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Objective: To understand trends in the knowledge, attitudes and practices (KAP) of pregnant women related to COVID‐19 in seven low‐ and middle‐income countries. Design: Multi‐country population‐based prospective observational study. Setting: Study sites in Bangladesh, the Demographic Republic of Congo (DRC), Guatemala, India (two sites), Kenya, Pakistan and Zambia. Population: Pregnant women in the Global Network's Maternal and Neonatal Health Registry (MNHR). Methods: Pregnant women enrolled in the MNHR were interviewed to assess their KAP related to COVID‐19 from September 2020 through July 2022 across all study sites. Main outcome measures: Trends of COVID‐19 KAP were assessed using the Cochran–Armitage test for trend. Results: A total of 52 297 women participated in this study. There were wide inter‐country differences in COVID‐19‐related knowledge. The level of knowledge of women in the DRC was much lower than that of women in the other sites. The ability to name COVID‐19 symptoms increased over time in the African sites, whereas no such change was observed in Bangladesh, Belagavi and Guatemala. All sites observed decreasing trends over time in women avoiding antenatal care visits. Conclusions: The knowledge and attitudes of pregnant women related to COVID‐19 varied substantially among the Global Network sites over a period of 2 years; however, there was very little change in knowledge related to COVID‐19 over time across these sites. The major change observed was that fewer women reported avoiding medical care because of COVID‐19 across all sites over time. [ABSTRACT FROM AUTHOR]

With the paucity of data available regarding COVID‐19 in pregnancy in low‐ and middle‐income countries (LMICs), near the start of the pandemic, the Global Network for Women's and Children's Health Research, funded by the National Institute of Child Health and Human Development (NICHD), initiated four separate studies to better understand the impact of the COVID‐19 pandemic in eight LMIC sites. These sites included: four in Asia, in Bangladesh, India (two sites) and Pakistan; three in Africa, in the Democratic Republic of the Congo (DRC), Kenya and Zambia; and one in Central America, in Guatemala. The first study evaluated changes in health service utilisation; the second study evaluated knowledge, attitudes and practices of pregnant women in relationship to COVID‐19 in pregnancy; the third study evaluated knowledge, attitude and practices related to COVID‐19 vaccination in pregnancy; and the fourth study, using antibody status at delivery, evaluated changes in antibody status over time in each of the sites and the relationship of antibody positivity with various pregnancy outcomes. Across the Global Network, in the first year of the study there was little reduction in health care utilisation and no apparent change in pregnancy outcomes. Knowledge related to COVID‐19 was highly variable across the sites but was generally poor. Vaccination rates among pregnant women in the Global Network were very low, and were considerably lower than the vaccination rates reported for the countries as a whole. Knowledge regarding vaccines was generally poor and varied widely. Most women did not believe the vaccines were safe or effective, but slightly more than half would accept the vaccine if offered. Based on antibody positivity, the rates of COVID‐19 infection increased substantially in each of the sites over the course of the pandemic. Most pregnancy outcomes were not worse in women who were infected with COVID‐19 during their pregnancies. We interpret the absence of an increase in adverse outcomes in women infected with COVID‐19 to the fact that in the populations studied, most COVID‐19 infections were either asymptomatic or were relatively mild. [ABSTRACT FROM AUTHOR]

Objective: To assess the impact of low‐dose aspirin (LDA) starting in early pregnancy on delaying preterm hypertensive disorders of pregnancy. Design: Non‐prespecified secondary analysis of a randomised masked trial of LDA. Setting: The study was conducted among women in the Global Network for Women's and Children's Health's Maternal and Newborn Health Registry (MNHR) clusters, a prospective, population‐based study in Kenya, Zambia, the Democratic Republic of the Congo (DRC), Pakistan, India (two sites‐Belagavi and Nagpur) and Guatemala. Population: Nulliparous singleton pregnancies between 6+0 weeks and 13+6 weeks in six low‐middle income countries (Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan, Zambia) enrolled in the ASPIRIN Trial. Methods: We compared the incidence of HDP at delivery at three gestational age periods (<28, <34 and <37 weeks) between women who were randomised to aspirin or placebo. Women were included if they were randomised and had an outcome at or beyond 20 weeks (Modified Intent to Treat). Main Outcome Measures: Our primary outcome was pregnancies with HDP associated with preterm delivery (HDP@delivery) before <28, <34 and <37 weeks. Secondary outcomes included small for gestational age (SGA) <10th percentile, <5th percentile, and perinatal mortality. Results: Among the 11 976 pregnancies, LDA did not significantly lower HDP@delivery <28 weeks (relative risk [RR] 0.18, 95% confidence interval [CI] 0.02–1.52); however, it did lower HDP@delivery <34 weeks (RR 0.37, 95% CI 0.17–0.81) and HDP@delivery <37 weeks (RR 0.66, 95% CI 0.49–0.90). The overall rate of HDP did not differ between the two groups (RR 1.08, 95% CI 0.94–1.25). Among those pregnancies who had HDP, SGA <10th percentile was reduced (RR 0.81, 95% CI 0.67–0.99), though SGA <5th percentile was not (RR 0.84, 95% CI 0.64–1.09). Similarly, perinatal mortality among pregnancies with HDP occurred less frequently (RR 0.55, 95% CI 0.33–0.92) in those receiving LDA. Pregnancies randomised to LDA delivered later with HDP compared with those receiving placebo (median gestational age 38.5 weeks vs. 37.9 weeks; p = 0.022). Conclusions: In this secondary analysis of a study of low‐risk nulliparous singleton pregnancies, early administration of LDA resulted in lower rates of preterm HDP and delivery before 34 and 37 weeks but not in the overall rate of HDP. These results suggest that LDA works in part by delaying HDP. [ABSTRACT FROM AUTHOR]

Objective: To determine the relation of COVID‐19 symptoms to COVID‐19 antibody positivity among unvaccinated pregnant women in low‐ and middle‐income countries (LMIC). Design: COVID‐19 infection status measured by antibody positivity at delivery was compared with the symptoms of COVID‐19 in the current pregnancy in a prospective, observational cohort study in seven LMICs. Setting: The study was conducted among women in the Global Network for Women's and Children's Health's Maternal and Newborn Health Registry (MNHR), a prospective, population‐based study in Kenya, Zambia, the Democratic Republic of the Congo (DRC), Bangladesh, Pakistan, India (Belagavi and Nagpur sites) and Guatemala. Population: Pregnant women enrolled in the ongoing pregnancy registry at study sites. Methods: Data on COVID‐19 symptoms during the current pregnancy were collected by trained staff between October 2020 and June 2022. COVID‐19 antibody testing was performed on samples collected at delivery. The relation between COVID‐19 antibody positivity and symptoms was assessed using generalised linear models with a binomial distribution adjusting for site and symptoms. Main outcome measures: COVID‐19 antibody status and symptoms of COVID‐19 among pregnant women. Results: Among 19 218 non‐vaccinated pregnant women who were evaluated, 14.1% of antibody‐positive women had one or more symptoms compared with 13.4% in antibody‐negative women. Overall, 85.3% of antibody‐positive women reported no COVID‐19 symptoms during the present pregnancy. Reported fever was significantly associated with antibody status (relative risk [RR] 1.10, 95% CI 1.03–11.18; P = 0.008). A multiple variable model adjusting for site and all eight symptoms during pregnancy showed similar results (RR 1.13, 95% CI 1.04–1.23; P = 0.012). None of the other symptoms was significantly related to antibody positivity. Conclusions: In a population‐based cohort in LMICs, unvaccinated pregnant women who were antibody‐positive had slightly more symptoms during their pregnancy and a small but significantly greater increase in fever. However, for prevalence studies, evaluating COVID‐19‐related symptoms does not appear to be useful in differentiating pregnant women who have had a COVID‐19 infection. [ABSTRACT FROM AUTHOR]

There is a substantial gap in our understanding of resuscitation practices following Helping Babies Breathe (HBB) training. We sought to address this gap through an analysis of observed resuscitations following HBB 2nd edition training in the Democratic Republic of the Congo. This is a secondary analysis of a clinical trial evaluating the effect of resuscitation training and electronic heart rate monitoring on stillbirths. We included in-born, liveborn neonates ≥28 weeks gestation whose resuscitation care was directly observed and documented. For the 2592 births observed, providers dried/stimulated before suctioning in 97% of cases and suctioned before ventilating in 100%. Only 19.7% of newborns not breathing well by 60 s (s) after birth ever received ventilation. Providers initiated ventilation at a median 347 s (>five minutes) after birth; no cases were initiated within the Golden Minute. During 81 resuscitations involving ventilation, stimulation and suction both delayed and interrupted ventilation with a median 132 s spent drying/stimulating and 98 s suctioning. This study demonstrates that HBB-trained providers followed the correct order of resuscitation steps. Providers frequently failed to initiate ventilation. When ventilation was initiated, it was delayed and interrupted by stimulation and suctioning. Innovative strategies targeting early and continuous ventilation are needed to maximize the impact of HBB. [ABSTRACT FROM AUTHOR]

Group B streptococcal (GBS) infection is a leading cause of neonatal morbidity and mortality globally. While prevention strategies for early onset GBS disease are well established, methods to prevent late-onset GBS disease do not eliminate disease burden, leaving potential for infection, and devastating consequences for affected neonates. Furthermore, the incidence of late-onset GBS has risen in recent years, with preterm infants at the highest risk of infection and death. Meningitis remains the most common and serious complication associated with late onset disease, occurring in 30 percent of cases. The assessment of risk for neonatal GBS infection should not be limited to the birth process or maternal screening results and intrapartum antibiotic prophylaxis treatment status. Horizontal transmission after birth from mothers, caregivers, and community sources has been observed. Late-onset GBS disease and its sequelae remain a significant risk to neonates, and clinicians should be able to recognize the signs and symptoms to provide timely antibiotic therapy. This article discusses of the pathogenesis, risk factors, clinical manifestations, diagnostics, and treatment of neonatal late-onset GBS infection and identifies implications for practicing clinicians. [ABSTRACT FROM AUTHOR]

Background: Globally, socioeconomic status (SES) is an important health determinant across a range of health conditions and diseases. However, measuring SES within low- and middle-income countries (LMICs) can be particularly challenging given the variation and diversity of LMIC populations. Objective: The current study investigates whether maternal SES as assessed by the newly developed Global Network-SES Index is associated with pregnancy outcomes (stillbirths, perinatal mortality, and neonatal mortality) in six LMICs: Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan, and Zambia. Methods: The analysis included data from 87,923 women enrolled in the Maternal and Newborn Health Registry of the NICHD-funded Global Network for Women's and Children's Health Research. Generalized estimating equations models were computed for each outcome by SES level (high, moderate, or low) and controlling for site, maternal age, parity, years of schooling, body mass index, and facility birth, including sampling cluster as a random effect. Results: Women with low SES had significantly higher risks for stillbirth (p < 0.001), perinatal mortality (p = 0.001), and neonatal mortality (p = 0.005) than women with high SES. In addition, those with moderate SES had significantly higher risks of stillbirth (p = 0.003) and perinatal mortality (p = 0.008) in comparison to those with high SES. Conclusion: The SES categories were associated with pregnancy outcomes, supporting the validity of the index as a non–income-based measure of SES for use in studies of pregnancy outcomes in LMICs. [ABSTRACT FROM AUTHOR]

Background The multicountry Women First trial demonstrated that nutritional supplementation initiated prior to conception (arm 1) or early pregnancy (arm 2) and continued until delivery resulted in significantly greater length at birth and 6 mo compared with infants in the control arm (arm 3). Objectives We evaluated intervention effects on infants' longitudinal growth trajectory from birth through 24 mo and identified predictors of length status and stunting at 24 mo. Methods Infants' anthropometry was obtained at 6, 12, 18, and 24 mo after the Women First trial (registered at clinicaltrials.gov as NCT01883193), which was conducted in low-resource settings: Democratic Republic of Congo, Guatemala, India, and Pakistan. Longitudinal models evaluated intervention effects on infants' growth trajectory from birth to 24 mo, with additional modeling used to identify adjusted predictors for growth trajectories and outcomes at 24 mo. Results Data for 2337 (95% of original live births) infants were evaluated. At 24 mo, stunting rates were 62.8%, 64.8%, and 66.3% for arms 1, 2, and 3, respectively (NS). For the length-for-age z -score (LAZ) trajectory, treatment arm was a significant predictor, with adjusted mean differences of 0.19 SD (95% CI: 0.08, 0.30; P  < 0.001) and 0.17 SD (95% CI: 0.07, 0.27; P  < 0.001) for arms 1 and 2, respectively. The strongest predictors of LAZ at 24 mo were birth LAZ <–2 and <–1 to ≥–2, with adjusted mean differences of –0.76 SD (95% CI: –0.93, –0.58; P  < 0.001) and –0.47 SD (95% CI: –0.56, –0.38; P  < 0.001), respectively. For infants with ultrasound-determined gestational age (n  = 1329), the strongest predictors of stunting were birth LAZ <–2 and <–1 to ≥– 2: adjusted relative risk of 1.62 (95% CI: 1.39, 1.88; P  < 0.001) and 1.46 (95% CI: 1.31, 1.62; P  < 0.001), respectively. Conclusions Substantial improvements in postnatal growth are likely to depend on improved intrauterine growth, especially during early pregnancy. [ABSTRACT FROM AUTHOR]

Objective: On a population basis, we assessed medical care for pregnant women in specific geographic regions of six countries before and during the first year of the COVID-19 pandemic in relationship to pregnancy outcomes.Design: Prospective, population-based study.Setting: Communities in Kenya, Zambia, the Democratic Republic of the Congo, Pakistan, India, and Guatemala.Population: Pregnant women enrolled in the Global Network for Women's and Children's Health's Maternal and Newborn Health Registry METHODS: Pregnancy/delivery care services and pregnancy outcomes in the pre-COVID-19 time-period (March 2019-February 2020) were compared to the COVID-19 time-period (March 2020-February 2021).Main Outcome Measures: Stillbirth, neonatal mortality, preterm birth, low birth weight, maternal mortality RESULTS: Across all sites, a small but statistically significant increase in home births occurred between the pre-COVID and COVID periods. (18.9% vs 20.3%, aRR 1.12 95% CI 1.05, 1.19). Also, a small but significant decrease in the mean number of antenatal care visits (4.1 - 4.0, p= <0.0001) was seen during the COVID-19 period. Of outcomes evaluated, overall, a small but significant decrease in low-birthweight in the COVID-19 period occurred (15.7% vs 14.6%, aRR 0.94 (0.89, 0.99), but we did not observe any significant differences in other outcomes. There was no change observed in maternal mortality or antenatal haemorrhage overall or at any of the sites.Conclusions: Small but significant increases in home births and decreases in the ANC services were observed during the initial COVID-19 period; however, there was not an increase in the stillbirth, neonatal mortality, maternal mortality, low birth weight or preterm birth rates during the COVID-19 period as compared to the prior year. Further research should help elucidate the relationship between access to and use of pregnancy-related medical services and birth outcomes over an extended period. [ABSTRACT FROM AUTHOR]

Background: Low dose aspirin (LDA) is an effective strategy to reduce preterm birth. However, LDA might have differential effects globally, based on the etiology of preterm birth. In some regions, malaria in pregnancy could be an important modifier of LDA on birth outcomes and anemia.Methods: This is a sub-study of the ASPIRIN trial, a multi-national, randomized, placebo controlled trial evaluating LDA effect on preterm birth. We enrolled a convenience sample of women in the ASPIRIN trial from the Democratic Republic of Congo (DRC), Kenya and Zambia. We used quantitative polymerase chain reaction to detect malaria. We calculated crude prevalence proportion ratios (PRs) for LDA by malaria for outcomes, and regression modelling to evaluate effect measure modification. We evaluated hemoglobin in late pregnancy based on malaria infection in early pregnancy.Results: One thousand four hundred forty-six women were analyzed, with a malaria prevalence of 63% in the DRC site, 38% in the Kenya site, and 6% in the Zambia site. Preterm birth occurred in 83 (LDA) and 90 (placebo) women, (PR 0.92, 95% CI 0.70, 1.22), without interaction between LDA and malaria (p = 0.75). Perinatal mortality occurred in 41 (LDA) and 43 (placebo) pregnancies, (PR 0.95, 95% CI 0.63, 1.44), with an interaction between malaria and LDA (p = 0.014). Hemoglobin was similar by malaria and LDA status.Conclusions: Malaria in early pregnancy did not modify the effects of LDA on preterm birth, but modified the effect of LDA on perinatal mortality. This effect measure modification deserves continued study as LDA is used in malaria endemic regions. [ABSTRACT FROM AUTHOR]

Background Adequate gestational weight gain (GWG) is essential for healthy fetal growth. However, in low- and middle-income countries, where malnutrition is prevalent, little information is available about GWG and how it might be modified by nutritional status and interventions. Objective We describe GWG and its associations with fetal growth and birth outcomes. We also examined the extent to which prepregnancy BMI, and preconception and early weight gain modify GWG, and its effects on fetal growth. Methods This was a secondary analysis of the Women First Trial, including 2331 women within the Democratic Republic of Congo (DRC), Guatemala, India, and Pakistan, evaluating weight gain from enrollment to ∼12 weeks of gestation and GWG velocity (kg/wk) between ∼12 and 32 weeks of gestation. Adequacy of GWG velocity was compared with 2009 Institute of Medicine recommendations, according to maternal BMI. Early weight gain (EWG), GWG velocity, and adequacy of GWG were related to birth outcomes using linear and Poisson models. Results GWG velocity (mean ± SD) varied by site: 0.22 ± 0.15 kg/wk in DRC, 0.30 ± 0.23 in Pakistan, 0.31 ± 0.14 in Guatemala, and 0.39 ± 0.13 in India, (P  <0.0001). An increase of 0.1 kg/wk in maternal GWG was associated with a 0.13 cm (95% CI: 0.07, 0.18, P  <0.001) increase in birth length and a 0.032 kg (0.022, 0.042, P  <0.001) increase in birth weight. Compared to women with inadequate GWG, women who had adequate GWG delivered newborns with a higher mean length and weight: 47.98 ± 2.04 cm compared with 47.40 ± 2.17 cm (P  <0.001) and 2.864 ± 0.425 kg compared with 2.764 ± 0.418 kg (P  <0.001). Baseline BMI, EWG, and GWG were all associated with birth length and weight. Conclusions These results underscore the importance of adequate maternal nutrition both before and during pregnancy as a potentially modifiable factor to improve fetal growth. [ABSTRACT FROM AUTHOR]

Objective: Legal, ethical, and regulatory requirements of medical research uniformly call for informed consent. We aimed to characterize and compare consent rates for neonatal randomized controlled trials in low- and lower middle-income countries versus high-income countries, and to evaluate the influence of study characteristics on consent rates. Methods: In this systematic review, we searched MEDLINE, EMBASE and Cochrane for randomized controlled trials of neonatal interventions in low- and lower middle-income countries or high-income countries published 01/01/2013 to 01/04/2018. Our primary outcome was consent rate, the proportion of eligible participants who consented amongst those approached, extracted from the article or email with the author. Using a generalised linear model for fractional dependent variables, we analysed the odds of consenting in low- and lower middle-income countries versus high-income countries across control types and interventions. Findings: We screened 3523 articles, yielding 300 eligible randomized controlled trials with consent rates available for 135 low- and lower middle-income country trials and 65 high-income country trials. Median consent rates were higher for low- and lower middle-income countries (95.6%; interquartile range (IQR) 88.2–98.9) than high-income countries (82.7%; IQR 68.6–93.0; p<0.001). In adjusted regression analysis comparing low- and lower middle-income countries to high-income countries, the odds of consent for no placebo-drug/nutrition trials was 3.67 (95% Confidence Interval (CI) 1.87–7.19; p = 0.0002) and 6.40 (95%CI 3.32–12.34; p<0.0001) for placebo-drug/nutrition trials. Conclusion: Neonatal randomized controlled trials in low- and lower middle-income countries report consistently higher consent rates compared to high-income country trials. Our study is limited by the overrepresentation of India among randomized controlled trials in low- and lower middle-income countries. This study raises serious concerns about the adequacy of protections for highly vulnerable populations recruited to clinical trials in low- and lower middle-income countries. [ABSTRACT FROM AUTHOR]

Background: Preterm birth continues to be a major public health problem contributing to 75% of the neonatal mortality worldwide. Low birth weight (LBW) is an important but imperfect surrogate for prematurity when accurate assessment of gestational age is not possible. While there is overlap between preterm birth and LBW newborns, those that are both premature and LBW are at the highest risk of adverse neonatal outcomes. Understanding the epidemiology of preterm birth and LBW is important for prevention and improved care for at risk newborns, but in many countries, data are sparse and incomplete. Methods: We conducted data analyses using the Global Network's (GN) population-based registry of pregnant women and their babies in rural communities in six low- and middle-income countries (Democratic Republic of Congo, Kenya, Zambia, Guatemala, India and Pakistan). We analyzed data from January 2014 to December 2018. Trained study staff enrolled all pregnant women in the study catchment area as early as possible during pregnancy and conducted follow-up visits shortly after delivery and at 42 days after delivery. We analyzed the rates of preterm birth, LBW and the combination of preterm birth and LBW and studied risk factors associated with these outcomes across the GN sites. Results: A total of 272,192 live births were included in the analysis. The overall preterm birth rate was 12.6% (ranging from 8.6% in Belagavi, India to 21.8% in the Pakistani site). The overall LBW rate was 13.6% (ranging from 2.7% in the Kenyan site to 21.4% in the Pakistani site). The overall rate of both preterm birth and LBW was 5.5% (ranging from 1.2% in the Kenyan site to 11.0% in the Pakistani site). Risk factors associated with preterm birth, LBW and the combination were similar across sites and included nulliparity [RR − 1.27 (95% CI 1.21–1.33)], maternal age under 20 [RR 1.41 (95% CI 1.32–1.49)] years, severe antenatal hemorrhage [RR 5.18 95% CI 4.44–6.04)], hypertensive disorders [RR 2.74 (95% CI − 1.21–1.33], and 1–3 antenatal visits versus four or more [RR 1.68 (95% CI 1.55–1.83)]. Conclusions: Preterm birth, LBW and their combination continue to be common public health problems at some of the GN sites, particularly among young, nulliparous women who have received limited antenatal care services. Trial registration The identifier of the Maternal and Newborn Health Registry at ClinicalTrials.gov is NCT01073475.Trial registration: The identifier of the Maternal and Newborn Health Registry at ClinicalTrials.gov is NCT01073475. [ABSTRACT FROM AUTHOR]

Background: Maternal mortality is a public health problem that disproportionately affects low and lower-middle income countries (LMICs). Appropriate data sources are lacking to effectively track maternal mortality and monitor changes in this health indicator over time. Methods: We analyzed data from women enrolled in the NICHD Global Network for Women's and Children's Health Research Maternal Newborn Health Registry (MNHR) from 2010 through 2018. Women delivering within research sites in the Democratic Republic of Congo, Guatemala, India (Nagpur and Belagavi), Kenya, Pakistan, and Zambia are included. We evaluated maternal and delivery characteristics using log-binomial models and multivariable models to obtain relative risk estimates for mortality. We used running averages to track maternal mortality ratio (MMR, maternal deaths per 100,000 live births) over time. Results: We evaluated 571,321 pregnancies and 842 maternal deaths. We observed an MMR of 157 / 100,000 live births (95% CI 147, 167) across all sites, with a range of MMRs from 97 (76, 118) in the Guatemala site to 327 (293, 361) in the Pakistan site. When adjusted for maternal risk factors, risks of maternal mortality were higher with maternal age > 35 (RR 1.43 (1.06, 1.92)), no maternal education (RR 3.40 (2.08, 5.55)), lower education (RR 2.46 (1.54, 3.94)), nulliparity (RR 1.24 (1.01, 1.52)) and parity > 2 (RR 1.48 (1.15, 1.89)). Increased risk of maternal mortality was also associated with occurrence of obstructed labor (RR 1.58 (1.14, 2.19)), severe antepartum hemorrhage (RR 2.59 (1.83, 3.66)) and hypertensive disorders (RR 6.87 (5.05, 9.34)). Before and after adjusting for other characteristics, physician attendance at delivery, delivery in hospital and Caesarean delivery were associated with increased risk. We observed variable changes over time in the MMR within sites. Conclusions: The MNHR is a useful tool for tracking MMRs in these LMICs. We identified maternal and delivery characteristics associated with increased risk of death, some might be confounded by indication. Despite declines in MMR in some sites, all sites had an MMR higher than the Sustainable Development Goals target of below 70 per 100,000 live births by 2030. Trial registration: The MNHR is registered at NCT01073475. [ABSTRACT FROM AUTHOR]

Background: Birth weight (BW) is a strong predictor of neonatal outcomes. The purpose of this study was to compare BWs between global regions (south Asia, sub-Saharan Africa, Central America) prospectively and to determine if trends exist in BW over time using the population-based maternal and newborn registry (MNHR) of the Global Network for Women'sand Children's Health Research (Global Network). Methods: The MNHR is a prospective observational population-based registryof six research sites participating in the Global Network (2013–2018), within five low- and middle-income countries (Kenya, Zambia, India, Pakistan, and Guatemala) in threeglobal regions (sub-Saharan Af rica, south Asia, Central America). The birth weights were obtained for all infants born during the study period. This was done either by abstracting from the infants' health facility records or from direct measurement by the registry staff for infants born at home. After controlling for demographic characteristics, mixed-effect regression models were utilized to examine regional differences in birth weights over time. Results: The overall BW meanswere higher for the African sites (Zambia and Kenya), 3186 g (SD 463 g) in 2013 and 3149 g (SD 449 g) in 2018, ascompared to Asian sites (Belagavi and Nagpur, India and Pakistan), 2717 g (SD450 g) in 2013 and 2713 g (SD 452 g) in 2018. The Central American site (Guatemala) had a mean BW intermediate between the African and south Asian sites, 2928 g (SD 452) in 2013, and 2874 g (SD 448) in 2018. The low birth weight (LBW) incidence was highest in the south Asian sites (India and Pakistan) and lowest in the African sites (Kenya and Zambia). The size of regional differences varied somewhat over time with slight decreases in the gap in birth weights between the African and Asian sites and slight increases in the gap between the African and Central American sites. Conclusions: Overall, BWmeans by global region did not change significantly over the 5-year study period. From 2013 to 2018, infants enrolled at the African sites demonstrated the highest BW means overall across the entire study period, particularly as compared to Asian sites. The incidence of LBW was highest in the Asian sites (India and Pakistan) compared to the African and Central American sites. Trial registration The study is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475. [ABSTRACT FROM AUTHOR]

Background: Oligohydramnios is a condition of abnormally low amniotic fluid volume that has been associated with poor pregnancy outcomes. To date, the prevalence of this condition and its outcomes has not been well described in low and low-middle income countries (LMIC) where ultrasound use to diagnose this condition in pregnancy is limited. As part of a prospective trial of ultrasound at antenatal care in LMICs, we sought to evaluate the incidence of and the adverse maternal, fetal and neonatal outcomes associated with oligohydramnios. Methods: We included data in this report from all pregnant women in community settings in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo (DRC) who received a third trimester ultrasound as part of the First Look Study, a randomized trial to assess the value of ultrasound at antenatal care. Using these data, we conducted a planned secondary analysis to compare pregnancy outcomes of women with to those without oligohydramnios. Oligohydramnios was defined as measurement of an Amniotic Fluid Index less than 5 cm in at least one ultrasound in the third trimester. The outcomes assessed included maternal morbidity and fetal and neonatal mortality, preterm birth and low-birthweight. We used pairwise site comparisons with Tukey-Kramer adjustment and multivariable logistic models using general estimating equations to account for the correlation of outcomes within cluster. Results: Of 12,940 women enrolled in the clusters in Guatemala, Pakistan, Zambia and the DRC in the First Look Study who had a third trimester ultrasound examination, 87 women were diagnosed with oligohydramnios, equivalent to 0.7% of those studied. Prevalence of detected oligohydramnios varied among study sites; from the lowest of 0.2% in Zambia and the DRC to the highest of 1.5% in Pakistan. Women diagnosed with oligohydramnios had higher rates of hemorrhage, fetal malposition, and cesarean delivery than women without oligohydramnios. We also found unfavorable fetal and neonatal outcomes associated with oligohydramnios including stillbirths (OR 5.16, 95%CI 2.07, 12.85), neonatal deaths < 28 days (OR 3.18, 95% CI 1.18, 8.57), low birth weight (OR 2.10, 95% CI 1.44, 3.07) and preterm births (OR 2.73, 95%CI 1.76, 4.23). The mean birth weight was 162 g less (95% CI -288.6, − 35.9) with oligohydramnios. Conclusions: Oligohydramnos was associated with worse neonatal, fetal and maternal outcomes in LMIC. Further research is needed to assess effective interventions to diagnose and ultimately to reduce poor outcomes in these settings. Trial registration: NCT01990625. [ABSTRACT FROM AUTHOR]

Background: Reported benefits of maternal nutrition supplements commenced during pregnancy in low-resource populations have typically been quite limited. Objectives: This study tested the effects on newborn size, especially length, of commencing nutrition supplements for women in low-resource populations ≥3 mo before conception (Arm 1), compared with the same supplement commenced late in the first trimester of pregnancy (Arm 2) or not at all (control Arm 3). Methods: Women First was a 3-arm individualized randomized controlled trial (RCT). The intervention was a lipid-based micronutrient supplement; a protein-energy supplement was also provided if maternal body mass index (kg/m²) was <20 or gestational weight gain was less than recommendations. Study sites were in rural locations of the Democratic Republic of the Congo (DRC), Guatemala, India, and Pakistan. The primary outcome was length-for-age z score (LAZ), with all anthropometry obtained <48 h post delivery. Because gestational ages were unavailable in DRC, outcomes were determined for all 4 sites from WHO newborn standards (non-gestational-age-adjusted, NGAA) as well as INTERGROWTH-21st fetal standards (3 sites, gestational age-adjusted, GAA). Results: A total of 7387 nonpregnant women were randomly assigned, yielding 2451 births with NGAA primary outcomes and 1465 with GAA outcomes. Mean LAZ and other outcomes did not differ between Arm 1 and Arm 2 using either NGAA or GAA. Mean LAZ (NGAA) for Arm 1 was greater than for Arm 3 (effect size: +0.19; 95% CI: 0.08, 0.30, P = 0.0008). For GAA outcomes, rates of stunting and small-for-gestational-age were lower in Arm 1 than in Arm 3 (RR: 0.69; 95% CI: 0.49, 0.98, P = 0.0361 and RR: 0.78; 95% CI: 0.70, 0.88, P < 0.001, respectively). Rates of preterm birth did not differ among arms. Conclusions: In low-resource populations, benefits on fetal growth–related birth outcomes were derived from nutrition supplements commenced before conception or late in the first trimester. [ABSTRACT FROM AUTHOR]

Objectives. To estimate the impact of hypothetical antimalarial and nutritional interventions (which reduce the prevalence of low midupper arm circumference [MUAC]) on the incidence of low birth weight (LBW). Methods. We analyzed data from 14 633 pregnancies from 13 studies conducted across Africa and the Western Pacific from 1996 to 2015. We calculated population intervention effects for increasing intermittent preventive therapy in pregnancy (IPTp), full coverage with bed nets, reduction in malaria infection at delivery, and reductions in the prevalence of low MUAC. Results. We estimated that, compared with observed IPTp use, administering 3 or more doses of IPTp to all women would decrease the incidence of LBW from 9.9% to 6.9% (risk difference = 3.0%;95% confidence interval = 1.7%, 4.0%). The intervention effects for eliminating malaria at delivery, increasing bed net ownership, and decreasing low MUAC prevalence were all modest. Conclusions. Increasing IPTp uptake to at least 3 doses could decrease the incidence of LBW in malaria-endemic countries. The impact of IPTp on LBW was greater than the effect of prevention of malaria, consistent with a nonmalarial effect of IPTp, measurement error, or selection bias. [ABSTRACT FROM AUTHOR]

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

Micronutrient deficiency is an important cause of growth stunting. To avoid micronutrient deficiency, the World Health Organization recommends complementary feeding with animal‐source foods. However, animal‐source foods are not readily available in many parts of the Democratic Republic of Congo (DRC). In such areas, caterpillars are a staple in adult diets and may be suitable for complementary feeding for infants and young children. We developed a cereal made from dried caterpillars and other locally available ingredients (ground corn, palm oil, sugar and salt), measured its macro‐ and micronutrient contents and evaluated for microbiologic contamination. Maternal and infant acceptability was evaluated among 20 mothers and their 8–10‐month‐old infants. Mothers were instructed in the preparation of the cereal and asked to evaluate the cereal in five domains using a Likert scale. Mothers fed their infants a 30‐g portion daily for 1 week. Infant acceptability was based on cereal consumption and the occurrence of adverse events. The caterpillar cereal contained 132 kcal, 6.9‐g protein, 3.8‐mg iron and 3.8‐mg zinc per 30 g and was free from microbiologic contamination. Mothers’ median ratings for cereal characteristics were (5 = like very much): overall impression = 4, taste = 5, smell = 4, texture = 4, colour = 5, and consistency = 4. All infants consumed more than 75% of the daily portions, with five infants consuming 100%. No serious adverse events were reported. We conclude that a cereal made from locally available caterpillars has appropriate macro‐ and micronutrient contents for complementary feeding, and is acceptable to mothers and infants in the DRC. [ABSTRACT FROM AUTHOR]

ObjectiveWe conducted a cluster-randomized controlled trial to assess the efficacy of a cereal made from caterpillars, a micronutrient-rich, locally available alternative animal-source food, on reducing stunting and anaemia in infants in the Democratic Republic of Congo.DesignSix-month-old infants were cluster randomized to receive either caterpillar cereal daily until 18 months of age or the usual diet. At 18 months of age, anthropometric measurements and biological samples were collected.SettingThe rural Equateur Province in the Democratic Republic of Congo.SubjectsOne hundred and seventy-five infants followed from 6 to 18 months of age.ResultsStunting was common at 6 months (35 %) and the prevalence increased until 18 months (69 %). There was no difference in stunting prevalence at 18 months between the intervention and control groups (67 % v. 71 %, P=0·69). Infants in the cereal group had higher Hb concentration than infants in the control group (10·7 v. 10·1 g/dl, P=0·03) and fewer were anaemic (26 v. 50 %, P=0·006), although there was no difference in estimates of body Fe stores (6·7 v. 7·2 mg/kg body weight, P=0·44).ConclusionsSupplementation of complementary foods with caterpillar cereal did not reduce the prevalence of stunting at 18 months of age. However, infants who consumed caterpillar cereal had higher Hb concentration and fewer were anaemic, suggesting that caterpillar cereal might have some beneficial effect. The high prevalence of stunting at 6 months and the lack of response to this micronutrient-rich supplement suggest that factors other than dietary deficiencies also contribute to stunting. [ABSTRACT FROM AUTHOR]

Background: Health centers in low-income countries often depend on donations to provide appropriate diagnostic equipment. However, donations are sometimes made without an understanding of the recipient's needs, practical constraints or sustainability of supplies. Methods:We donated a set of physical diagnostic equipment, non-invasive instrument tests and laboratory supplies to a rural health center in the Democratic Republic of Congo. We collected information on the usage and durability of equipment and supplies for each patient encounter over a 1-year period. Results:We recorded 913 patient encounters. The most commonly used physical diagnostic equipment were the stethoscope (98.9%; 903/913), thermometer (81.7%; 746/913), adult scale (81.4%; 744/913), stop watch (62.6%; 572/913), adult sphygmomanometer (55.8%; 510/913), infant scale (24.9%; 228/913), measuring tape (24.3%; 222/913) and fetoscope (23.8%; 218/913). The most commonly used laboratory tests were the blood smear for malaria (53.7%; 491/913), hematocrit (23.5%; 215/913), urinalysis (20.1%; 184/913) and sputum stain for TB (13.3%; 122/913). With the exception of a penlight and solar lantern, all equipment remained functional. Conclusions: This study adds valuable information about the utility and durability of equipment supplied to a health center in the Democratic Republic of Congo. Our results might aid in determining the appropriateness of donated medical equipment in similar settings. The selection of donated goods should be made with knowledge of the context in which it will be used, and utilization should be monitored. [ABSTRACT FROM AUTHOR]

Background: Because large, prospective, population-based data sets describing maternal outcomes are typically not available in low- and middle-income countries, it is difficult to monitor maternal mortality rates over time and to identify factors associated with maternal mortality. Early identification of risk factors is essential to develop comprehensive intervention strategies preventing pregnancy-related complications. Our objective was to describe maternal mortality rates in a large, multi-country dataset and to determine maternal, pregnancy-related, delivery and postpartum characteristics that are associated with maternal mortality. Methods: We collected data describing all pregnancies from 2010 to 2013 among women enrolled in the multinational Global Network for Women's and Children's Health Research Maternal and Neonatal Health Registry (MNHR). We reported the proportion of mothers who died per pregnancy and the maternal mortality ratio (MMR). Generalized linear models were used to evaluate the relationship of potential medical and social factors and maternal mortality and to develop point and interval estimates of relative risk associated with these factors. Generalized estimating equations were used to account for the correlation of outcomes within cluster to develop appropriate confidence intervals. Results: We recorded 277,736 pregnancies and 402 maternal deaths for an MMR of 153/100,000 live births. We observed an improvement in the total MMR from 166 in 2010 to 126 in 2013. The MMR in Latin American sites (91) was lower than the MMR in Asian (178) and African sites (125). When adjusted for study site and the other variables, no formal education (RR 3.2 [1.5, 6.9]), primary education only (RR 3.4 [1.6, 7.5]), secondary education only (RR 2.5 [1.1, 5.7]), lack of antenatal care (RR 1.8 [1.2, 2.5]), caesarean section delivery (RR 1.9 [1.3, 2.8]), hemorrhage (RR 3.3 [2.2, 5.1]), and hypertensive disorders (RR 7.4 [5.2, 10.4]) were associated with higher risks of death. Conclusions: The MNHR identified preventable causes of maternal mortality in diverse settings in low- and middleincome countries. The MNHR can be used to monitor public health strategies and determine their association with reducing maternal mortality. [ABSTRACT FROM AUTHOR]

Background: The Global Network for Women's and Children's Health Research (Global Network) supports and conducts clinical trials in resource-limited countries by pairing foreign and U.S. investigators, with the goal of evaluating low-cost, sustainable interventions to improve the health of women and children. Accurate reporting of births, stillbirths, neonatal deaths, maternal mortality, and measures of obstetric and neonatal care is critical to efforts to discover strategies for improving pregnancy outcomes in resource-limited settings. Because most of the sites in the Global Network have weak registration within their health care systems, the Global Network developed the Maternal Newborn Health Registry (MNHR), a prospective, population-based registry of pregnancies at the Global Network sites to provide precise data on health outcomes and measures of care. Methods: Pregnant women are enrolled in the MNHR if they reside in or receive healthcare in designated groups of communities within sites in the Global Network. For each woman, demographic, health characteristics and major outcomes of pregnancy are recorded. Data are recorded at enrollment, the time of delivery and at 42 days postpartum. Results: From 2010 through 2013 Global Network sites were located in Argentina, Guatemala, Belgaum and Nagpur, India, Pakistan, Kenya, and Zambia. During this period, 283,496 pregnant women were enrolled in the MNHR; this number represented 98.8% of all eligible women. Delivery data were collected for 98.8% of women and 42-day follow-up data for 98.4% of those enrolled. In this supplement, there are a series of manuscripts that use data gathered through the MNHR to report outcomes of these pregnancies. Conclusions: Developing public policy and improving public health in countries with poor perinatal outcomes is, in part, dependent upon understanding the outcome of every pregnancy. 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, populationbased registry, assesses pregnancy outcomes over time in support of efforts to develop improved perinatal healthcare in resource-limited areas. [ABSTRACT FROM AUTHOR]

Background: Neonatal deaths in first 28-days of life represent 47% of all deaths under the age of five years globally and are a focus of the United Nation's (UN's) Sustainable Development Goals. Pregnant women are delivering in facilities but that does not indicate quality of care during delivery and the postpartum period. The World Health Organization's Essential Newborn Care (ENC) package reduces neonatal mortality, but lacks a simple and valid composite index that measures its effectiveness. Methods: Data on 5 intra-partum and 3 post-partum practices (indicators) recommended as part of ENC, routinely collected in NICHD's Global Network's (GN) Maternal Newborn Health Registry (MNHR) between 2010 and 2013, were included. We evaluated if all 8 practices (Care around Delivery – CAD), combined as an index was associated with reduced early neonatal mortality rates (days 0–6 of life). Results: A total of 150,848 live births were included in the analysis. The individual indicators varied across sites. All components were present in 19.9% births (range 0.4 to 31% across sites). Present indicators (8 components) were associated with reduced early neonatal mortality [adjusted RR (95% CI):0.81 (0.77, 0.85); p < 0.0001]. Despite an overall association between CAD and early neonatal mortality (RR < 1.0 for all early mortality): delivery by skilled birth attendant; presence of fetal heart and delayed bathing were associated with increased early neonatal mortality. Conclusions: Present indicators (8 practices) of CAD were associated with a 19% reduction in the risk of neonatal death in the diverse health facilities where delivery occurred within the GN MNHR. These indicators could be monitored to identify facilities that need to improve compliance with ENC practices to reduce preventable neonatal deaths. Three of the 8 indicators were associated with increased neonatal mortality, due to baby being sick at birth. Although promising, this composite index needs refinement before use to monitor facility-based quality of care in association with early neonatal mortality. Trial registration The identifier of the Maternal Newborn Health Registry at ClinicalTrials.gov is NCT01073475. [ABSTRACT FROM AUTHOR]

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

Background: In many low and low-middle income countries, the incidence of polyhydramnios is unknown, in part because ultrasound technology is not routinely used. Our objective was to report the incidence of polyhydramnios in five low and low-middle income countries, to determine maternal characteristics associated with polyhydramnios, and report pregnancy and neonatal outcomes.Methods: We performed a secondary analysis of the First Look Study, a multi-national, cluster-randomized trial of ultrasound during prenatal care. We evaluated all women enrolled from Guatemala, Pakistan, Zambia, Kenya and the Democratic Republic of Congo (DRC) who received an examination by prenatal ultrasound. We used pairwise site comparisons with Tukey-Kramer adjustment and multivariable logistic models with general estimating equations to control for cluster-level effects. The diagnosis of polyhydramnios was confrimed by an U.S. based radiologist in a majority of cases (62%).Results: We identified 305/18,640 (1.6%) cases of polyhydramnios. 229 (75%) cases were from the DRC, with an incidence of 10%. A higher percentage of women with polyhydramnios experienced obstructed labor (7% vs 4%) and fetal malposition (4% vs 2%). Neonatal death was more common when polyhydramnios was present (OR 2.43; CI 1.15, 5.13).Conclusions: Polyhydramnios occured in these low and low-middle income countries at a rate similar to high-income contries except in the DRC where the incidence was 10%. Polyhydramnios was associated with obstructed labor, fetal malposition, and neonatal death.Trial Registration: NCT01990625 , November 21, 2013. [ABSTRACT FROM AUTHOR]