Midwife continuity of care models versus other models of care for childbearing women.

BACKGROUND: Midwives are primary providers of care for childbearing women globally and there is a need to establish whether there are differences in effectiveness between midwife continuity of care models and other models of care. This is an update of a review published in 2016. OBJECTIVES: To compare the effects of midwife continuity of care models with other models of care for childbearing women and their infants. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Trials Register, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) (17 August 2022), as well as the reference lists of retrieved studies. SELECTION CRITERIA: All published and unpublished trials in which pregnant women are randomly allocated to midwife continuity of care models or other models of care during pregnancy and birth. DATA COLLECTION AND ANALYSIS: Two authors independently assessed studies for inclusion criteria, scientific integrity, and risk of bias, and carried out data extraction and entry. Primary outcomes were spontaneous vaginal birth, caesarean section, regional anaesthesia, intact perineum, fetal loss after 24 weeks gestation, preterm birth, and neonatal death. We used GRADE to rate the certainty of evidence. MAIN RESULTS: We included 17 studies involving 18,533 randomised women. We assessed all studies as being at low risk of scientific integrity/trustworthiness concerns. Studies were conducted in Australia, Canada, China, Ireland, and the United Kingdom. The majority of the included studies did not include women at high risk of complications. There are three ongoing studies targeting disadvantaged women. Primary outcomes Based on control group risks observed in the studies, midwife continuity of care models, as compared to other models of care, likely increase spontaneous vaginal birth from 66% to 70% (risk ratio (RR) 1.05, 95% confidence interval (CI) 1.03 to 1.07; 15 studies, 17,864 participants; moderate-certainty evidence), likelyreduce caesarean sections from 16% to 15% (RR 0.91, 95% CI 0.84 to 0.99; 16 studies, 18,037 participants; moderate-certainty evidence), and likely result in little to no difference in intact perineum (29% in other care models and 31% in midwife continuity of care models, average RR 1.05, 95% CI 0.98 to 1.12; 12 studies, 14,268 participants; moderate-certainty evidence). There may belittle or no difference in preterm birth (< 37 weeks) (6% under both care models, average RR 0.95, 95% CI 0.78 to 1.16; 10 studies, 13,850 participants; low-certainty evidence). We arevery uncertain about the effect of midwife continuity of care models on regional analgesia (average RR 0.85, 95% CI 0.79 to 0.92; 15 studies, 17,754 participants, very low-certainty evidence), fetal loss at or after 24 weeks gestation (average RR 1.24, 95% CI 0.73 to 2.13; 12 studies, 16,122 participants; very low-certainty evidence), and neonatal death (average RR 0.85, 95% CI 0.43 to 1.71; 10 studies, 14,718 participants; very low-certainty evidence). Secondary outcomes When compared to other models of care, midwife continuity of care models likely reduce instrumental vaginal birth (forceps/vacuum) from 14% to 13% (average RR 0.89, 95% CI 0.83 to 0.96; 14 studies, 17,769 participants; moderate-certainty evidence), and may reduceepisiotomy 23% to 19% (average RR 0.83, 95% CI 0.77 to 0.91; 15 studies, 17,839 participants; low-certainty evidence). When compared to other models of care, midwife continuity of care models likelyresult in little to no difference inpostpartum haemorrhage (average RR 0.92, 95% CI 0.82 to 1.03; 11 studies, 14,407 participants; moderate-certainty evidence) and admission to special care nursery/neonatal intensive care unit (average RR 0.89, 95% CI 0.77 to 1.03; 13 studies, 16,260 participants; moderate-certainty evidence). There may be little or no difference in induction of labour (average RR 0.92, 95% CI 0.85 to 1.00; 14 studies, 17,666 participants; low-certainty evidence), breastfeeding initiation (average RR 1.06, 95% CI 1.00 to 1.12; 8 studies, 8575 participants; low-certainty evidence), and birth weight less than 2500 g (average RR 0.92, 95% CI 0.79 to 1.08; 9 studies, 12,420 participants; low-certainty evidence). We are very uncertain about the effect of midwife continuity of care models compared to other models of care onthird or fourth-degree tear (average RR 1.10, 95% CI 0.81 to 1.49; 7 studies, 9437 participants; very low-certainty evidence), maternal readmission within 28 days (average RR 1.52, 95% CI 0.78 to 2.96; 1 study, 1195 participants; very low-certainty evidence), attendance at birth by a known midwife (average RR 9.13, 95% CI 5.87 to 14.21; 11 studies, 9273 participants; very low-certainty evidence), Apgar score less than or equal to seven at five minutes (average RR 0.95, 95% CI 0.72 to 1.24; 13 studies, 12,806 participants; very low-certainty evidence) andfetal loss before 24 weeks gestation (average RR 0.82, 95% CI 0.67 to 1.01; 12 studies, 15,913 participants; very low-certainty evidence). No maternal deaths were reported across three studies. Although the observed risk of adverse events was similar between midwifery continuity of care models and other models, our confidence in the findings was limited. Our confidence in the findings was lowered by possible risks of bias, inconsistency, and imprecision of some estimates. There were no available data for the outcomes: maternal health status, neonatal readmission within 28 days, infant health status, and birth weight of 4000 g or more. Maternal experiences and cost implications are described narratively. Women receiving care from midwife continuity of care models, as opposed to other care models, generally reported more positive experiences during pregnancy, labour, and postpartum. Cost savings were noted in the antenatal and intrapartum periods in midwife continuity of care models. AUTHORS' CONCLUSIONS: Women receiving midwife continuity of care models were less likely to experience a caesarean section and instrumental birth, and may be less likely to experience episiotomy. They were more likely to experience spontaneous vaginal birth and report a positive experience. The certainty of some findings varies due to possible risks of bias, inconsistencies, and imprecision of some estimates. Future research should focus on the impact on women with social risk factors, and those at higher risk of complications, and implementation and scaling up of midwife continuity of care models, with emphasis on low- and middle-income countries.

A community-based mentoring scheme for pregnant and parenting adolescents in Sierra Leone: Protocol for a hybrid pilot cluster randomised controlled trial.

BACKGROUND: Sierra Leone has a very high maternal mortality rate, and this burden falls heavily on adolescents, a particularly vulnerable group; this is usually driven by poverty, lack of education and employment opportunities. In 2017, a local grassroots organisation, Lifeline Nehemiah Projects, developed a community-based mentoring intervention '2YoungLives' (2YLs) for adolescent girls in Eastern Freetown. We aim to formally assess the feasibility and implementation of the 2YL mentorship scheme in new communities in Sierra Leone. METHODS: A hybrid type 2 pilot cluster randomised controlled trial of the 2YL mentoring scheme in urban and rural communities living around twelve peripheral health units (PHU) across five districts in Sierra Leone. Clusters will be matched into pairs and randomisation will be determined by computer-generated random numbers via a secure web-based system hosted by MedSciNet. All under-eighteen adolescents identified as pregnant in the community and/or the PHU are included. Feasibility (recruitment, retention, and attrition rates; data collection and completeness; sample calculation) and primary clinical outcome data (composite of maternal deaths, stillbirths, neonatal deaths) will be collected. A mixed-methods process evaluation will explore implementation outcomes, mechanisms of change, contextual factors, experiences of care, and health and wellbeing. A concurrent cost-consequence analysis will be undertaken. Main trial analysis will be pragmatic, by intention to treat, and a complementary per protocol analysis will also be included. DISCUSSION: Improving health and wellbeing for adolescent girls (including sexual and reproductive health) remains a top priority in Sierra Leone indicated by several government policies targeted to this group, in which maternal and infant mortality are still persistently high. Supporting these girls and facilitating their wellbeing is imperative, along with sensitisation of communities, strengthening of youth friendly services and collaboration with stakeholders at all levels (government, regional, community, family). We believe 2YL supports the global holistic agenda to integrate and implement interventions across health, education, and social systems in order to protect, nurture, and support the health and development potential of every adolescent girl, and thus become a model of good practice for adolescent pregnancy, to be adopted more widely in Sierra Leone and elsewhere. TRIAL REGISTRATION: ISRCTN registry ISRCTN32414369. Prospectively registered on 14/03/2022.

Experiences of postpartum anxiety during the COVID-19 pandemic: A mixed methods study and demographic analysis.

INTRODUCTION: The first wave of the COVID-19 pandemic saw the reconfiguration of perinatal and maternity services, national lockdowns, and social distancing measures which affected the perinatal experiences of new and expectant parents. This study aimed to explore the occurrence of postpartum anxieties in people who gave birth during the pandemic. METHODS: An exploratory concurrent mixed-methods design was chosen to collect and analyse the quantitative and qualitative data of an online survey during the first UK lockdown. The survey included the Postpartum Specific Anxiety Scale-Research Short Form-for use in global Crises [PSAS-RSF-C] psychometric tool, and open-ended questions in relation to changes in birth plans and feelings about those changes and giving birth in a pandemic. Differences in measured scores were analysed for the participant's ethnicity, sexual orientation and disability using independent Student's t-tests, and for age, the analysis was completed using Pearson's correlation. Qualitative data from open-ended questions were analysed using a template analysis. RESULTS: A total of 1,754 new and expectant parents completed the survey between 10th and 24th April 2020, and 381 eligible postnatal women completed the psychometric test. We found 52.5% of participants reported symptoms consistent with a diagnosis of postnatal anxiety-significantly higher than the rates usually reported. Younger women and sexual minority women were more likely to score highly on the PSAS-RSF-C than their older or heterosexual counterparts (p<0.001). Younger participants reported anxieties in the 'infant safety and welfare' category, whilst lesbian, gay, bisexual, and pansexual participants scored highly in the 'psychosocial adjustment to motherhood' category. DISCUSSION: Postpartum anxiety is under-reported, and demographic differences in the rates of postpartum anxiety are under-researched. This research demonstrates for the first time a difference in postpartum anxiety rates amongst sexual minority women.

Targeted health and social care interventions for women and infants who are disproportionately impacted by health inequalities in high-income countries: a systematic review.

BACKGROUND: Disadvantaged populations (such as women from minority ethnic groups and those with social complexity) are at an increased risk of poor outcomes and experiences. Inequalities in health outcomes include preterm birth, maternal and perinatal morbidity and mortality, and poor-quality care. The impact of interventions is unclear for this population, in high-income countries (HIC). The review aimed to identify and evaluate the current evidence related to targeted health and social care service interventions in HICs which can improve health inequalities experienced by childbearing women and infants at disproportionate risk of poor outcomes and experiences. METHODS: Twelve databases searched for studies across all HICs, from any methodological design. The search concluded on 8/11/22. The inclusion criteria included interventions that targeted disadvantaged populations which provided a component of clinical care that differed from standard maternity care. RESULTS: Forty six index studies were included. Countries included Australia, Canada, Chile, Hong Kong, UK and USA. A narrative synthesis was undertaken, and results showed three intervention types: midwifery models of care, interdisciplinary care, and community-centred services. These intervention types have been delivered singularly but also in combination of each other demonstrating overlapping features. Overall, results show interventions had positive associations with primary (maternal, perinatal, and infant mortality) and secondary outcomes (experiences and satisfaction, antenatal care coverage, access to care, quality of care, mode of delivery, analgesia use in labour, preterm birth, low birth weight, breastfeeding, family planning, immunisations) however significance and impact vary. Midwifery models of care took an interpersonal and holistic approach as they focused on continuity of carer, home visiting, culturally and linguistically appropriate care and accessibility. Interdisciplinary care took a structural approach, to coordinate care for women requiring multi-agency health and social services. Community-centred services took a place-based approach with interventions that suited the need of its community and their norms. CONCLUSION: Targeted interventions exist in HICs, but these vary according to the context and infrastructure of standard maternity care. Multi-interventional approaches could enhance a targeted approach for at risk populations, in particular combining midwifery models of care with community-centred approaches, to enhance accessibility, earlier engagement, and increased attendance. TRIAL REGISTRATION: PROSPERO Registration number: CRD42020218357.

Prevalence and Persistence of Antibiotic Resistance Determinants in the Gut of Travelers Returning to the United Kingdom is Associated with Colonization by Pathogenic Escherichia coli.

The gut microbiota constitutes an ideal environment for the selection, exchange, and carriage of antibiotic resistance determinants (ARDs), and international travel has been identified as a risk factor for acquisition of resistant organisms. Here, we present a longitudinal metagenomic analysis of the gut resistome in travellers to "high-risk" countries (Gutback). Fifty volunteers, recruited at a travel clinic in London, United Kingdom, provided stool samples before (pre-travel), immediately after (post-travel), and 6 months after their return (follow-up) from a high-risk destination. Fecal DNA was extracted, metagenomic sequencing performed and the resistome profiled. An increase in abundance and diversity of resistome was observed after travel. Significant increases in abundance were seen in antimicrobial genes conferring resistance to macrolides, third-generation cephalosporins, aminoglycosides, and sulfonamides. There was a significant association with increased resistome abundance if the participant experienced diarrhea during travel or took antibiotics, but these two variables were co-correlated. The resistome abundance returned to pre-travel levels by the 6-month sample point but there was evidence of persistence of several ARDs. The post-travel samples had an increase in abundance Escherichia coli which was positively associated with many acquired resistant determinants. Virulence and phylogenetic profiling revealed pathogenic E. coli significantly contributed to this increase abundance. In summary, in this study, foreign travel remains a significant risk factor for acquisition of microbes conferring resistance to multiple classes of antibiotics, often associated with symptomatic exposure to diarrhoeagenic E. coli. IMPORTANCE A future where antimicrobial therapy is severely compromised by the increase in resistant organisms is of grave concern. Given the variability in prevalence and diversity of antimicrobial resistance determinants in different geographical settings, international travel is a known risk factor for acquisition of resistant organisms into the gut microbiota. In this study, we show the utility of metagenomic approaches to quantify the levels of acquisition and carriage of resistance determinants after travel to a "high-risk" setting. Significant modulation to the resistome was seen after travel that is largely resolved within 6 months, although evidence of persistence of several ARDs was observed. Risk factors for acquisition included experiencing a diarrheal episode and the use of antibiotics. Colonization by pathogenic Escherichia coli was correlated with an increase in acquisition of antimicrobial resistance determinants, and as such established public health guidance to travelers on food and water safety remain an important message to reduce the spread of antibiotic resistance.

A continuity of care programme for women at risk of preterm birth in the UK: Process evaluation of a hybrid randomised controlled pilot trial.

BACKGROUND: The development and evaluation of specific maternity care packages designed to address preterm birth remains a public health priority. We aim to evaluate the implementation, context, and potential mechanisms of action, of a new care pathway that combined midwifery continuity of care with a specialist obstetric clinic for women at risk of preterm birth (POPPIE) in London (UK). METHODS: We did a multiphase mixed method triangulation evaluation nested within a hybrid type 2, randomised controlled trial in London (United Kingdom). Pregnant women with identified risk factors for preterm birth were eligible for trial participation and randomly assigned (1:1) to either midwifery continuity of care linked to a specialist obstetric clinic (POPPIE group) or standard maternity care. The primary outcome was a composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth, analysed according to intention to treat. Clinical and process outcome data were abstracted from medical records and electronic data systems, and coded by study team members, who were masked to study group allocation. Implementation data were collected from meeting records and key documents, postnatal surveys (n = 164), semi-structured interviews with women (n = 30), healthcare providers and stakeholders (n = 24) pre-, mid and post implementation. Qualitative and quantitative data from meeting records and key documents were examined narratively. Qualitative data from interviews were analysed using three thematic frameworks: Proctor's (for implementation outcomes: appropriateness, adoption, feasibility, acceptability, fidelity, penetration, sustainability), the Consolidated Framework for Implementation Research (for determinants of implementation), and published program theories of continuity models (for potential mechanisms). Data triangulation followed a convergent parallel and pragmatic approach which brought quantitative and qualitative data together at the interpretation stage. We averaged individual implementation measures across all domains to give a single composite implementation strength score which was compared to the primary outcome. RESULTS: Between May 9, 2017, and Sep 30, 2018, 553 women were assessed for eligibility and 334 were enrolled with less than 6% of loss to follow up (169 were assigned to the POPPIE group; 165 were to the standard group). There was no difference in the primary outcome (POPPIE group 83·3% versus standard group 84·7%; risk ratio 0·98 [95% CI 0·90 to 1·08]). Appropriateness and adoption: The introduction of the POPPIE model was perceived as a positive fundamental change for local maternity services. Partnership working and additional funding were crucial for adoption. Fidelity: More than 75% of antenatal and postnatal visits were provided by a named or partner midwife, and a POPPIE midwife was present in more than 80% of births. Acceptability: Nearly 98% of women who responded to the postnatal survey were very satisfied with POPPIE model. Quantitative fidelity and acceptability results were supported by the qualitative findings. Penetration and sustainability: Despite delays (likely associated with lack of existing continuity models at the hospital), the model was embedded within established services and a joint decision was made to sustain and adapt the model after the trial (strongly facilitated by national maternal policy on continuity pathways). Potential mechanisms of impact identified included e.g. access to care, advocacy and perceptions of safety and trust. There was no association between implementation measures and the primary outcome. CONCLUSIONS: The POPPIE model of care was a feasible and acceptable model of care that was implemented with high fidelity and sustained in maternity services. Larger powered trials are feasible and needed in other settings, to evaluate the impact and implementation of continuity programmes in other communities affected by preterm birth and women who experience social disadvantage and vulnerability. TRIAL REGISTRATION: UKCRN Portfolio Database (prospectively registered, 24 April 2017): 31951. ISRCTN registry (retrospectively registered, 21 August 2017): ISRCTN37733900.

Midwifery continuity of care: A scoping review of where, how, by whom and for whom?

Systems of care that provide midwifery care and services through a continuity of care model have positive health outcomes for women and newborns. We conducted a scoping review to understand the global implementation of these models, asking the questions: where, how, by whom and for whom are midwifery continuity of care models implemented? Using a scoping review framework, we searched electronic and grey literature databases for reports in any language between January 2012 and January 2022, which described current and recent trials, implementation or scaling-up of midwifery continuity of care studies or initiatives in high-, middle- and low-income countries. After screening, 175 reports were included, the majority (157, 90%) from high-income countries (HICs) and fewer (18, 10%) from low- to middle-income countries (LMICs). There were 163 unique studies including eight (4.9%) randomised or quasi-randomised trials, 58 (38.5%) qualitative, 53 (32.7%) quantitative (cohort, cross sectional, descriptive, observational), 31 (19.0%) survey studies, and three (1.9%) health economics analyses. There were 10 practice-based accounts that did not include research. Midwives led almost all continuity of care models. In HICs, the most dominant model was where small groups of midwives provided care for designated women, across the antenatal, childbirth and postnatal care continuum. This was mostly known as caseload midwifery or midwifery group practice. There was more diversity of models in low- to middle-income countries. Of the 175 initiatives described, 31 (18%) were implemented for women, newborns and families from priority or vulnerable communities. With the exception of New Zealand, no countries have managed to scale-up continuity of midwifery care at a national level. Further implementation studies are needed to support countries planning to transition to midwifery continuity of care models in all countries to determine optimal model types and strategies to achieve sustainable scale-up at a national level.

Can birth outcome inequality be reduced using targeted caseload midwifery in a deprived diverse inner city population? A retrospective cohort study, London, UK.

OBJECTIVES: (1) To report maternal and newborn outcomes of pregnant women in areas of social deprivation in inner city London. (2) To compare the effect of caseload midwifery with standard care on maternal and newborn outcomes in this cohort of women. DESIGN: Retrospective observational cohort study. SETTING: Four council wards (electoral districts) in inner city London, where over 90% of residents are in the two most deprived quintiles of the English Index of Multiple Deprivation (IMD) (2019) and the population is ethnically diverse. PARTICIPANTS: All women booked for antenatal care under Guys and St Thomas' National Health Service Foundation Trust after 11 July 2018 (when the Lambeth Early Action Partnership (LEAP*) caseload midwifery team was implemented) until data collection 18 June 2020. This included 523 pregnancies in the LEAP area, of which 230 were allocated to caseload midwifery, and 8430 pregnancies from other areas. MAIN OUTCOME MEASURES: To explore if targeted caseload midwifery (known to reduce preterm birth) will improve important measurable outcomes (preterm birth, mode of birth and newborn outcomes). RESULTS: There was a significant reduction in preterm birth rate in women allocated to caseload midwifery, when compared with those who received traditional midwifery care (5.1% vs 11.2%; risk ratio: 0.41; p=0.02; 95% CI 0.18 to 0.86; number needed to treat: 11.9). Caesarean section births were significantly reduced in women allocated to caseload midwifery care, when compared with traditional midwifery care (24.3% vs 38.0%; risk ratio: 0.64: p=0.01; 95% CI 0.47 to 0.90; number needed to treat: 7.4) including emergency caesarean deliveries (15.2% vs 22.5%; risk ratio: 0.59; p=0.03; 95% CI 0.38 to 0.94; number needed to treat: 10) without increase in neonatal unit admission or stillbirth. CONCLUSION: This study shows that a model of caseload midwifery care implemented in an inner city deprived community improves outcome by significantly reducing preterm birth and birth by caesarean section when compared with traditional care. This data trend suggests that when applied to targeted groups (women in higher IMD quintile and women of diverse ethnicity) that the impact of intervention is greater.

Experiences of maternity care among women at increased risk of preterm birth receiving midwifery continuity of care compared to women receiving standard care: Results from the POPPIE pilot trial.

BACKGROUND: Midwifery continuity of care models for women at low and mixed risk of complications have been shown to improve women's experiences of care. However, there is limited research on care experiences among women at increased risk of preterm birth. We aimed to explore the experiences of care among women with risk factors for preterm birth participating in a pilot trial (POPPIE) of a midwifery continuity of care model which included a specialist obstetric clinic. METHODS: A total of 334 pregnant women identified at increased risk of preterm birth were randomly allocated to either midwifery continuity of care (POPPIE group) or standard maternity care. Women in both groups were followed up at six-to-eight weeks postpartum and were invited to complete a postnatal survey either online or by post. An equal status exploratory sequential mixed method design was chosen to collect and analyse the quantitative postnatal survey data and qualitative interviews data. The postnatal survey included measures of social support, trust, perceptions of safety, quality of care, control during childbirth, bonding and quality of life. Categorical data were analysed with chi-squared tests and continuous data were analysed with t-tests and/or Mann-Whitney U test to measure differences in measures scores among groups. The qualitative interview data were subjected to a thematic framework analysis. Data triangulation brought quantitative and qualitative data together at the interpretation stage. FINDINGS: A total of 166 women completed the survey and 30 women were interviewed (90 and 16 in POPPIE group; 76 and 14 in standard group). We found survey respondents in the POPPIE group, compared to respondents in the standard group, were significantly more likely to report greater trust in midwives (Mann-Whitney U, p<0.0001), greater perceptions of safety during the antenatal care (t-test, p = 0.0138), have a particular midwife to contact when they needed during their pregnancy (t-test, p<0.0001) and the postnatal period (chi-squared, p<0.0001). They reported increased involvement in decisions regarding antenatal, intrapartum and postnatal care (t-test, p = 0.002; p = 0.008; p = 0.006 respectively); and greater postnatal support and advice about: feeding the baby (chi-squared, p<0.0001), handling, settling and looking after the baby (chi-squared, p<0.0001), baby's health and progress (chi-squared, p = 0.039), their own health and recovery (chi-squared, p = 0.006) and who to contact about any emotional changes (chi-squared, p = 0.005). There were no significant differences between groups in the reporting of perceptions of safety during birth and the postnatal period, concerns raised during labour and birth taken seriously, being left alone during childbirth at a time of worries, control during labour, bonding, social support, and physical and mental health related quality of life after birth. Results from qualitative interviews provided insight and depth into many of these findings, with women in the POPPIE group reporting more positive experiences of bonding towards their babies and more positive physical health postnatally. CONCLUSIONS: Compared with standard maternity care, women at increased risk of PTB who received midwifery continuity of care were more likely to report increased perceptions of trust, safety and quality of care. TRIAL REGISTRATION: ISRCTN (Number: 37733900); UK CRN (ID: 31951).

A realist review to explore how midwifery continuity of care may influence preterm birth in pregnant women.

BACKGROUND: Midwifery continuity of care models are the only health system intervention associated with both a reduction in preterm birth (PTB) and an improvement in perinatal survival; however, questions remain about the mechanisms by which such positive outcomes are achieved. We aimed to uncover theories of change by which we can postulate how and why continuity of midwifery care models might affect PTB. METHODS: We followed Pawson's guidance for conducting a realist review and performed a comprehensive search to identify existing literature exploring the impact of continuity models on PTB in all pregnant women. A realist methodology was used to uncover the context (C), mechanisms (M), and outcomes (O) and to develop a group of CMO configurations to illuminate middle-range theories. RESULTS: Eleven papers were included from a wide variety of settings in the United Kingdom, Australia, and the United States. The majority of study participants had low socioeconomic status or social risk factors and received diverse models of midwifery continuity of care. Three themes-woman-midwife partnership, maternity pathways and processes, and system resources-encompassed ten CMO configurations. Building relationships, trust, confidence, and advocacy resulted in women feeling safer, less stressed, and more secure and respected, and encouraged them to access and engage in antenatal care with more opportunities for early prevention and diagnosis of complications, which facilitated effective management when compliance to guidelines was ensured. Organizational infrastructure, innovative partnerships, and robust community systems are crucial to overcome barriers, address women's complex needs, ensure quality of care, and reduce PTB risk. CONCLUSIONS: Pregnant women living in different contexts in the United Kingdom, Australia, and the United States at low and mixed risk of complications and with low socioeconomic status or social risk factors experienced continuity models in similar ways, and similar underlying mechanisms may have influenced PTB outcomes. Further research is required to understand how continuity models may influence behavioral change, physiological stress levels, ethnic disparities in PTB and care coordination, and navigation of health services.

Addressing inequities in maternal health among women living in communities of social disadvantage and ethnic diversity.

The response to the coronavirus outbreak and how the disease and its societal consequences pose risks to already vulnerable groups such those who are socioeconomically disadvantaged and ethnic minority groups. Researchers and community groups analysed how the COVID-19 crisis has exacerbated persisting vulnerabilities, socio-economic and structural disadvantage and discrimination faced by many communities of social disadvantage and ethnic diversity, and discussed future strategies on how best to engage and involve local groups in research to improve outcomes for childbearing women experiencing mental illness and those living in areas of social disadvantage and ethnic diversity. Discussions centred around: access, engagement and quality of care; racism, discrimination and trust; the need for engagement with community stakeholders; and the impact of wider social and economic inequalities. Addressing biomedical factors alone is not sufficient, and integrative and holistic long-term public health strategies that address societal and structural racism and overall disadvantage in society are urgently needed to improve health disparities and can only be implemented in partnership with local communities.

Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation-effectiveness, randomised controlled pilot trial in the UK.

BACKGROUND: Midwifery continuity of care is the only health system intervention shown to reduce preterm birth (PTB) and improve perinatal survival, but no trial evidence exists for women with identified risk factors for PTB. We aimed to assess feasibility, fidelity, and clinical outcomes of a model of midwifery continuity of care linked with a specialist obstetric clinic for women considered at increased risk for PTB. METHODS AND FINDINGS: We conducted a hybrid implementation-effectiveness, randomised, controlled, unblinded, parallel-group pilot trial at an inner-city maternity service in London (UK), in which pregnant women identified at increased risk of PTB were randomly assigned (1:1) to either midwifery continuity of antenatal, intrapartum, and postnatal care (Pilot study Of midwifery Practice in Preterm birth Including women's Experiences [POPPIE] group) or standard care group (maternity care by different midwives working in designated clinical areas). Pregnant women attending for antenatal care at less than 24 weeks' gestation were eligible if they fulfilled one or more of the following criteria: previous cervical surgery, cerclage, premature rupture of membranes, PTB, or late miscarriage; previous short cervix or short cervix this pregnancy; or uterine abnormality and/or current smoker of tobacco. Feasibility outcomes included eligibility, recruitment and attrition rates, and fidelity of the model. The primary outcome was a composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth. We analysed by intention to treat. Between 9 May 2017 and 30 September 2018, 334 women were recruited; 169 women were allocated to the POPPIE group and 165 to the standard group. Mean maternal age was 31 years; 32% of the women were from Black, Asian, and ethnic minority groups; 70% were in employment; and 46% had a university degree. Nearly 70% of women lived in areas of social deprivation. More than a quarter of women had at least one pre-existing medical condition and multiple risk factors for PTB. More than 75% of antenatal and postnatal visits were provided by a named/partner midwife, and a midwife from the POPPIE team was present at 80% of births. The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742). Infants in the POPPIE group were significantly more likely to have skin-to-skin contact after birth, to have it for a longer time, and to breastfeed immediately after birth and at hospital discharge. There were no differences in other secondary outcomes. The number of serious adverse events was similar in both groups and unrelated to the intervention (POPPIE group 6 versus standard group 5). Limitations of this study included the limited power and the nonmasking of group allocation; however, study assignment was masked to the statistician and researchers who analysed the data. CONCLUSIONS: In this study, we found that it is feasible to set up and achieve fidelity of a model of midwifery continuity of care linked with specialist obstetric care for women at increased risk of PTB in an inner-city maternity service in London (UK), but there is no impact on most outcomes for this population group. Larger appropriately powered trials are needed, including in other settings, to evaluate the impact of relational continuity and hypothesised mechanisms of effect based on increased trust and engagement, improved care coordination, and earlier referral on disadvantaged communities, including women with complex social factors and social vulnerability. TRIAL REGISTRATION: We prospectively registered the pilot trial on the UK Clinical Research Network Portfolio Database (ID number: 31951, 24 April 2017). We registered the trial on the International Standard Randomised Controlled Trial Number (ISRCTN) (Number: 37733900, 21 August 2017) and before trial recruitment was completed (30 September 2018) when informed that prospective registration for a pilot trial was also required in a primary clinical trial registry recognised by WHO and the International Committee of Medical Journal Editors (ICMJE). The protocol as registered and published has remained unchanged, and the analysis conforms to the original plan.

Seasonal variation in the performance of QuantiFERON-TB Gold In-Tube assays used for the diagnosis of tuberculosis infection.

This study aimed to determine whether there are seasonal changes in the performance of QuantiFERON-TB Gold In-Tube (QFT-GIT) assays, an interferon-gamma release assay widely used for the diagnosis of tuberculosis infection. Results of 31,932 QFT-GIT assays performed at a large independent, accredited diagnostic service provider in London, UK over a 4.5-year-period were analysed. The proportion of positive results was significantly lower in autumn (14.8%) than in spring (16.0%; p = 0.0366) and summer (17.5%; p < 0.0001), but similar to winter (15.2%; p = 0.4711). The proportion of indeterminate results was significantly higher in autumn (8.2%) than in spring (6.2%; p < 0.0001), summer (4.8%; p < 0.0001), and winter (6.2%; p < 0.0001). The highest proportions of indeterminate results were observed in October (8.4%) and November (8.8%), the lowest in June (4.5%). Our data show that significant seasonal variation occurs in the performance of QFT-GIT assays in a temperate climate setting. Potential underlying mechanisms, including host and environmental factors, are discussed.

Models of antenatal care to reduce and prevent preterm birth: a systematic review and meta-analysis.

OBJECTIVE: To assess the effectiveness of models of antenatal care designed to prevent and reduce preterm birth (PTB) in pregnant women. METHODS: We conducted a search of seven electronic databases and reference lists of retrieved studies to identify trials from inception up to July 2014 where pregnant women, regardless of risk factors for pregnancy complications, were randomly allocated to receive an alternative model of antenatal care or routine care. We pooled risks of PTB to determine the effect of alternative care models in all pregnant women. We also assessed secondary maternal and infant outcomes, women's satisfaction and economic outcomes. RESULTS: 15 trials involving 22,437 women were included. Pregnant women in alternative care models were less likely to experience PTB (risk ratio 0.84, 95% CI 0.74 to 0.96). The subgroup of women randomised to midwife-led continuity models of antenatal care were less likely to experience PTB (0.78, 0.66 to 0.91) but there was no significant difference between this group and women allocated to specialised care (0.92, 0.76 to 1.12) (interaction test for subgroup differences p=0.20). Overall low-risk women in alternative care models were less likely to have PTB (0.74, 0.59 to 0.93), but this effect was not significantly different from that in mixed-risk populations (0.91, 0.79 to 1.05) (subgroup p=0.13). CONCLUSIONS: Alternative models of antenatal care for all pregnant women are effective in reducing PTB compared with routine care, but no firm conclusions could be drawn regarding the relative benefits of the two models. Future research should evaluate the impact of antenatal care models which include more recent interventions and predictive tests, and which also offer continuity of care by midwives throughout pregnancy. PROSPERO REGISTRATION NUMBER: CRD42014007116.