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Abstract Background Preterm birth is a major cause of neonatal mortality, responsible for 28% of neonatal deaths overall. The administration of antenatal corticosteroids to women at high risk of preterm birth is a powerful perinatal intervention to reduce neonatal mortality in resource rich environments. The effect of antenatal steroids to reduce mortality and morbidity among preterm infants in hospital settings in developed countries with high utilization is well established, yet they are not routinely used in developing countries. The impact of increasing antenatal steroid use in hospital or community settings with low utilization rates and high infant mortality among premature infants due to lack of specialized services has not been well researched. There is currently no clear evidence about the safety of antenatal corticosteroid use for community-level births. Methods We hypothesize that a multi country, two-arm, parallel cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, will reduce neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six countries. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia will be randomized, and around 60,000 women and newborns will be enrolled. Kits containing vials of dexamethasone, syringes, gloves, and instructions for administration will be distributed. Improving the identification of women at high risk of preterm birth will be done by (1) diffusing recommendations for antenatal corticosteroids use to health providers, (2) training health providers on identification of women at high risk of preterm birth, (3) providing reminders to health providers on the use of the kits, and (4) using a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age. In both intervention and control clusters, health providers will be trained in essential newborn care for low birth weight babies. The primary outcome is neonatal mortality at 28 days of life in preterm infants. Trial registration ClinicalTrials.gov. Identifier: NCT01084096

Abstract Background Nearly half the world’s babies are born at home. We sought to evaluate the training, knowledge, skills, and access to medical equipment and testing for home birth attendants across 7 international sites. Methods Face-to-face interviews were done by trained interviewers to assess level of training, knowledge and practices regarding care during the antenatal, intrapartum and postpartum periods. The survey was administered to a sample of birth attendants conducting home or out-of-facility deliveries in 7 sites in 6 countries (India, Pakistan, Guatemala, Democratic Republic of the Congo, Kenya and Zambia). Results A total of 1226 home birth attendants were surveyed. Less than half the birth attendants were literate. Eighty percent had one month or less of formal training. Most home birth attendants did not have basic equipment (e.g., blood pressure apparatus, stethoscope, infant bag and mask manual resuscitator). Reporting of births and maternal and neonatal deaths to government agencies was low. Indian auxilliary nurse midwives, who perform some home but mainly clinic births, were far better trained and differed in many characteristics from the birth attendants who only performed deliveries at home. Conclusions Home birth attendants in low-income countries were often illiterate, could not read numbers and had little formal training. Most had few of the skills or access to tests, medications and equipment that are necessary to reduce maternal, fetal or neonatal mortality.

Abstract Background Prevention of diarrhea has presented indomitable challenges. A preventive strategy that has received significant interest is zinc supplementation. Existing literature including quantitative meta-analyses and systematic reviews tend to show that zinc supplementation is beneficial however evidence to the contrary is augmenting. We therefore conducted an updated and comprehensive meta-analytical synthesis of the existing literature on the effect of zinc supplementation in prevention of diarrhea. Methods EMBASE®, MEDLINE ® and CINAHL® databases were searched for published reviews and meta-analyses on the use of zinc supplementation for the prevention childhood diarrhea. Additional RCTs published following the meta-analyses were also sought. Effect of zinc supplementation on the following five outcomes was studied: incidence of diarrhea, prevalence of diarrhea, incidence of persistent diarrhea, incidence of dysentery and incidence of mortality. The published RCTs were combined using random-effects meta-analyses, subgroup meta-analyses, meta-regression, cumulative meta-analyses and restricted meta-analyses to quantify and characterize the role of zinc supplementation with the afore stated outcomes. Results We found that zinc supplementation has a modest beneficial association (9% reduction) with incidence of diarrhea, a stronger beneficial association (19% reduction) with prevalence of diarrhea and occurrence of multiple diarrheal episodes (28% reduction) but there was significant unexplained heterogeneity across the studies for these associations. Age, continent of study origin, zinc salt and risk of bias contributed significantly to between studies heterogeneity. Zinc supplementation did not show statistically significant benefit in reducing the incidence of persistent diarrhea, dysentery or mortality. In most instances, the 95% prediction intervals for summary relative risk estimates straddled unity. Conclusions Demonstrable benefit of preventive zinc supplementation was observed against two of the five diarrhea-related outcomes but the prediction intervals straddled unity. Thus the evidence for a preventive benefit of zinc against diarrhea is inconclusive. Continued efforts are needed to better understand the sources of heterogeneity. The outcomes of zinc supplementation may be improved by identifying subgroups that need zinc supplementation.

Abstract Background Maternal and newborn mortality rates remain unacceptably high, especially where the majority of births occur in home settings or in facilities with inadequate resources. The introduction of emergency obstetric and newborn care services has been proposed by several organizations in order to improve pregnancy outcomes. However, the effectiveness of emergency obstetric and neonatal care services has never been proven. Also unproven is the effectiveness of community mobilization and community birth attendant training to improve pregnancy outcomes. Methods/Design We have developed a cluster-randomized controlled trial to evaluate the impact of a comprehensive intervention of community mobilization, birth attendant training and improvement of quality of care in health facilities on perinatal mortality in low and middle-income countries where the majority of births take place in homes or first level care facilities. This trial will take place in 106 clusters (300-500 deliveries per year each) across 7 sites of the Global Network for Women's and Children's Health Research in Argentina, Guatemala, India, Kenya, Pakistan and Zambia. The trial intervention has three key elements, community mobilization, home-based life saving skills for communities and birth attendants, and training of providers at obstetric facilities to improve quality of care. The primary outcome of the trial is perinatal mortality. Secondary outcomes include rates of stillbirth, 7-day neonatal mortality, maternal death or severe morbidity (including obstetric fistula, eclampsia and obstetrical sepsis) and 28-day neonatal mortality. Discussion In this trial, we are evaluating a combination of interventions including community mobilization and facility training in an attempt to improve pregnancy outcomes. If successful, the results of this trial will provide important information for policy makers and clinicians as they attempt to improve delivery services for pregnant women and newborns in low-income countries. Trial Registration ClinicalTrials.gov NCT01073488

Abstract Background Diarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea. Zinc and copper stores in the body are known to be depleted during acute diarrhea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or bloody diarrhea. Methods We conducted a double-blind randomized controlled clinical trial in the Department of Pediatrics at Indira Gandhi Government Medical College Nagpur, India. Eight hundred and eight children aged 6 months to 59 months with acute diarrhea were individually randomized to placebo (Pl), zinc (Zn) only, and zinc and copper (Zn+Cu) together with standard treatment for acute diarrhea. Results The mean duration of diarrhea from enrolment and the mean stool weight during hospital stay were 63.7 hours and 940 grams, respectively, and there were no significant differences in the adjusted means across treatment groups. Similarly, the adjusted means of the amount of oral rehydration solution or intravenous fluids used, the proportion of participants with diarrhea more than 7 days from onset, and the severity of diarrhea indicated by more than three episodes of some dehydration or any episode of severe dehydration after enrolment, did not differ across the three groups. Conclusion The expected beneficial effects of zinc supplementation for acute diarrhea were not observed. Therapeutic Zn or Zn and Cu supplementation may not have a universal beneficial impact on the duration of acute diarrhea in children. Trial registration The study was registered as an International Standard Randomized Controlled Trial (ISRCTN85071383).

Abstract Background In the light of the ongoing debate about lowering the cut-off for acceptable blood lead level to Methods Using Brazelton's Neonatal Behavioral Assessment Scale (NBAS), an epidemiological approach and robust statistical techniques like multivariate linear regression, logistic regression, Poisson regression and structural equations modeling analyses we estimated the simultaneous indirect effects of umbilical cord blood lead (CBL) levels and other neonatal covariates on the NBAS clusters. Results We observed that when analyzed in all study subjects, the CBL levels independently and strongly influenced autonomic stability and abnormal reflexes clusters. However, when the analysis was restricted to neonates with CBL Conclusion Our results further endorse the need to be cognizant of the detrimental effects of blood lead on neonates even at a low-dose prenatal exposure.

Abstract Background The therapeutic effects of zinc and copper in reducing diarrheal morbidity have important cost implications. This health services research study evaluated the cost of treating a child with acute diarrhea in the hospital, the impact of micronutrient supplementation on the mean predicted costs and its cost-effectiveness as compared to using only standard oral rehydration solution (ORS), from the patient's and government's (providers) perspective. Methods Children aged 6 months to 59 months with acute diarrhea were randomly assigned to receive either the intervention or control. The intervention was a daily dose of 40 mg of zinc sulfate and 5 mg of copper sulfate powder dissolved in a liter of standard ORS (n = 102). The control was 50 mg of standard ORS powder dissolved in a liter of standard ORS (n = 98). The cost measures were the total mean cost of treating acute diarrhea, which included the direct medical, the direct non-medical and the indirect costs. The effectiveness measures were the probability of diarrhea lasting ≤ 4 days, the disability adjusted life years (DALYs) and mortality. Results The mean total cost of treating a child with acute diarrhea was US $14 of which the government incurred an expenditure of 66%. The factors that increased the total were the number of stools before admission (p = 0.01), fever (p = 0.01), increasing grade of dehydration (p = 0.00), use of antibiotics (p = 0.00), use of intra-venous fluids (p = 0.00), hours taken to rehydrate a child (p = 0.00), the amount of oral rehydration fluid used (p = 0.00), presence of any complications (p = 0.00) and the hospital stay (p = 0.00). The supplemented group had a 8% lower cost of treating acute diarrhea, their cost per unit health (diarrhea lasting ≤ 4 days) was 24% less and the incremental cost-effectiveness ratio indicated cost savings (in Rupees) with the intervention [-452; 95%CI (-11306, 3410)]. However these differences failed to reach conventional levels of significance. Conclusion An emphasis on the costs and economic benefits of an alternative therapy is an important aspect of health services research. The cost savings and the attractive cost-effectiveness indicates the need to further assess the role of micronutrients such as zinc and copper in the treatment of acute diarrhea in a larger and more varied population.

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 (<15 weeks), and a second capillary specimen in the 3rd trimester (>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<11.0 g/dL) prevalence using capillary specimens were 10.9 ± 1.5 g/dL and 51.1%; mean Hb concentration using venous blood specimens was estimated to be 11.3 ± 1.3 g/dL and anemia prevalence was 37.5%. The prevalence of iron, vitamin B12 and folate deficiencies were 40%, 30% and 0%, respectively. Among women with anemia in the 1st trimester (venous blood), 56% had concurrent iron deficiency (inflammation‐adjusted serum ferritin <15 µg/L) indicating that their anemia may be amenable to iron supplementation. In total, 21% of women had ID and anemia, 19% ID in the absence of anemia, 16.5% anemia in the absence of ID and 43.5% had neither. By the 3rd trimester, mean Hb from capillary specimens had declined to 10.1 ± 1.35 g/dL and anemia prevalence increased to 70.7%, despite 99.4% mothers reporting receipt of iron‐folic acid (IFA) supplements during her current pregnancy, and 83.9% reporting IFA consumption the previous day. Significant predictors of anemia in the 1st trimester (both venous and capillary) included the number of weeks gestation at the time of Hb assessment and inflammation‐adjusted serum ferritin. For 3rd trimester anemia, significant predictors included 1st trimester height, BMI and IFA consumption during the 3rd trimester (but not 1st trimester micronutrient biomarkers), indicating that IFA supplementation over the course of pregnancy may have influenced micronutrient status and anemia risk. Our findings highlight the severity of the burden of anemia and micronutrient deficiencies in Eastern Maharashtra, but also highlight that in many cases, ID and anemia affect different individuals. Preventing and managing anemia in pregnancy in India will require strengthening both clinical and community‐based strategies targeting iron deficiency, as well as other causes of anemia. Key messages: Anemia, iron deficiency and vitamin B12 deficiency were all highly prevalent in pregnant women in Eastern Maharashtra, India. The prevalence of anemia increased over the course of pregnancy despite high reported rates of receipt (99.4%) and consumption of iron folic acid supplements (83.9% in the previous day).Measuring hemoglobin concentration from single‐drop capillary blood specimens (from finger pricks) with a point‐of‐care analyzer (i.e. HemoCue Hb 201+) resulted in lower concentration estimates (10.9 g/dL vs. 11.3 g/dL) and higher anemia prevalence (51.1% vs. 37.5%) in the 1st trimester of pregnancy than venous blood tested in a laboratory with the cyanmethemoglobin method.Addressing anemia during pregnancy in India, and other Low‐ and Middle‐income country settings, will require strengthening clinical and community‐based strategies addressing iron deficiency, but also other nutritional and non‐nutritional causes of anemia. When possible, hemoglobin assessment should be conducted on venous blood specimens. [ABSTRACT FROM AUTHOR]

Background: Findings from research and recommendations from the World Health Organization favor restrictive use of episiotomy, but whether this guidance is being followed in India, and factors associated with its use, are not known. This study sought to document trends in use of episiotomy over a five-year period (2014–2018); to examine its relationship to maternal, pregnancy, and health-system characteristics; and to investigate its association with other obstetric interventions. Methods: We conducted a secondary analysis of data collected by the Maternal Newborn Health Registry, a prospective population-based pregnancy registry established in Central India (Nagpur, Eastern Maharashtra). We examined type of birth and use of episiotomy in vaginal deliveries from 2014 to 2018, as well as maternal and birth characteristics, health systems factors, and concurrent obstetric interventions associations with its use with multivariable Poisson regression models. Results: During the five-year interval, the rate of episiotomy in vaginal birth rose from 13 to 31% despite a decline in assisted vaginal birth. Associations with episiotomy were found for the following factors: prior birth, multiple gestations, seven or more years of maternal education, higher gestational age, higher birthweight, delivery by an obstetrician (as compared to midwife or general physician), and birth in hospital (as compared to clinic or health center). After adjusting for these factors, year over year rise in episiotomy was significant with an adjusted incidence rate ratio (AIRR) of 1.10 [95% confidence interval (CI) 1.08–1.12; p = 0.002]. We found an association between episiotomy and several other obstetric interventions, with the strongest relationship for maternal treatment with antibiotics (AIRR 4.23, 95% CI 3.12–5.73; p = 0.001). Conclusions: Episiotomy in this population-based sample from central India steadily rose from 2014 to 2018. This increase over time was observed even after adjusting for patient characteristics, obstetric risk factors, and health system features, such as specialty of the birthing provider. Our findings have important implications for maternal-child health and respectful maternity care given that most women prefer to avoid episiotomy; they also highlight a potential target for antibiotic stewardship as part of global efforts to combat antimicrobial resistance. Trial Registration: The study was registered at ClinicalTrials.gov under reference number NCT01073475. Plain English summary: Episiotomy is a surgical procedure to widen the vaginal opening for childbirth. It was once commonly used worldwide. However, because the procedure can cause pain to mothers and place them at risk for infections and serious tears to the vagina—especially when the cut is directly downward—research suggests it should be used sparingly. As such, it is now less often practiced in high-income countries, but whether the same is true in India is not known. To answer this question, we used a large population-based pregnancy registry, the Maternal Newborn Health Registry, from Central India (Nagpur) to assess the frequency of episiotomy use between 2014 and 2018 and if there were certain maternal characteristics, features of the health care system, and other pregnancy interventions that were related with its use. Over this five-year period, the use of episiotomy during vaginal birth rose more than two-fold. It was more often used on women who had never delivered a baby before, were further along in pregnancy, had higher levels of education, had heavier babies, or were carrying more than one baby. Obstetricians were more likely to perform episiotomy than midwives or general physicians and it was more likely to be performed in hospitals than in clinics or primary health centers. This rise during the five-year interval was significant even when accounting for these patient and provider characteristics, suggesting a shift in medical practice. Because this was an observational study more research is needed to determine if the associations we found are causal. [ABSTRACT FROM AUTHOR]

Limited guidelines exist regarding osteoporosis prevention in the general population. Despite being a subject of controversy, the majority of research suggests that decreased vitamin D levels correlate with increased bone turnover, that is, an important risk factor for osteoporosis development. In most guidelines, daily vitamin D supplementation is recommended. In persons with epilepsy (PWE), the situation is more complex, as other factors can increase the chance of being vitamin D deficient. Currently, there are no internationally accepted guidelines regarding monitoring bone health in PWE. Our aim was to review the existing evidence in PWE on: (1) risk factors for vitamin D deficiency, (2) the identification of higher risk groups, and (3) the optimal ways to monitor bone health. Our narrative review shows that: (1) anti‐seizure medication (ASM) use, especially enzyme‐inducing ASM (EIASM) and valproic acid, is identified as an important risk factor for impaired bone health (e.g., increased risk for osteoporosis/fractures and/or vitamin D deficiency); (2) higher risk groups within the PWE population are present: intellectual or physical disability, institutionalized patients, puberty, early onset epilepsy and developmental epileptic encephalopathies, postmenopausal women, and use of multiple ASM/concomitant drugs (e.g. corticosteroids); and (3) a monitoring scheme can be suggested including laboratory tests, bone density measurements, managing of risk factors, and/or vitamin D supplementation. Overall, regular vitamin D measurement in PWE is a cost‐effective and practical method for monitoring vitamin D deficiency, whereas in high‐risk patients the combination of vitamin D measurement and bone densitometry is recommended. There is not enough evidence to advocate continuous vitamin D supplementation in all PWE. Children with epilepsy should receive the recommended daily intake of vitamin D for age and additional monitoring and supplementation if at higher risk of deficiency. There is a need for prospective trials exploring the potential benefit of vitamin D supplementation in PWE. [ABSTRACT FROM AUTHOR]