The design and implementation of an obstetric triage system for unscheduled pregnancy related attendances: a mixed methods evaluation.

BACKGROUND: No standardised system of triage exists in Maternity Care and local audit identified this to be problematic. We designed, implemented and evaluated an Obstetric Triage System in a large UK maternity unit. This includes a standard clinical triage assessment by a midwife, within 15 min of attendance, leading to assignment to a category of clinical urgency (on a 4-category scale). This guides timing of subsequent standardised immediate care for the eight most common reasons for attendance. A training programme was integral to the introduction. METHODS: A mixed methods evaluation was conducted. A structured audit of 994 sets of maternity notes before and after implementation identified the number of women seen within 15 min of attendance. Secondary measures reviewed included time to subsequent care and attendance. An inter-operator reliability study using scenarios was completed by midwives. A focus group and two questionnaire studies were undertaken to explore midwives' views of the system and to evaluate the training. In addition a national postal survey of practice in UK maternity units was undertaken in 2015. RESULTS: The structured audit of 974/992 (98%) of notes demonstrated an increase in the number of women seen within 15 min of attendance from 39% before implementation to 54% afterwards (RR (95% CI) 1.4 (1.2, 1.7) p = <0.0001). Excellent inter-operator reliability (ICC 0.961 (95% CI 0.91-0.99)) was demonstrated with breakdown showing consistently good rates. Thematic analysis of focus group data (n = 12) informed the development of the questionnaire which was sent to all appropriate midwives. The response rate was 53/79 (67%) and the midwives reported that the new system helped them manage the department and improved safety. The National Survey (response rate 85/135 [63%]) demonstrated wide variation in where women are seen and staffing models in place. The majority of units 69/85 (81%) did not use a triage system based on clinical assessment to prioritise care. CONCLUSIONS: This obstetric triage system has excellent inter- operator reliability and appears to be a reliable way of assessing the clinical priority of women as well as improving organisation of the department. Our survey has demonstrated the widespread need for implementation of such a system.

Effects of lay support for pregnant women with social risk factors on infant development and maternal psychological health at 12 months postpartum.

BACKGROUND: The ELSIPS (Evaluation of Lay Support in Pregnant Women with Social Risk) RCT showed that lay support for women with social risk had a positive effect on maternal mental health and mother-infant bonding. This exploratory study examined whether these observed benefits would impact infant development at 1 year. METHODS: A sub-sample of women whose infants were under one year who had participated in the ELSIPS RCT which randomised women to receive either standard care or the services of a Pregnancy Outreach Worker (POW), and who were contactable, were eligible to participate in the follow up. At home visits, the Bayley Scales of Infant Development (3rd Edition) and standardised measures of depression, self efficacy, mind-mindedness and bonding were completed. RESULTS: 486 women were eligible for follow up, of whom 154 agreed to participate. 61/273 were successfully followed up in the standard maternity care arm and 51/213 in the POW arm. Women who completed follow up were less depressed and had higher selfefficacy scores at 8-12 weeks postpartum than those who did not complete follow up. There were no significant differences in maternal outcomes, infant cognitive development, receptive communication, expressive communication, fine motor development or social/emotional functioning between groups at 12 month follow up. Infants of mothers who received the POW intervention had significantly better gross motor development than infants whose mothers received standard care (p<0.03). CONCLUSIONS: The provision of lay support to women with social risk may facilitate infant gross motor skill development at one year but there were no other demonstrable benefits. The effects of the intervention may be underestimated given that those women who completed follow up had better mental health than the original study sample. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN35027323.

Evaluation of a bespoke training to increase uptake by midwifery teams of NICE Guidance for membrane sweeping to reduce induction of labour: a stepped wedge cluster randomised design.

BACKGROUND: National guidance recommends pregnant women are offered membrane sweeping at term to reduce induction of labour. Local audit suggested this was not being undertaken routinely across two maternity units in the West Midlands, UK between March and November 2012. METHODS: Bespoke training session for midwifery teams (nine community and one antenatal clinic) was developed to address identified barriers to encourage offer of membrane sweeping, together with an information leaflet for women and appointment of a champion within each team. The timing of training session on membrane sweeping to ten midwifery teams was randomly allocated using a stepped wedge cluster randomised design. All women who gave birth in the Trusts after 39 + 3/40 weeks gestation within the study time period were eligible. Relevant anonymised data were extracted from maternity notes for three months before and after training. Data were analysed using a generalised linear mixed model, allowing for clustering and adjusting for temporal effects. Primary outcomes were number of women offered and accepting membrane sweeping and average number of sweeps per woman. Sub-group comparisons were undertaken for adherence to Trust guidance and potential influence of pre-specified maternal characteristics. Data included whether sweeping was offered but declined and no record of membrane sweeping. RESULTS: Training was given to all teams as planned. Analyses included data from 2787 of the 2864 (97%) eligible low-risk women over 39 + 4 weeks pregnant. Characteristics of the women were similar before and after training. No evidence of difference in proportion of women being offered and accepting membrane sweeping (44.4% before training versus 46.8% after training (adjusted relative risk [aRR] = 0.90, 95% confidence interval [CI] = 0.71-1.13), nor in average number of sweeps per woman (0.603 versus 0.627, aRR = 0.83, 95% CI = 0.67-1.01). No differences in any secondary outcomes nor influence of maternal characteristics were demonstrated. The midwives evaluated training positively. CONCLUSIONS: This stepped wedge cluster trial enabled randomised evaluation within a natural roll-out and demonstrates the importance of robust evaluation in circumstances in which it is rarely undertaken. While the midwives evaluated the training positively, it did not appear to change practice. TRIALS REGISTRATION: ISRCTN14300475 . Registered on 23 August 2016.

Lay support for pregnant women with social risk: a randomised controlled trial.

OBJECTIVES: We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families. DESIGN: Prospective, pragmatic, individually randomised controlled trial. SETTING: 3 Maternity Trusts in West Midlands, UK. PARTICIPANTS: Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded. INTERVENTIONS: POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms. MAIN OUTCOME MEASURES: Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8-12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8-12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems. RESULTS: Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) -0.00, 95% CI (95% CI -0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD -0.79 (95% CI -1.56 to -0.02) was significantly better, although for all women recruited, no significant differences were seen (MD -0.59 (95% CI -1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group for all women (MD -0.30 (95% CI -0.61 to -0.00) p=0.05), and there were no differences in other secondary outcomes. CONCLUSIONS: This trial demonstrates differences in depressive symptomatology with addition of the POW service in the powered subgroup of women with 2 or more social risk factors. Addition to existing evidence indicates benefit from lay interventions in preventing postnatal depression. This finding is important for women and their families given the known effect of maternal depression on longer term childhood outcomes. TRIAL REGISTRATION NUMBER: ISRCTN35027323; Results.

Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS): a randomised controlled trial.

BACKGROUND: Maternal, neonatal and child health outcomes are worse in families from black and ethnic minority groups and disadvantaged backgrounds. There is little evidence on whether lay support improves maternal and infant outcomes among women with complex social needs within a disadvantaged multi-ethnic population in the United Kingdom (UK). METHOD/DESIGN: The aim of this study is to evaluate a lay Pregnancy Outreach Worker (POW) service for nulliparous women identified as having social risk within a maternity service that is systematically assessing social risks alongside the usual obstetric and medical risks. The study design is a randomised controlled trial (RCT) in nulliparous women assessed as having social risk comparing standard maternity care with the addition of referral to the POW support service. The POWs work alongside community midwifery teams and offer individualised support to women to encourage engagement with services (health and social care) from randomisation (before 28 weeks gestation) until 6 weeks after birth. The primary outcomes have been chosen on the basis that they are linked to maternal and infant health. The two primary outcomes are engagement with antenatal care, assessed by the number of antenatal visits; and maternal depression, assessed using the Edinburgh Postnatal Depression Scale at 8-12 weeks after birth. Secondary outcomes include maternal and neonatal morbidity and mortality, routine child health assessments, including immunisation uptake and breastfeeding at 6 weeks. Other psychological outcomes (self efficacy) and mother-to-infant bonding will also be collected using validated tools.A sample size of 1316 will provide 90% power (at the 5% significance level) to detect increased engagement with antenatal services of 1.5 visits and a reduction of 1.5 in the average EPDS score for women with two or more social risk factors, with power in excess of this for women with any social risk factor. Analysis will be by intention to treat. Qualitative research will explore the POWs' daily work in context. This will complement the findings of the RCT through a triangulation of quantitative and qualitative data on the process of the intervention, and identify other contextual factors that affect the implementation of the intervention. DISCUSSION: The trial will provide high quality evidence as to whether or not lay support (POW) offered to women identified with social risk factors improves engagement with maternity services and reduces numbers of women with depression. MREC NUMBER: 10/H1207/23 TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN35027323.

Characterization of cytolytic neutrophil activation in vitro by amorphous hydrated calcium phosphate as a model of biomaterial inflammation.

Calcium ions are utilized in biomolecular biomaterial design for osteomimetic scaffolds and as divalent cross-linking agents, typically for gelation of alginates, stabilisation of protein structure (e.g., fibrinogen) and enzyme activation (e.g., thrombin). Biological interactions with defined calcium phosphates (e.g., hydroxyapatite) are exploited for osteogenesis, although crystalline calcium phosphates (e.g., calcium pyrophosphate) stimulate inflammation. We found that the calcium concentration used in the manufacture of prototype dermal scaffolds made from fibrin/alginate composite was related to the inflammatory infiltration during in vivo integration. In investigating a cause for this inflammatory response, we have identified and characterized a cytolytic inflammatory effect of amorphous calcium phosphate (CaP) formed in physiological solutions, relevant to biomaterial biocompatibility. Isolated human neutrophils (Nφ) were incubated in phosphate-buffered saline with CaCl(2) ranging 2.5-20 mM total calcium. Nφ activation was assessed by morphology and integrin-ß2 (CD18a) expression. Mediator release (Nφ-elastase, IL-8, and TNFα) was measured from both Nφ and whole blood cultures plus CaCl(2). CaP exposure increased CD18a expression over 1 h (maximal at 10 mM calcium/ phosphate) with concurrent phagocytosis, cytolysis, and Nφ-elastase release. CaCl(2) induced expression of IL-8 and TNFα in whole blood cultures. These results suggest that CaP formed from the resorption of calcium-containing biomaterials could induce inflammation and accelerate biomaterial degradation, driving further CaP release. This demonstrates a novel mechanism for biomaterial-induced inflammation. The in vitro system described could aid preclinical evaluation of novel biomaterial inflammatory potential.

The quantitative assessment of wrinkle depth: turning the microscope on botulinum toxin type A.

This prospective study was designed to produce a quantitative model for wrinkle depth assessment, and to compare scientific and clinical methods of evaluation, in the context of botulinum toxin type A treatment. Ten patients were assessed at baseline and 3 weeks after treatment using silicone masks and standardized photography in forehead, glabellar, and lateral canthal areas, at rest and during maximal expression. Wrinkle depth was measured on masks using multiphoton microscopy. Clinical improvement was judged by a panel of observers according to the Hay scale. There was a statistically significant improvement in wrinkle depth after treatment in all areas. Dynamic rhytides demonstrated greatest improvement, notably in the forehead (89% reduction). The objective improvement in static rhytides (43%-56%) has not previously been demonstrated. Clinical evaluation was less accurate than scientific methodology for static lines. This model may have a place in comparing products or treatment regimes, particularly when changes are subtle.