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Background Studies examining the association between in utero Zika virus (ZIKV) exposure and child neurodevelopmental outcomes have produced varied results limited by the absence of a comparison group. The present study aimed to assess the neurodevelopmental outcomes among a cohort of children born with normal head circumference from pregnant people enrolled in the Zika in Pregnancy in Honduras (ZIPH) cohort study between July and December 2016. Methods Enrollment of pregnant people was voluntary and occurred during their first prenatal visit at a health center in Tegucigalpa, with collection of venous blood. Children with the following characteristics were selected for the longitudinal follow-up study: normal birth head circumference, > 6 months of age, born at one of two hospitals in Tegucigalpa, and known in utero ZIKV exposure status. In utero exposure to ZIKV was defined as a positive prenatal ZIKV IgM and/or positive ZIKV RNA result at enrollment. The developmental evaluation included Spanish language versions of the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) and the Ages & Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2). Results One hundred fifty-two children were assessed between May 2018 and March 2020. The mean age was 2.0 years, and > 93% had adequate anthropometric growth. Sixty children were exposed to ZIKV during pregnancy. BSID-III and ASQ:SE-2 were performed in 151 and 152 children, respectively. Forty-one children had a delay (

Previous studies have shown the influence of the physical and social environments on the development of obesity and non-communicable diseases (NCD). An obesogenic environment promotes higher dietary energy intakes and sedentary behaviors while limiting opportunities or incentives for active living. This paper presents a dataset with key attributes of the food and physical activity built environment, including green spaces, quality of streets and sidewalks, and different types of food retail outlets in four cities of the Southern Cone of Latin America. A total of 139 representative neighborhoods randomly selected from: Marcos Paz and Bariloche (Argentina), Temuco (Chile) and Canelones-Barros Blancos (Uruguay) were evaluated, where standardized community walks were conducted for direct observation of the built environment. This dataset will contribute valuable data to the evaluation of obesogenic environments in the region, and could be linked to additional ecological information about risk factors for NCDs and socio-economic features from other sources. Understanding environmental influences on cardiovascular risk factors and individual habits may help explain NCD outcomes and plan urban policies., Measurement(s)features of the built environmentTechnology Type(s)ObservationSample Characteristic - Environmentbuilt environmentSample Characteristic - LocationArgentina • Chile • Uruguay Machine-accessible metadata file describing the reported data: 10.6084/m9.figshare.14892147

Background Numerous vaccines have been evaluated and approved for coronavirus disease 2019 (COVID-19). Since pregnant persons have been excluded from most clinical trials of COVID-19 vaccines, sufficient data regarding safety of these vaccines for the pregnant persons and their fetus have rarely been available at the time of product licensure. However, as COVID-19 vaccines have been deployed, data on the safety, efficacy or effectiveness, reactogenicity, and immunogenicity of COVID-19 vaccines for pregnant persons and neonates are becoming increasingly available. A living systematic review (LSR) of the safety and effectiveness of COVID-19 vaccines for pregnant persons and newborns could provide information necessary to help guide vaccine policy decisions. Methods We aim to conduct a LSR based on biweekly searches of medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries to systematically identify relevant studies of COVID-19 vaccines for pregnant persons. Pairs of reviewers will independently select, extract data, and conduct risk of bias assessments. We will include randomized clinical trials, quasi-experimental studies, cohort, case-control, cross-sectional studies, and case reports. Primary outcomes will be the safety (i.e., impacts on obstetric and neonatal outcomes), efficacy or effectiveness of COVID-19 vaccines in pregnant persons. Secondary outcomes will be immunogenicity and reactogenicity. We will conduct paired meta-analyses, including pre-specified subgroup and sensitivity analyses, and will use the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to evaluate the certainty of evidence. Conclusion This will be the first living systematic review (LSR) and meta-analysis assessing the safety, reactogenicity, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons. An online interactive dashboard for data visualization using Microsoft Power BI will be developed to regularly update and disseminate the latest findings (an in-progress version is available at https://safeinpregnancy.org/lsr/). In addition, the findings will be disseminated through publications and presentations.

Background Chagas is a public health problem, especially in Latin America, exacerbated by migratory movements and increasing urbanization. Argentina is among the countries with the highest estimated prevalence in the region, with 1,500,000 people infected, with mother to child as the main mode of transmission. Vertical transmission has been significantly reduced by treating women of childbearing age; several guidelines in the region recommend treatment as a primary prevention strategy for the child and a secondary prevention strategy for women and their families. Despite recommendations, women of childbearing age are not always treated, and children do not receive timely diagnosis and treatment. The objective of this research was to design an implementation strategy to improve using Chagas guidelines focused on attending women of childbearing age and children at the primary healthcare level and pilot it in three primary health care centers in Argentina. Methods We conducted a pilot feasibility study using the Consolidated Framework for Implementation Research. A qualitative process evaluation was conducted using semi-structured interviews with health care providers and observations in primary health care centers. Results We developed a multifaceted implementation strategy including training, flowcharts and reminders, a register of suspected and confirmed cases, and the selection of a management facilitator. The pilot study took place between September 2019 and May 2020. The implementation level was heterogeneous and varied depending on the components, being the facilitating factors, the simplicity of the intervention, professionals’ willingness to expand the indication of serologic tests, and staff commitment to the adoption of intervention components. The main barriers found were the change of authorities at the local level, some professionals´ reluctance to administer etiological treatment, staff shortages, lack of diagnostic supplies, and the health emergency caused by the COVID-19 pandemic. Conclusions Behavioral change strategies should be applied to improve implementation to address some of the main barriers, including support actions offered by opinion leaders, medical experts, and local health authorities. Rapid diagnostic tests should be readily available to maintain behavior changes. We suggest further refinement of the strategy and its implementation in more centers to assess outcomes prospectively with a hybrid implementation research design.

Background: There is an urgent need for active safety surveillance to monitor vaccine exposure during pregnancy in low- and middle-income countries (LMICs). Existing maternal, newborn, and child health (MNCH) data collection systems could serve as platforms for post-marketing active surveillance of maternal immunization safety. To identify sites using existing systems, a thorough assessment should be conducted. Therefore, this study had the objectives to first develop an assessment tool and then to use this tool in sites using MNCH data collection systems through informant interviews.Methods: We conducted a rapid review of the literature to identify frameworks on population health or post-marketing drug surveillance. Four frameworks that met the eligibility criteria were identified and served to develop an assessment tool capable of evaluating sites that could support active monitoring of vaccine safety during pregnancy. We conducted semi-structured interviews in six geographical sites using MNCH data collection systems (DHIS2, INDEPTH, and GNMNHR) to complete the domains included in the assessment tool. Results: We interviewed a total of 9 stakeholders including: central-level systems key informants and/or site level managers from DHIS2 and GNMNHR; DHIS2 in Kampala (Uganda) and Kigali (Rwanda); GNMNHR from Belagavi (​​India) and Lusaka (Zambia); and INDEPTH from Nanoro (Burkina Faso) and Manhica (Mozambique). Similarities among sites were found regarding some domains such as data confidentiality, data management policies, and data quality monitoring. Four of the six sites met some domains to be eligible as potential sites for active surveillance of vaccinations during pregnancy such as routine collection of MNCH individual data, and capability of electronically integrating individual MNCH outcomes with information related to vaccine exposure during pregnancy. Those sites were: Rwanda (DHIS2), Manhica (IN-DEPTH), Lusaka (GNMNHR), and Belagavi (GNMNHR)Conclusion: This study's findings should inform the successful implementation of active safety surveillance of vaccines during pregnancy by integrating the currently used individual MNCH data collection systems in some sites in LMICs.

Background: Chagas is a public health problem, especially in Latin America, exacerbated by migratory movements and increasing urbanization. Argentina has the highest number of cases in the region, with 1,500,000 infected people, with mother-to-child as the primary mode of transmission. Vertical transmission has been significantly reduced by treating women of childbearing age; several guidelines in the region recommend treatment as a primary prevention strategy for the child and a secondary prevention strategy for women and their families. Despite recommendations, women of childbearing age are not always treated, and children do not receive timely diagnosis and treatment. The objective of this research was to design an implementation strategy to improve using Chagas guidelines at the primary healthcare level and pilot it to assess its feasibility and the factors that influence its implementation in three primary health care centers, Argentina. Methods: We conducted a pilot feasibility study using the Consolidated Framework for Implementation Research. A qualitative process evaluation was conducted using semi-structured interviews with health care providers and observations in primary health care centers. Results: We developed a multifaceted implementation strategy including training, flowcharts and reminders, a register of suspected and confirmed Chagas cases, and the selection of a management facilitator. The pilot study took place between September 2019 and May 2020. The implementation level was heterogeneous and varied depending on the components, being the facilitating factors, the simplicity of the intervention, professionals’ willingness to expand the indication of serologic tests, and staff commitment to the adoption of intervention components. The main barriers were the change of authorities at the local level, some professionals´ reluctance to administer etiological treatment, staff shortages, lack of diagnostic supplies (linked to contextual factors), and the health emergency caused by the COVID-19 pandemic. Conclusions: Behavioral change strategies should be applied to improve implementation to address some of the main barriers, including support actions offered by opinion leaders, medical experts, and local health authorities. Rapid diagnostic tests should be readily available to maintain behavior changes. We suggest further refinement of the strategy and its implementation in more centers to assess outcomes prospectively with a hybrid implementation research design.

The impact of Zika virus (ZIKV) infection on pregnancies shows regional variation emphasizing the importance of studies in different geographical areas. We conducted a prospective study in Tegucigalpa, Honduras, recruiting 668 pregnant women between July 20, 2016, and December 31, 2016. We performed Trioplex real-time reverse transcriptase–PCR (rRT-PCR) in 357 serum samples taken at the first prenatal visit. The presence of ZIKV was confirmed in seven pregnancies (7/357, 2.0%). Nine babies (1.6%) had microcephaly (head circumference more than two SDs below the mean), including two (0.3%) with severe microcephaly (head circumference [HC] more than three SDs below the mean). The mothers of both babies with severe microcephaly had evidence of ZIKV infection. A positive ZIKV Trioplex rRT-PCR was associated with a 33.3% (95% CI: 4.3–77.7%) risk of HC more than three SDs below the mean.

BACKGROUND: Therapies to interrupt the progression of early coronavirus disease 2019 (Covid-19) remain elusive. Among them, convalescent plasma administered to hospitalized patients has been unsuccessful, perhaps because antibodies should be administered earlier in the course of illness. METHODS We conducted a randomized, double-blind, placebo-controlled trial of convalescent plasma with high IgG titers against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in older adult patients within 72 hours after the onset of mild Covid-19 symptoms. The primary end point was severe respiratory disease, defined as a respiratory rate of 30 breaths per minute or more, an oxygen saturation of less than 93% while the patient was breathing ambient air, or both. The trial was stopped early at 76% of its projected sample size because cases of Covid-19 in the trial region decreased considerably and steady enrollment of trial patients became virtually impossible. RESULTS A total of 160 patients underwent randomization. In the intention-to-treat population, severe respiratory disease developed in 13 of 80 patients (16%) who received convalescent plasma and 25 of 80 patients (31%) who received placebo (relative risk, 0.52; 95% confidence interval [CI], 0.29 to 0.94; P = 0.03), with a relative risk reduction of 48%. A modified intention-to-treat analysis that excluded 6 patients who had a primary end-point event before infusion of convalescent plasma or placebo showed a larger effect size (relative risk, 0.40; 95% CI, 0.20 to 0.81). No solicited adverse events were observed. CONCLUSIONS Early administration of high-titer convalescent plasma against SARS-CoV-2 to mildly ill infected older adults reduced the progression of Covid-19. (Funded by the Bill and Melinda Gates Foundation and the Fundación INFANT Pandemic Fund; Dirección de Sangre y Medicina Transfusional del Ministerio de Salud number, PAEPCC19, Plataforma de Registro Informatizado de Investigaciones en Salud number, 1421, and ClinicalTrials.gov number, NCT04479163.). Fil: Libster, Romina Paula. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Pérez Marc, Gonzalo. Hospital Militar Central, Buenos Aires; Argentina Fil: Wappner, Diego. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Coviello, Silvina Andrea. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Bianchi, Alejandra. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Braem, Virginia. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Esteban, Ignacio. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Caballero, Mauricio Tomás. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Wood, Cristian. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Berrueta, Mabel. Hospital Militar Central; Argentina Fil: Rondan, Aníbal. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Lescano, Gabriela Mariel. Hospital Dr. Carlos Bocalandro; Argentina Fil: Cruz, Pablo. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Ritou, Yvonne. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Fernández Viña, Valeria Silvina. Hospital Simplemente Evita; Argentina Fil: Álvarez Paggi, Damián Jorge. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Esperante, Sebastian. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Instituto de Investigaciones Bioquímicas de Buenos Aires. Fundación Instituto Leloir. Instituto de Investigaciones Bioquímicas de Buenos Aires; Argentina Fil: Ferreti, Adrián. Hospital Dr. Carlos Bocalandro; Argentina Fil: Ofman, Gaston. University of Oklahoma; Estados Unidos Fil: Ciganda, Álvaro. Gobierno de la Provincia de Buenos Aires. Hospital Interzonal Especializado de Agudos y Cronicos San Juan de Dios.; Argentina Fil: Rodriguez, Rocío. Hospital Simplemente Evita; Argentina Fil: Lantos, Jorge. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Valentini, Ricardo. No especifíca; Fil: Itcovici, Nicolás. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Hintze, Alejandra. No especifíca; Fil: Oyarvide, M. Laura. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Etchegaray, Candela. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Neira, Alejandra. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Name, Ivonne. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Alfonso, Julieta. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Swiss Medical Group; Argentina Fil: López Castelo, Rocío. Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"; Argentina Fil: Caruso, Gisela. Hospital Militar Central; Argentina Fil: Rapelius, Sofía. Hospital Militar Central; Argentina Fil: Alvez, Fernando. Hospital Militar Central; Argentina Fil: Etchenique, Federico. Hospital Militar Central; Argentina Fil: Dimase, Federico. Hospital Militar Central; Argentina Fil: Alvarez, Darío. Hospital Militar Central; Argentina Fil: Aranda, Sofía S.. Hospital Militar Central; Argentina Fil: Sánchez Yanotti, Clara Inés. Hospital Militar Central; Argentina Fil: De Luca, Julián. Hospital Militar Central; Argentina Fil: Jares Baglivo, Sofía. Hospital Militar Central; Argentina Fil: Laudanno, Sofía. Fundación Hematológica Sarmiento; Argentina Fil: Nowogrodzki, Florencia. Swiss Medical Group; Argentina Fil: Larrea, Ramiro. Hospital Municipal San Isidro; Argentina Fil: Silveyra, María. Hospital Militar Central; Argentina Fil: Leberzstein, Gabriel. No especifíca; Fil: Debonis, Alejandra. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Molinos, Juan. Fundación para la Investigación en Infectología Infantil; Argentina Fil: González, Miguel. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Perez, Eduardo. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Kreplak, Nicolás. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Pastor Argüello, Susana. Fundación para la Investigación en Infectología Infantil; Argentina Fil: Gibbons, Luz. Hospital Municipal de San Isidro; Argentina Fil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Bergel, Eduardo. Sanatorio Sagrado Corazón; Argentina Fil: Polack, Fernando Pedro. Provincia de Buenos Aires. Ministerio de Salud; Argentina

IntroductionMost efforts to assess maternal health indicator validity focus on measures of service coverage. Fewer measures focus on the upstream enabling environment, and such measures are typically not research validated. Thus, methods for validating system and policy-level indicators are not well described. This protocol describes original multicountry research to be conducted in Argentina, Ghana and India, to validate 10 indicators from the monitoring framework for the ‘Strategies toward Ending Preventable Maternal Mortality’ (EPMM). The overall aim is to improve capacity to drive and track progress towards achieving the priority recommendations in the EPMM strategies. This work is expected to contribute new knowledge on validation methodology and reveal important information about the indicators under study and the phenomena they target for monitoring. Validating the indicators in three diverse settings will explore the external validity of results.Methods and analysisThis observational study explores the validity of 10 indicators from the EPMM monitoring framework via seven discrete validation exercises that will use mixed methods: (1) cross-sectional review of policy data, (2) retrospective review of facility-level patient and administrative data and (3) collection of primary quantitative and qualitative cross-sectional data from health service providers and clients. There is a specific methodological approach and analytic plan for each indicator, directed by unique, relevant validation research questions.Ethics and disseminationThe protocol was approved by the Office of Human Research Administration at Harvard University in November 2019. Individual study sites received approval via local institutional review boards by January 2020 except La Pampa, Argentina, approved June 2020. Our dissemination plan enables unrestricted access and reuse of all published research, including data sets. We expect to publish at least one peer-reviewed publication per validation exercise. We will disseminate results at conferences and engage local stakeholders in dissemination activities in each study country.

Background Global mechanisms have been established to monitor and facilitate state accountability regarding the legal status of abortion. However, there is little evidence describing whether these mechanisms capture accurate data. Moreover, it is uncertain whether the “legal status of abortion” is a valid proxy measure for access to safe abortion, pursuant to the global goals of reducing preventable maternal mortality and advancing reproductive rights. Therefore, this study sought to assess the accuracy of reported monitoring data, and to determine whether evidence supports the consistent application of domestic law by health care professionals such that legality of abortion functions as a valid indicator of access. Methods and findings We conducted a validation study using three countries as illustrative case examples: Argentina, Ghana, and India. We compared data reported by two global monitoring mechanisms (Countdown to 2030 and the Global Abortion Policies Database) against domestic source documents collected through in-depth policy review. We then surveyed health care professionals authorized to perform abortions about their knowledge of abortion law in their countries and their personal attitudes and practices regarding provision of legal abortion. We compared professionals’ responses to the domestic legal frameworks described in the source documents to establish whether professionals consistently applied the law as written. This analysis revealed weaknesses in the criterion validity and construct validity of the “legal status of abortion” indicator. We detected discrepancies between data reported by the global monitoring and accountability mechanisms and the domestic policy reviews, even though all referenced the same source documents. Further, provider surveys unearthed important context-specific barriers to legal abortion not captured by the indicator, including conscientious objection and imposition of restrictions at the provider’s discretion. Conclusions Taken together, these findings denote weaknesses in the indicator “legal status of abortion” as a proxy for access to safe abortion, as well as inaccuracies in data reported to global monitoring mechanisms. This information provides important groundwork for strengthening indicators for monitoring access to abortion and for renewed advocacy to assure abortion rights worldwide.

Background Rapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed. Methods We conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185). Results We retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. Conclusion This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.

BackgroundPregnant women with COVID-19 are at an increased risk of severe COVID-19 illness as well as adverse pregnancy and birth outcomes. Many countries are vaccinating or considering vaccinating pregnant women with limited available data about the safety of this strategy. Early identification of safety concerns of COVID-19 vaccines, including their components, or their technological platforms is therefore urgently needed.MethodsWe conducted a rapid systematic review, as the first phase of an ongoing full systematic review, to evaluate the safety of COVID-19 vaccines in pregnant women, including their components, and their technological platforms (whole virus, protein, viral vector or nucleic acid) used in other vaccines, following the Cochrane methods and the PRISMA statement for reporting (PROSPERO-CRD42021234185).We searched literature databases, COVID-19 and pregnancy registries from inception February 2021 without time or language restriction and explored the reference lists of relevant systematic reviews retrieved. We selected studies of any methodological design that included at least 50 pregnant women or pregnant animals exposed to the vaccines that were selected for review by the COVAX MIWG in August 2020 or their components or platforms included in the COVID-19 vaccines, and evaluated adverse events during pregnancy and the neonatal period.Pairs of reviewers independently selected studies through the COVIDENCE web software and performed the data extraction through a previously piloted online extraction form. Discrepancies were resolved by consensus.ResultsWe identified 6768 records, 256 potentially eligible studies were assessed by full-text, and 37 clinical and non-clinical studies (38 reports, involving 2,397,715 pregnant women and 56 pregnant animals) and 12 pregnancy registries were included.Most studies (89%) were conducted in high-income countries. The most frequent study design was cohort studies (n=21), followed by surveillance studies, randomized controlled trials, and registry analyses. Most studies (76%) allowed comparisons between vaccinated and unvaccinated pregnant women (n=25) or animals (n=3) and reported exposures during the three trimesters of pregnancy.The most frequent exposure was to AS03 adjuvant in the context of A/H1N1 pandemic influenza vaccines (n=24), followed by aluminum-based adjuvants (n=11). Aluminum phosphate was used in Respiratory Syncytial Virus Fusion candidate vaccines (n=3) and Tdap vaccines (n=3). Different aluminum-based adjuvants were used in hepatitis vaccines. The replication-deficient simian adenovirus ChAdOx1 was used for a Rift Valley fever vaccine. Only one study reported exposure to messenger RNA (mRNA) COVID-19 vaccines that also used lipid nanoparticles. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03) - corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns.ConclusionThis rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines that were selected for review by the COVAX MIWG or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted given their novelty. Our findings support current WHO guidelines recommending that pregnant women may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.

Objectives: Describe the time elapsed from the diagnosis to treatment with chemotherapy for patients with breast and lung cancer at public and private hospitals in Buenos Aires. Design: Retrospective cohort study. Setting: Three public and three private academic hospitals in Buenos Aires. Participants: Patients with breast (n = 168) or lung cancer (n = 100) diagnosis treated with chemotherapy. Main outcomes measures: Clinical and sociodemographic data were collected in a stratified sample. We used the Kaplan–Meier estimator to analyse the time elapsed and the log rank test to compare both groups Results: For breast cancer patients, median time elapsed between diagnosis and treatment with chemotherapy was 76 days (95% CI: 64–86) in public and 60 days (95% CI: 52–65) in private hospitals (P = 0.0001). For adjuvant and neoadjuvant treatments, median time was 130 (95% CI: 109–159) versus 64 (95% CI: 56–73) days (P < 0.0001) and 57 days (95% CI: 49–75) versus 26 (95% CI: 16–41) days, respectively (P = 0.0002). There were no significant differences in the time from first consultation to diagnosis. In patients with lung cancer, median time from diagnosis to treatment was 71 days (95% CI: 60–83) in public hospitals and 31 days (95% CI: 24–39) in private hospitals (P = 0.0002). In the metastatic setting, median time to treatment was 63 days (95% CI: 45–83) in public and 33 (95% CI: 26–44) days in private hospitals (P = 0.005). Conclusions: There are significant disparity in the access to treatment with chemotherapy for patients in Buenos Aires, Argentina. Fil: Recondo, Gonzalo. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina Fil: Cosacow, César. Centro de Educación Medica E Invest.clinicas; Argentina Fil: Cutuli, Hernán Javier. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Oncología "Ángel H. Roffo"; Argentina Fil: Cermignani, Luciano. Hospital Alemán; Argentina Fil: Straminsky, Samanta. Gobierno de la Ciudad de Buenos Aires. Hospital General de Agudos "Juan A. Fernández"; Argentina Fil: Naveira, Martin. Hospital Británico de Buenos Aires; Argentina Fil: Pitzzu, Martin. Gobierno de la Ciudad Autónoma de Buenos Aires. Hospital General de Agudos Carlos Durand; Argentina Fil: De Ronato, Gabriela. Gobierno de la Ciudad de Buenos Aires. Hospital General de Agudos "Juan A. Fernández"; Argentina Fil: Nacuzzi, Gabriela. Gobierno de la Ciudad Autónoma de Buenos Aires. Hospital General de Agudos Carlos Durand; Argentina Fil: Taetti, Gonzalo. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Oncología "Ángel H. Roffo"; Argentina Fil: Corsico, Santiago. Hospital Británico de Buenos Aires; Argentina Fil: Berrueta, Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Colucci, Giuliana. Centro de Educación Medica E Invest.clinicas; Argentina Fil: Gibbons, Luz. Centro de Educación Medica E Invest.clinicas; Argentina Fil: Gutierrez, Laura. Centro de Educación Medica E Invest.clinicas; Argentina Fil: García Elorrio, Ezequiel. Centro de Educación Medica E Invest.clinicas; Argentina

The partograph is the most commonly used labour monitoring tool in the world. However, it has been used incorrectly or inconsistently in many settings. In 2018, a WHO expert group reviewed and revised the design of the partograph in light of emerging evidence, and they developed the first version of the Labour Care Guide (LCG). The objective of this study was to explore opinions of skilled health personnel on the first version of the WHO Labour Care Guide.Skilled health personnel (including obstetricians, midwives and general practitioners) of any gender from Africa, Asia, Europe and Latin America were identified through a large global research network. Country coordinators from the network invited 5 to 10 mid-level and senior skilled health personnel who had worked in labour wards anytime in the last 5 years. A self-administered, anonymous, structured, online questionnaire including closed and open-ended questions was designed to assess the clarity, relevance, appropriateness of the frequency of recording, and the completeness of the sections and variables on the LCG.A total of 110 participants from 23 countries completed the survey between December 2018 and January 2019. Variables included in the LCG were generally considered clear, relevant and to have been recorded at the appropriate frequency. Most sections of the LCG were considered complete. Participants agreed or strongly agreed with the overall design, structure of the LCG, and the usefulness of reference thresholds to trigger further assessment and actions. They also agreed that LCG could potentially have a positive impact on clinical decision-making and respectful maternity care. Participants disagreed with the value of some variables, including coping, urine, and neonatal status.Future end-users of WHO Labour Care Guide considered the variables to be clear, relevant and appropriate, and, with minor improvements, to have the potential to positively impact clinical decision-making and respectful maternity care.ANTECEDENTES: El partograma es la herramienta para el monitoreo del trabajo de parto más utilizada a nivel mundial. Sin embargo, en muchos entornos se utiliza de manera incorrecta o inconsistente. En 2018, un grupo de expertos de la OMS evaluó y modificó el diseño del partograma teniendo en cuenta la nueva evidencia científica, y elaboró la primera versión de la Guía para la Atención del Trabajo de Parto. El objetivo de este estudio fue explorar las perspectivas y opiniones de los profesionales de la salud sobre la primera versión de la Guía para la Atención del Trabajo de Parto. MéTODOS: Se identificó a profesionales de salud de servicios de maternidad (incluidos obstetras, parteras profesionales y médicos generalistas) de cualquier género de África, Asia, Europa y América Latina a través de una red de investigación internacional. Los coordinadores de países de la red invitaron entre 5 y 10 profesionales con nivel de experiencia media o avanzada que hubieran trabajado en servicios de maternidad en los últimos 5 años. Se diseñó un cuestionario en línea, autoadministrado, anónimo y estructurado que incluía preguntas cerradas y abiertas para evaluar la claridad, la pertinencia, la adecuación de la frecuencia de registro y la exhaustividad de las secciones y variables de la Guía para la Atención del Trabajo de Parto.Un total de 110 participantes de 23 países completaron la encuesta entre diciembre de 2018 y enero de 2019. Las variables incluidas en la Guía para la Atención del Trabajo de Parto se consideraron en general claras, pertinentes y con una frecuencia de registro apropiada. La mayoría de las secciones de la Guía para la Atención del Trabajo de Parto se consideraron completas. Los participantes estuvieron de acuerdo o muy de acuerdo con el diseño general, la estructura de la Guía para la Atención del Trabajo de Parto, y la utilidad de los umbrales de referencia para desencadenar evaluaciones y acciones adicionales. También estuvieron de acuerdo en que la Guía para la Atención del Trabajo de Parto tendrá un impacto positivo en la toma de decisiones clínicas y en el cuidado respetuoso. Los participantes no estuvieron de acuerdo con algunos parámetros propuestos en la Guía para la Atención del Trabajo de Parto, incluyendo el manejo de la situación por parte de las mujeres, parámetros urinarios y el estado neonatal.Los futuros usuarios de la Guía para la Atención del Trabajo de Parto consideraron que las variables eran claras, pertinentes y apropiadas, y que, con pequeñas mejoras, podría tener un impacto positivo en la toma de decisiones clínicas y la atención respetuosa del parto.RéSUMé: CONTEXTE: Le partogramme est l'outil de suivi du travail le plus couramment utillis dans le monde. Cependant, il est utilisé de façon incorrecte ou non uniforme dans de nombreux contextes. En 2018, un groupe d'experts de l'OMS a examiné et révisé la conception du partogramme à la lumière de nouvelles données et a développé la première version du Guide de Gestion du Travail. L'objectif de cette étude était d'explorer les points de vue et les opinions du personnel de santé qualifié sur la première version du Guide de Gestion du Travail de l'OMS. MéTHODES: Un vaste réseau mondial de recherche a permis d'identifier le personnel de santé qualifié (y compris des obstétriciens, des sages-femmes et des médecins généralistes) des deux sexes, en Afrique, Asie, Europe et en Amérique latine. Les coordinateurs nationaux du réseau ont invité entre 5 et 10 personnels de santé qualifiés de niveau intermédiaire à supérieur, et ayant travaillé dans des services de maternité à au cours des 5 dernières années. Un questionnaire en ligne, structuré, anonyme et à remplir soi-même, comprenant des questions fermées et ouvertes, a été conçu pour évaluer la clarté, la pertinence, la convenance de la fréquence d'enregistrement et l’intégrité des variables du Guide de Gestion du Travail. RéSULTATS: Au total, 110 participants de 23 pays ont répondu à l'enquête entre décembre 2018 et janvier 2019. Les variables incluses dans le Guide de Gestion du Travail ont t généralement considérées claires, pertinentes et avec une fréquence d'enregistrement appropriée. La plupart des sections du Guide de Gestion du Travail sont considérées complètes. Les participants ont approuvé ou fortement approuvé le concept générale, la structure du Guide de Gestion du Travail et l'utilité des seuils de référence pour déclencher une évaluation et des actions supplémentaires. Ils ont également convenu que le Guide de Gestion du Travail aura potentiellement un impact positif sur les prise de décisions cliniques et les soins maternels respectueux. Les personnes interrogées ont exprimé leur désaccord avec la valeur de certaines variables, notamment la capacité d'adaptation, l'urine et l'état néonatal. CONCLUSIONS: Les futurs utilisateurs du le Guide de Gestion du Travail ont estimé que les variables étaient claires, pertinentes et appropriées, et qu'elles pourraient avoir un impact positif sur la prise de décision clinique et les soins de maternit respectueux, moyennant quelques améliorations mineures.

Background We conducted an overview of systematic reviews (SRs) summarizing the best evidence regarding the effect of COVID-19 on maternal and child health following Cochrane methods and PRISMA statement for reporting (PROSPERO-CRD42020208783). Methods We searched literature databases and COVID-19 research websites from January to October 2020. We selected relevant SRs reporting adequate search strategy, data synthesis, risk of bias assessment, and/or individual description of included studies describing COVID-19 and pregnancy outcomes. Pair of reviewers independently selected studies through COVIDENCE web-software, performed the data extraction, and assessed its quality through the AMSTAR-2 tool. Discrepancies were resolved by consensus. Each SR’s results were synthesized and for the most recent, relevant, comprehensive, and with the highest quality, by predefined criteria, we presented GRADE evidence tables. Results We included 66 SRs of observational studies out of 608 references retrieved and most (61/66) had "critically low" overall quality. We found a relatively low degree of primary study overlap across SRs. The most frequent COVID-19 clinical findings during pregnancy were fever (28–100%), mild respiratory symptoms (20–79%), raised C-reactive protein (28–96%), lymphopenia (34–80%), and pneumonia signs in diagnostic imaging (7–99%). The most frequent maternal outcomes were C-section (23–96%) and preterm delivery (14–64%). Most of their babies were asymptomatic (16–93%) or presented fever (0–50%), low birth weight (5–43%) or preterm delivery (2–69%). The odds ratio (OR) of receiving invasive ventilation for COVID-19 versus non-COVID-19 pregnant women was 1.88 (95% Confidence Interval [CI] 1.36–2.60) and the OR that their babies were admitted to neonatal intensive care unit was 3.13 (95%CI 2.05–4.78). The risk of congenital transmission or via breast milk was estimated to be low, but close contacts may carry risks. Conclusion This comprehensive overview supports that pregnant women with COVID-19 may be at increased risk of adverse pregnancy and birth outcomes and low risk of congenital transmission. Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Bardach, Ariel Esteban. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Comandé, Daniel. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Berrueta, Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Argento, Fernando J.. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Rodriguez Cairoli, Federico. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Zamora, Natalia. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Santa María, Victoria. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Xiong, Xu. University of Tulane; Estados Unidos Fil: Zaraa, Sabra. University of Washington; Estados Unidos Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Buekens, Pierre. University of Tulane; Estados Unidos

BackgroundTherapies to interrupt progression of early COVID-19 remain elusive. Among them, convalescent plasma in hospitalized patients was unsuccessful, perhaps because antibody should be administered earlier. We advanced plasma infusions to the first 72 hours of symptoms to arrest COVID-19 progression.MethodsA randomized, double-blind, placebo-controlled trial of convalescent plasma with high IgG titers against SARS-CoV2 in elderly subjects within 72 hours of mild COVID-19 symptoms. The primary endpoint was severe respiratory disease defined as a respiratory rate ≥30 and/or an O2satResults160 patients underwent randomization. In the intention-to-treat analysis (ITT), 13/80(16.2%) patients receiving plasma vs. 25/80(31.2%) receiving placebo experienced severe respiratory disease [RR(95%CI)= 0.52(0.29,0.94); p=0.026)] with an RRR=48%.A modified ITT analysis, excluding six subjects who experienced the primary endpoint before infusion, showed a larger effect size [RR(95%CI) = 0.40(0.20, 0.81), p=0.007]. High- and low-titer donor analyses, based on a median IgG titer=1:3,200, evidenced a dose-dependent response with an RRR=73.3% for recipients of high-titer plasma (p=0.016) and a number needed to treat (NNT)=4.4. All secondary endpoints exhibited trends towards protection. No solicited adverse events were observed.ConclusionsEarly administration of high-titer convalescent plasma against SARS-CoV2 to mildly ill infected seniors reduced COVID-19 progression. This safe, inexpensive, outpatient intervention facilitates access to treatment from industrialized to LMIC, can decompress demands on hospitals, and may contribute to save lives.Funded by The Bill & Melinda Gates Foundation and The Fundación INFANT Pandemic Fund. Registered in the Dirección de Sangre y Medicina Transfusional del Ministerio de Salud (PAEPCC19), Plataforma PRIISA (1421), and clinicaltrials.gov (NCT04479163).All authors have completed the ICMJE uniform disclosure form atwww.icmje.org/coi_disclosure.pdfand declare: no support from any organization for the submitted work; RL, GPM, DW and FPP are investigators in a phase 3 SARS CoV2 trial from Pfizer; no other relationships or activities that could appear to have influenced the submitted work.

Introduction The World Health Organization’s (WHO) Labour Care Guide (LCG) is a “next‐generation” partograph based on WHO’s latest intrapartum care recommendations. It aims to optimize clinical care provided to women and their experience of care. We evaluated the LCG’s usability, feasibility, and acceptability among maternity care practitioners in clinical settings. Methods Mixed‐methods evaluation with doctors, midwives, and nurses in 12 health facilities across Argentina, India, Kenya, Malawi, Nigeria, and Tanzania. Purposively sampled and trained practitioners applied the LCG in low‐risk women during labor and rated experiences, satisfaction, and usability. Practitioners were invited to focus group discussions (FGDs) to share experiences and perceptions of the LCG, which were subjected to framework analysis. Results One hundred and thirty‐six practitioners applied the LCG in managing labor and birth of 1,226 low‐risk women. The majority of women had a spontaneous vaginal birth (91.6%); two cases of intrapartum stillbirths (1.63 per 1000 births) occurred. Practitioner satisfaction with the LCG was high, and median usability score was 67.5%. Practitioners described the LCG as supporting precise and meticulous monitoring during labor, encouraging critical thinking in labor management, and improving the provision of woman‐centered care. Conclusions The LCG is feasible and acceptable to use across different clinical settings and can promote woman‐centered care, though some design improvements would benefit usability. Implementing the LCG needs to be accompanied by training and supportive supervision, and strategies to promote an enabling environment (including updated policies on supportive care interventions, and ensuring essential equipment is available).

BackgroundRetrospective observational studies suggest that transmission of the Trypanosoma cruzi does not occur in treated women when pregnant later in life. The level of parasitemia is a known risk factor for congenital transmission. Benznidazole (BZN) is the drug of choice for preconceptional treatment to reduce parasitic load. The BENEFIT trial, conducted in Argentina, compared a BZN 60-day/300 mg per day (60d/300mg) course (for subjects weighing 60kg) vs. placebo among patients with Chagas’ cardiomyopathy. The rate of conversion to negative conventional PCR (PCR) in the blood was 66.2% in the BZN group vs. 33.5% in the placebo group. Of concern, the rate of treatment interruption caused by adverse events was 23.9% in the BZN group.The fear of treatment-related side effects limits the implementation of the Argentine guideline recommending BZN 60d/300mg (or equivalent) treatment of T. cruzi seropositive women during the postpartum period to prevent transmission in a future pregnancy. A short and low dose BZN treatment might reduce major side effects and increase compliance, but its efficacy to reduce T. cruzi parasitic load compared to the standard 60d/300mg course is not yet established. Observational, animal, and pharmacokinetics (PK) studies suggest that the 60d/300mg course may be overdosing patients unnecessarily and increasing adverse events. Young and healthy subjects might have lower rates of treatment failures and adverse events. Clinical trials testing alternative BZN courses among women of reproductive age are urgently needed.Methods and designWe are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short low dose 30-day treatment with BZN 150mg/day (30d/150mg) vs. BZN 60d/300mg. We will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at six months postpartum, and follow them up with the following specific aims:Specific Aim 1: to measure the effect of BZN 30d/150mg compared to 60d/300mg preconceptional treatment on parasitic load measured by the frequency of positive Polymerase Chain Reaction (PCR) (primary outcome) and by real-time quantitative PCR (qPCR), immediately (Specific Aim 1a) and 10 months (Specific Aim 1b) after treatment.Hypothesis 1a: the frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg will be non-inferior (Non-Inferiority (NI) margin for PCR: 10% absolute difference) to BZN 60d/300mg.Hypothesis 1b: the frequency of positive PCR and the parasitic load measured by qPCR 10 months after BZN 30d/150mg will be non-inferior (NI margin for PCR: 9% absolute difference) to BZN 60d/300mg.Specific Aim 2: to measure the frequency of serious adverse events and/or any adverse event leading to treatment interruption of BZN 30d/150mg compared to 60d/300mg.Hypothesis 2: the frequency of serious adverse events and/or any adverse event leading to treatment interruption will be 50% lower with BZN 30d/150mg than with BZN 60d/300mg.Trial registration: ClinicalTrials.gov. Identifier: NCT03672487. Registed 14 September 2018, https://clinicaltrials.gov/ct2/show/NCT03672487?recrs=a&cond=Chagas+Disease&cntry=AR&draw=2&rank=3

Background and aims Ulcerative Colitis (UC) and Crohn’s Disease (CD) have a major impact on quality of life and medical costs. The aim of the study was to estimate the prevalence, incidence and clinical phenotypes of Inflammatory Bowel Disease (IBD) cases in Mexico and Colombia. Methods We analyzed official administrative and health databases, used mathematical modelling to estimate the incidence and complete prevalence, and performed a case-series of IBD patients at a referral center both in Mexico and Colombia. Results The age-adjusted complete prevalence of UC per 100,000 inhabitants for 2015/2016 ranged from 15.65 to 71.19 in Mexico and from 27.40 to 69.97 in Colombia depending on the model considered. The prevalence of CD per 100,000 inhabitants in Mexico ranged from 15.45 to 18.08 and from 16.75 to 18.43 in Colombia. In Mexico, the age-adjusted incidence of UC per 100,000 inhabitants per year ranged from 0.90 to 2.30, and from 0.55 to 2.33 in Colombia. The incidence for CD in Mexico ranged from 0.35 to 0.66 whereas in Colombia, the age-adjusted incidence of CD ranged from 0.30 to 0.57. The case-series included 200 IBD patients from Mexico and 204 patients from Colombia. The UC/CD prevalence ratio in Mexico and Colombia was 1.50:1 and 4.5:1 respectively. In Mexico, the female/male prevalence ratio for UC was 1.50:1 and 1.28:1 for CD, while in Colombia this ratio was 0.68:1 for UC and 0.8:1 for CD. In Mexico the relapse rate for UC was 63.3% and 72.5% for CD, while those rates in Colombia were 58.2% for UC and 58.3% for CD. Conclusions The estimated burden of disease of IBD in Mexico and Colombia is not negligible. Although these findings need to be confirmed by population-based studies, they are useful for decision-makers, practitioners and patients with this condition. Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Virgilio, Sacha Alexis. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Berrueta, Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Claire Soto, Natalie. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Ciganda, Álvaro. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Rojas Illanes, Moisés Freddy. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Rubio Martinez, Briseida. Hospital Dr. Bernardo Sepúlveda; México Fil: Gamba, Johana. Fundación Universitaria Sanitas; Colombia Fil: González Salazar, Carlos Arturo. Fundación Universitaria Sanitas; Colombia Fil: Rocha Rodríguez, José Nicolás. Fundación Universitaria Sanitas; Colombia Fil: Scarpellini, Bruno. No especifíca; Fil: Bravo Perdomo, Ana María. No especifíca; Fil: Machnicki, Gerardo. No especifíca; Fil: Aldunate, Leandro. No especifíca; Fil: De Paula, Juan. Hospital Italiano; Argentina Fil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina

To assess whether the implementation of a package of activities through the joint action of three international healthcare professional associations (HCPAs) increased the use of essential interventions (EIs) for delivery and neonatal care.A noncontrolled pre-intervention versus post-intervention study was conducted from June 13 to December 13, 2016, among women older than 18 years of age, who had delivered at one of two urban tertiary hospitals in Nepal.The study included 9252 women. Minimal change was found after the implementation of EIs that were used frequently at baseline (e.g. social support during delivery in the emergency room, and promotion and support for early initiation of breastfeeding). By contrast, an increase was recorded for some EIs that had not been used regularly at baseline. For example, the rate of timely administration of prophylactic antibiotics before cesarean delivery increased from 0.0% (0/496) to 94.0% (409/435) at one hospital. Nonetheless, some EIs with low use at baseline did not show improvement after implementation (e.g. kangaroo mother care).The present study strengthened previous findings regarding the uptake of EIs following joint promotion by HCPAs in low-income settings.

Objective To assess whether the implementation of a package of activities through the joint action of the three international healthcare professionals associations (HCPAs) increased the use of intrapartum and postnatal essential interventions (EIs) in two hospitals in Uganda. Methods A non-controlled before-and-after study was undertaken to evaluate the effect of a package of activities designed to change practice relating to nine EIs among providers. Coverage of the EIs was measured in a 3-month pre-implementation period and a 3-month post-implementation period in 2014. Data were obtained for women older than 18 years who delivered vaginally or by cesarean. Results: Overall, 4816 women were included. Level of use remained high for EIs used widely at baseline. Some EIs that had low use at baseline did not show improvement after the implementation. Promotion of breastfeeding showed a significant improvement in the Kampala hospital, from 8.5% (8/94) to 25.6% (30/117; P=0.001), whereas promotion of hygiene in cord care improved at the Mbarara hospital, from 0.1% (2/1592) to 46.0% (622/1351; P

Severe sepsis (SS) is one of the leading causes of pediatric mortality in Argentina. The objective was to describe the epidemiological characteristics and to analyze risk factors associated with mortality from SS among patients hospitalized in pediatric intensive care units (PICU) in Argentina.Observational, prospective cohort study among patients with SS hospitalized in PICUs in Argentina from 8/1/2008 to 9/30/2008.Two thousand five hundred and fifty nine patients were admitted at 59 PICUs. A total of 315 patients (335 events) were included. Patients' median age was 8 months (1-182). The frequency was 13.8 %, and 28-day mortality was 31.6 %. Patients with a higher mortality were those who were coming from rural areas, had comorbidities at the time of admission or a history of cancer, had shock or acute respiratory distress syndrome (ARDS), were administered low-dose corticosteroids or vasoactive drugs or more than 60 ml/kg of fluid in the first hour and in the first 6hours, and had severe malnutrition. Following adjustment by severity using a multivariate logistic regression model, only coming from a rural area, having shock or ARDS remained associated with 28-day mortality. Forty per cent of patients received antibiotics 60 minutes after diagnosis.SS is an event with a high frequency and mortality in Argentina. In the severity adjusted multivariate analysis, only coming from a rural area, having ARDS and/or shock were associated with higher mortality.Introducción. La sepsis grave (SG) es una de las principales causas de mortalidad pediátrica en Argentina. El objetivo fue describir las características epidemiológicas y analizar los factores asociados a la mortalidad de la SG en pacientes internados en unidades de cuidados intensivos pediátricos (UCIP) de Argentina. Pacientes y métodos. Estudio observacional, de cohorte prospectiva en pacientes con SG internados en UCIP de Argentina del 1/8/2008 al 30/9/2008. Resultados. En 59 UCIP, ingresaron 2559 pacientes. Se incluyeron 315 pacientes, que tuvieron 335 eventos. La mediana de edad fue 8 meses (1-182). La frecuencia fue del 13,8 % y la mortalidad a los 28 días, del 31,6 %. Tuvieron mayor mortalidad quienes procedían del ámbito rural, presentaban una comorbilidad al ingresar o antecedentes oncológicos, tenían shock o síndrome de dificultad respiratoria aguda (SDRA), recibieron corticoides en bajas dosis o drogas vasoactivas o más de 60 ml/kg de fluidos en la primera hora y en las 6 primeras horas, y los desnutridos graves. Al ajustarse por gravedad en un modelo de regresión logística multivariado, solo mantuvieron la asociación con mortalidad a los 28 días el provenir del ámbito rural, tener shock o SDRA. El 40 % de los pacientes recibieron antibióticos después de los 60 minutos del diagnóstico. Conclusiones. La SG es un evento de elevada frecuencia y mortalidad en Argentina. En el análisis multivariado ajustado por gravedad, solo provenir del área rural, la presencia de SDRA y/o de shock se asociaron a mayor mortalidad.

Introduction: Argentina and Uruguay have a high prevalence of smoking during pregnancy. However, and despite national recommendations, pregnant women are not routinely receiving cessation counseling during antenatal care (ANC). We evaluated a multifaceted strategy designed to increase the frequency of pregnant women who received a brief smoking cessation counseling based on the 5As (Ask, Advise, Assess, Assist, and Arrange). Methods: We randomly assigned (1:1) 20 ANC clusters in Buenos Aires, Argentina and Montevideo, Uruguay to receive a multifaceted intervention to implement brief smoking cessation counseling into routine ANC, or to receive no intervention. The primary outcome was the frequency of women who recalled receiving the 5As during ANC at more than one visit. Frequency of women who smoked until the end of pregnancy, and attitudes and readiness of ANC providers towards providing counseling were secondary outcomes. Women’s outcomes were measured at baseline and at the end of the 14- to 18-month intervention, by administering questionnaires at the postpartum hospital stay. Self-reported cessation was verified with saliva cotinine. The trial took place between October 03, 2011 and November 29, 2013. Results: The rate of women who recalled receiving the 5As increased from 14.0% to 33.6% in the intervention group (median rate change, 22.1%), and from 10.8% to 17.0% in the control group (median rate change, 4.6%; P = .001 for the difference in change between groups). The effect of the intervention was larger in Argentina than in Uruguay. The proportion of women who continued smoking during pregnancy was unchanged at follow-up in both groups and the relative difference between groups was not statistically significant (ratio of odds ratios 1.16, 95% CI: 0.98–1.37; P = .086). No significant changes were observed in knowledge, attitudes, and self-confidence of ANC providers. Conclusions: The intervention showed a moderate effect in increasing the proportion of women who recalled receiving the 5As, with a third of women receiving counseling in more than one visit. However, the frequency of women who smoked until the end of the pregnancy was not significantly reduced by the intervention. Implications: No implementation trials of smoking cessation interventions for pregnant women have been carried out in Latin American or in middle-income countries where health care systems or capacities may differ. We evaluated a multifaceted strategy designed to increase the frequency of pregnant women who receive brief smoking cessation counseling based on the 5As in Argentina and Uruguay. We found that the intervention showed a moderate effect in increasing the proportion of women receiving the 5As, with a third of women receiving counseling in more than one visit. However, the frequency of women who smoked until the end of the pregnancy was not significantly reduced by the intervention. Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Alemán, Alicia. Unidad de Investigación Clínica y Epidemiológica Montevideo; Uruguay Fil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Morello, Paola. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Colomar, Mercedes. Unidad de Investigación Clínica y Epidemiológica Montevideo; Uruguay Fil: Tong, Van T.. Centers for Disease Control and Prevention; Estados Unidos Fil: Dietz, Patricia M.. Centers for Disease Control and Prevention; Estados Unidos Fil: Farr, Sherry L.. Centers for Disease Control and Prevention; Estados Unidos Fil: Ciganda, Alvaro. Unidad de Investigación Clínica y Epidemiológica Montevideo; Uruguay Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Llambí, Laura. Universidad de la República. Facultad de Medicina. Hospital de Clínicas; Uruguay Fil: Becú, Ana. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Smith, Ruben A.. Centers for Disease Control and Prevention; Estados Unidos Fil: Johnson, Carolyn. Tulane School of Public Health and Tropical Medicine; Estados Unidos Fil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Buekens, Pierre M.. Tulane School of Public Health and Tropical Medicine; Estados Unidos