stockings with resting in left lateral position or reflexology with rest for 15 minutes for the reduction of leg oedema. One trial compared standing water immersion for 20 minutes with sitting upright in a chair with legs elevated for 20 minutes. Women standing in water were allowed to stand or walk in place. One trial compared 20 minutes of daily foot massage for five consecutive days and usual prenatal care versus usual prenatal care. The final trial compared three treatment groups for treating leg oedema in pregnancy. The first group was assigned to lateral supine bed rest at room temperature, women in the second group were asked to sit in a bathtub of waist-deep water at 32 ± 0.5 C with their legs horizontal and the third group included the women who were randomised to sitting immersed in shoulder-deep water at 32 ± 0.5 C with legs extended downward. We did not include this study in the analysis as outcomes reported in the paper were not pre-specified outcomes of this review.We planned to use GRADE methods to assess outcomes for two different comparisons and assign a quality rating. However, only two out of three outcomes for one comparison were reported and could be assessed. Evidence from one trial (rutoside versus placebo) for the outcomes of reduction in symptoms and incidence of complications associated with varicose veins and oedema was assessed as of moderate quality. Rutoside versus placeboOne trial involving 69 women, reported that rutoside significantly reduced the symptoms associated with varicose veins (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.11 to 3.22; moderate quality evidence). The incidence of complications (deep vein thrombosis) did not differ significantly between the two groups (risk ratio (RR) 0.17, 95% CI 0.01 to 3.49; moderate quality evidence). There were no significant differences in side-effects (RR 1.30, 95% CI 0.23 to 7.28). Women's perception of pain was not reported in this trial. External pneumatic intermittent compression versus restOne trial, involving 35 women, reported no significant difference in lower leg volume when compression stockings were compared against rest (mean difference (MD) -258.80, 95% CI -566.91 to 49.31). Reflexology versus restingAnother trial, involving 55 women, compared reflexology with rest. Reflexology significantly reduced the symptoms associated with oedema (reduction in symptoms: RR 9.09, 95% CI 1.41 to 58.54). The same study showed a trend towards satisfaction and acceptability with the intervention (RR 6.00, 95% CI 0.92 to 39.11). Water immersion versus leg elevationThere was evidence from one trial, involving 32 women, to suggest that water immersion for 20 minutes in a swimming pool reduces leg volume (RR 0.43, 95% CI 0.22 to 0.83). Foot massage versus routine careOne trial, involving 80 women reported no significant difference in lower leg circumference when foot massage was compared against routine care (MD -0.11, 95% CI -1.02 to 0.80).No other primary or secondary outcomes were reported in the trials. AUTHORS' CONCLUSIONS: There is moderate quality evidence to suggest that rutosides appear to help relieve the symptoms of varicose veins in late pregnancy. However, this finding is based on one study (69 women) and there are not enough data presented in the study to assess its safety in pregnancy. Reflexology or water immersion appears to help improve symptoms for women with leg oedema, but again this is based on two small studies (43 and 32 women, respectively).

Fetal movement counting for assessment of fetal wellbeing.

BACKGROUND: Fetal movement counting is a method by which a woman quantifies the movements she feels to assess the condition of her baby. The purpose is to try to reduce perinatal mortality by alerting caregivers when the baby might be compromised. This method may be used routinely, or only in women who are considered at increased risk of complications affecting the baby. Fetal movement counting may allow the clinician to make appropriate interventions in good time to improve outcomes. On the other hand, fetal movement counting may cause unnecessary anxiety to pregnant women, or elicit unnecessary interventions. OBJECTIVES: To assess outcomes of pregnancy where fetal movement counting was done routinely, selectively or was not done at all; and to compare different methods of fetal movement counting. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster-RCTs where fetal movement counting was assessed as a method of monitoring fetal wellbeing. DATA COLLECTION AND ANALYSIS: Two review authors assessed studies for eligibility, assessed the methodological quality of included studies and independently extracted data from studies. Where possible the effects of interventions were compared using risk ratios (RR), and presented with 95% confidence intervals (CI). For some outcomes, the quality of the evidence was assessed using the GRADE approach. MAIN RESULTS: Five studies (71,458 women) were included in this review; 68,654 in one cluster-RCT. None of these five trials were assessed as having low risk of bias on all seven risk of bias criteria. All included studies except for one (which included high-risk women as participants) included women with uncomplicated pregnancies.Two studies compared fetal movement counting with standard care, as defined by trial authors. Two included studies compared two types of fetal movement counting; once a day fetal movement counting (Cardiff count-to-10) with more than once a day fetal movement counting methods. One study compared fetal movement counting with hormone assessment.(1) Routine fetal movement counting versus mixed or undefined fetal movement countingNo study reported on the primary outcome 'perinatal death or severe morbidity'. In one large cluster-RCT, there was no difference in mean stillbirth rates per cluster (standard mean difference (SMD) 0.23, 95% CI -0.61 to 1.07; participants = 52 clusters; studies = one, low quality evidence). The other study reported no fetal deaths. There was no difference in caesarean section rate between groups (RR 0.93, 95% CI 0.60 to 1.44; participants = 1076; studies = one,low quality evidence). Maternal anxiety was significantly reduced with routine fetal movement counting (SMD -0.22, 95% CI -0.35 to -0.10; participants = 1013; studies = one, moderate quality evidence). Maternal-fetal attachment was not significantly different (SMD -0.02, 95% CI -0.15 to 0.11; participants = 951; studies = one, low quality evidence). In one study antenatal admission after reporting of decreased fetal movements was increased (RR 2.72, 95% CI 1.34 to 5.52; participants = 123; studies = one). In another there was a trend to more antenatal admissions per cluster in the counting group than in the control group (SMD 0.38, 95% CI -0.17 to 0.93; participants = 52 clusters; studies = one, low quality evidence). Birthweight less than 10th centile was not significantly different between groups (RR 0.98, 95% CI 0.66 to 1.44; participants = 1073; studies = one, low quality evidence). The evidence was of low quality due to imprecise results and because of concerns regarding unclear risk of bias. (2) Formal fetal movement counting (Modified Cardiff method) versus hormone analysisThere was no difference between the groups in the incidence of caesarean section (RR 1.18, 95% CI 0.83 to 1.69; participants = 1191; studies = one). Women in the formal fetal movement counting group had significantly fewer hospital visits than those randomised to hormone analysis (RR 0.26, 95% CI 0.20 to 0.35), whereas there were fewer Apgar scores less than seven at five minutes for women randomised to hormone analysis (RR 1.72, 95% CI 1.01 to 2.93). No other outcomes reported showed statistically significant differences. 'Perinatal death or severe morbidity' was not reported. (3) Formal fetal movement counting once a day (count-to-10) versus formal fetal movement counting method where counting was done more than once a day (after meals)The incidence of caesarean section did not differ between the groups under this comparison (RR 2.33, 95% CI 0.61 to 8.99; participants = 1400; studies = one). Perinatal death or severe morbidity was not reported. Women were more compliant in using the count-to-10 method than they were with other fetal movement counting methods, citing less interruption with daily activities as one of the reasons (non-compliance RR 0.25, 95% CI 0.19 to 0.32).Except for one cluster-RCT, included studies were small and used different comparisons, making it difficult to measure the outcomes using meta-analyses. The nature of the intervention measured also did not allow blinding of participants and clinicians.. AUTHORS' CONCLUSIONS: This review does not provide sufficient evidence to influence practice. In particular, no trials compared fetal movement counting with no fetal movement counting. Only two studies compared routine fetal movements with standard antenatal care, as defined by trial authors. Indirect evidence from a large cluster-RCT suggested that more babies at risk of death were identified in the routine fetal monitoring group, but this did not translate to reduced perinatal mortality. Robust research by means of studies comparing particularly routine fetal movement counting with selective fetal movement counting is needed urgently, as it is a common practice to introduce fetal movement counting only when there is already suspected fetal compromise.

The natural history of conducting and reporting clinical trials: interviews with trialists.

BACKGROUND: To investigate the nature of the research process as a whole, factors that might influence the way in which research is carried out, and how researchers ultimately report their findings. METHODS: Semi-structured qualitative telephone interviews with authors of trials, identified from two sources: trials published since 2002 included in Cochrane systematic reviews selected for the ORBIT project; and trial reports randomly sampled from 14,758 indexed on PubMed over the 12-month period from August 2007 to July 2008. RESULTS: A total of 268 trials were identified for inclusion, 183 published since 2002 and included in the Cochrane systematic reviews selected for the ORBIT project and 85 randomly selected published trials indexed on PubMed. The response rate from researchers in the former group was 21% (38/183) and in the latter group was 25% (21/85). Overall, 59 trialists were interviewed from the two different sources. A number of major but related themes emerged regarding the conduct and reporting of trials: establishment of the research question; identification of outcome variables; use of and adherence to the study protocol; conduct of the research; reporting and publishing of findings. Our results reveal that, although a substantial proportion of trialists identify outcome variables based on their clinical experience and knowing experts in the field, there can be insufficient reference to previous research in the planning of a new trial. We have revealed problems with trial recruitment: not reaching the target sample size, over-estimation of recruitment potential and recruiting clinicians not being in equipoise. We found a wide variation in the completeness of protocols, in terms of detailing study rationale, outlining the proposed methods, trial organisation and ethical considerations. CONCLUSION: Our results confirm that the conduct and reporting of some trials can be inadequate. Interviews with researchers identified aspects of clinical research that can be especially challenging: establishing appropriate and relevant outcome variables to measure, use of and adherence to the study protocol, recruiting of study participants and reporting and publishing the study findings. Our trialists considered the prestige and impact factors of academic journals to be the most important criteria for selecting those to which they would submit manuscripts.

Fetal vibroacoustic stimulation for facilitation of tests of fetal wellbeing.

BACKGROUND: Acoustic stimulation of the fetus has been suggested to improve the efficiency of antepartum fetal heart rate testing. OBJECTIVES: To assess the advantages and disadvantages of the use of fetal vibroacoustic stimulation in conjunction with tests of fetal wellbeing. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2013). SELECTION CRITERIA: All published and unpublished randomised controlled trials assessing the merits of the use of fetal vibroacoustic stimulation in conjunction with tests of fetal wellbeing. DATA COLLECTION AND ANALYSIS: All review authors independently extracted data and assessed trial quality. Authors of published and unpublished trials were contacted for further information. MAIN RESULTS: Altogether 12 trials with a total of 6822 participants were included. Fetal vibroacoustic stimulation reduced the incidence of non-reactive antenatal cardiotocography test (nine trials; average risk ratio (RR) 0.62, 95% confidence interval (CI) 0.48 to 0.81). Vibroacoustic stimulation compared with mock stimulation evoked significantly more fetal movements when used in conjunction with fetal heart rate testing (one trial, RR 0.23, 95% CI 0.18 to 0.29). AUTHORS' CONCLUSIONS: Vibroacoustic stimulation offers benefits by decreasing the incidence of non-reactive cardiotocography and reducing the testing time. Further randomised trials should be encouraged to determine not only the optimum intensity, frequency, duration and position of the vibroacoustic stimulation, but also to evaluate the efficacy, predictive reliability, safety and perinatal outcome of these stimuli with cardiotocography and other tests of fetal wellbeing.

Telephone support for women during pregnancy and the first six weeks postpartum.

BACKGROUND: Telephone communication is increasingly being accepted as a useful form of support within health care. There is some evidence that telephone support may be of benefit in specific areas of maternity care such as to support breastfeeding and for women at risk of depression. There is a plethora of telephone-based interventions currently being used in maternity care. It is therefore timely to examine which interventions may be of benefit, which are ineffective, and which may be harmful. OBJECTIVES: To assess the effects of telephone support during pregnancy and the first six weeks post birth, compared with routine care, on maternal and infant outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (23 January 2013) and reference lists of all retrieved studies. SELECTION CRITERIA: We included randomised controlled trials, comparing telephone support with routine care or with another supportive intervention aimed at pregnant women and women in the first six weeks post birth. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed studies identified by the search strategy, carried out data extraction and assessed risk of bias. Data were entered by one review author and checked by a second. Where necessary, we contacted trial authors for further information on methods or results. MAIN RESULTS: We have included data from 27 randomised trials involving 12,256 women. All of the trials examined telephone support versus usual care (no additional telephone support). We did not identify any trials comparing different modes of telephone support (for example, text messaging versus one-to-one calls). All but one of the trials were carried out in high-resource settings. The majority of studies examined support provided via telephone conversations between women and health professionals although a small number of trials included telephone support from peers. In two trials women received automated text messages. Many of the interventions aimed to address specific health problems and collected data on behavioural outcomes such as smoking cessation and relapse (seven trials) or breastfeeding continuation (seven trials). Other studies examined support interventions aimed at women at high risk of postnatal depression (two trials) or preterm birth (two trials); the rest of the interventions were designed to offer women more general support and advice.For most of our pre-specified outcomes few studies contributed data, and many of the results described in the review are based on findings from only one or two studies. Overall, results were inconsistent and inconclusive although there was some evidence that telephone support may be a promising intervention. Results suggest that telephone support may increase women's overall satisfaction with their care during pregnancy and the postnatal period, although results for both periods were derived from only two studies. There was no consistent evidence confirming that telephone support reduces maternal anxiety during pregnancy or after the birth of the baby, although results on anxiety outcomes were not easy to interpret as data were collected at different time points using a variety of measurement tools. There was evidence from two trials that women at high risk of depression who received support had lower mean depression scores in the postnatal period, although there was no clear evidence that women who received support were less likely to have a diagnosis of depression. Results from trials offering breastfeeding telephone support were also inconsistent, although the evidence suggests that telephone support may increase the duration of breastfeeding. There was no strong evidence that women receiving telephone support were less likely to be smoking at the end of pregnancy or during the postnatal period.For infant outcomes, such as preterm birth and infant birthweight, overall, there was little evidence. Where evidence was available, there were no clear differences between groups. Results from two trials suggest that babies whose mothers received support may have been less likely to have been admitted to a neonatal intensive care unit (NICU), although it is not easy to understand the mechanisms underpinning this finding. AUTHORS' CONCLUSIONS: Despite some encouraging findings, there is insufficient evidence to recommend routine telephone support for women accessing maternity services, as the evidence from included trials is neither strong nor consistent. Although benefits were found in terms of reduced depression scores, breastfeeding duration and increased overall satisfaction, the current trials do not provide strong enough evidence to warrant investment in resources.

Effect of partogram use on outcomes for women in spontaneous labour at term.

BACKGROUND: The partogram (sometimes known as partograph) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partogram is to provide a pictorial overview of labour, to alert midwives and obstetricians to deviations in maternal or fetal wellbeing and labour progress. Charts often contain pre-printed alert and action lines. An alert line represents the slowest 10% of primigravid women's labour progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour. OBJECTIVES: To determine the effect of use of partogram on perinatal and maternal morbidity and mortality.To determine the effect of partogram design on perinatal and maternal morbidity and mortality. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2013). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials involving a comparison of partogram with no partogram, or comparison between different partogram designs. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining authors assessed the studies independently. MAIN RESULTS: We have included six studies involving 7706 women in this review; two studies assessed partogram versus no partogram and the remainder assessed different partogram designs. There was no evidence of any difference between partogram and no partogram in caesarean section (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.24 to 1.70); instrumental vaginal delivery (RR 1.00, 95% CI 0.85 to 1.17) or Apgar score less than seven at five minutes (RR 0.77, 95% CI 0.29 to 2.06) between the groups. When compared to a four-hour action line, women in the two-hour action line group were more likely to require oxytocin augmentation (RR 1.14, 95% CI 1.05 to 1.22). When the three- and four-hour action line groups were compared, caesarean section rate was lowest in the four-hour action line group and this difference was statistically significant (RR 1.70, 95% CI 1.07 to 2.70, n = 613, one trial). When a partogram with a latent phase (composite) and one without (modified) were compared, the caesarean section rate was lower in the partograph without a latent phase (RR 2.45, 95% CI 1.72 to 3.50, n = 743, one trial). AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot recommend routine use of the partogram as part of standard labour management and care. Given the fact that the partogram is currently in widespread use and generally accepted, it appears reasonable, until stronger evidence is available, that partogram use should be locally determined. Further trial evidence is required to establish the efficacy of partogram use.

Amniotomy for shortening spontaneous labour.

BACKGROUND: Intentional artificial rupture of the amniotic membranes during labour, sometimes called amniotomy or 'breaking of the waters', is one of the most commonly performed procedures in modern obstetric and midwifery practice. The primary aim of amniotomy is to speed up contractions and, therefore, shorten the length of labour. However, there are concerns regarding unintended adverse effects on the woman and baby. OBJECTIVES: To determine the effectiveness and safety of amniotomy alone for routinely shortening all labours that start spontaneously. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2013). SELECTION CRITERIA: Randomised controlled trials comparing amniotomy alone versus intention to preserve the membranes. We excluded quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two review authors assessed identified studies for inclusion, assessed risk of bias and extracted data. Primary analysis was by intention-to-treat. MAIN RESULTS: We have included 15 studies in this updated review, involving 5583 women. Amniotomy alone versus intention to preserve the membranes (no amniotomy) for spontaneous labour There was no clear statistically significant difference between women in the amniotomy and control groups in length of the first stage of labour (mean difference (MD) -20.43 minutes, 95% confidence interval (CI) -95.93 to 55.06), caesarean section (risk ratio (RR) 1.27, 95% CI 0.99 to 1.63), maternal satisfaction with childbirth experience (MD -1.10, 95% CI -7.15 to 4.95) or Apgar score less than seven at five minutes (RR 0.53, 95% CI 0.28 to 1.00). There was no consistency between trials regarding the timing of amniotomy during labour in terms of cervical dilatation. Amniotomy alone versus intention to preserve the membranes (no amniotomy) for spontaneous labours that have become prolonged There was no clear statistically significant difference between women in the amniotomy and control group in caesarean section (RR 0.95, 95% CI 0.15 to 6.08), maternal satisfaction with childbirth experience (MD 22.00, 95% CI 2.74 to 41.26) or Apgar score less than seven at five minutes (RR 2.86, 95% CI 0.12 to 66.11). AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot recommend that amniotomy should be introduced routinely as part of standard labour management and care. We recommend that the evidence presented in this review should be made available to women offered an amniotomy and may be useful as a foundation for discussion and any resulting decisions made between women and their caregivers.

Vibroacoustic stimulation for fetal assessment in labour in the presence of a nonreassuring fetal heart rate trace.

BACKGROUND: Fetal vibroacoustic stimulation (VAS) is a simple, non-invasive technique where a device is placed on the maternal abdomen over the region of the fetal head and sound is emitted at a predetermined level for several seconds. It is hypothesised that the resultant startle reflex in the fetus and subsequent fetal heart rate (FHR) acceleration or transient tachycardia following VAS provide reassurance of fetal well-being. This technique has been proposed as a tool to assess fetal well-being in the presence of a nonreassuring cardiotocographic (CTG) trace during the first and second stages of labour. OBJECTIVES: To evaluate the clinical effectiveness and safety of VAS in the assessment of fetal well-being during labour, compared with mock or no stimulation for women with a singleton pregnancy exhibiting a nonreassuring FHR pattern. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (6 September 2012) and reference lists of all retrieved articles. We sought unpublished trials and abstracts submitted to major international congresses and contacted expert informants. SELECTION CRITERIA: All published and unpublished randomised trials that compared maternal and fetal/neonatal/infant outcomes when VAS was used to evaluate fetal status in the presence of a nonreassuring CTG trace during labour, compared with mock or no stimulation. DATA COLLECTION AND ANALYSIS: Two review authors independently sought to assess for inclusion all the potential studies we identified as a result of the search strategy. We planned to resolve any disagreement through discussion or, if required, to consult a third person. Where there was uncertainty about a particular study, we attempted to contact study authors for additional information. However, these attempts were unsuccessful. MAIN RESULTS: The search strategies yielded six studies for consideration of inclusion. However, none of these studies fulfilled the requirements for inclusion in this review. AUTHORS' CONCLUSIONS: There are currently no randomised controlled trials that address the safety and efficacy of VAS used to assess fetal well-being in labour in the presence of a nonreassuring CTG trace. Although VAS has been proposed as a simple, non-invasive tool for assessment of fetal well-being, there is insufficient evidence from randomised trials on which to base recommendations for use of VAS in the evaluation of fetal well-being in labour in the presence of a nonreassuring CTG trace.

Amniotomy for shortening spontaneous labour.

BACKGROUND: Intentional artificial rupture of the amniotic membranes during labour, sometimes called amniotomy or 'breaking of the waters', is one of the most commonly performed procedures in modern obstetric and midwifery practice. The primary aim of amniotomy is to speed up contractions and, therefore, shorten the length of labour. However, there are concerns regarding unintended adverse effects on the woman and baby. OBJECTIVES: To determine the effectiveness and safety of amniotomy alone for routinely shortening all labours that start spontaneously. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2010). SELECTION CRITERIA: Randomised controlled trials comparing amniotomy alone versus intention to preserve the membranes. We excluded quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two authors assessed identified studies for inclusion, assessed risk of bias and extracted data. Primary analysis was by intention to treat. MAIN RESULTS: We have included 15 studies in this updated review, involving 5583 women. In the current review, data for women with spontaneous normal labour were pooled with data from one trial (involving 61 women) where women had spontaneous, but prolonged labour.There was no clear statistically significant difference between the amniotomy and control groups in length of the first stage of labour (mean difference (MD) -20.43 minutes, 95% confidence interval (CI) -95.93 to 55.06), caesarean section (risk ratio (RR) 1.27, 95% CI 0.99 to 1.62), maternal satisfaction with childbirth experience (standardised mean difference (SMD) 0.27, 95% CI -0.49 to 1.04) or low Apgar score less than seven at five minutes (RR 0.57, 95% CI 0.31 to 1.06). There was no consistency between papers regarding the timing of amniotomy during labour in terms of cervical dilatation. AUTHORS' CONCLUSIONS: On the basis of the findings of this review, we cannot recommend that amniotomy should be introduced routinely as part of standard labour management and care. We recommend that the evidence presented in this review should be made available to women offered an amniotomy and may be useful as a foundation for discussion and any resulting decisions made between women and their caregivers.