Unveiling the strong positive relationship: Maternal characteristics and neonatal outcomes in the Better Outcomes in Labour Difficulty (BOLD) study - a secondary analysis validating neonatal near miss classification.

Background: The near miss concept, denoting near collisions between aircraft, originated in aeronautics, but has recently been transferred to the neonatal context as a way of evaluating the quality of health services for newborns, especially in settings with reduced child mortality. However, there is yet no consensus regarding the underlying criteria. The most common indicators used to assess health care quality include mortality (maternal and neonatal) and life-threatening conditions. Using the World Health Organization (WHO) Better Outcomes in Labour Difficulty (BOLD) prospective cohort study data set, we conducted a secondary analysis to validate the near miss concept and explore the association between maternal and neonatal outcomes. Methods: We studied 10 203 singleton mothers treated between December 2014 and November 2015 in nine Nigerian and four Ugandan hospitals. We validated the near miss concept by testing the diagnostic accuracy (sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and odds ratio (OR)) using death as the reference variable and calculating the maternal and neonatal case fatality rates. We performed ordinal and binomial logistic regression, with the independent variables being those that had P < 0.1 in the univariate analyses. We considered the significance level of 5%. Results: We validated the neonatal near miss concept using the BOLD study data. We observed maternal and neonatal case fatality rates of 70.2% and 6.5%, with an increasing severity relationship between maternal and neonatal outcomes (P < 0.05). Ordinal logistic regression showed that gestational age <37 or >41 weeks and <8 antenatal consultations were related to a higher risk of neonatal severe outcomes, while maternal age between 30 and 34 years functioned as a protective factor against severe neonatal outcomes (SNO). Binomial logistic regression showed gestational age <37(OR = 1.46; 95% confidence interval (CI) = 1.07-1.94) or >41 weeks (OR = 2.26; 95% CI = 1.55-3.20), low educational level (OR = 1.76; 95% CI = 1.12-2.69), overweight/obesity (OR = 1.23; 95% CI = 1.02-1.47), one previous cesarean section (OR = 1.90; 95% CI = 1.36-2.61), one previous abortion (OR = 1.25; 95% CI = 1.00-1.56), and previous chronic condition (OR = 1.83; 95% CI = 1.37-2.41) were risk factors for SNO. Conclusions: The neonatal near miss concept could be used as a parameter for analysis in different health systems, to ensure that measuring of neonatal severity is comparable across health care units. In this analysis, we observed a progressive association between maternal severity and the severity of the newborns' outcomes.

LioNeo project: a randomised double-blind clinical trial for nutrition of very-low-birth-weight infants.

We assessed the effectiveness of lyophilised banked human milk (HM) as a fortifier to feed very-low-birth-weight infants (VLBWI). This study aimed to evaluate the safety and tolerability of HM with HM lyophilisate as an additive compared with the standard additive (cows' milk protein). In this phase I double-blind randomised controlled clinical trial, set in the intensive and intermediate care units of a tertiary hospital, forty VLBWI were enrolled and allocated into two groups: HM plus HM lyophilisate (LioNeo) or HM plus commercial additive (HMCA). The inclusion criteria were preterm infants, birth weight 750-1500 g, small or adequate for gestational age, exclusively receiving donor HM, volume ≥ 100 ml/kg per d and haemodynamically stable. Participants were followed up for 21 consecutive days. The primary outcome measures were necrotising enterocolitis (NEC), late-onset sepsis (LOS), death, gastrointestinal (GI) bleeding or perforation, diarrhoea, regurgitation, vomiting and abdominal distension. The LioNeo and HMCA groups had similar weights at baseline. The regression models showed no differences between the groups in terms of the primary outcomes. Diarrhoea, GI perforation, NEC and LOS were absent in the LioNeo group (one LOS and one NEC in the HMCA group). Multiple regression analysis with the total volume of milk as a covariate did not show significant differences. The lyophilisation of donor HM was considered safe and tolerable for use in stable haemodynamically VLBWI.

Home versus inpatient induction of labour for improving birth outcomes.

BACKGROUND: The setting in which induction of labour takes place (home or inpatient) is likely to have implications for safety, women's experiences and costs. Home induction may be started at home with the subsequent active phase of labour happening either at home or in a healthcare facility (hospital, birth centre, midwifery-led unit). More commonly, home induction starts in a healthcare facility, then the woman goes home to await the start of labour. Inpatient induction takes place in a healthcare facility where the woman stays while awaiting the start of labour. OBJECTIVES: To assess the effects on neonatal and maternal outcomes of third trimester home induction of labour compared with inpatient induction using the same method of induction. SEARCH METHODS: For this update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (31 January 2020)), and reference lists of retrieved studies. SELECTION CRITERIA: Published and unpublished randomised controlled trials (RCTs) in which home and inpatient settings for induction have been compared. We included conference abstracts but excluded quasi-randomised trials and cross-over studies. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study reports for inclusion. Two review authors carried out data extraction and assessment of risk of bias independently. GRADE assessments were checked by a third review author. MAIN RESULTS: We included seven RCTs, six of which provided data on 1610 women and their babies. Studies were undertaken between 1998 and 2015, and all were in high- or upper-middle income countries. Most women were induced for post dates. Three studies reported government funding, one reported no funding and three did not report on their funding source. Most GRADE assessments gave very low-certainty evidence, downgrading mostly for high risk of bias and serious imprecision. 1. Home compared to inpatient induction with vaginal prostaglandin E (PGE) (two RCTs, 1028 women and babies; 1022 providing data). Although women's satisfaction may be slightly better in home settings, the evidence is very uncertain (mean difference (MD) 0.16, 95% confidence interval (CI) -0.02 to 0.34, 1 study, 399 women), very low-certainty evidence. There may be little or no difference between home and inpatient induction for other primary outcomes, with all evidence being very low certainty: - spontaneous vaginal birth (average risk ratio (RR) [aRR] 0.91, 95% CI 0.69 to 1.21, 2 studies, 1022 women, random-effects method); - uterine hyperstimulation (RR 1.19, 95% CI 0.40 to 3.50, 1 study, 821 women); - caesarean birth (RR 1.01, 95% CI 0.81 to 1.28, 2 studies, 1022 women); - neonatal infection (RR 1.29, 95% CI 0.59 to 2.82, 1 study, 821 babies); - admission to neonatal intensive care unit (NICU) (RR 1.20, 95% CI 0.50 to 2.90, 2 studies, 1022 babies). Studies did not report serious neonatal morbidity or mortality. 2. Home compared to inpatient induction with controlled release PGE (one RCT, 299 women and babies providing data). There was no information on whether the questionnaire on women's satisfaction with care used a validated instrument, but the findings presented showed no overall difference in scores. We found little or no difference between the groups for other primary outcomes, all also being very low-certainty evidence: - spontaneous vaginal birth (RR 0.94, 95% CI 0.77 to 1.14, 1 study, 299 women); - uterine hyperstimulation (RR 1.01, 95% CI 0.51 to 1.98, 1 study, 299 women); - caesarean births (RR 0.95, 95% CI 0.64 to 1.42, 1 study, 299 women); - admission to NICU (RR 1.38, 0.57 to 3.34, 1 study, 299 babies). The study did not report on neonatal infection nor serious neonatal morbidity or mortality. 3. Home compared to inpatient induction with balloon or Foley catheter (four RCTs; three studies, 289 women and babies providing data). It was again unclear whether questionnaires reporting women's experiences/satisfaction with care were validated instruments, with one study (48 women, 69% response rate) finding women were similarly satisfied. Home inductions may reduce the number of caesarean births, but the data are also compatible with a slight increase and are of very low-certainty (RR 0.64, 95% CI 0.41 to 1.01, 2 studies, 159 women). There was little or no difference between the groups for other primary outcomes with all being very low-certainty evidence: - spontaneous vaginal birth (RR 1.04, 95% CI 0.54 to 1.98, 1 study, 48 women): - uterine hyperstimulation (RR 0.45, 95% CI 0.03 to 6.79, 1 study, 48 women); - admission to NICU (RR 0.37, 95% CI 0.07 to 1.86, 2 studies, 159 babies). There were no serious neonatal infections nor serious neonatal morbidity or mortality in the one study (involving 48 babies) assessing these outcomes. AUTHORS' CONCLUSIONS: Data on the effectiveness, safety and women's experiences of home versus inpatient induction of labour are limited and of very low-certainty. Given that serious adverse events are likely to be extremely rare, the safety data are more likely to come from very large observational cohort studies rather than relatively small RCTs.

A communication and information strategy in health and preparation for childbirth: a randomized cluster trial (PRENACEL). / Estratégia de comunicação e informação em saúde e a percepção de sentir-se preparada para o parto: ensaio aleatorizado por conglomerados (PRENACEL).

PRENACEL is a study that incorporates two innovative approaches to maternal and perinatal health: the need to improve women's level of satisfaction with the birthing experience and an assessment of the impacts of information and communication technologies in health. The approaches involve a communication program via short cellphone text messages, developed for Brazilian pregnant women in prenatal care in the Brazilian Unified National Health System. The analysis aims to determine whether the program contributes positively to women's perceived preparedness for childbirth. A randomized cluster trial was performed in 20 primary care units in Ribeirão Preto, São Paulo State, in 2015 and 2016. Data were collected for 1,210 women from interviews and patient charts. The data were submitted to two analytical models, per protocol and intention-to-treat. Women that had received information from the PRENACEL program during pregnancy were more likely to feel prepared for labor and delivery and to feel that prenatal care had helped them feel more prepared. There were also positive impacts on bonding with the newborn and breastfeeding in the delivery room and on knowledge of obstetric interventions. No differences were seen in the other maternal and perinatal outcomes, including women's satisfaction with the birthing care. PRENACEL can help expand women's access to strategic information for them to feel better prepared for the birthing experience.

O PRENACEL é uma pesquisa que incorpora duas abordagens inovadoras para a saúde materna e perinatal: a necessidade de melhorar os níveis de satisfação das mulheres com a experiência do parto; e, a avaliação de impactos do uso de tecnologias de informação e comunicação em saúde. Trata-se de um programa de comunicação via mensagens curtas de textos no celular desenvolvido para gestantes brasileiras atendidas no pré-natal do Sistema Único de Saúde. Nesta análise, pretende-se determinar se o programa contribui positivamente para a percepção das mulheres de sentirem-se melhor preparadas para o parto. Um ensaio aleatorizado por conglomerados foi realizado em 20 unidades de saúde da atenção primária de Ribeirão Preto, São Paulo, entre 2015 e 2016. Dados de entrevista e revisão de prontuários foram coletados de 1210 mulheres. Estes foram submetidos a dois modelos de análise, por protocolo e intenção de tratamento. Receber informações do programa PRENACEL durante a gestação foi associado a um aumento na percepção das mulheres de se sentirem melhor preparadas para o parto, e na percepção de que o pré-natal colabora para que se sintam mais preparadas. Também foram observados impactos positivos no estabelecimento do contato pele a pele e aleitamento materno em sala de parto e no conhecimento sobre intervenções obstétricas. Não foram encontradas diferenças nos demais desfechos maternos e perinatais avaliados, incluindo a satisfação das mulheres com o atendimento ao parto. O PRENACEL pode contribuir com a ampliação do acesso das mulheres a informações que lhes sejam estratégicas para que se sintam mais bem preparadas para a experiência do parto.

PRENACEL es una investigación que incorpora dos abordajes innovadores para la salud materna y perinatal: la necesidad de mejorar los niveles de satisfacción de las mujeres que han vivido la experiencia de un parto; además de la evaluación de los impactos del uso de tecnologías de la información y comunicación en salud. Se trata de un programa de comunicación vía mensajes cortos de texto en el móvil, desarrollado para gestantes brasileñas atendidas en el servicio prenatal del Sistema Único de Salud. En este análisis se pretende determinar si el programa contribuye positivamente a la percepción de las mujeres respecto a sentirse mejor preparadas para el parto. Se realizó un ensayo aleatorizado por conglomerados en 20 unidades de salud de atención primaria en Ribeirão Preto, São Paulo, entre 2015 y 2016. Los datos de entrevista y revisión de registros médicos se recogieron con 1.210 mujeres. Estos se sometieron a dos modelos de análisis, por protocolo e intención de tratamiento. Recibir información del programa PRENACEL durante la gestación se asoció a un aumento de la percepción de las mujeres en cuanto a sentirse mejor preparadas para el parto, y desde la percepción de que el periodo prenatal presta apoyo para que se sientan más preparadas. También se observaron impactos positivos en el establecimiento del contacto piel con piel, lactancia materna en sala de parto, y en el conocimiento sobre intervenciones obstétricas. No se observaron diferencias en los demás desenlaces maternos y perinatales evaluados, incluyendo la satisfacción de las mujeres con la atención durante el parto. PRENACEL puede contribuir a la ampliación del acceso de las mujeres a información que les resulte estratégica para que se sientan mejor preparadas durante la experiencia del parto.

Estratégia de comunicação e informação em saúde e a percepção de sentir-se preparada para o parto: ensaio aleatorizado por conglomerados (PRENACEL) / Estrategia de comunicación e información en salud y la percepción de sentirse preparada para el parto: ensayo aleatorizado por conglomerados (PRENACEL) / A communication and information strategy in health and preparation for childbirth: a randomized cluster trial (PRENACEL)

Resumo: O PRENACEL é uma pesquisa que incorpora duas abordagens inovadoras para a saúde materna e perinatal: a necessidade de melhorar os níveis de satisfação das mulheres com a experiência do parto; e, a avaliação de impactos do uso de tecnologias de informação e comunicação em saúde. Trata-se de um programa de comunicação via mensagens curtas de textos no celular desenvolvido para gestantes brasileiras atendidas no pré-natal do Sistema Único de Saúde. Nesta análise, pretende-se determinar se o programa contribui positivamente para a percepção das mulheres de sentirem-se melhor preparadas para o parto. Um ensaio aleatorizado por conglomerados foi realizado em 20 unidades de saúde da atenção primária de Ribeirão Preto, São Paulo, entre 2015 e 2016. Dados de entrevista e revisão de prontuários foram coletados de 1210 mulheres. Estes foram submetidos a dois modelos de análise, por protocolo e intenção de tratamento. Receber informações do programa PRENACEL durante a gestação foi associado a um aumento na percepção das mulheres de se sentirem melhor preparadas para o parto, e na percepção de que o pré-natal colabora para que se sintam mais preparadas. Também foram observados impactos positivos no estabelecimento do contato pele a pele e aleitamento materno em sala de parto e no conhecimento sobre intervenções obstétricas. Não foram encontradas diferenças nos demais desfechos maternos e perinatais avaliados, incluindo a satisfação das mulheres com o atendimento ao parto. O PRENACEL pode contribuir com a ampliação do acesso das mulheres a informações que lhes sejam estratégicas para que se sintam mais bem preparadas para a experiência do parto.

Resumen: PRENACEL es una investigación que incorpora dos abordajes innovadores para la salud materna y perinatal: la necesidad de mejorar los niveles de satisfacción de las mujeres que han vivido la experiencia de un parto; además de la evaluación de los impactos del uso de tecnologías de la información y comunicación en salud. Se trata de un programa de comunicación vía mensajes cortos de texto en el móvil, desarrollado para gestantes brasileñas atendidas en el servicio prenatal del Sistema Único de Salud. En este análisis se pretende determinar si el programa contribuye positivamente a la percepción de las mujeres respecto a sentirse mejor preparadas para el parto. Se realizó un ensayo aleatorizado por conglomerados en 20 unidades de salud de atención primaria en Ribeirão Preto, São Paulo, entre 2015 y 2016. Los datos de entrevista y revisión de registros médicos se recogieron con 1.210 mujeres. Estos se sometieron a dos modelos de análisis, por protocolo e intención de tratamiento. Recibir información del programa PRENACEL durante la gestación se asoció a un aumento de la percepción de las mujeres en cuanto a sentirse mejor preparadas para el parto, y desde la percepción de que el periodo prenatal presta apoyo para que se sientan más preparadas. También se observaron impactos positivos en el establecimiento del contacto piel con piel, lactancia materna en sala de parto, y en el conocimiento sobre intervenciones obstétricas. No se observaron diferencias en los demás desenlaces maternos y perinatales evaluados, incluyendo la satisfacción de las mujeres con la atención durante el parto. PRENACEL puede contribuir a la ampliación del acceso de las mujeres a información que les resulte estratégica para que se sientan mejor preparadas durante la experiencia del parto.

Abstract: PRENACEL is a study that incorporates two innovative approaches to maternal and perinatal health: the need to improve women's level of satisfaction with the birthing experience and an assessment of the impacts of information and communication technologies in health. The approaches involve a communication program via short cellphone text messages, developed for Brazilian pregnant women in prenatal care in the Brazilian Unified National Health System. The analysis aims to determine whether the program contributes positively to women's perceived preparedness for childbirth. A randomized cluster trial was performed in 20 primary care units in Ribeirão Preto, São Paulo State, in 2015 and 2016. Data were collected for 1,210 women from interviews and patient charts. The data were submitted to two analytical models, per protocol and intention-to-treat. Women that had received information from the PRENACEL program during pregnancy were more likely to feel prepared for labor and delivery and to feel that prenatal care had helped them feel more prepared. There were also positive impacts on bonding with the newborn and breastfeeding in the delivery room and on knowledge of obstetric interventions. No differences were seen in the other maternal and perinatal outcomes, including women's satisfaction with the birthing care. PRENACEL can help expand women's access to strategic information for them to feel better prepared for the birthing experience.

Clinical and Vitamin Response to a Short-Term Multi-Micronutrient Intervention in Brazilian Children and Teens: From Population Data to Interindividual Responses.

SCOPE: Micronutrients are in small amounts in foods, act in concert, and require variable amounts of time to see changes in health and risk for disease. These first principles are incorporated into an intervention study designed to develop new experimental strategies for setting target recommendations for food bioactives for populations and individuals. METHODS AND RESULTS: A 6-week multivitamin/mineral intervention is conducted in 9-13 year olds. Participants (136) are (i) their own control (n-of-1); (ii) monitored for compliance; (iii) measured for 36 circulating vitamin forms, 30 clinical, anthropometric, and food intake parameters at baseline, post intervention, and following a 6-week washout; and (iv) had their ancestry accounted for as modifier of vitamin baseline or response. The same intervention is repeated the following year (135 participants). Most vitamins respond positively and many clinical parameters change in directions consistent with improved metabolic health to the intervention. Baseline levels of any metabolite predict its own response to the intervention. Elastic net penalized regression models are identified, and significantly predict response to intervention on the basis of multiple vitamin/clinical baseline measures. CONCLUSIONS: The study design, computational methods, and results are a step toward developing recommendations for optimizing vitamin levels and health parameters for individuals.

Towards a consensus definition of maternal sepsis: results of a systematic review and expert consultation.

BACKGROUND: There is a need for a clear and actionable definition of maternal sepsis, in order to better assess the burden of this condition, trigger timely and effective treatment and allow comparisons across facilities and countries. The objective of this study was to review maternal sepsis definitions and identification criteria and to report on the results of an expert consultation to develop a new international definition of maternal sepsis. METHODS: All original and review articles and WHO documents, as well as clinical guidelines providing definitions and/or identification criteria of maternal sepsis were included. A multidisciplinary international panel of experts was surveyed through an online consultation in March-April 2016 on their opinion on the existing sepsis definitions, including new definition of sepsis proposed for the adult population (2016 Third International Consensus Definitions for Sepsis and Septic Shock) and importance of different criteria for identification of maternal sepsis. The definition was agreed using an iterative process in an expert face-to-face consensus development meeting convened by WHO and Jhpiego. RESULTS: Standardizing the definition of maternal sepsis and aligning it with the current understanding of sepsis in the adult population was considered a mandatory step to improve the assessment of the burden of maternal sepsis by the expert panel. The literature review and expert consultation resulted in a new WHO consensus definition "Maternal sepsis is a life-threatening condition defined as organ dysfunction resulting from infection during pregnancy, child-birth, post-abortion, or post-partum period". Plans are in progress to validate the new WHO definition of maternal sepsis in a large international population. CONCLUSION: The operationalization of the new maternal sepsis definition requires generation of a set of practical criteria to identify women with sepsis. These criteria should enable clinicians to focus on the timely initiation of actionable elements of care (administration of antimicrobials and fluids, support of vital organ functions, and referral) and improve maternal outcomes.

Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage: a systematic review.

INTRODUCTION: Women with postpartum haemorrhage (PPH) in developing countries often present in critical condition when treatment might be insufficient to save lives. Few studies have shown that application of non-pneumatic anti-shock garment (NASG) could improve maternal survival. METHODS: A systematic review of the literature explored the effect of NASG use compared with standard care for treating PPH. Medline, EMBASE and PubMed were searched. Methodological quality was assessed following the criteria suggested by the Cochrane Effective Practice and Organization of Care Group. Guidelines on Meta-analysis of Observational Studies in Epidemiology were used for reporting the results. Mantel-Haenszel methods for meta-analysis of risk ratios were used. RESULTS: Six out 31 studies met the inclusion criteria; only one cluster randomized controlled trial (c-RCT). Among observational studies, NASG fared better than standard care regarding maternal mortality reduction (Relative Risk (RR) 0.52 (95% Confidence interval (CI) 0.36 to 0.77)). A non-significant reduction of maternal mortality risk was observed in the c-RCT (RR: 0.43 (95% CI: 0.14 to 1.33)). No difference was observed between NASG use and standard care on use of blood products. Severe maternal outcomes were used as proxy for maternal death with similar pattern corroborating the trend towards beneficial effects associated with NASG. CONCLUSION: NASG is a temporizing alternative measure in PPH management that shows a trend to reduce PPH-related deaths and severe morbidities. In settings where delays in PPH management are common, particularly where constraints to offer blood products and definitive treatment exist, use of NASG is an intervention that should be considered as a policy option while the standard conditions for care are being optimized.