Eff ect of participatory women’s groups facilitated by Accredited Social Health Activists on birth outcomes in rural eastern India: a cluster-randomised controlled trial

Background A quarter of the world’s neonatal deaths and 15% of maternal deaths happen in India. Few community-based strategies to improve maternal and newborn health have been tested through the country’s government-approved Accredited Social Health Activists (ASHAs). We aimed to test the eff ect of participatory women’s groups facilitated by ASHAs on birth outcomes, including neonatal mortality. Methods In this cluster-randomised controlled trial of a community intervention to improve maternal and newborn health, we randomly assigned (1:1) geographical clusters in rural Jharkhand and Odisha, eastern India to intervention (participatory women’s groups) or control (no women’s groups). Study participants were women of reproductive age (15–49 years) who gave birth between Sept 1, 2009, and Dec 31, 2012. In the intervention group, ASHAs supported women’s groups through a participatory learning and action meeting cycle. Groups discussed and prioritised maternal and newborn health problems, identifi ed strategies to address them, implemented the strategies, and assessed their progress. We identifi ed births, stillbirths, and neonatal deaths, and interviewed mothers 6 weeks after delivery. The primary outcome was neonatal mortality over a 2 year follow up. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN31567106. Findings Between September, 2009, and December, 2012, we randomly assigned 30 clusters (estimated population 156 519) to intervention (15 clusters, estimated population n=82 702) or control (15 clusters, n=73 817). During the follow-up period (Jan 1, 2011, to Dec 31, 2012), we identifi ed 3700 births in the intervention group and 3519 in the control group. One intervention cluster was lost to follow up. The neonatal mortality rate during this period was 30 per 1000 livebirths in the intervention group and 44 per 1000 livebirths in the control group (odds ratio [OR] 0.69, 95% CI 0·53–0·89). Interpretation ASHAs can successfully reduce neonatal mortality through participatory meetings with women’s groups. This is a scalable community-based approach to improving neonatal survival in rural, underserved areas of India

Effect of participatory women's groups facilitated by Accredited Social Health Activists on birth outcomes in rural eastern India: A cluster-randomised controlled trial

Background: A quarter of the world's neonatal deaths and 15% of maternal deaths happen in India. Few community-based strategies to improve maternal and newborn health have been tested through the country's government-approved Accredited Social Health Activists (ASHAs). We aimed to test the effect of participatory women's groups facilitated by ASHAs on birth outcomes, including neonatal mortality. Methods: In this cluster-randomised controlled trial of a community interve

Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs) to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial

Background: Around a quarter of the world's neonatal and maternal deaths occur in India. Morbidity and mortality are highest in rural areas and among the poorest wealth quintiles. Few interventions to improve maternal and newborn health outcomes with government-mandated community health workers have been rigorously evaluated at scale in this setting.The study aims to assess the impact of a community mobilisation intervention with women's groups facilitated by ASHAs to improve maternal and newborn health outcomes among rural tribal communities of Jharkhand and Orissa.Methods/design: The study is a cluster-randomised controlled trial and will be implemented in five districts, three in Jharkhand and two in Orissa. The unit of randomisation is a rural cluster of approximately 5000 population. We identified villages within rural, tribal areas of five districts, approached them for participation in the study and enrolled them into 30 clusters, with approximately 10 ASHAs per cluster. Within each district, 6 clusters were randomly allocated to receive the community intervention or to the control group, resulting in 15 intervention and 15 control clusters. Randomisation was carried out in the presence of local stakeholders who selected the cluster numbers and allocated them to intervention or control using a pre-generated random number sequence. The intervention is a participatory learning and action cycle where ASHAs support community women's groups through a four-phase process in which they identify and prioritise local maternal and newborn health problems, implement strategies to address these and evaluate the result. The cycle is designed to fit with the ASHAs' mandate to mobilise communities for health and to complement their other tasks, including increasing institutional delivery rates and providing home visits to mothers and newborns. The trial's primary endpoint is neonatal mortality during 24 months of intervention. Additional endpoints include home care practices and health care-seeking in the antenatal, delivery and postnatal period. The impact of the intervention will be measured through a prospective surveillance system implemented by the project team, through which mothers will be interviewed around six weeks after delivery. Cost data and qualitative data are collected for cost-effectiveness and process evaluations

Explaining the impact of a women's group led community mobilisation intervention on maternal and newborn health outcomes: the Ekjut trial process evaluation

Background: Few large and rigorous evaluations of participatory interventions systematically describe their context and implementation, or attempt to explain the mechanisms behind their impact. This study reports process evaluation data from the Ekjut cluster-randomised controlled trial of a participatory learning and action cycle with women's groups to improve maternal and newborn health outcomes in Jharkhand and Orissa, eastern India (20052008). The study demonstrated a 45% reduction in neonatal mortality in the last two years of the intervention, largely driven by improvements in safe practices for home deliveries.Methods: A participatory learning and action cycle with 244 women's groups was implemented in 18 intervention clusters covering an estimated population of 114 141. We describe the context, content, and implementation of this intervention, identify potential mechanisms behind its impact, and report challenges experienced in the field. Methods included a review of intervention documents, qualitative structured discussions with group members and non-group members, meeting observations, as well as descriptive statistical analysis of data on meeting attendance, activities, and characteristics of group attendees.Results: Six broad, interrelated factors influenced the intervention's impact: (1) acceptability; (2) a participatory approach to the development of knowledge, skills and 'critical consciousness'; (3) community involvement beyond the groups; (4) a focus on marginalized communities; (5) the active recruitment of newly pregnant women into groups; (6) high population coverage. We hypothesize that these factors were responsible for the increase in safe delivery and care practices that led to the reduction in neonatal mortality demonstrated in the Ekjut trial.Conclusions: Participatory interventions with community groups can influence maternal and child health outcomes if key intervention characteristics are preserved and tailored to local contexts. Scaling-up such interventions requires (1) a detailed understanding of the way in which context affects the acceptability and delivery of the intervention; (2) planned but flexible replication of key content and implementation features; (3) strong support for participatory methods from implementing agencies

Predictive factors of aneuploidy in infertile patients undergoing IVF: a retrospective analysis in a private IVF practice

Abstract Background PGT-A has become an important part of IVF treatments. Despite its increased use, there are contradicting results on its role in improving reproductive outcomes of ART cycles. Given that aneuploidy is a main limiting factor for IVF success, we aimed to study the predictive factors of aneuploidy in infertile patients undergoing IVF and hence highlight the patients who would benefit the most from genetic testing. Results A retrospective analysis of 1242 blastocysts biopsied in the setting of PGT-A cycles was performed. The euploid group included 703 embryos, while the aneuploid group had 539 embryos. The factors included in the analyses were the couple’s history as well as the embryo characteristics. The primary outcome was the rate of aneuploid embryos per patient’s history as well as per embryo characteristics. The aneuploidy rate (AR) in our cohort was 43.4%. The woman’s age was found to be a significant predictor (OR 1.045, 95% CI 1.008–1.084, p = 0.016). Biopsy on day 5 as well as degree of expansion 3 was also found to affect significantly (OR 0.724, 95% CI .541–.970, p = 0.03 and OR 2.645, 95% CI 1.252–5.585, p = 0.011). Lack of consanguinity decreased the AR by an OR 0.274 with 95% CI .137–.547, p < 0.001. The number of blastocysts available, trophectoderm quality, embryo grade, gonadotropins as well as trigger used were not found to be significant predictors (p = 0.495, 0.649, 0.264, 0.717 and 0.659 respectively). Conclusion Advanced female age, consanguinity, the day of embryo biopsy, and the degree of blastocyst expansion were all found to affect the incidence of AR. The age of the male partner, cause of infertility, and grade of embryo at biopsy were not found to correlate with aneuploidy

Predictors of maternal psychological distress in rural India: a cross-sectional community-based study

Maternal common mental disorders are prevalent in low-resource settings and have far-reaching consequences for maternal and child health. We assessed the prevalence and predictors of psychological distress as a proxy for common mental disorders among mothers in rural Jharkhand and Orissa, eastern India, where over 40% of the population live below the poverty line and access to reproductive and mental health services is low. Method: We screened 5801 mothers around 6 weeks after delivery using the Kessler-10 item scale, and identified predictors of distress using multiple hierarchical logistic regression. Results: 11.5% (95% CI: 10.7-12.3) of mothers had symptoms of distress (K10 score > 15). High maternal age, low asset ownership, health problems in the antepartum, delivery or postpartum periods, caesarean section, an unwanted pregnancy for the mother, small perceived infant size and a stillbirth or neonatal death were all independently associated with an increased risk of distress. The loss of an infant or an unwanted pregnancy increased the risk of distress considerably (AORs: 7.06 95% CI: 5.51-9.04 and 1.49, 95% CI: 1.12-1.97, respectively). Limitations: We did not collect data on antepartum depression, domestic violence or a mother's past birth history, and were therefore unable to examine the importance of these factors as predictors of psychological distress. Conclusions: Mothers living in underserved areas of India who experience infant loss, an unwanted pregnancy, health problems in the perinatal and postpartum periods and socio-economic disadvantage are at increased risk of distress and require access to reproductive healthcare with integrated mental health interventions

Improved neonatal survival after participatory learning and action with women’s groups: a prospective study in rural eastern India

OBJECTIVE: To determine whether a women’s group intervention involving participatory learning and action has a sustainable and replicable effect on neonatal survival in rural, eastern India. METHODS: From 2004 to 2011, births and neonatal deaths in 36 geographical clusters in Jharkhand and Odisha were monitored. Between 2005 and 2008, these clusters were part of a randomized controlled trial of how women’s group meetings involving participatory learning and action influence maternal and neonatal health. Between 2008 and 2011, groups in the original intervention clusters (zone 1) continued to meet to discuss post-neonatal issues and new groups in the original control clusters (zone 2) met to discuss neonatal health. Logistic regression was used to examine neonatal mortality rates after 2008 in the two zones. FINDINGS: Data on 41 191 births were analysed. In zone 1, the intervention’s effect was sustained: the cluster-mean neonatal mortality rate was 34.2 per 1000 live births (95% confidence interval, CI: 28.3–40.0) between 2008 and 2011, compared with 41.3 per 1000 live births (95% CI: 35.4–47.1) between 2005 and 2008. The effect of the intervention was replicated in zone 2: the cluster-mean neonatal mortality rate decreased from 61.8 to 40.5 per 1000 live births between two periods: 2006–2008 and 2009–2011 (odds ratio: 0.69, 95% CI: 0.57–0.83). Hygiene during delivery, thermal care of the neonate and exclusive breastfeeding were important factors. CONCLUSION: The effect of participatory women’s groups on neonatal survival in rural India, where neonatal mortality is high, was sustainable and replicable

Vaccine Breakthrough Infections by SARS-CoV-2 Variants after ChAdOx1 nCoV-19 Vaccination in Healthcare Workers

This study elucidated the clinical, humoral immune response and genomic analysis of vaccine breakthrough (VBT) infections after ChAdOx1 nCoV-19/Covishield vaccine in healthcare workers (HCWs). Amongst 1858 HCWs, 1639 had received either two doses (1346) or a single dose (293) of ChAdOx1 nCoV-19 vaccine. SARS-CoV-2 IgG antibodies and neutralizing antibodies were measured in the vaccinated group and the development of SARS-CoV-2 infection was monitored.Forty-six RT-PCR positive samples from the 203 positive samples were subjected to whole genome sequencing (WGS). Of the 203 (10.92%) infected HCWs, 21.46% (47/219) were non-vaccinated, which was significantly more than 9.52% (156/1639) who were vaccinated and infection was higher in doctors and nurses. Unvaccinated HCWs had 1.57 times higher risk compared to partially vaccinated HCWs and 2.49 times higher risk than those who were fully vaccinated.The partially vaccinated were at higher risk than the fully vaccinated (RR 1.58). Antibody non-response was seen in 3.44% (4/116), low antibody levels in 15.51% (18/116) and medium levels were found in 81.03% (94/116). Fully vaccinated HCWs had a higher antibody response at day 42 than those who were partially vaccinated (8.96 + 4.00 vs. 7.17 + 3.82). Whole genome sequencing of 46 samples revealed that the Delta variant (B.1.617.2) was predominant (69.5%). HCWs who had received two doses of vaccine showed better protection from mild, moderate, or severe infection, with a higher humoral immune response than those who had received a single dose. The genomic analysis revealed the predominance of the Delta variant (B.1.617.2) in the VBT infections