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Background: Second-stage caesarean sections, of which there are around 34,000 per year in the UK, have greater maternal and perinatal morbidity than those in the first stage. The fetal head is often deeply impacted in the maternal pelvis, and extraction can be difficult. Numerous techniques are reported, but the superiority of one over another is contentious and there is no national guidance. Objective To determine the feasibility of a randomised trial of different techniques for managing an impacted fetal head during emergency caesarean. Design A scoping study with five work packages: (1) national surveys to determine current practice and acceptability of research in this area, and a qualitative study to determine acceptability to women who have experienced a second-stage caesarean; (2) a national prospective observational study to determine incidence and rate of complications; (3) a Delphi survey and consensus meeting on choice of techniques and outcomes for a trial; (4) the design of a trial; and (5) a national survey and qualitative study to determine acceptability of the proposed trial. Setting Secondary care. Participants Health-care professionals, pregnant women, women who have had a second-stage caesarean, and parents. Results Most (244/279, 87%) health-care professionals believe that a trial in this area would help guide their practice, and 90% (252/279) would be willing to participate in such a trial. Thirty-eight per cent (98/259) of parents reported that they would take part. Women varied in which technique they thought was most acceptable. Our observational study found that impacted head is common (occurring in 16% of second-stage caesareans) and leads to both maternal (41%) and neonatal (3.5%) complications. It is most often treated by an assistant pushing the head up vaginally. We designed a randomised clinical trial comparing the fetal pillow with the vaginal push technique. The vast majority of health-care professionals, 83% of midwives and 88% of obstetricians, would be willing to participate in the trial proposed, and 37% of parents reported that they would take part. Our qualitative study found that most participants thought the trial would be feasible and acceptable. Limitations Our survey is subject to the limitation that, although responses refer to contemporaneous real cases, they are self-reported by the surgeon and collected after the event. Willingness to participate in a hypothetical trial may not translate into recruitment to a real trial. Conclusions We proposed a trial to compare a new device, the fetal pillow, with a long-established procedure, the vaginal push technique. Such a trial would be widely supported by health-care professionals. We recommend that it be powered to test an effect on important short term maternal and baby outcomes which would require 754 participants per group. Despite the well-known difference between intent and action, this would be feasible within the UK. Future work We recommend a randomised controlled trial of two techniques for managing an impacted fetal head with an in-built internal pilot phase and alongside economic and qualitative substudies. Study registration This study is registered as Research Registry 4942. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 6. See the NIHR Journals Library website for further project information. Plain language summary: One-quarter of UK pregnant women have a caesarean section. Most of these procedures are straightforward, but in a small number of cases unexpected complications can make the birth difficult. One complication, an impacted fetal head, may happen when caesarean sections are done in the second ‘pushing’ stage of labour. If the baby’s head is low and wedged in the woman’s pelvis, lifting it can be difficult, which can result in damage to the mother’s womb and vagina, and to her baby. Occasionally, babies die. There are different techniques doctors and midwives can use to make these births easier, but there is uncertainty around which is best. To plan a trial to test these techniques, we needed to know how often impacted head happens, what techniques are used to manage it and whether or not research is acceptable to parents and health-care professionals. We surveyed doctors and midwives to find out which techniques they use and what training they need. We surveyed parents and pregnant women and interviewed women who had experienced a second-stage caesarean. We collected information from UK hospitals to find out how common this is and the impact on women and babies. We found out the following: Around 7% of caesareans take place in second stage, and impacted fetal head occurs in 16% of these births. One-third of women would consent to take part in a trial, if the complication happened to them. Nearly all midwives and doctors thought that this research was important and would be willing to take part. Using all of the information we collected, we designed a clinical trial. We wanted to compare two techniques for managing an impacted fetal head. The first is the vaginal push technique, where the doctor or midwife puts their hand into the mother’s vagina to push her baby’s head up, and the second is the fetal pillow, a device inserted into the mother’s vagina before the operation starts to dislodge the baby’s head upwards. Scientific summary: Background Emergency caesarean section (CS) performed in the second stage of labour, which occurs in 34,000 births per annum in the UK, has greater perinatal and maternal morbidity than CS performed in the first stage. Second-stage CS may be complicated by the fetal head being deeply impacted in the maternal pelvis, which occurs in 1.5% of all emergency CSs. Complications include longer delivery times, uterine tears, injury to the baby and even, albeit rarely, death. Numerous techniques to assist in delivery of an impacted fetal head (IFH) are reported. The superiority of one technique over another is contentious. At present, there is no national guidance on what techniques to employ. Research questions What are the current practice, level of experience and training requirements for managing an IFH during emergency CS among UK obstetricians, obstetric anaesthetists and midwives? What are the views of pregnant women and their partners on research in this area? How acceptable is a randomised trial in this area to women who have experienced a second-stage caesarean birth, and what are their views on the different proposed techniques for managing an IFH? What is the incidence of IFH and maternal and neonatal complications arising from IFH in the UK? What techniques and outcomes do health-care professionals and parents think should be included in a randomised trial in IFH? What should the design be for a randomised trial in IFH? How acceptable is the randomised trial we have designed to health-care professionals, women who have experienced a second-stage caesarean birth and pregnant women? Methods We undertook a national survey of obstetricians, trainee obstetricians, obstetric anaesthetists and midwives to determine current practice, level of experience and training requirements for managing IFH during emergency CS. We also undertook a national survey of parents to determine their views on this topic. Individual face-to-face interviews with women who have experienced a second-stage CS were carried out to determine the acceptability of a randomised trial in this area and their views on the different proposed techniques for managing IFH. A national, prospective UK Obstetric Surveillance System (UKOSS) surveillance study was undertaken to determine the incidence and consequences of IFH in the UK. Based on the findings of previous work packages, we conducted a Delphi survey followed by a virtual consensus meeting of experts and important stakeholders to decide which techniques should be tested in any trial and which outcomes should be included. A randomised trial of different techniques for managing IFH during emergency CS was designed. We undertook a national survey of lead obstetricians, pregnant women and midwives to determine the feasibility and acceptability of the randomised trial designed. Three sets of individual telephone or video interviews were carried out with lead obstetricians/senior obstetric trainees, women who have experienced a second-stage CS and primiparous women to determine the acceptability and feasibility of the planned trial. Results The majority (89%) of health-care professionals stated that a clinical trial in this area would help to guide their clinical practice, and 87% would be willing to participate in such a trial. In addition, 37% of parents reported that they would be either likely or very likely to take part, or neutral. Women varied in which technique they thought was most acceptable, and their trust in medical expertise and prioritising the safety of the baby were important moderators of acceptability. Our national prospective observational study found that impacted head is common, occurring in 16% of second-stage caesarean births in the UK, and leads to both maternal and neonatal complications. Overall, 230 (41%) women and 20 babies (3.5%) experienced complications. Thirteen babies (2%) died or sustained severe injury. Seven suffered bony fracture, two brachial plexus injury and one facial palsy. Three had moderate or severe hypoxic ischaemic encephalopathy, and seven were cooled. Four babies died: one prior to the caesarean, one with multiple abnormalities and two as a direct result of complications caused by IFH. IFH is currently most often treated by an assistant pushing the head up vaginally during the CS. Data from earlier work packages were used throughout the project, culminating in the design of a randomised clinical trial. Our proposed trial would compare a new device, the fetal pillow, with a procedure used for many years, the vaginal push technique, for preventing IFH. Most doctors and midwives believed that such a trial would be important and were willing to recruit participants to one. About one in three women said that they would be willing to join such a trial. The only interventions that were more popular with patients were tocolysis and the head-down technique. Both of these are adjunct techniques used by all obstetricians and, therefore, are not suitable for evaluation in a trial. The required sample size of such a trial depends on whether it is powered to show a difference in severe maternal morbidity (control event rate 2.3%, 4698 participants per group), a difference in fetal short-term morbidity (control event rate 13.7%, 754 participants per group) or only a difference in less severe maternal events, including haemorrhage over 1000 ml (control event rate 27%, 322 participants per group). We believe that it is not feasible to conduct the trial powered on severe maternal morbidity. However, parents and doctors believe that a trial to test the effect of different procedures on meaningful baby outcomes is important. We therefore recommend that the required sample size would be 754 per group. The vast majority of midwives (83%) and obstetricians (88%) would be willing to participate in the clinical trial proposed. In addition, 37% of parents reported that they would be either likely or very likely to take part, or neutral. Our qualitative study found that most participants thought that the trial would be feasible and acceptable. Conclusions We recommend that a randomised trial with an internal pilot phase comparing a new device, the fetal pillow, with a procedure used for many years, the vaginal push technique, for managing IFH be conducted. This trial is widely supported by health-care professionals. We recommend that the definitive trial be powered to test an effect on important short-term maternal and baby outcomes, which would require 754 participants per group. A sufficient number of women would be willing to be join such a trial to make it likely to be feasible in the UK. Study registration This study is registered as Research Registry 4942. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 6. See the NIHR Journals Library website for further project information.

Background: Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy. Objective: To determine the cost‐effectiveness of daily all‐over‐body application of emollient during the first year of life for preventing atopic eczema in high‐risk children at 2 years from a health service perspective. We also considered a 5‐year time horizon as a sensitivity analysis. Methods: A within‐trial economic evaluation using data on health resource use and quality of life captured as part of the BEEP trial alongside the trial data. Parents/carers of 1394 infants born to families at high risk of atopic disease were randomised 1:1 to the emollient group, which were advised to apply emollient (Doublebase Gel or Diprobase Cream) to their child at least once daily to the whole body during the first year of life or usual care. Both groups received advice on general skin care. The main economic outcomes were incremental cost‐effectiveness ratio (ICER), defined as incremental cost per percentage decrease in risk of eczema in the primary cost‐effectiveness analysis. Secondary analysis, undertaken as a cost‐utility analysis, reports incremental cost per Quality‐Adjusted Life Year (QALY) where child utility was elicited using the proxy CHU‐9D at 2 years. Results: At 2 years, the adjusted incremental cost was £87.45 (95% CI −54.31, 229.27) per participant, whilst the adjusted proportion without eczema was 0.0164 (95% CI −0.0329, 0.0656). The ICER was £5337 per percentage decrease in risk of eczema. Adjusted incremental QALYs were very slightly improved in the emollient group, 0.0010 (95% CI −0.0069, 0.0089). At 5 years, adjusted incremental costs were lower for the emollient group, −£106.89 (95% CI −354.66, 140.88) and the proportion without eczema was −0.0329 (95% CI −0.0659, 0.0002). The 5‐year ICER was £3201 per percentage decrease in risk of eczema. However, when inpatient costs due to wheezing were excluded, incremental costs were lower and incremental effects greater in the usual care group. Conclusions: In line with effectiveness endpoints, advice given in the BEEP trial to apply daily emollient during infancy for eczema prevention in high‐risk children does not appear cost‐effective. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of emollients for preventing atopic dermatitis/eczema is controversial. The Barrier Enhancement for Eczema Prevention trial evaluated the effects of daily emollients during the first year of life on atopic dermatitis and atopic conditions to age 5 years. Methods: 1394 term infants with a family history of atopic disease were randomized (1:1) to daily emollient plus standard skin‐care advice (693 emollient group) or standard skin‐care advice alone (701 controls). Long‐term follow‐up at ages 3, 4 and 5 years was via parental questionnaires. Main outcomes were parental report of a clinical diagnosis of atopic dermatitis and food allergy. Results: Parents reported more frequent moisturizer application in the emollient group through to 5 years. A clinical diagnosis of atopic dermatitis between 12 and 60 months was reported for 188/608 (31%) in the emollient group and 178/631 (28%) in the control group (adjusted relative risk 1.10, 95% confidence interval 0.93 to 1.30). Although more parents in the emollient group reported food reactions in the previous year at 3 and 4 years, cumulative incidence of doctor‐diagnosed food allergy by 5 years was similar between groups (92/609 [15%] emollients and 87/632 [14%] controls, adjusted relative risk 1.11, 95% confidence interval 0.84 to 1.45). Findings were similar for cumulative incidence of asthma and hay fever. Conclusions: Daily emollient application during the first year of life does not prevent atopic dermatitis, food allergy, asthma or hay fever. [ABSTRACT FROM AUTHOR]

Summary: The UK Dermatology Clinical Trials Network (UK DCTN) was formed in 2002 with the aim of developing and supporting high‐quality independent national clinical trials that address prioritized research questions for people with skin disease. Its philosophy is to democratize UK dermatological clinical research and to tackle important clinical questions that industry has no incentive to answer. The network also plays a key role in training and capacity development. Its membership of over 1000 individuals includes dermatology consultants, trainees, dermatology nurses, general practitioners, methodologists and patients. Its organizational structures are lean and include a co‐ordinating team based at the Centre of Evidence‐Based Dermatology in Nottingham, and an executive with independent members to ensure probity and business progression. A prioritization panel and steering group enable a pipeline of projects to be prioritized and refined for external funding from independent sources. The UK DCTN has supported and completed 12 national clinical trials, attracting investment of over £15 million into UK clinical dermatology research. Trials have covered a range of interventions from drugs such as doxycycline (BLISTER), silk clothing for eczema (CLOTHES) and surgical interventions for hidradenitis suppurativa (THESEUS). Trial results are published in prestigious journals and have global impact. Genuine partnership with patients and carers has been a strong feature of the network since its inception. The UK DCTN is proud of its first 20 years of collaborative work, and aims to remain at the forefront of independent dermatological health technology assessment, as well as expanding into areas including diagnostics, artificial intelligence, efficient studies and innovative designs. [ABSTRACT FROM AUTHOR]

Background The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease. Methods and findings This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects. Conclusions Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema. Trial registration Current Controlled Trials ISRCTN77261365, Author(s): Kim S. Thomas 1,*, Lucy E. Bradshaw 2, Tracey H. Sach 3, Jonathan M. Batchelor 1, Sandra Lawton 4, Eleanor F. Harrison 2, Rachel H. Haines 2, Amina Ahmed [...]