Neonatal mortality risk of vulnerable newborns by fine stratum of gestational age and birthweight for 230 679 live births in nine low- and middle-income countries, 2000-2017.

OBJECTIVE: To describe the mortality risks by fine strata of gestational age and birthweight among 230 679 live births in nine low- and middle-income countries (LMICs) from 2000 to 2017. DESIGN: Descriptive multi-country secondary data analysis. SETTING: Nine LMICs in sub-Saharan Africa, Southern and Eastern Asia, and Latin America. POPULATION: Liveborn infants from 15 population-based cohorts. METHODS: Subnational, population-based studies with high-quality birth outcome data were invited to join the Vulnerable Newborn Measurement Collaboration. All studies included birthweight, gestational age measured by ultrasound or last menstrual period, infant sex and neonatal survival. We defined adequate birthweight as 2500-3999 g (reference category), macrosomia as ≥4000 g, moderate low as 1500-2499 g and very low birthweight as <1500 g. We analysed fine strata classifications of preterm, term and post-term: ≥42+0 , 39+0 -41+6 (reference category), 37+0 -38+6 , 34+0 -36+6 ,34+0 -36+6 ,32+0 -33+6 , 30+0 -31+6 , 28+0 -29+6 and less than 28 weeks. MAIN OUTCOME MEASURES: Median and interquartile ranges by study for neonatal mortality rates (NMR) and relative risks (RR). We also performed meta-analysis for the relative mortality risks with 95% confidence intervals (CIs) by the fine categories, stratified by regional study setting (sub-Saharan Africa and Southern Asia) and study-level NMR (≤25 versus >25 neonatal deaths per 1000 live births). RESULTS: We found a dose-response relationship between lower gestational ages and birthweights with increasing neonatal mortality risks. The highest NMR and RR were among preterm babies born at <28 weeks (median NMR 359.2 per 1000 live births; RR 18.0, 95% CI 8.6-37.6) and very low birthweight (462.8 per 1000 live births; RR 43.4, 95% CI 29.5-63.9). We found no statistically significant neonatal mortality risk for macrosomia (RR 1.1, 95% CI 0.6-3.0) but a statistically significant risk for all preterm babies, post-term babies (RR 1.3, 95% CI 1.1-1.5) and babies born at 370 -386 weeks (RR 1.2, 95% CI 1.0-1.4). There were no statistically significant differences by region or underlying neonatal mortality. CONCLUSIONS: In addition to tracking vulnerable newborn types, monitoring finer categories of birthweight and gestational age will allow for better understanding of the predictors, interventions and health outcomes for vulnerable newborns. It is imperative that all newborns from live births and stillbirths have an accurate recorded weight and gestational age to track maternal and neonatal health and optimise prevention and care of vulnerable newborns.

Quality of vital event data for infant mortality estimation in prospective, population-based studies: an analysis of secondary data from Asia, Africa, and Latin America.

INTRODUCTION: Infant and neonatal mortality estimates are typically derived from retrospective birth histories collected through surveys in countries with unreliable civil registration and vital statistics systems. Yet such data are subject to biases, including under-reporting of deaths and age misreporting, which impact mortality estimates. Prospective population-based cohort studies are an underutilized data source for mortality estimation that may offer strengths that avoid biases. METHODS: We conducted a secondary analysis of data from the Child Health Epidemiology Reference Group, including 11 population-based pregnancy or birth cohort studies, to evaluate the appropriateness of vital event data for mortality estimation. Analyses were descriptive, summarizing study designs, populations, protocols, and internal checks to assess their impact on data quality. We calculated infant and neonatal morality rates and compared patterns with Demographic and Health Survey (DHS) data. RESULTS: Studies yielded 71,760 pregnant women and 85,095 live births. Specific field protocols, especially pregnancy enrollment, limited exclusion criteria, and frequent follow-up visits after delivery, led to higher birth outcome ascertainment and fewer missing deaths. Most studies had low follow-up loss in pregnancy and the first month with little evidence of date heaping. Among studies in Asia and Latin America, neonatal mortality rates (NMR) were similar to DHS, while several studies in Sub-Saharan Africa had lower NMRs than DHS. Infant mortality varied by study and region between sources. CONCLUSIONS: Prospective, population-based cohort studies following rigorous protocols can yield high-quality vital event data to improve characterization of detailed mortality patterns of infants in low- and middle-income countries, especially in the early neonatal period where mortality risk is highest and changes rapidly.

Neonatal mortality risk of vulnerable newborns: A descriptive analysis of subnational, population-based birth cohorts for 238 203 live births in low- and middle-income settings from 2000 to 2017.

OBJECTIVE: We aimed to understand the mortality risks of vulnerable newborns (defined as preterm and/or born weighing smaller or larger compared to a standard population), in low- and middle-income countries (LMICs). DESIGN: Descriptive multi-country, secondary analysis of individual-level study data of babies born since 2000. SETTING: Sixteen subnational, population-based studies from nine LMICs in sub-Saharan Africa, Southern and Eastern Asia, and Latin America. POPULATION: Live birth neonates. METHODS: We categorically defined five vulnerable newborn types based on size (large- or appropriate- or small-for-gestational age [LGA, AGA, SGA]), and term (T) and preterm (PT): T + LGA, T + SGA, PT + LGA, PT + AGA, and PT + SGA, with T + AGA (reference). A 10-type definition included low birthweight (LBW) and non-LBW, and a four-type definition collapsed AGA/LGA into one category. We performed imputation for missing birthweights in 13 of the studies. MAIN OUTCOME MEASURES: Median and interquartile ranges by study for the prevalence, mortality rates and relative mortality risks for the four, six and ten type classification. RESULTS: There were 238 203 live births with known neonatal status. Four of the six types had higher mortality risk: T + SGA (median relative risk [RR] 2.6, interquartile range [IQR] 2.0-2.9), PT + LGA (median RR 7.3, IQR 2.3-10.4), PT + AGA (median RR 6.0, IQR 4.4-13.2) and PT + SGA (median RR 10.4, IQR 8.6-13.9). T + SGA, PT + LGA and PT + AGA babies who were LBW, had higher risk compared with non-LBW babies. CONCLUSIONS: Small and/or preterm babies in LIMCs have a considerably increased mortality risk compared with babies born at term and larger. This classification system may advance the understanding of the social determinants and biomedical risk factors along with improved treatment that is critical for newborn health.

Validation of MINORMIX Approach for Estimation of Low Birthweight Prevalence Using a Rural Nepal Dataset.

BACKGROUND: The Global Nutrition Target of reducing low birthweight (LBW) by ≥30% between 2012 and 2025 has led to renewed interest in producing accurate, population-based, national LBW estimates. Low- and middle-income countries rely on household surveys for birthweight data. These data are frequently incomplete and exhibit strong "heaping." Standard survey adjustment methods produce estimates with residual bias. The global database used to report against the LBW Global Nutrition Target adjusts survey data using a new MINORMIX (multiple imputation followed by normal mixture) approach: 1) multiple imputation to address missing birthweights, followed by 2) use of a 2-component normal mixture model to account for heaping of birthweights. OBJECTIVES: To evaluate the performance of the MINORMIX birthweight adjustment approach and alternative methods against gold-standard measured birthweights in rural Nepal. METHODS: As part of a community-randomized trial in rural Nepal, we measured "gold-standard" birthweights at birth and returned 1-24 mo later to collect maternally reported birthweights using standard survey methods. We compared estimates of LBW from maternally reported data derived using: 1) the new MINORMAX approach; 2) the previously used Blanc-Wardlaw adjustment; or 3) no adjustment for missingness or heaping against our gold standard. We also assessed the independent contribution of multiple imputation and curve fitting to LBW adjustment. RESULTS: Our gold standard found 27.7% of newborns were LBW. The unadjusted LBW estimate based on maternal report with simulated missing birthweights was 14.5% (95% CI: 11.6, 18.0%). Application of the Blanc-Wardlaw adjustment increased the LBW estimate to 20.6%. The MINORMIX approach produced an estimate of 26.4% (95% CI: 23.5, 29.3%) LBW, closest to and with bounds encompassing the measured point estimate. CONCLUSIONS: In a rural Nepal validation dataset, the MINORMIX method generated a more accurate LBW estimate than the previously applied adjustment method. This supports the use of the MINORMIX method to produce estimates for tracking the LBW Global Nutrition Target.

Demographic, socio-economic, obstetric, and behavioral factors associated with small-and large-for-gestational-age from a prospective, population-based pregnancy cohort in rural Nepal: a secondary data analysis.

BACKGROUND: In South Asia, a third of babies are born small-for-gestational age (SGA). The risk factors are well described in the literature, but many studies are in high-and-middle income countries or measure SGA on facility births only. There are fewer studies that describe the prevalence of risk factors for large-for-gestational age (LGA) in low-income countries. We aim to describe the factors associated with SGA and LGA in a population-based cohort of pregnant women in rural Nepal. METHODS: This is a secondary data analysis of community-based trial on neonatal oil massage (22,545 women contributing 39,479 pregnancies). Demographic, socio-economic status (SES), medical/obstetric history, and timing of last menstruation were collected at enrollment. Vital signs, illness symptoms, and antenatal care (ANC) attendance were collected throughout the pregnancy and neonatal weight was measured for live births. We conducted multivariate analysis using multinomial, multilevel logistic regression, reporting the odds ratio (OR) with 95% confidence intervals (CIs). Outcomes were SGA, LGA compared to appropriate-for-gestational age (AGA) and were multiply imputed using birthweight recalibrated to time at delivery. RESULTS: SGA was associated with nulligravida (OR: 2.12 95% CI: 1.93-2.34), gravida/nulliparous (OR: 1.86, 95% CI: 1.26-2.74), interpregnancy intervals less than 18 months (OR: 1.16, 95% CI: 1.07-1.27), and poor appetite/vomiting in the second trimester, (OR: 1.27, 95% CI: 1.19-1.35). Greater wealth (OR: 0.78, 95% CI: 0.69-0.88), swelling of hands/face in the third trimester (OR: 0.81, 95% CI: 0.69-0.94) parity greater than five (OR: 0.77, 95% CI: 0.65-0.92), male fetal sex (OR: 0.91, 95% CI: 0.86-0.98), and increased weight gain (OR: 0.93 per weight kilogram difference between 2nd and 3rd trimester, 95% CI: 0.92-0.95) were protective for SGA. Four or more ANC visits (OR: 0.53, 95% CI: 0.41-0.68) and respiratory symptoms in the third trimester (OR: 0.67, 95% CI: 0.54-0.84) were negatively associated with LGA, and maternal age < 18 years (OR: 1.39, 95% CI: 1.03-1.87) and respiratory symptoms in the second trimester (OR: 1.27, 95% CI: 1.07-1.51) were positively associated with LGA. CONCLUSIONS: Our findings are in line with known risk factors for SGA. Because the prevalence and mortality risk of LGA babies is low in this population, it is likely LGA status does not indicate underlaying illness. Improved and equitable access to high quality antenatal care, monitoring for appropriate gestational weight gain and increased monitoring of women with high-risk pregnancies may reduce prevalence and improve outcomes of SGA babies. TRIAL REGISTRATION: The study used in this secondary data analysis was registered at Clinicaltrials.gov NCT01177111.

Modeling of Future COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Rates and Nonpharmaceutical Intervention Scenarios - United States, April-September 2021.

After a period of rapidly declining U.S. COVID-19 incidence during January-March 2021, increases occurred in several jurisdictions (1,2) despite the rapid rollout of a large-scale vaccination program. This increase coincided with the spread of more transmissible variants of SARS-CoV-2, the virus that causes COVID-19, including B.1.1.7 (1,3) and relaxation of COVID-19 prevention strategies such as those for businesses, large-scale gatherings, and educational activities. To provide long-term projections of potential trends in COVID-19 cases, hospitalizations, and deaths, COVID-19 Scenario Modeling Hub teams used a multiple-model approach comprising six models to assess the potential course of COVID-19 in the United States across four scenarios with different vaccination coverage rates and effectiveness estimates and strength and implementation of nonpharmaceutical interventions (NPIs) (public health policies, such as physical distancing and masking) over a 6-month period (April-September 2021) using data available through March 27, 2021 (4). Among the four scenarios, an accelerated decline in NPI adherence (which encapsulates NPI mandates and population behavior) was shown to undermine vaccination-related gains over the subsequent 2-3 months and, in combination with increased transmissibility of new variants, could lead to surges in cases, hospitalizations, and deaths. A sharp decline in cases was projected by July 2021, with a faster decline in the high-vaccination scenarios. High vaccination rates and compliance with public health prevention measures are essential to control the COVID-19 pandemic and to prevent surges in hospitalizations and deaths in the coming months.

Effect of birthweight measurement quality improvement on low birthweight prevalence in rural Ethiopia.

BACKGROUND: Low birthweight (LBW) (< 2500 g) is a significant determinant of infant morbidity and mortality worldwide. In low-income settings, the quality of birthweight data suffers from measurement and recording errors, inconsistent data reporting systems, and missing data from non-facility births. This paper describes birthweight data quality and the prevalence of LBW before and after implementation of a birthweight quality improvement (QI) initiative in Amhara region, Ethiopia. METHODS: A comparative pre-post study was performed in selected rural health facilities located in West Gojjam and South Gondar zones. At baseline, a retrospective review of delivery records from February to May 2018 was performed in 14 health centers to collect birthweight data. A birthweight QI initiative was introduced in August 2019, which included provision of high-quality digital infant weight scales (precision 5 g), routine calibration, training in birth weighing and data recording, and routine field supervision. After the QI implementation, birthweight data were prospectively collected from late August to early September 2019, and December 2019 to June 2020. Data quality, as measured by heaping (weights at exact multiples of 500 g) and rounding to the nearest 100 g, and the prevalence of LBW were calculated before and after QI implementation. RESULTS: We retrospectively reviewed 1383 delivery records before the QI implementation and prospectively measured 1371 newborn weights after QI implementation. Heaping was most frequently observed at 3000 g and declined from 26% pre-initiative to 6.7% post-initiative. Heaping at 2500 g decreased from 5.4% pre-QI to 2.2% post-QI. The percentage of rounding to the nearest 100 g was reduced from 100% pre-initiative to 36.5% post-initiative. Before the QI initiative, the prevalence of recognized LBW was 2.2% (95% confidence interval [CI]: 1.5-3.1) and after the QI initiative increased to 11.7% (95% CI: 10.1-13.5). CONCLUSIONS: A QI intervention can improve the quality of birthweight measurements, and data measurement quality may substantially affect estimates of LBW prevalence.

Reliability of maternal recall of delivery and immediate newborn care indicators in Sarlahi, Nepal.

BACKGROUND: The intrapartum period is a time of high mortality risk for newborns and mothers. Numerous interventions exist to minimize risk during this period. Data on intervention coverage are needed for health system improvement. Maternal report of intrapartum interventions through surveys is the primary source of coverage data, but they may be invalid or unreliable. METHODS: We assessed the reliability of maternal report of delivery and immediate newborn care for a sample of home and health facility births in Sarlahi, Nepal. Mothers were visited as soon as possible following delivery (< 72 h) and asked to report circumstances of labor and delivery. A subset was revisited 1-24 months after delivery and asked to recall interventions received using standard household survey questions. We assessed the reliability of each indicator by comparing what mothers reported immediately after delivery against what they reported at the follow-up survey. We assessed potential variation in reliability of maternal report by characteristics of the mother, birth event, or intervention prevalence. RESULTS: One thousand five hundred two mother/child pairs were included in the reliability study, with approximately half of births occurring at home. A higher proportion of women who delivered in facilities reported "don't know" when asked to recall specific interventions both initially and at follow-up. Most indicators had high observed percent agreement, but kappa values were below 0.4, indicating agreement was primarily due to chance. Only "received any injection during delivery" demonstrated high reliability among all births (kappa: 0.737). The reliability of maternal report was typically lower among women who delivered at a facility. There was no difference in reliability based on time since birth of the follow-up interview. We observed over-reporting of interventions at follow-up that were more common in the population and under-reporting of less common interventions. CONCLUSIONS: This study reinforces previous findings that mothers are unable to report reliably on many interventions within the peripartum period. Household surveys which rely on maternal report, therefore, may not be an appropriate method for collecting data on coverage of many interventions during the peripartum period. This is particularly true among facility births, where many interventions may occur without the mother's full knowledge.

Prevalence of symptomatic urinary incontinence and pelvic organ prolapse among women in rural Nepal.

INTRODUCTION AND HYPOTHESIS: Although pelvic floor disorders (PFDs) are a significant public health issue in higher income countries, less is known about these disorders and associated risk factors in low income countries. We aimed to determine prevalence and associated risk factors for stress urinary incontinence (SUI), urge urinary incontinence (UUI), and pelvic organ prolapse (POP) in reproductive age women in Sarlahi District in rural Nepal. METHODS: We conducted a community-based cross-sectional survey of parous, reproductive age women in rural Nepal and screened for pelvic floor disorders using validated screening questions for PFDs. Overall frequency of self-reported symptoms for SUI, UUI, and POP was estimated and compared across demographic and pregnancy history information. RESULTS: Of 14,469 women available for analysis, the mean (SD, range) age was 33.5 (8.2, 13-52) years, and median (range) number of pregnancies was 4 (1-15). The prevalence of SUI was 24.1% (95% CI: 23.3-24.8), of UUI was 13.5% (95% CI: 13.0-14.1), and of POP was 8.0% (95% CI: 7.5-8.4). Bivariate analysis identified the risk of PFD increased incrementally with age and number of vaginal deliveries; these covariates were highly correlated. Multivariable logistic regression revealed age, vaginal deliveries, and previous pelvic surgeries were independently associated with PFD. CONCLUSIONS: PFDs are common in a community of parous, reproductive age women in rural Nepal. Risk factors for these conditions are similar to risk factors found in higher income countries.

Coverage of the WHO's four essential elements of newborn care and their association with neonatal survival in southern Nepal.

BACKGROUND: Despite recent improvements in child survival, neonatal mortality continues to decline at a slower rate and now represents 47% of under-five deaths globally. The World Health Organization developed core indicators to better monitor the quality of maternal and newborn health services. One such indicator for newborn health is "the proportion of newborns who received all four elements of essential care". The four elements are immediate and thorough drying, skin to skin contact, delayed cord clamping, and early initiation of breastfeeding. Although there is existing evidence demonstrating an association with decreased neonatal mortality for each element individually, the cumulative impact has not yet been examined. METHODS: This analysis uses data from a randomized trial to examine the impact of sunflower versus mustard seed oil massage on neonatal mortality and morbidity in the Sarlahi district in Southern Nepal from 2010 to 2017. The proportion of newborn infants receiving an intervention was the exposure and neonatal mortality was the outcome in this analysis. Neonatal mortality was defined as a death between three hours and less than 28 days of age. Associations between neonatal mortality and the essential elements were estimated by Cox proportion hazards models. The hazard ratios and corresponding 95% confidence intervals were reported. RESULTS: 28,121 mother-infant pairs and 753 neonatal deaths were included. The percent receiving the individual elements ranged from 19.5% (skin to skin contact) to 68.2% (delayed cord clamping). The majority of infants received one or two of the elements of essential care, with less than 1% receiving all four. Skin to skin contact and early initiation of breastfeeding were associated with lower risk of neonatal mortality (aHR = 0.64 [0.51, 0.81] and aHR = 0.72 [0.60, 0.87], respectively). The risk of mortality declined as the number of elements received increased; receipt of one element compared to zero was associated with a nearly 50% reduction in risk of mortality and receipt of all four elements resulted in a 72% decrease in risk of mortality. CONCLUSIONS: The receipt of one or more of the four essential elements of newborn care was associated with improved neonatal survival. The more elements of care received, the more survival improved.

Nausea, vomiting and poor appetite during pregnancy and adverse birth outcomes in rural Nepal: an observational cohort study.

BACKGROUND: Nausea and vomiting are experienced by a majority of pregnant women worldwide. Previous studies have yielded conflicting results regarding their impact on birth outcomes and few studies have examined this relationship in settings with limited resources. We aimed to determine the effect of nausea, vomiting and poor appetite during pregnancy on birth outcomes in rural Nepal. METHODS: Observational cohort study using data collected in two randomized, community-based trials to assess the effect of influenza immunization during pregnancy on reproductive and respiratory outcomes among pregnant women and their offspring. Pregnant women in Sarlahi District, Nepal were recruited from 2011 to 2013. Exposure was defined as nausea, vomiting or poor appetite at any point during pregnancy and by trimester; symptoms were recorded monthly throughout pregnancy. Adverse outcomes were low birth weight (LBW), preterm birth and small for gestational age (SGA). Adjusted relative risks (aRR) with 95% CIs are reported from Poisson regressions with robust variance. RESULTS: Among 3,623 pregnant women, the cumulative incidence of nausea, vomiting or poor appetite was 49.5% (n = 1793) throughout pregnancy and 60.6% (n = 731) in the first trimester. Significantly higher aRRs of LBW and SGA were observed among women experiencing symptoms during pregnancy as compared to symptom free women (LBW: aRR 1.20; 95% CI 1.05 1.28; SGA: aRR 1.16; 95% CI 1.05 1.28). Symptoms in the first trimester were not significantly associated with any of the outcomes. In the second trimester, we observed significantly higher aRRs for LBW and SGA (LBW: aRR 1.17; 95% CI 1.01 1.36; SGA: aRR 1.16; 95% CI 1.05 1.29) and a significantly lower aRR for preterm birth (aRR 0.75; 95% CI 0.59 0.96). In the third trimester, we observed significantly higher aRRs for LBW and SGA (LBW: aRR 1.20; 95% CI 1.01 1.43; SGA: aRR 1.14; 95% CI 1.01 1.29). CONCLUSIONS: Symptoms of nausea, vomiting or poor appetite during pregnancy are associated with LBW, SGA and preterm birth in a setting with limited resources, especially beyond the first trimester. TRIAL REGISTRATION: Prospectively registered at ClinicalTrials.gov on Dec 17, 2009 ( NCT01034254 ).

Barriers to maternal retention in HIV care in Ghana: key differences during pregnancy and the postpartum period.

BACKGROUND: Maternal retention in HIV care is lower for women in the postpartum period than during pregnancy, but the reasons are poorly understood. We examined key differences in barriers to retention in HIV care during and after pregnancy. METHODS: We conducted semi-structured, in-depth interviews with 30 postpartum women living with HIV. Participants were recruited from two tertiary facilities implementing Option B+ for prevention of mother-to-child HIV transmission in Accra, Ghana. We collected data from mothers who had disengaged from HIV care and those who were still engaged in care. The interviews were analyzed using principles adapted from grounded theory. RESULTS: Participants' experiences and narratives showed that retention in HIV care was more challenging during the postpartum period than during pregnancy. Poor maternal physical health (from birth complications and cesarean section), socio-cultural factors (norms about newborn health and pregnancy), and economic difficulties linked to childbirth (such as unemployment, under-employment, and debt) made the costs of retention in HIV care more economically and socially expensive in the postpartum period than during pregnancy. Some participants also shared that transportation costs and resulting dependence on a partner to pay increased during the postpartum period because of a strong shift in maternal preference for private modes of transportation due to HIV stigma and the desire to protect the newborn. These factors played a larger role in the postpartum period than during pregnancy and created a significant barrier to retention. A conceptual model of how these factors interrelate, the synergy between them, and how they affect retention in the postpartum period is presented. CONCLUSIONS: In Ghana, lower retention in HIV care in the postpartum period compared to in pregnancy may be primarily driven by social, economic, and newborn health factors. Multifaceted economic-based and stigma-reduction interventions are needed to increase retention in maternal HIV care after childbirth.

Community-based cluster randomized controlled trial: empowering households to identify and provide appropriate care for low-birthweight newborns in Nepal.

BACKGROUND: Most newborn deaths occur among those of low birthweight (LBWt), due to prematurity &/or impaired fetal growth. Simple practices can substantially mitigate this risk. In low-income country settings where many births occur at home, strategies are needed that empower mothers to determine if their babies are at higher risk and, if so, to take measures to reduce risk. Earlier studies suggest that foot-length may be a good proxy for birthweight. An earlier Nepal study found a 6.9 cm cut-off performed relatively well, differentiating normal from low birthweight. METHODS: Community-based, cluster-randomized controlled trial. OBJECTIVE: to determine whether family-administered screening, associated with targeted messages improves care practices known to mitigate LBWt-associated risks. PARTICIPANTS: women participating in a parent trial in rural Nepal, recruited late in pregnancy. Women were given a 6.9 cm card to assess whether the baby's foot is small; if so, to call a number on the card for advice. Follow-up visits were made over the 2 weeks following the birth, assessing for 2 behavioral outcomes: reported skin-to-skin thermal care, and care-seeking outside the home; assessed restricting to low birthweight (using 2 cutoffs: 2500 g and 2000 g). Randomization: 17 clusters intervention, 17 control. The study also documented performance along the presumed causal chain from intervention through behavioral impact. RESULTS: 2022 intervention, 2432 control. Intervention arm: 519 had birthweight < 2500 g (vs. 663 among controls), of which 503 were available for analysis (vs. 649 among controls). No significant difference found on care-seeking; for those < 2500 g RR 1.13 (95%CI: 0.97-1.131). A higher proportion of those in the intervention arm reported skin-to-skin thermal care than among controls; for those < 2500 g RR 2.50 (95%CI: 2.01-3.1). However, process measures suggest this apparent effect cannot be attributed to the intervention; the card performed poorly as a proxy for LBWt, misclassifying 84.5% of those < 2000 as normal weight. CONCLUSIONS: Although the trial found an apparent effect on one of the behavioral outcomes, this cannot be attributed to the intervention; most likely it was a result of pure chance. Other approaches are needed for identifying small, at-risk babies in such settings, and targeting them for appropriate care messaging. TRIAL REGISTRATION: ClinicalTrials.gov NCT02802332 , registered 6/16/2016.

Assessment of facility and health worker readiness to provide quality antenatal, intrapartum and postpartum care in rural Southern Nepal.

BACKGROUND: Increased coverage of antenatal care and facility births might not improve maternal and newborn health outcomes if quality of care is sub-optimal. Our study aimed to assess the facility readiness and health worker knowledge required to provide quality maternal and newborn care. METHODS: Using an audit tool and interviews, respectively, facility readiness and health providers' knowledge of maternal and immediate newborn care were assessed at all 23 birthing centers (BCs) and the District hospital in the rural southern Nepal district of Sarlahi. Facility readiness to perform specific functions was assessed through descriptive analysis and comparisons by facility type (health post (HP), primary health care center (PHCC), private and District hospital). Knowledge was compared by facility type and by additional skilled birth attendant (SBA) training. RESULTS: Infection prevention items were lacking in more than one quarter of facilities, and widespread shortages of iron/folic acid tablets, injectable ampicillin/gentamicin, and magnesium sulfate were a major barrier to facility readiness. While parenteral oxytocin was commonly provided, only the District hospital was prepared to perform all seven basic emergency obstetric and newborn care signal functions. The required number of medical doctors, nurses and midwives were present in only 1 of 5 PHCCs. Private sector SBAs had significantly lower knowledge of active management of third stage of labor and correct diagnosis of severe pre-eclampsia. While half of the health workers had received the mandated additional two-month SBA training, comparison with the non-trained group showed no significant difference in knowledge indicators. CONCLUSIONS: Facility readiness to provide quality maternal and newborn care is low in this rural area of Nepal. Addressing the gaps by facility type through regular monitoring, improving staffing and supply chains, supervision and refresher trainings is important to improve quality.

Feasibility of training community health workers to conduct periodontal examinations: a validation study in rural Nepal.

BACKGROUND: In many low- and middle-income countries, insufficient human resources limit access to oral health services. Shifting clinical tasks to less specialized health professionals, such as community health workers, has been used as a strategy to expand the health workforce, especially in remote or underserved locations. The objective of this study was to evaluate the validity of periodontal examinations conducted by auxiliary nurse midwives in a rural home setting in Nepal. METHODS: Twenty-one pregnant women < 26 weeks gestation from Sarlahi District, Nepal, underwent full mouth periodontal examinations measuring probing depth (PD) and bleeding on probing (BOP) on 6 sites per tooth by one of five auxiliary nurse midwives, who were trained for this study but had no previous training in dentistry. After a 15-min break, each participant was examined again by an experienced dentist. Measures of validity for PD and BOP were calculated comparing the pooled and individual auxiliary nurse midwives to the dentist. A multivariable GEE model estimated the effect of periodontal characteristics on agreement between the auxiliary nurse midwives and the dentist. RESULTS: Participant mean age was 22 years (SD: ±3 years), mean PD was 1.4 mm (SD: 03 mm), and 86% of women had BOP (according to the dentist). Percent agreement, weighted kappa scores, and intraclass correlation coefficients for PD, with an allowance of ±1 mm, exceeded 99%, 0.7, and 0.9, respectively, indicating an acceptable level of agreement. Auxiliary nurse midwives tended to report higher PD scores relative to the dentist, although this over-estimation was small and unlikely to impact population-based estimates of important indicators of oral health status. GEE regression modeling indicated similar agreement for mandible vs. maxilla, left vs. right side, and PD (≤2 mm, > 2 mm), and lower agreement for posterior teeth and lingual and proximal sites. CONCLUSION: Auxiliary nurse midwives were able to accurately conduct periodontal examinations in a rural home setting, suggesting the potential to shift tasks away from highly trained dentists and periodontal examiners in low-resource communities. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01177111 (Nepal Oil Massage Study); registered on August 6th, 2010.

Causes and incidence of community-acquired serious infections among young children in south Asia (ANISA): an observational cohort study.

BACKGROUND: More than 500 000 neonatal deaths per year result from possible serious bacterial infections (pSBIs), but the causes are largely unknown. We investigated the incidence of community-acquired infections caused by specific organisms among neonates in south Asia. METHODS: From 2011 to 2014, we identified babies through population-based pregnancy surveillance at five sites in Bangladesh, India, and Pakistan. Babies were visited at home by community health workers up to ten times from age 0 to 59 days. Illness meeting the WHO definition of pSBI and randomly selected healthy babies were referred to study physicians. The primary objective was to estimate proportions of specific infectious causes by blood culture and Custom TaqMan Array Cards molecular assay (Thermo Fisher, Bartlesville, OK, USA) of blood and respiratory samples. FINDINGS: 6022 pSBI episodes were identified among 63 114 babies (95·4 per 1000 livebirths). Causes were attributed in 28% of episodes (16% bacterial and 12% viral). Mean incidence of bacterial infections was 13·2 (95% credible interval [CrI] 11·2-15·6) per 1000 livebirths and of viral infections was 10·1 (9·4-11·6) per 1000 livebirths. The leading pathogen was respiratory syncytial virus (5·4, 95% CrI 4·8-6·3 episodes per 1000 livebirths), followed by Ureaplasma spp (2·4, 1·6-3·2 episodes per 1000 livebirths). Among babies who died, causes were attributed to 46% of pSBI episodes, among which 92% were bacterial. 85 (83%) of 102 blood culture isolates were susceptible to penicillin, ampicillin, gentamicin, or a combination of these drugs. INTERPRETATION: Non-attribution of a cause in a high proportion of patients suggests that a substantial proportion of pSBI episodes might not have been due to infection. The predominance of bacterial causes among babies who died, however, indicates that appropriate prevention measures and management could substantially affect neonatal mortality. Susceptibility of bacterial isolates to first-line antibiotics emphasises the need for prudent and limited use of newer-generation antibiotics. Furthermore, the predominance of atypical bacteria we found and high incidence of respiratory syncytial virus indicated that changes in management strategies for treatment and prevention are needed. Given the burden of disease, prevention of respiratory syncytial virus would have a notable effect on the overall health system and achievement of Sustainable Development Goal. FUNDING: Bill & Melinda Gates Foundation.

Low Birthweight, Retention in HIV Care, and Adherence to ART Among Postpartum Women Living with HIV in Ghana.

Care for low birthweight (LBW) infants can contribute to psychological difficulties and stigma among mothers living with HIV, creating challenges for antiretroviral therapy (ART) adherence and retention in HIV care. We explored how caring for LBW infants affects maternal ART adherence and retention in care. We conducted 30 in-depth interviews with postpartum women living with HIV in Accra, Ghana: 15 with LBW infants and 15 with normal birthweight (NBW) infants. Compared to mothers with NBW infants, mothers with LBW infants described how caring for their newborns led to increased caregiver burden, prolonged hospital stays, and stigma-contributing to incomplete ART adherence and missed clinical appointments. For a few women, care for LBW infants created opportunities for re-engagement in HIV care and motivation to adhere to ART. Results suggest women living with HIV and LBW babies in Ghana face increased challenges that impact their adherence to care and ART.

Validity of self-reported receipt of iron supplements during pregnancy: implications for coverage measurement.

BACKGROUND: Iron-deficiency anemia during pregnancy is an underlying cause of maternal deaths, and reducing risk through routine iron supplementation is a key component of antenatal care (ANC) programs in most low- and middle income countries. Supplementation coverage during pregnancy is estimated from maternal self-reports in population-based household surveys, yet recall bias and social desirability bias lead to errors of unknown magnitude. METHODS: We linked data from household and health facility surveys from 16 countries to estimate input-adjusted coverage of iron supplementation during pregnancy. We assessed the validity of reported receipt of iron supplements in client exit interviews using direct observation as the gold standard across 9 countries with a recent Service Provision Assessment (SPA). Using a sample of 227 women who participated in the Nepal Oil Massage Study (NOMS), we also assessed the validity of self-reported receipt of iron folic acid (IFA) supplements. We used Poisson regression models to explore the association between client and health facility characteristics and agreement of self-reported receipt of iron supplements compared to direct observation. RESULTS: Across the 16 countries, iron supplements were in supply at most of the 9215 sampled health facilities offering ANC services (91%). We estimated that between 48 and 93% of women attended at least one ANC visit at a health facility with iron supplements available. The specificity of recall of receipt of iron supplementation immediately following a visit was 79.3% and the sensitivity was 88.7% for the entire sample. Individual-level accuracy was high (Area under the curve > 0.7) and population bias low (0.75 < inflation factor < 1.25) across all countries. By contrast, in the NOMS sub-study, the accuracy of self-reported receipt of IFA supplements after 1-2 years was poor (sensitivity 86.1%, specificity 34.3%). Adjusted regression analyses indicated that older age and higher level of education were associated with poorer agreement between self-reports and direct observation. CONCLUSIONS: These findings suggest the need for caution when using self-reported measures with an extended recall period. Further validation studies using conditions similar to widely used population-based household surveys are warranted.

Urinary tract infections in pregnancy in a rural population of Bangladesh: population-based prevalence, risk factors, etiology, and antibiotic resistance.

BACKGROUND: Urinary tract infection (UTI) in pregnancy, including asymptomatic bacteriuria, is associated with maternal morbidity and adverse pregnancy outcomes, including preterm birth and low birthweight. In low-middle income countries (LMICs), the capacity for screening and treatment of UTIs is limited. The objective of this study was to describe the population-based prevalence, risk factors, etiology and antimicrobial resistance patterns of UTIs in pregnancy in Bangladesh. METHODS: In a community-based cohort in Sylhet district, Bangladesh, urine specimens were collected at the household level in 4242 pregnant women (< 20 weeks gestation) for culture and antibiotic susceptibility testing. Basic descriptive analysis was performed, as well as logistic regression to calculate adjusted odds ratios (aOR) for UTI risk factors. RESULTS: The prevalence of UTI was 8.9% (4.4% symptomatic UTI, 4.5% asymptomatic bacteriuria). Risk factors for UTI in this population included maternal undernutrition (mid-upper arm circumference <23 cm: aOR= 1.29, 95% CI: 1.03-1.61), primiparity (aOR= 1.45, 95% CI: 1.15-1.84), and low paternal education (no education: aOR= 1.56, 95% CI: 1.09-2.22). The predominant uro-pathogens were E. coli (38% of isolates), Klebsiella (12%), and staphyloccocal species (23%). Group B streptococcus accounted for 5.3% of uro-pathogens. Rates of antibiotic resistance were high, with only two-thirds of E. coli susceptible to 3rd generation cephalosporins. CONCLUSIONS: In Sylhet, Bangladesh, one in 11 women had a UTI in pregnancy, and approximately half of cases were asymptomatic. There is a need for low-cost and accurate methods for UTI screening in pregnancy and efforts to address increasing rates of antibiotic resistance in LMIC.

Prevalence of and risk factors for abnormal vaginal flora and its association with adverse pregnancy outcomes in a rural district in north-east Bangladesh.

INTRODUCTION: The role of screening and treatment for abnormal vaginal flora (AVF) on adverse pregnancy outcomes remains unclear. Using data from women who participated in a population-based cluster randomized trial who were screened and treated for AVF, we report risk factors for AVF and association of persistent AVF with adverse perinatal outcomes. MATERIAL AND METHODS: Pregnant women (n = 4221) <19 weeks of gestation provided self-administered mid-vaginal swabs; smears were Nugent-scored. AVF was treated with oral clindamycin; if AVF was present 3 weeks after treatment, persistent AVF was re-treated. We examined risk factors for AVF and the association of persistent AVF with adverse pregnancy outcomes. RESULTS: The prevalence of AVF was 16.5%: 9.8% of women had bacterial vaginosis and 6.8% had intermediate flora. Lower economic and educational status of women were associated with increased risk of AVF. One-third of women with AVF had persistent abnormal flora; these women had a higher risk of a composite measure of adverse pregnancy outcomes from 20 to <37 weeks (preterm live birth, preterm still birth, late miscarriage) (relative risk [RR] 1.33, 95% confidence interval [CI] 1.07-1.65) and of late miscarriage alone (RR 4.15, 95% CI 2.12-8.12) compared to women without AVF. CONCLUSIONS: In this study in Sylhet District, Bangladesh, rates of AVF and persistent AVF were high and persistent AVF was associated with adverse pregnancy outcomes, with an especially high associated risk for late miscarriage. Further characterization of the microbiome and relative bacterial species density associated with persistent AVF is needed.