CRADLE-5: a stepped-wedge type 2 hybrid implementation-effectiveness cluster randomised controlled trial to evaluate the real-world scale-up of the CRADLE Vital Signs Alert intervention into routine maternity care in Sierra Leone-study protocol.

BACKGROUND: The CRADLE Vital Signs Alert intervention (an accurate easy-to-use device that measures blood pressure and pulse with inbuilt traffic-light early warning system, and focused training package) was associated with reduced rates of eclampsia and maternal death when trialled in urban areas in Sierra Leone. Subsequently, implementation was successfully piloted as evidenced by measures of fidelity, feasibility and adoption. The CRADLE-5 trial will examine whether national scale-up, including in the most rural areas, will reduce a composite outcome of maternal and fetal mortality and maternal morbidity and will evaluate how the CRADLE package can be embedded sustainably into routine clinical pathways. METHODS: CRADLE-5 is a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care across eight rural districts in Sierra Leone (Bonthe, Falaba, Karene, Kailahun, Koinadugu, Kono, Moyamba, Tonkolili). Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023). All women identified as pregnant or within six-weeks postpartum presenting for maternity care in the district are included. Primary outcome data (composite rate of maternal death, stillbirth, eclampsia and emergency hysterectomy) will be collected. A mixed-methods process and scale-up evaluation (informed by Medical Research Council guidance for complex interventions and the World Health Organization ExpandNet tools) will explore implementation outcomes of fidelity, adoption, adaptation and scale-up outcomes of reach, maintenance, sustainability and integration. Mechanisms of change and contextual factors (barriers and facilitators) will be assessed. A concurrent cost-effectiveness analysis will be undertaken. DISCUSSION: International guidance recommends that all pregnant and postpartum women have regular blood pressure assessment, and healthcare staff are adequately trained to respond to abnormalities. Clinical effectiveness to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability of the CRADLE intervention at scale has yet to be investigated. This trial will explore whether national scale-up of the CRADLE intervention reduces maternal and fetal mortality and severe maternal adverse outcomes and understand the strategies for adoption, integration and sustainability in low-resource settings. If successful, the aim is to develop an adaptable, evidence-based scale-up roadmap to improve maternal and infant outcomes. TRIAL REGISTRATION: ISRCTN 94429427. Registered on 20 April 2022.

Bacterial Isolates and Antibiotic Resistance of Escherichia coli Isolated from Fresh Poultry Excreta Used for Vegetable Farming in Freetown, Sierra Leone.

The transfer of antibiotic resistance from animals to humans is of concern in recent times. One potential source of such transfer is the untreated poultry excreta used as manure in farming. We aim to identify bacterial isolates and antibiotic susceptibility patterns of Escherichia coli in poultry excreta in Sierra Leone. This was a cross-sectional study of fresh poultry excreta samples collected from four commercial poultry sites in Freetown, Sierra Leone, from June−September 2021. Bacterial isolates were tested against eight antibiotics using established standards. Of 100 samples, 93 showed Escherichia coli (93%): of those, eight isolates also had Salmonella (8%). E. coli was 100% resistant to all three 'Watch' drugs (erythromycin, cefoxitin and streptomycin) and tetracycline. E. coli was least resistant to ampicillin (12%), followed by chloramphenicol (35%). The prevalence of multidrug resistance was 95.6%. Multiple antibiotic resistance index ranged from 0.5−0.7 (optimal < 0.2), indicating high prior exposure to antibiotics in these poultries. Such high levels of resistance in E. coli isolated from poultry excreta could pose a serious threat to humans. We recommend (i) routine surveillance to monitor antibiotic resistance in poultry excreta, (ii) using poultry excreta as manure only after treatment and (iii) restricting the use of antibiotics as prophylactics and growth promoters in poultry feeds.

Advancing maternal and perinatal health in low- and middle-income countries: A multi-country review of policies and programmes.

The Sustainable Development Goals prioritize maternal mortality reduction, with a global average target of < 70 per 100,000 live births by 2030. Current pace of reduction is far short of what is needed to achieve the global target. It is estimated that globally there are 300,000 maternal deaths, 2.4 million newborn deaths and 2 million stillbirths annually. Majority of these deaths occur in low-and-middle-income countries. Global initiatives like, Ending Preventable Maternal Mortality (EPMM) and Every Newborn Action Plan (ENAP), have outlined the broad strategies for maternal and newborn health programmes. A set of coverage targets and ten milestones were launched to support low-and-middle-income countries in accelerating progress in improving maternal, perinatal and newborn health and wellbeing. WHO, UNICEF and UNFPA, undertook a scoping review to understand how country strategies evolved in different contexts over the past two decades to improve maternal survival and wellbeing, and how countries in similar settings could accelerate progress considering the changing epidemiology and demography. Case studies were conducted to inform countries in similar settings and various global initiatives. Six countries were selected based on standard criteria-Cambodia, Democratic Republic of the Congo, Georgia, Guatemala, Pakistan and Sierra Leone representing different stages of the obstetric transition. A conceptual framework, encapsulating the interrelated factors impacting maternal health outcomes, was used to organize data collection and analysis. While all six countries made remarkable progress in improving maternal and perinatal health, the pace of progress and the factors influencing the successes and challenges varied across the countries. The context, opportunities and challenges varied from country to country. Two strategic directions were identified for next steps including the need to implement and evaluate innovative service delivery models using an updated obstetric transition as an organizing framework and expanding our vision to address equity and well-being.