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Background: Hydroxyurea and blood transfusion therapies remain the main therapeutic strategies for Sickle cell disease. Preliminary data suggest substantial variation and inconsistencies in practice of these two therapeutic modalities in South Asia. In this systematic review we searched Medline, Cochrane library and Scopus for articles on usage of hydroxyurea and blood transfusion therapies for sickle cell disease in South Asia published in English between October 2005 and October 2020.Results: We selected 41 papers: 33 from India, 3 from Sri Lanka, 2 each from Pakistan and Bangladesh and one from Nepal. Only 14 prospective trials focused on hydroxyurea therapy from which majority (n = 10; 71.4%) adopted fixed low dose (10 mg/kg/day) regimen. With hydroxyurea therapy, 12 and 9 studies reported significant reductions in vaso-occlusive crises and transfusion requirement respectively. Severe anaemia (haemoglobin level < 6-7 g/dl) was the commonest indicator (n = 8) for transfusion therapy followed by vaso-occlusive crisis.Conclusions: Published data on the hydroxyurea and transfusion therapies in South Asia are limited and heterogeneous. A clear gap of knowledge exists about the nature of the sickle cell disease in the Indian subcontinent particularly from countries outside India necessitating further evidence-based assessments and interventions. [ABSTRACT FROM AUTHOR]

Background: Health service and health outcome data collection across many low- and middle-income countries (LMICs) is, to date largely paper-based. With the development and increased availability of reliable technology, electronic tablets could be used for electronic data collection in such settings. This paper describes our experiences with implementing electronic data collection methods, using electronic tablets, across different settings in four LMICs.Methods: Within our research centre, the use of electronic data collection using electronic tablets was piloted during a healthcare facility assessment study in Ghana. After further development, we then used electronic data collection in a multi-country, cross-sectional study to measure ill-health in women during and after pregnancy, in India, Kenya and Pakistan. All data was transferred electronically to a central research team in the UK where it was processed, cleaned, analysed and stored.Results: The healthcare facility assessment study in Ghana demonstrated the feasibility and acceptability to healthcare providers of using electronic tablets to collect data from seven healthcare facilities. In the maternal morbidity study, electronic data collection proved to be an effective way for healthcare providers to document over 400 maternal health variables, in 8530 women during and after pregnancy in India, Kenya and Pakistan.Conclusions: Electronic data collection provides an effective platform which can be used successfully to collect data from healthcare facility registers and from patients during health consultations; and to transfer large quantities of data. To ensure successful electronic data collection and transfer between settings, we recommend that close attention is paid to study design, data collection, tool design, local internet access and device security. [ABSTRACT FROM AUTHOR]

Hypertensive disorders of pregnancy (HDP), particularly pre-eclampsia and eclampsia, remain one of the leading causes of maternal mortality and are contributory in many foetal/newborn deaths. This editorial discusses a supplement of seven papers which provide the results of the first round of the CLIP (Community Level Interventions for Pre-eclampsia) Feasibility Studies. These studies report a number of enablers and barriers in each setting, which have informed the implementation of a cluster-randomized trial (cRCT) aimed at reducing pre-eclampsia-related, and all-cause, maternal and perinatal mortality and major morbidity using community-based identification and treatment of pre-eclampsia in selected geographies of Nigeria, Mozambique, Pakistan and India. This supplement unpacks the diverse community perspectives on determinants of maternal health, variant health worker knowledge and routine management of HDP, and viability of task sharing for preeclampsia identification and management in select settings. These studies demonstrate the need for strategies to improve health worker knowledge and routine management of HDP and consideration of expanding the role of community health workers to reach the most remote women and families with health education and access to health services. [ABSTRACT FROM AUTHOR]

Background: Despite growing evidence of the impacts of exclusively breastfeeding infants during the first 6 months of life on preventing childhood infections and ensuring optimal health, only a small number of studies have quantified this association in South Asia. Methods: We analyzed data from the Demographic and Health Surveys in Afghanistan (2015; n = 3462), Bangladesh (2017–2018; n = 1084), India (2019–2021; n = 26,101), Nepal (2022; n = 581), and Pakistan (2017–2018; n = 1,306), including babies aged 0–6 months. Multivariate logistic regression models were used to determine the association between exclusive breastfeeding in the last 24 h and diarrhoea, acute respiratory infections, and fever in the two weeks before the survey. We also examined the association between other infant and young feeding indicators and these outcomes. Results: Infants who were exclusive breastfed had decreased odds of diarrhoea in Afghanistan (AOR: 0.49, 95% CI 0.35, 0.70), India (AOR: 0.80, 95% CI 0.70, 0.91), and Nepal (AOR: 0.42, 95% CI 0.20, 0.89). Compared with infants who were not exclusive breastfed, infants who were exclusively breastfed were less likely to have fever in Afghanistan (AOR: 0.36, 95% CI 0.26, 0.50) and India (AOR: 0.75, 95% CI 0.67, 0.84). Exclusive breastfeeding was associated with lower odds of acute respiratory infections in Afghanistan (AOR: 0.57, 95% CI 0.39, 0.83). Early initiation of breastfeeding was protective against diarrhoea in India. Bottle feeding was a risk factor for diarrhoea in India and for fever in Afghanistan and India. Bottle feeding was also a risk factor for acute respiratory infection in Afghanistan and India. Conclusions: Not exclusive breastfeeding is a risk factor for diarrhoea, acute respiratory infections, and fever in some South Asian countries. These findings could have substantial implications for global and national efforts to increase exclusive breastfeeding rates. More support, advocacy, and action are required to boost breastfeeding rates as a crucial public health measure. [ABSTRACT FROM AUTHOR]

Background: Rates of perinatal depression (antenatal and postnatal depression) in South Asia are among the highest in the world. The delivery of effective psychological treatments for perinatal depression through existing health systems is a challenge due to a lack of human resources. This paper reports on a trial protocol that aims to evaluate the effectiveness and cost-effectiveness of the Thinking Healthy Programme delivered by peers (Thinking Healthy Programme Peer-delivered; THPP), for women with moderate to severe perinatal depression in rural and urban settings in Pakistan and India.Methods/design: THPP is evaluated with two randomised controlled trials: a cluster trial in Rawalpindi, Pakistan, and an individually randomised trial in Goa, India. Trial participants are pregnant women who are registered with the lady health workers in the study area in Pakistan and pregnant women attending outpatient antenatal clinics in India. They will be screened using the patient health questionnaire-9 (PHQ-9) for depression symptoms and will be eligible if their PHQ-9 is equal to or greater than 10 (PHQ-9 ≥ 10). The sample size will be 560 and 280 women in Pakistan and India, respectively. Women in the intervention arm (THPP) will be offered ten individual and four group sessions (Pakistan) or 6-14 individual sessions (India) delivered by a peer (defined as a mother from the same community who is trained and supervised in delivering the intervention). Women in the control arm (enhanced usual care) will receive health care as usual, enhanced by providing the gynaecologist or primary-health facilities with adapted WHO mhGAP guidelines for depression treatment, and providing the woman with her diagnosis and information on how to seek help for herself. The primary outcomes are remission and severity of depression symptoms at the 6-month postnatal follow-up. Secondary outcomes include remission and severity of depression symptoms at the 3-month postnatal follow-up, functional disability, perceived social support, breastfeeding rates, infant height and weight, and costs of health care at the 3- and 6-month postnatal follow-ups. The primary analysis will be intention-to-treat.Discussion: The trials have the potential to strengthen the evidence on the effectiveness and cost-effectiveness of an evidence-based psychological treatment recommended by the World Health Organisation and delivered by peers for perinatal depression. The trials have the unique opportunity to overcome the shortage of human resources in global mental health and may advance our understanding about the use of peers who work in partnership with the existing health systems in low-resource settings.Trial Registration: Pakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014) India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014). [ABSTRACT FROM AUTHOR]

Malnutrition among children is pervasive in South Asia and there are also reports of overnutrition. To better understand this phenomenon, we need a composite measure. However, the existing measures such as CIAF (Composite Index of Anthropometric Failure) and its revised version have ignored the overnutrition aspect of the phenomenon. This study proposes an extended version of CIAF which also considers overnutrition. This new measure was compared with the existing measures by using data from 1990 to 2018 for three selected South Asian countries including Pakistan, India and Bangladesh. We also examined the effects of socioeconomic and environmental variables on the outcome variable. The results reveal that the new measure (ECIAF) is better at measuring the phenomena. The burden of overall malnutrition has been decreased in the region. However, an increase in the concomitant prevalence of wasting and underweight is observed in both Pakistan and India and stunting and overweight is observed only in India. Besides, political stability, prevalence of undernourishment, anemia in children, mother's education, household size, dependency ratio, air pollution and unimproved sanitation are significantly correlated with childhood malnutrition. The findings also testified to long-run cointegrating relationship among the variables. [ABSTRACT FROM AUTHOR]

Background: Severe mental illness (SMI) presents a major challenge worldwide, affecting approximately 5–8% of the world's population. It causes significant distress to affected people, families and wider communities, generating high costs through loss of productivity and ongoing healthcare use. Over 75% of patients with psychosis receive inadequate care and experience a negative financial impact and reduced quality of life (QoL). It is therefore a priority to reduce the treatment gap by providing low-cost, effective interventions for people with psychosis. Our research project, PIECEs, is designed to explore, adapt and test a low-cost, approach (DIALOG+) that makes use of existing resources to improve community-based care for patients with psychosis. The research will be conducted in two urban sites: Karachi, Pakistan and Chennai, India. DIALOG+ is a novel, technology-assisted and resource-oriented intervention, based on QoL research, concepts of patient-centred communication, IT developments and solution-focused therapy. However, the approach has not been rigorously tested within India and Pakistan. Our randomised controlled trial (RCT) aims to test the effectiveness and cost-effectiveness of DIALOG+ in improving the QoL and clinical outcomes for individuals with long-term psychosis being treated in the community in India and Pakistan. Methods: To assess the acceptability, feasibility, and cost effectiveness of DIALOG+, we will conduct a cluster RCT with 210 patients and 14 clinicians in each country. The intervention will be used during a routine interaction between a clinician and a patient. It consists of a patient-centred assessment (the DIALOG scale) whereby the clinician invites the patient to rate their satisfaction with different life domains and treatment aspects, which forms the active control group. The intervention group will follow this up with a four-step solution-focused approach to identify the patient's resources and develop solutions to deal with the patient's concerns (DIALOG+). Discussion: If shown to be effective DIALOG+ has the potential to improve community-based care and the QoL for millions of people within India and Pakistan who experience psychosis. Trial registration: The trial was registered prospectively on the ISRCTN Registry: ISRCTN13022816 on 9 February 2022. [ABSTRACT FROM AUTHOR]

Background: Acute kidney injury (AKI) was common in the first two waves of the SARS-COV-2 pandemic in critically ill patients. A high percentage of these patients required renal replacement therapy and died in the hospital.Methods: The present study examines the clinical presentation, laboratory parameters and therapeutic interventions in critically ill patients with AKI admitted to the ICU in two centres, one each in India and Pakistan. Patient and outcome details of all critically ill COVID 19 patients admitted to the ICU requiring renal replacement therapy were collected. Data was analysed to detect patient variables associated with mortality.Results: A total of 1,714 critically ill patients were admitted to the ICUs of the two centres. Of these 393 (22.9%) had severe acute kidney injury (AKIN stage 3) requiring dialysis. Of them, 60.5% were men and the mean (± SD) age was 58.78 (± 14.4) years. At the time of initiation of dialysis, 346 patients (88%) were oligo-anuric. The most frequent dialysis modality in these patients was intermittent hemodialysis (48.1%) followed by slow low efficiency dialysis (44.5%). Two hundred and six (52.4%) patients died. The mortality was higher among the Indian cohort (68.1%) than the Pakistani cohort (43.4%). Older age (age > 50 years), low serum albumin altered sensorium, need for slower forms of renal replacement therapy and ventilatory support were independently associated with mortality.Conclusion: There was a very high mortality in patients with COVID-19 associated AKI undergoing RRT in the ICUs in this cohort from the Indian sub-continent. [ABSTRACT FROM AUTHOR]

Background: Perinatal mental health (PMH) is a worldwide public health issue crossing cultural boundaries. However, the prevalence of PMH conditions vary considerably. These disparities stem in part from poor understanding and stigma surrounding PMH which hinder pregnant women from seeking mental health care and may exacerbate their conditions. Bangladesh, India and Pakistan are South Asian countries with a higher burden of PMH conditions than in the Global North-West and very different social and cultural norms around gender and mental health. The aim of this systematic review (PROSPERO Ref: CRD42020167903) was to identify, synthesise and appraise the available literature on perceptions and attitudes of perinatal (pregnant and postpartum) women, their families and healthcare providers surrounding PMH in Bangladesh, India and Pakistan. Methods: Five electronic databases, MEDLINE, Embase, PsycINFO, Scopus and Web of science, and grey literature were searched using predefined search terms. Qualitative or quantitative articles with a qualitative component reporting perceptions and attitudes surrounding PMH in Bangladesh, India and Pakistan were eligible for inclusion, if published in English between January 2000 and January 2021. The Critical Appraisal Skills Programme Qualitative Research Checklist and Newcastle–Ottawa Scale for cross-sectional studies were used to assess study quality. Findings were synthesised using thematic synthesis, as described by Thomas and Harden 2008. Results: Eight studies were included. Five overarching themes comprising 17 sub-categories were identified. These descriptive themes were: perceived causes of PMH, perceived symptoms of PMH, perceptions of motherhood, accessing PMH care and emotional sharing and coping strategies. Sociocultural expectations underpin many of the themes identified in this review including the importance of familial and societal causes of PMH, emphasis on physical symptoms, sacredness of motherhood, lack of awareness, stigma, shame, limited resources allocated for mental health and lack of emotional sharing. Conclusions: There is a complex range of perceptions and attitudes around PMH which influence women's experiences and access to PMH care. These findings will inform policy and practice through targeted interventions to tackle stigmatising attitudes and increasing education and training for healthcare providers. [ABSTRACT FROM AUTHOR]

Background: The study aims to predict and assess cardiovascular disease (CVD) patterns in highly affected countries such as Pakistan, India, China, Kenya, the USA, and Sweden. The data for CVD deaths was gathered from 2005 to 2019. Methods: We utilized non-homogenous discrete grey model (NDGM) to predict growth of cardiovascular deaths in selected countries. We take this process a step further by utilizing novel Synthetic Relative Growth Rate (RGR) and Synthetic Doubling Time (Dt) model to assess how many years it takes to reduce the cardiovascular deaths double in numbers. Results: The results reveal that the USA and China may lead in terms of raising its number of deaths caused by CVDs till 2027. However, doubling time model suggests that USA may require 2.3 years in reducing the cardiovascular deaths. Conclusions: This study is significant for the policymakers and health practitioners to ensure the execution of CVD prevention measures to overcome the growing burden of CVD deaths. [ABSTRACT FROM AUTHOR]

Background: Few studies have shown how the move toward institutional delivery in low and middle-income countries (LMIC) impacts stillbirth and newborn mortality. Objectives: The study evaluated trends in institutional delivery in research sites in Belagavi and Nagpur India, Guatemala, Kenya, Pakistan, and Zambia from 2010 to 2018 and compared them to changes in the rates of neonatal mortality and stillbirth. Methods: We analyzed data from a nine-year interval captured in the Global Network (GN) Maternal Newborn Health Registry (MNHR). Mortality rates were estimated from generalized estimating equations controlling for within-cluster correlation. Cluster-level analyses were performed to assess the association between institutional delivery and mortality rates. Results: From 2010 to 2018, a total of 413,377 deliveries in 80 clusters across 6 sites in 5 countries were included in these analyses. An increase in the proportion of institutional deliveries occurred in all sites, with a range in 2018 from 57.7 to 99.8%. In 2010, the stillbirth rates ranged from 19.3 per 1000 births in the Kenyan site to 46.2 per 1000 births in the Pakistani site and by 2018, ranged from 9.7 per 1000 births in the Belagavi, India site to 40.8 per 1000 births in the Pakistani site. The 2010 neonatal mortality rates ranged from 19.0 per 1000 live births in the Kenyan site to 51.3 per 1000 live births in the Pakistani site with the 2018 neonatal mortality rates ranging from 9.2 per 1000 live births in the Zambian site to 50.2 per 1000 live births in the Pakistani site. In multivariate modeling, in some but not all sites, the reductions in stillbirth and neonatal death were significantly associated with an increase in the institutional deliveries. Conclusions: There was an increase in institutional delivery rates in all sites and a reduction in stillbirth and neonatal mortality rates in some of the GN sites over the past decade. The relationship between institutional delivery and a decrease in mortality was significant in some but not all sites. However, the stillbirth and neonatal mortality rates remain at high levels. Understanding the relationship between institutional delivery and stillbirth and neonatal deaths in resource-limited environments will enable development of targeted interventions for reducing the mortality burden. Trial registration: The study is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475. [ABSTRACT FROM AUTHOR]

Background: Oral cancer is a growing problem worldwide, with high incidence rates in South Asian countries. With increasing numbers of South Asian immigrants in developed countries, a possible rise in oral cancer cases is expected given the high prevalence in their source countries and the continued oral cancer risk behaviours of immigrants. The aim of this review is to synthesise existing evidence regarding knowledge, attitudes and practices of South Asian immigrants in developed countries regarding oral cancer.Methods: Five electronic databases were systematically searched to identify original, English language articles focussing on oral cancer risk knowledge, attitudes and practices of South Asian immigrants in developed countries. All studies that met the following inclusion criteria were included: conducted among South Asian immigrants in developed countries; explored at least one study outcome (knowledge or attitudes or practices); used either qualitative, quantitative or mixed methods. No restrictions were placed on the publication date, quality and setting of the study.Results: A total of 16 studies involving 4772 participants were reviewed. These studies were mainly conducted in the USA, UK, Italy and New Zealand between 1994 and 2018. Findings were categorised into themes of oral cancer knowledge, attitudes and practices. General lack of oral cancer risk knowledge (43-76%) among participants was reported. More than 50% people were found engaging in one or more oral cancer risk practices like smoking, betel quid/pan/gutka chewing. Some of the participants perceived betel quid/pan/gutka chewing habit good for their health (12-43.6%).Conclusion: This review has shown that oral cancer risk practices are prevalent among South Asian immigrants who possess limited knowledge and unfavourable attitude in this area. Culturally appropriate targeted interventions and strategies are needed to raise oral cancer awareness among South Asian communities in developed countries. [ABSTRACT FROM AUTHOR]

Background: Maternal stature and body mass indices (BMI) of non-pregnant women (NPW) of child bearing age are relevant to maternal and offspring health. The objective was to compare anthropometric indices of NPW in four rural communities in low- to low-middle income countries (LMIC).Methods: Anthropometry and maternal characteristics/household wealth questionnaires were obtained for NPW enrolled in the Women First Preconception Maternal Nutrition Trial. Body mass index (BMI, kg/m2) was calculated. Z-scores were determined using WHO reference data.Results: A total of 7268 NPW participated in Equateur, DRC (n = 1741); Chimaltenango, Guatemala (n = 1695); North Karnataka, India (n = 1823); and Thatta, Sindh, Pakistan (n = 2009). Mean age was 23 y and mean parity 1.5. Median (P25-P75) height (cm) ranged from 145.5 (142.2-148.9) in Guatemala to 156.0 (152.0-160.0) in DRC. Median weight (kg) ranged from 44.7 (39.9-50.3) in India to 52.7 (46.9-59.8) in Guatemala. Median BMI ranged from 19.4 (17.6-21.9) in India to 24.9 (22.3-28.0) in Guatemala. Percent stunted (<-2SD height for age z-score) ranged from 13.9% in DRC to 80.5% in Guatemala; % underweight (BMI <18.5) ranged from 1.2% in Guatemala to 37.1% in India; % overweight/obese (OW, BMI ≥25.0) ranged from 5.7% in DRC to 49.3% in Guatemala. For all sites, indicators for higher SES and higher age were associated with BMI. Lower SES women were underweight more frequently and higher SES women were OW more frequently at all sites. Younger women tended to be underweight, while older women tended to be OW.Conclusions: Anthropometric data for NPW varied widely among low-income rural populations in four countries located on three different continents. Global comparisons of anthropometric measurements across sites using standard reference data serve to highlight major differences among populations of low-income rural NPW and assist in evaluating the rationale for and the design of optimal intervention trials.Trial Registration: ClinicalTrials.gov # NCT01883193 (18 June 2013, retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: Globally, pre-eclampsia and eclampsia are major contributors to maternal and perinatal mortality; of which the vast majority of deaths occur in less developed countries. In addition, a disproportionate number of morbidities and mortalities occur due to delayed access to health services. The Community Level Interventions for Pre-eclampsia (CLIP) Trial aims to task-shift to community health workers the identification and emergency management of pre-eclampsia and eclampsia to improve access and timely care. Literature revealed paucity of published feasibility assessments prior to initiating large-scale community-based interventions. Arguably, well-conducted feasibility studies can provide valuable information about the potential success of clinical trials prior to implementation. Failure to fully understand the study context risks the effective implementation of the intervention and limits the likelihood of post-trial scale-up. Therefore, it was imperative to conduct community-level feasibility assessments for a trial of this magnitude. Methods: A mixed methods design guided by normalization process theory was used for this study in Nigeria, Mozambique, Pakistan, and India to explore enabling and impeding factors for the CLIP Trial implementation. Qualitative data were collected through participant observation, document review, focus group discussion and in-depth interviews with diverse groups of community members, key informants at community level, healthcare providers, and policy makers. Quantitative data were collected through health facility assessments, self-administered community health worker surveys, and household demographic and health surveillance. Results: Refer to CLIP Trial feasibility publications in the current and/or forthcoming supplement. Conclusions: Feasibility assessments for community level interventions, particularly those involving task-shifting across diverse regions, require an appropriate theoretical framework and careful selection of research methods. The use of qualitative and quantitative methods increased the data richness to better understand the community contexts. [ABSTRACT FROM AUTHOR]

Background: Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention. Methods: The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5th percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth. Results: After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters. Conclusions: In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial. Trial registration: clinicaltrials.gov (NCT01084096) [ABSTRACT FROM AUTHOR]

Background: The Antenatal Corticosteroid Trial assessed the feasibility, effectiveness, and safety of a multifaceted intervention to increase the use of antenatal corticosteroids (ACS) in mothers at risk of preterm birth at all levels of care in low and middle-income countries. The intervention effectively increased the use of ACS but was associated with an overall increase in neonatal deaths. We aimed to explore plausible pathways through which this intervention increased neonatal mortality. Methods: We conducted a series of secondary analyses to assess whether ACS or other components of the multifaceted intervention that might have affected the quality of care contributed to the increased mortality observed: 1) we compared the proportion of neonatal deaths receiving ACS between the intervention and control groups; 2) we compared the antenatal and delivery care process in all births between groups; 3) we compared the rates of possible severe bacterial infection between groups; and 4) we compared the frequency of factors related to ACS administration or maternal high risk conditions at administration between the babies who died and those who survived 28 days among all births in the intervention group identified as high risk for preterm birth and received ACS. Results: The ACS exposure among the infants who died up to 28 days was 29 % in the intervention group compared to 6 % in controls. No substantial differences were observed in antenatal and delivery care process between groups. The risk of pSBI plus neonatal death was significantly increased in intervention clusters compared to controls (2.4 % vs. 2.0 %, adjusted RR 1.17, 95 % CI 1.04-1.30, p = 0.008], primarily for infants with birth weight at or above the 25th percentile. Regarding factors related to ACS administration, term infants who died were more likely to have mothers who received ACS within 7 days of delivery compared to those who survived 28 days (26.5 % vs 17.9 %, p = 0.014), and their mothers were more likely to have been identified as high risk for hypertension and less likely for signs of preterm labor. Conclusions: These results suggest that ACS more than other components of the intervention may have contributed to the overall increased neonatal mortality. ACS may have also been involved in the observed increased risk of neonatal infection and death. Further trials are urgently needed to clarify the effectiveness and safety of ACS on neonatal health in low resource settings. [ABSTRACT FROM AUTHOR]

Background: Possible severe bacterial infections (pSBI) continue to be a leading cause of global neonatal mortality annually. With the recent publications of simplified antibiotic regimens for treatment of pSBI where referral is not possible, it is important to know how and where to target these regimens, but data on the incidence and outcomes of pSBI are limited. Methods: We used data prospectively collected at 7 rural community-based sites in 6 low and middle income countries participating in the NICHD Global Network's Maternal and Newborn Health Registry, between January 1, 2010 and December 31, 2013. Participants included pregnant women and their live born neonates followed for 6 weeks after delivery and assessed for maternal and infant outcomes. Results: In a cohort of 248,539 infants born alive between 2010 and 2013, 32,088 (13 %) neonates met symptomatic criteria for pSBI. The incidence of pSBI during the first 6 weeks of life varied 10 fold from 3 % (Zambia) to 36 % (Pakistan), and overall case fatality rates varied 8 fold from 5 % (Kenya) to 42 % (Zambia). Significant variations in incidence of pSBI during the study period, with proportions decreasing in 3 sites (Argentina, Kenya and Nagpur, India), remaining stable in 3 sites (Zambia, Guatemala, Belgaum, India) and increasing in 1 site (Pakistan), cannot be explained solely by changing rates of facility deliveries. Case fatality rates did not vary over time. Conclusions: In a prospective population based registry with trained data collectors, there were wide variations in the incidence and case fatality of pSBI in rural communities and in trends over time. Regardless of these variations, the burden of pSBI is still high and strategies to implement timely diagnosis and treatment are still urgently needed to reduce neonatal mortality. Trial registration: The study was registered at ClinicalTrials.gov (NCT01073475). [ABSTRACT FROM AUTHOR]

Background: The Antenatal Corticosteroid Trial (ACT) assessed the feasibility, effectiveness, and safety of a multifaceted intervention to increase the use of antenatal corticosteroids (ACS) in mothers at risk of preterm birth at all levels of care in low and middle-income countries. The intervention effectively increased the use of ACS but had no overall impact on neonatal mortality in the targeted <5th percentile birth weight infants. Being in the intervention clusters was also associated with an overall increase in neonatal deaths. We sought to explore plausible pathways through which this intervention increased neonatal mortality. Methods: We conducted secondary analyses to assess site differences in outcome and potential explanations for the differences in outcomes if found. By site, and in the intervention and control clusters, we evaluated characteristics of the mothers and care systems, the proportion of the <5th percentile infants and the overall population that received ACS, the rates of possible severe bacterial infection (pSBI), determined from clinical signs, and neonatal mortality rates. Results: There were substantial differences between the sites in both participant and health system characteristics, with Guatemala and Argentina generally having the highest levels of care. In some sites there were substantial differences in the health system characteristics between the intervention and control clusters. The increase in ACS in the intervention clusters was similar among the sites. While overall, there was no difference in neonatal mortality among <5th percentile births between the intervention and control clusters, Guatemala and Pakistan both had significant reductions in neonatal mortality in the <5th percentile infants in the intervention clusters. The improvement in neonatal mortality in the Guatemalan site in the <5th percentile infants was associated with a higher level of care at the site and an improvement in care in the intervention clusters. There was a significant increase overall in neonatal mortality in the intervention clusters compared to the control. Across sites, this increase in neonatal mortality was statistically significant and most apparent in the African sites. This increase in neonatal mortality was accompanied by a significant increase in pSBI in the African sites. Conclusions: The improvement in neonatal mortality in the Guatemalan site in the <5th percentile infants was associated with a higher level of care and an improvement in care in the intervention clusters. The increase in neonatal mortality in the intervention clusters across all sites was largely driven by the poorer outcomes in the African sites, which also had an increase in pSBI in the intervention clusters. We emphasize that these results come from secondary analyses. Additional prospective studies are needed to assess the effectiveness and safety of ACS on neonatal health in low resource settings. Trial registration: Trial registration: clinicaltrials.gov (NCT01084096) [ABSTRACT FROM AUTHOR]

Background: One in four Australians is born overseas and 47% are either born overseas or have a parent who was. Obstetric and psychosocial risk factors for these women may differ.Method: Data from one Sydney hospital (2012-2013) of all births recorded in the ObstetriX database were analysed (n = 3,092). Demographics, obstetric and psychosocial risk profile, obstetric interventions and complications and selected maternal and neonatal outcomes were examined for women born in Australia and overseas.Results: Women born in Australia were younger, more likely to be primiparous (28.6 v 27.5%), be obese (32.0% v 21.4%), smoke (19.7 % v 3.0%), have an epidural (26.2% v 20.2%) and were less likely to have gestational diabetes mellitus (GDM) (6.8% v 13.7% when compared to non-Australian born women. The highest rates of GDM, Gestational Hypertension (GH) and maternal anaemia were seen in women born in China, the Philippines and Pakistan respectively. Differences were also seen in psychosocial screening between Australian and non-Australian women with Australian-born women more likely to smoke and report a mental health disorder. There was an association between having an Edinburgh Postnatal Depression Scale (EPDS) ≥ 13 and other psychosocial issues, such as thoughts of self-harm, domestic violence, childhood abuse etc. These women were also less likely to breastfeed. Women with an EPDS ≥ 13 at booking compared to women with EPDS ≤12 had a higher chance of being diagnosed with GDM (AOR 1.85 95% CI 1.14-3.0).Conclusions: There are significant differences in obstetric and psychosocial risk profiles and maternal and neonatal outcomes between Australian-born and non-Australian born women. In particular there appears to be an association between an EPDS of ≥13 and developing GDM, which warrants further investigation. [ABSTRACT FROM AUTHOR]

Background: Quality assurance (QA) is a process that should be an integral part of research to protect the rights and safety of study participants and to reduce the likelihood that the results are affected by bias in data collection. Most QA plans include processes related to study preparation and regulatory compliance, data collection, data analysis and publication of study results. However, little detailed information is available on the specific procedures associated with QA processes to ensure high-quality data in multi-site studies. Methods: The Global Network for Women's and Children's Health Maternal Newborn Health Registy (MNHR) is a prospective population-based registry of pregnancies and deliveries that is carried out in 8 international sites. Since its inception, QA procedures have been utilized to ensure the quality of the data. More recently, a training and certification process was developed to ensure that standardized, scientifically accurate clinical definitions are used consistently across sites. Staff complete a web-based training module that reviews the MNHR study protocol, study forms and clinical definitions developed by MNHR investigators and are certified through a multiple choice examination prior to initiating study activities and every six months thereafter. A standardized procedure for supervision and evaluation of field staff is carried out to ensure that research activites are conducted according to the protocol across all the MNHR sites. Conclusions: We developed standardized QA processes for training, certification and supervision of the MNHR, a multisite research registry. It is expected that these activities, together with ongoing QA processes, will help to further optimize data quality for this protocol. [ABSTRACT FROM AUTHOR]

Background: Due to high fertility rates in some low and lower-middle income countries, the interval between pregnancies can be short, which may lead to adverse maternal and neonatal outcomes. Methods: We analyzed data from women enrolled in the NICHD Global Network Maternal Newborn Health Registry (MNHR) from 2013 through 2018. We report maternal characteristics and outcomes in relationship to the inter-delivery interval (IDI, time from previous delivery [live or stillborn] to the delivery of the index birth), by category of 6–17 months (short), 18–36 months (reference), 37–60 months, and 61–180 months (long). We used non-parametric tests for maternal characteristics, and multivariable logistic regression models for outcomes, controlling for differences in baseline characteristics. Results: We evaluated 181,782 women from sites in the Democratic Republic of Congo, Zambia, Kenya, Guatemala, India, and Pakistan. Women with short IDI varied by site, from 3% in the Zambia site to 20% in the Pakistan site. Relative to a 18–36 month IDI, women with short IDI had increased risk of neonatal death (RR = 1.89 [1.74, 2.05]), stillbirth (RR = 1.70 [1.56, 1.86]), low birth weight (RR = 1.38 [1.32, 1.44]), and very low birth weight (RR = 2.35 [2.10, 2.62]). Relative to a 18–36 month IDI, women with IDI of 37–60 months had an increased risk of maternal death (RR 1.40 [1.05, 1.88]), stillbirth (RR 1.14 [1.08, 1.22]), and very low birth weight (RR 1.10 [1.01, 1.21]). Relative to a 18–36 month IDI, women with long IDI had increased risk of maternal death (RR 1.54 [1.10, 2.16]), neonatal death (RR = 1.25 [1.14, 1.38]), stillbirth (RR = 1.50 [1.38, 1.62]), low birth weight (RR = 1.22 [1.17, 1.27]), and very low birth weight (RR = 1.47 [1.32,1.64]). Short and long IDIs were also associated with increased risk of obstructed labor, hemorrhage, hypertensive disorders, fetal malposition, infection, hospitalization, preterm delivery, and neonatal hospitalization. Conclusions: IDI varies by site. When compared to 18–36 month IDI, women with both short IDI and long IDI had increased risk of adverse maternal and neonatal outcomes. Trial registration: The MNHR is registered at NCT01073475. [ABSTRACT FROM AUTHOR]

Background: In South Asia, where most stillbirths and neonatal deaths occur, much remains unknown about the causes of these deaths. About one-third of neonatal deaths are attributed to prematurity, yet the specific conditions which cause these deaths are often unclear as is the etiology of stillbirths. In low-resource settings, most women are not routinely tested for infections and autopsy is rare. Methods: This prospective, cohort study will be conducted in hospitals in Davengere, India and Karachi, Pakistan. All women who deliver either a stillbirth or a preterm birth at one of the hospitals will be eligible for enrollment. With consent, the participant and, when applicable, her offspring, will be followed to 28-days post-delivery. A series of research tests will be conducted to determine infection and presence of other conditions which may contribute to the death. In addition, all routine clinical investigations will be documented. For both stillbirths and preterm neonates who die ≤ 28 days, with consent, a standard autopsy as well as minimally invasive tissue sampling will be conducted. Finally, an expert panel will review all available data for stillbirths and neonatal deaths to determine the primary and contributing causes of death using pre-specified guidance. Conclusion: This will be among the first studies to prospectively obtain detailed information on causes of stillbirth and preterm neonatal death in low-resource settings in Asia. Determining the primary causes of death will be important to inform strategies most likely to reduce the high mortality rates in South Asia. Trial registration: Clinicaltrials.gov (NCT03438110) Clinical Trial Registry of India (CTRI/2018/03/012281). [ABSTRACT FROM AUTHOR]

Background: Stillbirth rates remain high, especially in low and middle-income countries, where rates are 25 per 1000, ten-fold higher than in high-income countries. The United Nations' Every Newborn Action Plan has set a goal of 12 stillbirths per 1000 births by 2030 for all countries. Methods: From a population-based pregnancy outcome registry, including data from 2010 to 2016 from two sites each in Africa (Zambia and Kenya) and India (Nagpur and Belagavi), as well as sites in Pakistan and Guatemala, we evaluated the stillbirth rates and rates of annual decline as well as risk factors for 427,111 births of which 12,181 were stillbirths. Results: The mean stillbirth rates for the sites were 21.3 per 1000 births for Africa, 25.3 per 1000 births for India, 56.9 per 1000 births for Pakistan and 19.9 per 1000 births for Guatemala. From 2010 to 2016, across all sites, the mean stillbirth rate declined from 31.7 per 1000 births to 26.4 per 1000 births for an average annual decline of 3.0%. Risk factors for stillbirth were similar across the sites and included maternal age < 20 years and age > 35 years. Compared to parity 1–2, zero parity and parity > 3 were both associated with increased stillbirth risk and compared to women with any prenatal care, women with no prenatal care had significantly increased risk of stillbirth in all sites. Conclusions: At the current rates of decline, stillbirth rates in these sites will not reach the Every Newborn Action Plan goal of 12 per 1000 births by 2030. More attention to the risk factors and treating the causes of stillbirths will be required to reach the Every Newborn Action Plan goal of stillbirth reduction. Trial registration: NCT01073475. [ABSTRACT FROM AUTHOR]