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Background: The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe. Methods: Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in science communication. We searched for, and evaluated, relevant existing materials and developed additional materials and tools, making them freely available under a Creative Commons licence. Results: The principal communication materials developed were: 1. A website (http://ecranproject.eu) in six languages, including a Media centre section to help journalists to disseminate information about the ECRAN project 2. An animated film about clinical trials, dubbed in the 23 official languages of the European Community, and an interactive tutorial 3. An inventory of resources, available in 23 languages, searchable by topic, author, and media type 4. Two educational games for young people, developed in six languages 5. Testing Treatments interactive in a dozen languages, including five official European Community languages 6. An interactive tutorial slide presentation testing viewers' knowledge about clinical trials Conclusions: Over a 2-year project, our multidisciplinary and multinational consortium was able to produce, and make freely available in many languages, new materials to promote public knowledge about the importance of independent and international clinical trials. Sustained funding for the ECRAN information platform could help to promote successful recruitment to independent clinical trials supported through the European Clinical Research Infrastructure Network.

Objective: (Primary): to establish the effect of antenatal group self-hypnosis for nulliparous women on intra-partum epidural use Design: Multi-method RCT Setting: Three NHS Trusts Population: Nulliparous women not planning elective caesarean, without medication for hypertension and without psychological illness. Methods: Randomisation at 28-32 weeks gestation to usual care, or to usual care plus brief self-hypnosis training (two x 90 minute groups at around 32 and 35 weeks gestation; daily audio self-hypnosis CD). Follow up at two and six weeks postnatal. Main outcome measures:- Primary: epidural analgesia Secondary: associated clinical and psychological outcomes; economic analysis. Results: 680 women were randomised. There was no statistically significant difference in epidural use: 27.9% (intervention), 30.3% (control), odds ratio (OR) 0.89 (95% confidence interval (CI): 0.64 to 1.24), or in 27 of 29 pre-specified secondary clinical and psychological outcomes. Women in the intervention group had lower actual than anticipated levels of fear and anxiety between baseline and two weeks post natal (anxiety: OR -0.72, 95% CI -1.16 to -0.28, P= 0.001); fear (OR -0.62, 95% CI -1.08 to -0.16, p = 0.009) Postnatal response rates were 67% overall at two weeks. The additional cost of the intervention per woman was £4.83 (CI -£257.93 to £267.59). Conclusions: Allocation to two third-trimester group self-hypnosis training sessions did not significantly reduce intra-partum epidural analgesia use or a range of other clinical and psychological variables. The impact of women’s anxiety and fear about childbirth needs further investigation. Trial registration: ISRCTN27575146 http://www.controlled-trials.com/ISRCTN27575146

Background: Vaginal examinations have become a routine intervention in labour as a means of assessing labour progress. Used at regular intervals, either alone or as a component of the partogram (a pre-printed form providing a pictorial overview of the progress of labour), the aim is to assess if labour is progressing physiologically, and to provide an early warning of slow progress. Abnormally slow progress can be a sign of labour dystocia, which is associated with maternal and fetal morbidity and mortality, particularly in low-income countries where appropriate interventions cannot easily be accessed. However, over-diagnosis of dystocia can lead to iatrogenic morbidity from unnecessary intervention (e.g. operative vaginal birth or caesarean section). It is, therefore, important to establish whether or not the routine use of vaginal examinations is an effective intervention, both as a diagnostic tool for true labour dystocia, and as an accurate measure of physiological labour progress. Objectives: To compare the effectiveness, acceptability and consequences of digital vaginal examination(s) (alone or within the context of the partogram) with other strategies, or different timings, to assess progress during labour at term. Search strategy: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 February 2013) and reference lists of identified studies. Selection criteria: We included randomised controlled trials (RCTs) of vaginal examinations (including digital assessment of the consistency of the cervix, and the degree of dilation and position of the opening of the uterus (cervical os); and position and station of the fetal presenting part, with or without abdominal palpation) compared with other ways of assessing progress of labour. We also included studies assessing different timings of vaginal examinations. We excluded quasi-RCTs and cross-over trials. We also excluded trials with a primary focus on assessing progress of labour using the part

Objective To explore whether women view decision-making surrounding vaginal or caesarean birth as their choice. Design Longitudinal cohort study utilising quantitative (questionnaire, routinely collected data) and qualitative (in-depth interviews) methods simultaneously. Setting A large hospital providing National Health Service maternity care in the UK. Sample Four-hundred and fifty-four primigravid women. Methods Women completed up to three questionnaires between their antenatal booking appointment and delivery. Amongst these women, 153 were interviewed at least once during pregnancy (between 24 and 36 weeks) and/or after 12 moths after birth. Data were also obtained from women’s hospital delivery records. Descriptive statistical analysis was performed (survey and delivery data). Interview data were analysed using a seven-stage sequential form of qualitative analysis. Results Whilst many women supported the principle of choice, they identified how, in practice their autonomy was limited by individual circumstance and available care provision. All women felt that concerns about their baby’s or their own health should take precedence over personal preference. Moreover, expressing a preference for either vaginal or caesarean birth was inherently problematic as choice until the time of delivery was neither static nor final. Women did not have autonomous choice over their actual birth method, but neither did they necessarily want it. Conclusions The results of this large exploratory study suggest that choice may not be the best concept through which to approach the current arrangements for birth in the UK. Moreover, they challenge the notion of choice that currently prevails in international debates about caesarean delivery for maternal request.

Objective To explore whether women view decision-making surrounding vaginal or caesarean birth as their choice. Design Longitudinal cohort study utilising quantitative (questionnaire, routinely collected data) and qualitative (in-depth interviews) methods simultaneously. Setting A large hospital providing National Health Service maternity care in the UK. Sample Four-hundred and fifty-four primigravid women. Methods Women completed up to three questionnaires between their antenatal booking appointment and delivery. Amongst these women, 153 were interviewed at least once during pregnancy (between 24 and 36 weeks) and/or after 12 moths after birth. Data were also obtained from women’s hospital delivery records. Descriptive statistical analysis was performed (survey and delivery data). Interview data were analysed using a seven-stage sequential form of qualitative analysis. Results Whilst many women supported the principle of choice, they identified how, in practice their autonomy was limited by individual circumstance and available care provision. All women felt that concerns about their baby’s or their own health should take precedence over personal preference. Moreover, expressing a preference for either vaginal or caesarean birth was inherently problematic as choice until the time of delivery was neither static nor final. Women did not have autonomous choice over their actual birth method, but neither did they necessarily want it. Conclusions The results of this large exploratory study suggest that choice may not be the best concept through which to approach the current arrangements for birth in the UK. Moreover, they challenge the notion of choice that currently prevails in international debates about caesarean delivery for maternal request.