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Background: Anemia during pregnancy may be associated with poor infant outcomes, although its consequences may vary based on etiology and timing. Objectives: We examined the associations between anemia and anemia-related biomarkers during pregnancy and infant outcomes [birthweight, gestational age at birth, birthweight-for-gestational age percentile, and infant hemoglobin (Hb) at 6 wk of age] in Nagpur, Eastern Maharashtra, India. Methods: We conducted a prospective cohort study of 200 pregnant women. In the first trimester, venous blood was collected to assess Hb via cyanmethemoglobin analysis, micronutrient status (ferritin, vitamin B12, and folate), and inflammation (C-reactive protein). Hb was also assessed in capillary samples using a hemoglobinometer in the first and third trimesters for mothers and at 6 wk for infants. Associations were assessed using generalized linear models controlling for background characteristics. Results: In the first trimester, high (compared with normal) venous Hb was significantly associated with lower gestational age at birth [β: −1.0 wk, 95% confidence interval (CI): −1.9, −0.2] and higher birthweight-for-gestational age percentile (β: 20.1, 95% CI: 9.0, 31.2). Mild anemia, moderate anemia, and high (compared with normal) capillary Hb were significantly associated with lower birthweight (β: −147.7 g, 95% CI: −243.4, −51.7; β: −77.7 g, 95% CI: −123.9, −31.4; and β: −236.0 g, 95% CI: −478.0, −48.1) and birthweight-for-gestational age percentile (β: −7.3, 95% CI: −13.7, −0.9; β: −8.4, 95% CI: −14.1, −2.8; and β: −8.9, 95% CI: −15.9, −1.9). Higher serum ferritin was significantly associated with higher birthweight (β: 2.0 g, 95% CI: 0.1, 3.9) and gestational age at birth (β: 0.01 wk, 95% CI: 0.00, 0.01). In the third trimester, mild anemia was significantly associated with lower gestational age at birth (β: −0.5 wk, 95% CI: −0.7, −0.3). Conclusions: Associations between maternal anemia during pregnancy and infant outcomes were mixed indicating further studies are needed to better understand these relationships.

Abstract Approximately half of pregnant women in India are anemic, representing over 7.5 million women. Few studies have assessed the relationship between multiple micronutrient deficiencies and anemia during pregnancy or the trajectory of hemoglobin (Hb) during pregnancy in low‐resource settings. We enrolled 200 pregnant women from the Maternal and Newborn Health (MNH) registry, a population‐based pregnancy and birth registry in Eastern Maharashtra, India to address these gaps. The women provided capillary (finger‐prick) and venous blood specimens at enrollment (27 weeks). Capillary specimens were analyzed at the time of collection with a HemoCue Hb 201+; venous specimens were shipped on dry ice to a laboratory for cyanmethemoglobin assessment. In the 1st trimester, mean Hb concentration and anemia (Hb

Abstract Objective Our objective was to analyze a prospective population-based registry including five sites in four low- and middle-income countries to observe characteristics associated with vaginal birth after cesarean versus repeat cesarean birth, as well as maternal and newborn outcomes associated with the mode of birth among women with a history of prior cesarean. Hypothesis Maternal and perinatal outcomes among vaginal birth after cesarean section will be similar to those among recurrent cesarean birth. Methods A prospective population-based study, including home and facility births among women enrolled from 2017 to 2020, was performed in communities in Guatemala, India (Belagavi and Nagpur), Pakistan, and Bangladesh. Women were enrolled during pregnancy, and delivery outcome data were collected within 42 days after birth. Results We analyzed 8267 women with a history of prior cesarean birth; 1389 (16.8%) experienced vaginal birth after cesarean, and 6878 (83.2%) delivered by a repeat cesarean birth. Having a repeat cesarean birth was negatively associated with a need for curettage (ARR 0.12 [0.06, 0.25]) but was positively associated with having a blood transfusion (ARR 3.74 [2.48, 5.63]). Having a repeat cesarean birth was negatively associated with stillbirth (ARR 0.24 [0.15, 0.49]) and, breast-feeding within an hour of birth (ARR 0.39 [0.30, 0.50]), but positively associated with use of antibiotics (ARR 1.51 [1.20, 1.91]). Conclusions In select South Asian and Latin American low- and middle-income sites, women with a history of prior cesarean birth were 5 times more likely to deliver by cesarean birth in the hospital setting. Those who delivered vaginally had less complicated pregnancy and labor courses compared to those who delivered by repeat cesarean birth, but they had an increased risk of stillbirth. More large scale studies are needed in Low Income Country settings to give stronger recommendations. Trial registration NCT01073475, Registered February 21, 2010, https://clinicaltrials.gov/ct2/show/record/NCT01073475 .

Abstract Background Low birth weight (LBW,

Nearly one quarter (600,000) of all neonatal deaths worldwide per year occur in India. To reduce neonatal mortality, the Indian Ministry of Health and Family Welfare established neonatal care units, including neonatal intensive care units and specialized neonatal care units to provide immediate care at birth, resuscitation for asphyxiation, postnatal care, follow up for high-risk newborns, immunization, and referral for additional or complex healthcare services. Despite these efforts, neonatal mortality remains high, and measures taken to reduce mortality have been severely challenged by multiple problems caused by the Covid-19 pandemic. In this qualitative study, we conducted seven focus group discussions with newborn care unit nurses and pediatric residents and 35 key informant interviews with pediatricians, residents, nurses, annual equipment maintenance contractors, equipment manufacturers, and Ministry personnel in the Vidarbha region of Maharashtra between December 2019 and November 2020. The goal of the study was to understand barriers and facilitators to providing optimal care to neonates, including the challenges imposed by the Covid-19 pandemic. Covid-19 exacerbated existing barriers to providing optimal care to neonates in these newborn care units. As a result of Covid-19, we found the units were even more short-staffed than usual, with trained pediatric nurses and essential equipment diverted from newborn care to attend to patients with Covid-19. Regular training of neonatal nursing staff was also disrupted due to Covid-19, leaving many staff without the skills to provide optimate care to neonates. Infection control was also exacerbated by Covid-19. This study highlights the barriers to providing optimal care for neonates were made even more challenging during Covid-19 because of the diversion of critically important neonatal equipment and staff trained to use that equipment to Covid-19 wards. The barriers at the individual, facility, and systems levels will remain challenging as the Covid-19 pandemic continues.

Objectives: We determined the pulse oximetry benefit in pediatric pneumonia mortality risk stratification and chest-indrawing pneumonia in-hospital mortality risk factors. Methods: We report the characteristics and in-hospital pneumonia-related mortality of children aged 2-59 months who were included in the Pneumonia Research Partnership to Assess WHO Recommendations dataset. We developed multivariable logistic regression models of chest-indrawing pneumonia to identify mortality risk factors. Results: Among 285,839 children, 164,244 (57.5%) from hospital-based studies were included. Pneumonia case fatality risk (CFR) without pulse oximetry measurement was higher than with measurement (5.8%, 95% confidence interval [CI] 5.6-5.9% vs 2.1%, 95% CI 1.9-2.4%). One in five children with chest-indrawing pneumonia was hypoxemic (19.7%, 95% CI 19.0-20.4%), and the hypoxemic CFR was 10.3% (95% CI 9.1-11.5%). Other mortality risk factors were younger age (either 2-5 months [adjusted odds ratio (aOR) 9.94, 95% CI 6.67-14.84] or 6-11 months [aOR 2.67, 95% CI 1.71-4.16]), moderate malnutrition (aOR 2.41, 95% CI 1.87-3.09), and female sex (aOR 1.82, 95% CI 1.43-2.32). Conclusion: Children with a pulse oximetry measurement had a lower CFR. Many children hospitalized with chest-indrawing pneumonia were hypoxemic and one in 10 died. Young age and moderate malnutrition were risk factors for in-hospital chest-indrawing pneumonia-related mortality. Pulse oximetry should be integrated in pneumonia hospital care for children under 5 years.

IntroductionDepression is a leading cause of disability worldwide, affecting up to 300 million people globally. Despite its high prevalence and debilitating effects, only one-third of patients newly diagnosed with depression initiate treatment. Electronic cognitive behavioural therapy (e-CBT) is an effective treatment for depression and is a feasible solution to make mental health care more accessible. Due to its online format, e-CBT can be combined with variable therapist engagement to address different care needs. Typically, a multi-professional care team determines which combination therapy most benefits the patient. However, this process can add to the costs of these programs. Artificial intelligence (AI) has been proposed to offset these costs.MethodsThis study is a double-blinded randomized controlled trial recruiting individuals experiencing depression. The degree of care intensity a participant will receive will be randomly decided by either: (1) a machine learning algorithm, or (2) an assessment made by a group of healthcare professionals. Subsequently, participants will receive depression-specific e-CBT treatment through the secure online platform. There will be three available intensities of therapist interaction: (1) e-CBT; (2) e-CBT with a 15–20-min phone/video call; and (3) e-CBT with pharmacotherapy. This approach aims to accurately allocate care tailored to each patient’s needs, allowing for more efficient use of resources.DiscussionArtificial intelligence and providing patients with varying intensities of care can increase the efficiency of mental health care services. This study aims to determine a cost-effective method to decrease depressive symptoms and increase treatment adherence to online psychotherapy by allocating the correct intensity of therapist care for individuals diagnosed with depression. This will be done by comparing a decision-making machine learning algorithm to a multi-professional care team. This approach aims to accurately allocate care tailored to each patient’s needs, allowing for more efficient use of resources with the convergence of technologies and healthcare.EthicsThe study received ethics approval and began participant recruitment in December 2022. Participant recruitment has been conducted through targeted advertisements and physician referrals. Complete data collection and analysis are expected to conclude by August 2024.Clinical trial registrationClinicalTrials.Gov, identifier NCT04747873.

BackgroundGeneralized anxiety disorder (GAD) is a debilitating mental health disorder with first-line treatments include cognitive behavioral therapy (CBT) and pharmacotherapy. CBT is costly, time-consuming, and inaccessible. Electronic delivery (e-CBT) is a promising solution to address these barriers. However, due to the novelty of this intervention, more research testing the e-CBT efficacy independently and in conjunction with other treatments is needed.ObjectiveThis study investigated the efficacy of e-CBT compared to and in conjunction with pharmacotherapy for GAD.MethodsThis study employed a quasi-experimental design where patients selected their preferred treatment modality. Patients with GAD were enrolled in either e-CBT, medication, or combination arms. The 12-week e-CBT program was delivered through a digital platform. The medications followed clinical guidelines. The efficacy of each arm was evaluated using questionnaires measuring depression, anxiety, and stress severity, as well as quality of life.ResultsThere were no significant differences between arms (N e-CBT = 41; N Medication = 41; N Combination = 33) in the number of weeks completed or baseline scores. All arms showed improvements in anxiety scores after treatment. The medication and combination arms improved depression scores. The e-CBT and Combination arms improved quality of life, and the combination arm improved stress scores. There were no differences between the groups in depression, anxiety, or stress scores post-treatment. However, the combination arm had a significantly larger improvement in quality of life. Gender and treatment arm were not predictors of dropout, whereas younger age was.ConclusionIncorporating e-CBT on its own or in combination with pharmaceutical interventions is a viable option for treating GAD. Treating GAD with e-CBT or medication appears to offer significant improvements in symptoms, with no meaningful difference between the two. Combining the treatments also offer significant improvements, while not necessarily superior to either independently. The findings suggest that all options are viable. Taking the patient’s preferred treatment route based on their lifestyle, personality, and beliefs into account when deciding on treatment should be a priority for care providers.

Objectives We examined gestational age (GA) estimates for live and still births, and prematurity rates based on last menstrual period (LMP) compared with ultrasonography (USG) among pregnant women at seven sites in six low-resource countries.Design Prospective cohort studySetting and participants This study included data from the Global Network’s population-based Maternal and Newborn Health Registry which follows pregnant women in six low-income and middle-income countries (Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan and Zambia). Participants in this analysis were 42 803 women, including their 43 230 babies, who registered for the study in their first trimester based on GA estimated either by LMP or USG and had a live or stillbirth with an estimated GA of 20–42 weeks.Outcome measures GA was estimated in weeks and days based on LMP and/or USG. Prematurity was defined as GA of 20 weeks+0 days through 36 weeks+6 days, calculated by both USG and LMP.Results Overall, average GA varied ≤1 week between LMP and USG. Mean GA for live births by LMP was lower than by USG (adjusted mean difference (95% CI) = −0.23 (–0.29 to –0.17) weeks). Among stillbirths, a higher GA was estimated by LMP than USG (adjusted mean difference (95% CI)= 0.42 (0.11 to 0.72) weeks). Preterm birth rates for live births were significantly higher when dated by LMP (adjusted rate difference (95% CI)= 4.20 (3.56 to 4.85)). There was no significant difference in preterm birth rates for stillbirths.Conclusion The small differences in GA for LMP versus USG in the Guatemalan and Indian sites suggest that LMP may be a useful alternative to USG for GA dating during the first trimester until availability of USG improves in those areas. Further research is needed to assess LMP for first-trimester GA dating in other regions with limited access to USG.Trial registration number NCT01073475.

Introduction Maternal and neonatal infections are among the most frequent causes of maternal and neonatal mortality, and current antibiotic strategies have been ineffective in preventing many of these deaths. A randomised clinical trial conducted in a single site in The Gambia showed that treatment with an oral dose of 2 g azithromycin versus placebo for all women in labour reduced certain maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. In a large, multinational randomised trial, we will evaluate the impact of azithromycin given in labour to improve maternal and newborn outcomes.Methods and analysis This randomised, placebo-controlled, multicentre clinical trial includes two primary hypotheses, one maternal and one neonatal. The maternal hypothesis is to test whether a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labour will reduce maternal death or sepsis. The neonatal hypothesis will test whether this intervention will reduce intrapartum/neonatal death or sepsis. The intervention is a single, prophylactic intrapartum oral dose of 2 g azithromycin, compared with a single intrapartum oral dose of an identical appearing placebo. A total of 34 000 labouring women from 8 research sites in sub-Saharan Africa, South Asia and Latin America will be randomised with a one-to-one ratio to intervention/placebo. In addition, we will assess antimicrobial resistance in a sample of women and their newborns.Ethics and dissemination The study protocol has been reviewed and ethics approval obtained from all the relevant ethical review boards at each research site. The results will be disseminated via peer-reviewed journals and national and international scientific forums.Trial registration number NCT03871491 (https://clinicaltrials.gov/ct2/show/NCT03871491?term=NCT03871491&draw=2&rank=1).

ObjectiveThe increased prevalence of major depressive disorder (MDD) amid the COVID-19 pandemic has resulted in substantial growth in online mental health care delivery. Compared to its in-person counterpart, online cognitive behavioral therapy (e-CBT) is a time-flexible and cost-effective method of improving MDD symptoms. However, how its efficacy compares to in-person CBT is yet to be explored. Therefore, the current study compared the efficacy of a therapist-supported, electronically delivered e-CBT program to in-person therapy in individuals diagnosed with MDD.MethodsParticipants (n = 108) diagnosed with MDD selected either a 12 week in-person CBT or an asynchronous therapist-supported e-CBT program. E-CBT participants (n = 55) completed weekly interactive online modules delivered through a secure cloud-based online platform (Online Psychotherapy Tool; OPTT). These modules were followed by homework in which participants received personalized feedback from a trained therapist. Participants in the in-person CBT group (n = 53) discussed sessions and homework with their therapists during one-hour weekly meetings. Program efficacy was evaluated using clinically validated symptomatology and quality of life questionnaires.ResultsBoth treatments yielded significant improvements in depressive symptoms and quality of life from baseline to post-treatment. Participants who opted for in-person therapy presented significantly higher baseline symptomatology scores than the e-CBT group. However, both treatments demonstrated comparable significant improvements in depressive symptoms and quality of life from baseline to post-treatment. e-CBT seems to afford higher participant compliance as dropouts in the e-CBT group completed more sessions on average than those in the in-person CBT group.ConclusionThe findings support e-CBT with therapist guidance as a suitable option to treat MDD. Future studies should investigate how treatment accessibility is related to program completion rates in the e-CBT vs. in-person group.Clinical Trial RegistrationClinicalTrials.Gov Protocol Registration and Results System (NCT04478058); clinicaltrials.gov/ct2/show/NCT04478058.

Summary: Background: Premature birth is associated with an increased risk of mortality and morbidity, and strategies to prevent preterm birth are few in number and resource intensive. In 2020, the ASPIRIN trial showed the efficacy of low-dose aspirin (LDA) in nulliparous, singleton pregnancies for the prevention of preterm birth. We sought to investigate the cost-effectiveness of this therapy in low-income and middle-income countries. Methods: In this post-hoc, prospective, cost-effectiveness study, we constructed a probabilistic decision tree model to compare the benefits and costs of LDA treatment compared with standard care using primary data and published results from the ASPIRIN trial. In this analysis from a health-care sector perspective, we considered the costs and effects of LDA treatment, pregnancy outcomes, and neonatal health-care use. We did sensitivity analyses to understand the effect of the price of the LDA regimen, and the effectiveness of LDA in reducing both preterm birth and perinatal death. Findings: In model simulations, LDA was associated with 141 averted preterm births, 74 averted perinatal deaths, and 31 averted hospitalisations per 10 000 pregnancies. The reduction in hospitalisation resulted in a cost of US$248 per averted preterm birth, $471 per averted perinatal death, and $15·95 per disability-adjusted life year. Interpretation: LDA treatment in nulliparous, singleton pregnancies is a low-cost, effective treatment to reduce preterm birth and perinatal death. The low cost per disability-adjusted life year averted strengthens the evidence in support of prioritising the implementation of LDA in publicly funded health care in low-income and middle-income countries. Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development.

In nutritional epidemiological studies, it is imperative to collect high-quality data to ensure accurate dietary assessment. However, dietary data collection using traditional paper forms has several limitations that may compromise data quality. The aim of this study was to propose novel methods to design and develop software applications (Apps) for dietary data collection to assess the nutritional status of pregnant women and infants. This study is part of the M-SAKHI (Mobile-Solutions for Aiding Knowledge for Health Improvement) cluster randomised controlled trial (cRCT) implemented in central India. Three tablet-based software Apps were developed in this study: the ACEC (Automated Coding and Energy Calculation) App to establish a generic cooked food recipe database, the FFQ (Food Frequency Questionnaire), and the IDR (24 h Infant Dietary Recall) Apps to collect dietary data from pregnant women and their infants from rural area of Bhandara and Nagpur districts. Regional food lists, recipes, and portion resource kits were developed to support the data collection using the Apps. In conclusion, the Apps were user-friendly, required minimal prior training, had built-in validation checks for erroneous data entry and provided automated calculations. The Apps were successfully deployed in low-resource rural settings to accurately collect high-quality regional cooked food data and individual-level dietary data of pregnant women and their infants.

Introduction: We evaluated knowledge, attitudes, and practices (KAP) related to influenza and influenza vaccination among pregnant women in three selected countries. Methods: During 2017, pregnant women seeking antenatal care at hospitals at participating sites were enrolled. We described characteristics and responses to KAP questions. We also evaluated predictors associated with influenza vaccination during pregnancy at sites with substantial influenza vaccine uptake by multivariable logistic regression. Results: Overall, 4,648 pregnant women completed the survey. There were substantial differences among the three survey populations; only 8% of the women in Nagpur had heard of influenza, compared to 90% in Lima and 96% in Bangkok (p-value

Sustainably addressing the crisis of undernutrition for children and adolescents in underserved and resource-limited communities will require, among other investments, interventions aimed at optimizing the diets of these vulnerable populations. However, to date, there are substantial global gaps in the collection of dietary data in children and adolescents. This review article summarizes the challenges and opportunities in assessing diet among children and adolescents in India. National surveys in India identify the scale of the triple burden of malnutrition (undernutrition, micronutrient deficiencies and overnutrition) in children and adolescents and assess key nutrition and food security indicators for making informed policy decisions. However, national surveys do not collect data on diet, instead relying on anthropometry, biomarkers of micronutrient deficiencies, and summary measures of diet, such as the WHO infant and young child feeding summary indicators. Sub-national surveys and the scientific literature thus fill important gaps in describing the nutrient intakes of children and adolescents in India; however large gaps remain. Future research can be improved by investments in infrastructure to streamline the assessment of diet in India. The current challenges confronting the collection and analysis of high-quality dietary data occur in both the data collection and data analysis phases. Common methods for assessing diets in low-resource settings—such as 24 h recalls and food frequency questionnaires are particularly challenging to implement well in young children and adolescents due to motivation and memory issues in young respondents. Additionally, there are challenges with parental recall including children having multiple caretakers and meals outside the home. Furthermore, analysis of dietary data is hindered by the lack of affordable, accessible software for dietary data analysis relevant to the diversity in Indian diets. New technologies can address some of the challenges in dietary data collection and analysis, but to date, there are no platforms designed for population-level dietary assessment in India. Public and private sector investment in dietary assessment, as well as collaboration of researchers and the creation of open-source platforms for the sharing of data inputs (local food lists, recipe databases, etc.) will be essential to build infrastructure to better understand the diets of children and adolescents in India and improve dietary interventions in these target groups.

Background: Approximately 25% of all neonatal deaths worldwide occur in India. The Indian Government has established Special Neonatal Care Units (SNCUs) in district and sub-district level hospitals to reduce neonatal mortality, but mortality rates have stagnated. Reasons include lack of personnel and training and sub-optimal quality of care. The role of medical equipment is critical for the care of babies, but its role in improving neonatal outcomes has not been well studied. Methods: In a qualitative study, we conducted seven focus group discussions with SNCU nurses and pediatric residents and thirty-five key informant interviews and with pediatricians, residents, nurses, annual equipment maintenance contractors, equipment manufacturers, and Ministry of Health personnel in Maharashtra between December 2019 and November 2020. The goal of the study was to understand challenges to SNCU care. In this paper, we focus on current gaps and future needs for SNCU equipment, quality of the power supply, and use of SNCU equipment. Results: Respondents described a range of issues but highlighted poor power quality as an important cause of equipment malfunction. Other concerns were lack of timely repair that resulted in needed equipment being unavailable for neonatal care. Participants recommended procuring uninterrupted power supply (UPS) to protect equipment, improving quality/durability of equipment to withstand constant use, ensuring regular proactive maintenance for SNCU equipment, and conducting local power audits to discern and address the causes of power fluctuations. Conclusions: Poor power quality and its negative impact on equipment function are major unaddressed concerns of those responsible for the care and safety of babies in SNCUs in Central India. Further research on the power supply and protection of neonatal equipment is needed to determine a cost-effective way to improve access to supportive care in SNCUs and desired improvements in neonatal mortality rates.

Abstract 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 Background To determine the gender differences in neonatal mortality, stillbirths, and perinatal mortality in south Asia using the Global Network data from the Maternal Newborn Health Registry. Methods This study is a secondary analysis of prospectively collected data from the three south Asian sites of the Global Network. The maternal and neonatal demographic, clinical characteristics, rates of stillbirths, early neonatal mortality (1–7 days), late neonatal mortality (8–28 days), mortality between 29–42 days and the number of infants hospitalized after birth were compared between the male and female infants. Results Between 2010 and 2018, 297,509 births [154,790 males (52.03%) and 142,719 females (47.97%)] from two Indian sites and one Pakistani site were included in the analysis [288,859 live births (97.1%) and 8,648 stillbirths (2.9%)]. The neonatal mortality rate was significantly higher in male infants (33.2/1,000 live births) compared to their female counterparts (27.4/1,000, p

Abstract Background The Global Network for Women's and Children’s Health Research (Global Network) conducts clinical trials in resource-limited countries through partnerships among U.S. investigators, international investigators based in in low and middle-income countries (LMICs) and a central data coordinating center. The Global Network’s objectives include evaluating low-cost, sustainable interventions to improve women’s and children’s health in LMICs. Accurate reporting of births, stillbirths, neonatal deaths, maternal mortality, and measures of obstetric and neonatal care is critical to determine strategies for improving pregnancy outcomes. In response to this need, the Global Network developed the Maternal Newborn Health Registry (MNHR), a prospective, population-based registry of pregnant women, fetuses and neonates receiving care in defined catchment areas at the Global Network sites. This publication describes the MNHR, including participating sites, data management and quality and changes over time. Methods Pregnant women who reside in or receive healthcare in select communities are enrolled in the MNHR of the Global Network. For each woman and her offspring, sociodemographic, health care, and the major outcomes through 42-days post-delivery are recorded. Study visits occur at enrollment during pregnancy, at delivery and at 42 days postpartum. Results From 2010 through 2018, the Global Network MNHR sites were located in Guatemala, Belagavi and Nagpur, India, Pakistan, Democratic Republic of Congo, Kenya, and Zambia. During this period at these sites, 579,140 pregnant women were consented and enrolled in the MNHR, nearly 99% of all eligible women. Delivery data were collected for 99% of enrolled women and 42-day follow-up data for 99% of those delivered. In this supplement, the trends over time and assessment of differences across geographic regions are analyzed in a series of 18 manuscripts utilizing the MNHR data. Conclusions Improving maternal, fetal and newborn health in countries with poor outcomes requires an understanding of the characteristics of the population, quality of health care and outcomes. Because the worst pregnancy outcomes typically occur in countries with limited health registration systems and vital records, alternative registration systems may prove to be highly valuable in providing data. The MNHR, an international, multicenter, population-based registry, assesses pregnancy outcomes over time in support of efforts to develop improved perinatal healthcare in resource-limited areas. Trial Registration The Maternal Newborn Health Registry is registered at Clinicaltrials.gov (ID# NCT01073475). Registered February 23, 2019. https://clinicaltrials.gov/ct2/show/NCT01073475

Abstract 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 Background The Helping Babies Breathe (HBB) educational program focuses on training of first-level birth attendants in neonatal resuscitation skills for the first minute of life (The Golden Minute). Pre-post studies of HBB implementation in sub-Saharan Africa and Asia have shown reductions in facility-based very early neonatal mortality and stillbirth rates. However, the Global Network pre-post HBB Implementation Study (GN-HBB-IS) found no difference in day 7 perinatal mortality rates (PMR-D7) among births to women participating in the Global Network’s Maternal and Newborn Health Registry. To address potential differences in perinatal outcomes in births occurring in facilities that implemented HBB vs. all births occurring in the communities served by facilities that implemented HBB, we compared day-1 perinatal mortality rates (PMR-D1) among births occurring pre and post HBB implementation in facilities in Nagpur, India, one of the 3 sites participating in the GN-HBB-IS. Methods We hypothesized that there would be a 20% decrease in the Nagpur facility based PMR-D1 in the 12 months post GN HBB implementation from the pre-period. We explored pre-post differences in stillbirth rates (SBR) and day-1 neonatal mortality rates (NMR-D1). Results Of the 15 facilities trained for the GN-HBB-IS, 13 participated in the Nagpur HBB Facility Study (Nagpur-HBB-FS). There were 38,078 facility births in the 12 months before the GN-HBB-IS and 40,870 facility births in the 12 months after the GN-HBB-IS. There was 11% overlap between the registry births analyzed in the GN-HBB-IS and the facility births analyzed in the Nagpur-HBB-FS. In the Nagpur-HBB-FS, there was a pre-post reduction of 16% in PMR-D1 (p = 0.0001), a 14% reduction in SBR (p = 0.002) and a 20% reduction NMR-D1 (p = 0.006). Conclusions In the Nagpur-HBB-FS, PMR-D1, stillbirths and NMR-D1 were significantly lower after HBB implementation. These benefits did not translate to improvements in PMR-D7 in communities served by these facilities, possibly because facilities in which HBB was implemented covered an insufficient proportion of community births or because additional interventions are needed after day 1 of life. Further studies are needed to determine how to translate facility-based improvements in PMR-D1 to improved neonatal survival in the community. Trial registration The Global Network HBB Implementation Study (GN-HBB-IS) was registered at ClinicalTrials.gov: NCT01681017.

BackgroundMajor depressive disorder (MDD) is a prevalent and debilitating mental health disorder. Among different therapeutic approaches (eg, medication and psychotherapy), psychotherapy in the form of cognitive behavioral therapy (CBT) is considered the gold standard treatment for MDD. However, although efficacious, CBT is not readily accessible to many patients in need because of hurdles such as stigma, long wait times, high cost, the large time commitment for health care providers, and cultural or geographic barriers. Electronically delivered cognitive behavioral therapy (e-CBT) can effectively address many of these accessibility barriers. ObjectiveThis study aims to investigate the efficacy and feasibility of implementing an e-CBT program compared with in-person treatment for MDD. It is hypothesized that the e-CBT program will offer results comparable with those of the in-person treatment program, regarding symptom reduction and quality of life improvement. MethodsThis nonrandomized controlled trial intervention will provide e-CBT for MDD through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants (aged 18-65 years) will be offered 12 weekly sessions of an e-CBT program tailored to MDD to address their depressive symptoms. Participants (n=55) will complete predesigned modules and homework assignments while receiving personalized feedback and interacting with a therapist through the platform. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared with that of a group (n=55) receiving in-person CBT. Questionnaires will be completed at baseline, at week 6 and week 12, and at a 6-month follow-up. Focus groups will be conducted to investigate personal, cultural, and social factors impacting the accessibility and feasibility of implementing a web-based psychotherapy tool from a patient and care provider perspective. Inclusion criteria include diagnosis of MDD, competence to consent to participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation. ResultsEthics approval was obtained in January 2019, and recruitment of participants began in June 2019. Recruitment has been conducted via social media, web-based communities, and physician referrals. To date, 52 participants have been recruited to the e-CBT group, and 48 patients have been recruited to the in-person CBT group. Data collection is expected to be completed by March 2021, and analyses are expected to be completed by June 2021, as linear regression (for continuous outcomes) and binomial regression analysis (for categorical outcomes) are still being conducted. ConclusionsThe results of this study can provide valuable information for the development of more accessible and scalable mental health interventions with increased care capacity for MDD, without sacrificing the quality of care. Trial RegistrationClinicalTrials.gov NCT04478058; http://clinicaltrials.gov/ct2/show/NCT04478058 International Registered Report Identifier (IRRID)DERR1-10.2196/27489

Abstract Few studies have assessed whether women and infants in rural and peri‐urban communities in South Asia experience seasonal fluctuations in nutritional status; however, a handful of studies have documented seasonal variability in risk factors for undernutrition including food availability, physical activity and infections. We used data from the Maternal and Newborn Health (MNH) registry, a population‐based pregnancy and birth registry in Eastern Maharashtra, India, to analyse seasonal trends in birthweight and maternal nutritional status—body mass index (BMI) and haemoglobin—in the first trimester of pregnancy. We plotted monthly and seasonal trends in birthweight, and maternal BMI and haemoglobin, and used multivariable regression models to identify seasonal and maternal characteristics that predicted each outcome. Between October 2014 and January 2018, MNH included 29,253 livebirths with recorded birthweight. BMI was assessed in 15,252 women less than 12 weeks of gestation and haemoglobin in 18,278 women less than 13 weeks of gestation. Maternal characteristics (age, education, parity and height) were significantly associated with nutritional status; however, there were minimal seasonal fluctuations in birthweight or maternal nutrition. There were significant secular trends in maternal haemoglobin; between 2014 and 2018, the prevalence of maternal anaemia decreased from 91% to 79% and moderate or severe anaemia from 53% to 37%. The prevalence of maternal underweight (45.3%) and overweight (9.8%) and low birthweight (19.1%) remained relatively constant over the study period. Our findings highlight that in some rural and peri‐urban areas in South Asia, tackling systemic drivers of malnutrition may be more effective than targeted interventions based on season.

BACKGROUND: The daily use of low-dose aspirin may be a safe, widely available, and inexpensive intervention for reducing the risk of preterm birth. Data on the potential side effects of low-dose aspirin use during pregnancy in low- and middle-income countries are needed. OBJECTIVE: This study aimed to assess differences in unexpected emergency medical visits and potential maternal side effects from a randomized, double-blind, multicountry, placebo-controlled trial of low-dose aspirin use (81 mg daily, from 6 to 36 weeks’ gestation). STUDY DESIGN: This study was a secondary analysis of data from the Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas trial, a trial of the Global Network for Women's and Children's Health conducted in India (2 sites), Pakistan, Guatemala, Democratic Republic of the Congo, Kenya, and Zambia. The outcomes for this analysis were unexpected emergency medical visits and the occurrence of the following potential side effects—overall and separately—nausea, vomiting, rash or hives, diarrhea, gastritis, vaginal bleeding, allergic reaction, and any other potential side effects. Analyses were performed overall and by geographic region. RESULTS: Between the aspirin (n=5943) and placebo (n=5936) study groups, there was no statistically significant difference in the risk of unexpected emergency medical visits or the risk of any potential side effect (overall). Of the 8 potential side effects assessed, only 1 (rash or hives) presented a different risk by treatment group (4.2% in the aspirin group vs 3.5% in the placebo group; relative risk, 1.20; 95% confidence interval, 1.01–1.43; P=.042). CONCLUSION: The daily use of low-dose aspirin seems to be a safe intervention for reducing the risk of preterm birth and well tolerated by nulliparous pregnant women between 6 and 36 weeks’ gestation in low- and middle-income countries.

IntroductionRates of cesarean sections (CS) have increased dramatically over the past two decades in India. This increase has been disproportionately high in private facilities, but little is known about the drivers of the CS rate increase and how they vary over time and geographically.MethodsWomen enrolled in the Nagpur, India site of the Global Network for Women's and Children's Health Research Maternal and Neonatal Health Registry, who delivered in a health facility with CS capability were included in this study. The trend in CS rates from 2010 to 2017 in public and private facilities were assessed and displayed by subdistrict. Multivariable generalized estimating equations models were used to assess the association of delivering in private versus public facilities with having a CS, adjusting for known risk factors.ResultsCS rates increased substantially between 2010 and 2017 at both public and private facilities. The odds of having a CS at a private facility were 40% higher than at a public facility after adjusting for other known risk factors. CS rates had unequal spatial distributions at the subdistrict level.DiscussionOur study findings contribute to the knowledge of increasing CS rates in both public and private facilities in India. Maps of the spatial distribution of subdistrict-based CS rates are helpful in understanding patterns of CS deliveries, but more investigation as to why clusters of high CS rates have formed in warranted.

Abstract Background Every year, nearly one million deaths occur due to suboptimal breastfeeding. If universally practiced, exclusive breastfeeding alone prevents 11.6% of all under 5 deaths. Among strategies to improve exclusive breastfeeding rates, counselling by peers or health workers, has proven to be highly successful. With growing availability of cell phones in India, they are fast becoming a medium to spread information for promoting healthcare among pregnant women and their families. This study was conducted to assess effectiveness of cell phones for personalized lactation consultation to improve breastfeeding practices. Methods This was a two arm, pilot study in four urban maternity hospitals, retrained in Baby Friendly Hospital Initiative. The enrolled mother-infant pairs resided in slums and received healthcare services at the study sites. The control received routine healthcare services, whereas, the intervention received weekly cell phone counselling and daily text messages, in addition to counselling the routine healthcare services. Results 1036 pregnant women were enrolled (518 - intervention and 518 - control). Rates of timely initiation of breastfeeding were significantly higher in intervention as compared to control (37% v/s 24%, p

Abstract Background The World Health Organization identifies pregnant women as at high-risk for severe influenza, but influenza vaccines are underutilized among pregnant women. Data on influenza burden during pregnancy are largely limited to high-income countries and data on the impact of influenza on birth and perinatal outcomes are scarce. Methods/design This prospective, longitudinal cohort study of pregnant women in middle-income countries is designed to address three primary objectives: 1) to evaluate the effect of laboratory-confirmed influenza during pregnancy on pregnancy and perinatal outcomes; 2) to estimate the incidences of all-cause acute respiratory illness and laboratory-confirmed influenza during pregnancy; and 3) to examine the clinical spectrum of illness associated with influenza viruses. Through a multi-country network approach, three sites aim to enroll cohorts of 1500–3000 pregnant women just before local influenza seasons. Women aged ≥ 18 years with expected delivery dates ≥ 8 weeks after the start of the influenza season are eligible. Women are followed throughout pregnancy through twice weekly surveillance for influenza symptoms (≥ 1 of myalgia, cough, runny nose, sore throat, or difficulty breathing) and have mid-turbinate nasal swabs collected for influenza virus testing during illness episodes. Primary outcomes include relative risk of preterm birth and mean birth weight among term singleton infants of women with and without reverse transcription polymerase chain reaction-confirmed influenza during pregnancy. Gestational age is determined by ultrasound at

Abstract Background Presently, preterm birth is globally the leading cause of neonatal mortality. Prompt community based identification of women at high risk for preterm births (HRPB) can either help to avert preterm births or avail effective interventions to reduce neonatal mortality due to preterm births. We evaluated the performance of a package to train community workers to detect the presence of signs or symptoms of HRPB. Methods Pregnant women enrolled in the intervention arm of a cluster randomized trial of Antenatal Corticosteroids (ACT Trial) conducted at Nagpur, India were informed about 4 directly observable signs and symptoms of preterm labor. Community health workers actively monitored these women from 24 to 36 weeks of gestation for these signs or symptoms. If they were present (HRPB positive) the identified women were brought to government health facilities for assessment and management. HRPB positive could also be determined by the provider if the woman presented directly to the facility. Risk stratification was based on the number of signs or symptoms present. The outcome of preterm birth was based on the clinical assessment of gestational age

Abstract Background Over the last decade, infant and young child feeding (IYCF) indicators in India have improved. However, poor IYCF practices are still apparent, associated with pervasive high rates of child under-nutrition. Interventions to improve IYCF need augmentation by appropriate policy support to consolidate gains. The aim of this study was to identify opportunities to strengthen and support IYCF policies through a policy content and stakeholder network analysis. Methods IYCF policies and guidelines were systematically mapped and coded using predetermined themes. Six ‘net-map’ group interviews were conducted for stakeholder analysis with data analyzed using ORA (organizational risk analyzer, copyright Carley, Carnegie Mellon University) software. The study was carried out at a national level and in the states of Maharashtra and unified Andhra Pradesh. Results Thirty relevant policy documents were identified. Support for IYCF was clearly apparent and was actioned within sectoral policies and strategic plans. We identified support for provision of information to mothers and caregivers in both sectoral and high-level/strategic policy documents. At a sectoral level, there was support for training health care workers and for enabling mothers to access IYCF. Opportunities to strengthen policy included expanding coverage and translating policy goals into implementation level documents. At the national level, Ministry of Women and Child Development [MoWCD], Ministry of Health and Family Welfare [MoHFW] and the Prime Minister’s Nutrition Council [PMNC] were the most influential actors in providing technical support while MoHFW, MoWCD, and Bill Melinda Gates Foundation were the most influential actors in providing funding and were therefore influential stakeholders in shaping IYCF policies and programs. Conclusion We identified a wide range of strengths in the IYCF policy environment in India and also opportunities for improvement. One key strength is the integration of IYCF policies into a range of agendas and guidelines related to health and child development service delivery at the national and state level. However, the lack of a specific national policy on IYCF means that there is no formal mechanism for review and monitoring implementation across sectors and jurisdictions. Another opportunity identified is the development of IYCF policy guidelines in emergencies and for tribal populations.

Abstract Background South Asian countries experience some of the highest levels of child undernutrition in the world, strongly linked to poor infant and young child feeding (IYCF) practices. Strong and responsive policy support is essential for effective interventions to improve IYCF. This study aimed to identify opportunities for strengthening the policy environment in the region to better support appropriate infant and young child feeding. Methods We mapped policies relevant to infant and young child feeding in India, Pakistan, Bangladesh, Sri Lanka and Nepal, based on a common matrix. The matrix described potentially relevant policies ranging from high-level strategic policy documents to implementation-level guidelines. We analyzed the data based on themes focused on caregiver interactions with IYCF interventions: provision of correct information to mothers, training of frontline workers, enabling mothers to engage with service providers and strategic support for IYCF. Results Policy support for IYCF was present in relation to each of the themes assessed. In all countries, there was support for nutrition in National Development Plans, and all countries had some level of maternity protection and restrictions on marketing of breast milk substitutes. Sectoral and implementation-level policy documents contained provisions for system strengthening for IYCF and for training of frontline workers. Conclusions The key opportunities for strengthening IYCF policy support were in relation to translating strategic directives into implementation level documents; improving multi-sectoral support and coordination; and increased clarity regarding roles and responsibilities of frontline workers interacting with mothers. These findings can support efforts to strengthen IYCF policy at the national and regional level.

Abstract Background Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) may substantially reduce the rate of PTB. Methods Hypothesis: LDA initiated in the first trimester reduces the risk of preterm birth. Study Design Type: Prospective randomized, placebo-controlled, double-blinded multi-national clinical trial conducted in seven low and middle income countries. Trial will be individually randomized with one-to-one ratio (intervention/control) Population: Nulliparous women between the ages of 14 and 40, with a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin. Intervention: Daily administration of low dose (81 mg) aspirin, initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA, compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly. Outcomes Primary outcome: Incidence of PTB (birth prior to 37 0/7 weeks GA). Secondary outcomes Incidence of preeclampsia/eclampsia, small for gestational age and perinatal mortality. Discussion This study is unique as it will examine the impact of LDA early in pregnancy in low-middle income countries with preterm birth as a primary outcome. The importance of developing low-cost, high impact interventions in low-middle income countries is magnified as they are often unable to bear the financial costs of treating illness. Trial registration ClinicalTrials.gov identifier: NCT02409680 Date: March 30, 2015

Objective Our objective was to describe trends in caesarean section (CS) rates, characteristics of women delivering by CS, reasons for CS and impact of CS on perinatal mortality, in a rural Indian population.Design Secondary data analysis using a prospective population-based registry.Setting Four districts in Eastern Maharashtra, India, 2010 to 2013.Participants 39 026 pregnant women undergoing labour and delivery.Main outcomes CS, single most likely reason, perinatal mortality.Results Overall, 20% of the women delivered by CS. Rates increased from 17.4% in 2010 to 22.7% in 2013 (p

Summary: Background: Caesarean section prevalence is increasing in Asia and Latin America while remaining low in most African regions. Caesarean section delivery is effective for saving maternal and infant lives when they are provided for medically-indicated reasons. On the basis of ecological studies, caesarean delivery prevalence between 9% and 19% has been associated with better maternal and perinatal outcomes, such as reduced maternal land fetal mortality. However, the specific prevalence of obstetric and medical complications that require caesarean section have not been established, especially in low-income and middle-income countries (LMICs). We sought to provide information to inform the approach to the provision of caesarean section in low-resource settings. Methods: We did a literature review to establish the prevalence of obstetric and medical conditions for six potentially life-saving indications for which caesarean section could reduce mortality in LMICs. We then analysed a large, prospective population-based dataset from six LMICs (Argentina, Guatemala, Kenya, India, Pakistan, and Zambia) to determine the prevalence of caesarean section by indication for each site. We considered that an acceptable number of events would be between the 25th and 75th percentile of those found in the literature. Findings: Between Jan 1, 2010, and Dec 31, 2013, we enrolled a total of 271 855 deliveries in six LMICs (seven research sites). Caesarean section prevalence ranged from 35% (3467 of 9813 deliveries in Argentina) to 1% (303 of 16 764 deliveries in Zambia). Argentina's and Guatemala's sites all met the minimum 25th percentile for five of six indications, whereas sites in Zambia and Kenya did not reach the minimum prevalence for caesarean section for any of the indications. Across all sites, a minimum overall caesarean section of 9% was needed to meet the prevalence of the six indications in the population studied. Interpretation: In the site with high caesarean section prevalence, more than half of the procedures were not done for life-saving conditions, whereas the sites with low proportions of caesarean section (below 9%) had an insufficient number of caesarean procedures to cover those life-threatening causes. Attempts to establish a minimum caesarean prevalence should go together with focusing on the life-threatening causes for the mother and child. Simple methods should be developed to allow timely detection of life-threatening conditions, to explore actions that can remedy those conditions, and the timely transfer of women with those conditions to health centres that could provide adequate care for those conditions. Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Objective To quantify maternal, fetal and neonatal mortality in low- and middle-income countries, to identify when deaths occur and to identify relationships between maternal deaths and stillbirths and neonatal deaths. Methods A prospective study of pregnancy outcomes was performed in 106 communities at seven sites in Argentina, Guatemala, India, Kenya, Pakistan and Zambia. Pregnant women were enrolled and followed until six weeks postpartum. Findings Between 2010 and 2012, 214 070 of 220 235 enrolled women (97.2%) completed follow-up. The maternal mortality ratio was 168 per 100 000 live births, ranging from 69 per 100 000 in Argentina to 316 per 100 000 in Pakistan. Overall, 29% (98/336) of maternal deaths occurred around the time of delivery: most were attributed to haemorrhage (86/336), pre-eclampsia or eclampsia (55/336) or sepsis (39/336). Around 70% (4349/6213) of stillbirths were probably intrapartum; 34% (1804/5230) of neonates died on the day of delivery and 14% (755/5230) died the day after. Stillbirths were more common in women who died than in those alive six weeks postpartum (risk ratio, RR: 9.48; 95% confidence interval, CI: 7.97–11.27), as were perinatal deaths (RR: 4.30; 95% CI: 3.26–5.67) and 7-day (RR: 3.94; 95% CI: 2.74–5.65) and 28-day neonatal deaths (RR: 7.36; 95% CI: 5.54–9.77). Conclusion Most maternal, fetal and neonatal deaths occurred at or around delivery and were attributed to preventable causes. Maternal death increased the risk of perinatal and neonatal death. Improving obstetric and neonatal care around the time of birth offers the greatest chance of reducing mortality.

BackgroundAnemia affects upwards of 50% of pregnant women in developing countries and is associated with adverse outcomes for mother and child. We hypothesized that exposure to smoke from biomass fuel--which is widely used for household energy needs in resource-limited settings--could exacerbate anemia in pregnancy, possibly as a result of systemic inflammation.ObjectiveTo evaluate whether exposure to smoke from biomass fuel (wood, straw, crop residues, or dung) as opposed to clean fuel (electricity, liquefied petroleum gas, natural gas, or biogas) is an independent risk factor for anemia in pregnancy, classified by severity.MethodsA secondary analysis was performed using data collected from a rural pregnancy cohort (N = 12,782) in Nagpur, India in 2011-2013 as part of the NIH-funded Maternal and Newborn Health Registry Study. Multinomial logistic regression was used to estimate the effect of biomass fuel vs. clean fuel use on anemia in pregnancy, controlling for maternal age, body mass index, education level, exposure to household tobacco smoke, parity, trimester when hemoglobin was measured, and receipt of prenatal iron and folate supplements.ResultsThe prevalence of any anemia (hemoglobin < 11 g/dl) was 93% in biomass fuel users and 88% in clean fuel users. Moderate-to-severe anemia (hemoglobin < 10 g/dl) occurred in 53% and 40% of the women, respectively. Multinomial logistic regression showed higher relative risks of mild anemia in pregnancy (hemoglobin 10-11 g/dl; RRR = 1.38, 95% CI = 1.19-1.61) and of moderate-to-severe anemia in pregnancy (RRR = 1.79, 95% CI = 1.53-2.09) in biomass fuel vs. clean fuel users, after adjusting for covariates.ConclusionIn our study population, exposure to biomass smoke was associated with higher risks of mild and moderate-to-severe anemia in pregnancy, independent of covariates.Trial registrationClinicalTrials.gov NCT 01073475.

BACKGROUND: For over a decade, the importance of zinc in the treatment of acute and persistent diarrhea has been recognized. In spite of recently published reviews, there remain several unanswered questions about the role of zinc supplementation in childhood diarrhea in the developing countries. Our study aimed to assess the therapeutic benefits of zinc supplementation in the treatment of acute or persistent diarrhea in children, and to examine the causes of any heterogeneity of response to zinc supplementation. METHODS AND FINDINGS: EMBASE, MEDLINE and CINAHL databases were searched for published reviews and meta-analyses on the use of zinc supplementation for the prevention and treatment of childhood diarrhea. Additional RCTs published following the meta-analyses were also sought. The reviews and published RCTs were qualitatively mapped followed by updated random-effects meta-analyses, subgroup meta-analyses and meta-regression to quantify and characterize the role of zinc supplementation with diarrhea-related outcomes. We found that although there was evidence to support the use of zinc to treat diarrhea in children, there was significant unexplained heterogeneity across the studies for the effect of zinc supplementation in reducing important diarrhea outcomes. Zinc supplementation reduced the mean duration of diarrhea by 19.7% but had no effect on stool frequency or stool output, and increased the risk of vomiting. Our subgroup meta-analyses and meta-regression showed that age, stunting, breast-feeding and baseline zinc levels could not explain the heterogeneity associated with differential reduction in the mean diarrheal duration. However, the baseline zinc levels may not be representative of the existing zinc deficiency state. CONCLUSIONS: Understanding the predictors of zinc efficacy including the role of diarrheal disease etiology on the response to zinc would help to identify the populations most likely to benefit from supplementation. To improve the programmatic use of zinc, further evaluations of the zinc salts used, the dose, the frequency and duration of supplementation, and its acceptability are required. The significant heterogeneity of responses to zinc suggests the need to revisit the strategy of universal zinc supplementation in the treatment children with acute diarrhea in developing countries.