Detection and Risk Stratification of Women at High Risk of Preterm Birth in Rural Communities near Nagpur, India

Background: Presently, preterm birth is globally the leading cause of neonatal mortality. Prompt community based identification of women at high risk for preterm births (HRPB) can either help to avert preterm births or avail effective interventions to reduce neonatal mortality due to preterm births. We evaluated the performance of a package to train community workers to detect the presence of signs or symptoms of HRPB. Methods: Pregnant women enrolled in the intervention arm of a cluster randomized trial of Antenatal Corticosteroids (ACT Trial) conducted at Nagpur, India were informed about 4 directly observable signs and symptoms of preterm labor. Community health workers actively monitored these women from 24 to 36 weeks of gestation for these signs or symptoms. If they were present (HRPB positive) the identified women were brought to government health facilities for assessment and management. HRPB positive could also be determined by the provider if the woman presented directly to the facility. Risk stratification was based on the number of signs or symptoms present. The outcome of preterm birth was based on the clinical assessment of gestational age \u3c 37 weeks at delivery or a birth weight of \u3c2000 g. Results: Between July 1, 2012 and 30 November, 2013, 686 of 7050 (9.7%) pregnant women studied, delivered preterm. 732 (10.4%) women were HRPB positive, of whom 333 (45.5%) delivered preterm. Of the remaining 6318(89.6%) HRPB negative women 353 (5.6%) delivered preterm. The likelihood ratio (LR) of a preterm birth in the HRPB positives was 8.14 (95% confidence interval 7.16-9.26). The LR of a preterm birth increased in women who had more signs or symptoms of HRBP (p \u3c 0.00001). More signs or symptoms of HRPB were also associated with a shorter time to delivery, lower birth weight and higher rates of stillbirths, neonatal deaths and postnatal complications. Addition of risk stratification improved the prediction of preterm delivery (Integrated Discrimination Improvement 17% (95% CI 15-19%)). Conclusions: The package for detection of signs and symptoms of HRPB is feasible, promising and likely to improve management of preterm labor. Trial registration: NCT01073475 on February 21, 2010 and NCT01084096 on March 9, 2010

Exclusive Breastfeeding and Developmental and Behavioral Status in Early Childhood

Breastfeeding during infancy may have beneficial effects on various developmental outcomes in childhood. In this study, exclusively breastfed infants were randomly assigned to receive complementary foods from the age of 4 months in addition to breast milk (CF, n = 60), or to exclusively breastfeed to 6 months (EBF, n = 59). At 18 months and again at 30–35 months of age, the children were evaluated with the Parent’s Evaluation of Developmental Status questionnaire (PEDS) and the Brigance Screens-II. The parents completed the PEDS questionnaire at both time intervals and the children underwent the Brigance Screens-II at 30–35 months. At 30–35 months, no significant differences were seen in developmental scores from the Brigance screening test (p = 0.82). However, at 30–35 months a smaller percentage of parents in group CF (2%) had concerns about their children’s gross motor development compared to those in group EBF (19%; p = 0.01), which remained significant when adjusted for differences in pre-randomization characteristics (p = 0.03). No sustained effect of a longer duration of exclusive breastfeeding was seen on selected measures of developmental and behavioral status at 18 months, although at 30–35 months, a smaller percentage of parents of children introduced to complementary foods at four months of age expressed concerns about their gross motor development

Similarity of chest X-ray and thermal imaging of focal pneumonia: a randomised proof of concept study at a large urban teaching hospital

OBJECTIVE: To assess the diagnostic accuracy of thermal imaging (TI) in the setting of focal consolidative pneumonia with chest X-ray (CXR) as the gold standard. SETTING: A large, 973-bed teaching hospital in Boston, Massachusetts. PARTICIPANTS: 47 patients enrolled, 15 in a training set, 32 in a test set. Age range 10 months to 82 years (median=50 years). MATERIALS AND METHODS: Subjects received CXR with subsequent TI within 4 hours of each other. CXR and TI were assessed in blinded random order. Presence of focal opacity (pneumonia) on CXR, the outcome parameter, was recorded. For TI, presence of area(s) of increased heat (pneumonia) was recorded. Fisher\u27s exact test was used to assess the significance of the correlations of positive findings in the same anatomical region. RESULTS: With TI compared with the CXR (the outcome parameter), sensitivity was 80.0% (95% CIs 29.9% to 98.9%), specificity was 57.7% (95% CI 37.2% to 76.0%). Positive predictive value of TI was 26.7% (95% CI 8.9% to 55.2%) and its negative predictive value was 93.8% (95% CI 67.7% to 99.7%). CONCLUSIONS: This feasibility study confirms proof of concept that chest TI is consistent with CXR in suggesting similarly localised focal pneumonia with high sensitivity and negative predictive value. Further investigation of TI as a point-of-care imaging modality is warranted

The relationship between birth intervals and adverse maternal and neonatal outcomes in six low and lower-middle income countries

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

Assessment of Obstetric and Neonatal Health Services in Developing Country Health Facilities

OBJECTIVE: To describe the staffing and availability of medical equipment and medications and the performance of procedures at health facilities providing maternal and neonatal care at African, Asian, and Latin American sites participating in a multicenter trial to improve emergency obstetric/neonatal care in communities with high maternal and perinatal mortality. STUDY DESIGN: In 2009, prior to intervention, we surveyed 136 hospitals and 228 clinics in 7 sites in Africa, Asia, and Latin America regarding staffing, availability of equipment/medications, and procedures including cesarean section. RESULTS: The coverage of physicians and nurses/midwives was poor in Africa and Latin America. In Africa, only 20% of hospitals had full-time physicians. Only 70% of hospitals in Africa and Asia had performed cesarean sections in the last 6 months. Oxygen was unavailable in 40% of African hospitals and 17% of Asian hospitals. Blood was unavailable in 80% of African and Asian hospitals. CONCLUSIONS: Assuming that adequate facility services are necessary to improve pregnancy outcomes, it is not surprising that maternal and perinatal mortality rates in the areas surveyed are high. The data presented emphasize that to reduce mortality in these areas, resources that result in improved staffing and sufficient equipment, supplies, and medication, along with training, are required.Fil: Manasyan, Albert. Centre for Infectious Disease Zambia; Zambia. University of Alabama at Birmingahm; Estados UnidosFil: Saleem, Sarah. Aga Khan University; PakistánFil: Koso Thomas, Marion. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Estados UnidosFil: Althabe, Fernando. Instituto de Efectividad Clínica y Política de Salud. Departamento de Investigación en Salud Madre e Infantil. Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Pasha, Omrana. Aga Khan University; PakistánFil: Chomba, Elwyn. Centre for Infectious Disease Zambia; Zambia. University of Alabama at Birmingahm; Estados Unidos. University of Zambia; ZambiaFil: Goudar, Shivaprasad S.. KLE; IndiaFil: Patel, Archana. Indira Gandhi Government Medical College; IndiaFil: Esamai, Fabian. Moi University; KeniaFil: Garces, Ana. Francisco Marroquin University; GuatemalaFil: Kodkany, Bhala. KLE; IndiaFil: Belizan, Jose. Instituto de Efectividad Clínica y Política de Salud. Departamento de Investigación en Salud Madre e Infantil. Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: McClure, Elizabeth M.. Research Triangle Institute; Estados UnidosFil: Derman, Richard J.. Christiana Health Care; Estados UnidosFil: Hibberd, Patricia. Indiana University; Estados UnidosFil: Liechty, Edward A.. Massachusetts General Hospital for Children; Estados UnidosFil: Hambidge, K. Michael. State University of Colorado Boulder; Estados UnidosFil: Carlo, Waldemar A.. Centre for Infectious Disease Zambia; ZambiaFil: Buekens, Pierre. Tulane School of Public Health and Tropical Medicine; Estados UnidosFil: Moore, janet. Research Triangle Institute; Estados UnidosFil: Wright, Linda L.. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Estados UnidosFil: Goldenberg, Robert L.. Columbia University; Estados Unido

Gender variations in neonatal and early infant mortality in India and Pakistan: A secondary analysis from the global network maternal newborn health registry

Background: To determine the gender differences in neonatal mortality, stillbirths, and perinatal mortality in south Asia using the Global Network data from the Maternal Newborn Health Registry.Methods: This study is a secondary analysis of prospectively collected data from the three south Asian sites of the Global Network. The maternal and neonatal demographic, clinical characteristics, rates of stillbirths, early neonatal mortality (1-7 days), late neonatal mortality (8-28 days), mortality between 29-42 days and the number of infants hospitalized after birth were compared between the male and female infants.Results: Between 2010 and 2018, 297,509 births [154,790 males (52.03%) and 142,719 females (47.97%)] from two Indian sites and one Pakistani site were included in the analysis [288,859 live births (97.1%) and 8,648 stillbirths (2.9%)]. The neonatal mortality rate was significantly higher in male infants (33.2/1,000 live births) compared to their female counterparts (27.4/1,000, p \u3c 0.001). The rates of stillbirths (31.0 vs. 26.9/1000 births) and early neonatal mortality (27.1 vs 21.6/1000 live births) were also higher in males. However, there were no significant differences in late neonatal mortality (6.3 vs. 5.9/1000 live births) and mortality between 29-42 days (2.1 vs. 1.9/1000 live births) between the two groups. More male infants were hospitalized within 42 days after birth (1.8/1000 vs. 1.3/1000 live births, p \u3c 0.001) than females.Conclusion: The risks of stillbirths, and early neonatal mortality were higher among male infants than their female counterparts. However, there was no gender difference in mortality after 7 days of age. Our results highlight the importance of stratifying neonatal mortality into early and late neonatal period to better understand the impact of gender on neonatal mortality. The information from this study will help in developing strategies and identifying measures that can reduce differences in sex-specific mortality

The global network maternal newborn health registry: A multi-country, community-based registry of pregnancy outcomes

Background: The Global Network for Women\u27s and Children\u27s Health Research (Global Network) conducts clinical trials in resource-limited countries through partnerships among U.S. investigators, international investigators based in in low and middle-income countries (LMICs) and a central data coordinating center. The Global Network\u27s objectives include evaluating low-cost, sustainable interventions to improve women\u27s and children\u27s health in LMICs. Accurate reporting of births, stillbirths, neonatal deaths, maternal mortality, and measures of obstetric and neonatal care is critical to determine strategies for improving pregnancy outcomes. In response to this need, the Global Network developed the Maternal Newborn Health Registry (MNHR), a prospective, population-based registry of pregnant women, fetuses and neonates receiving care in defined catchment areas at the Global Network sites. This publication describes the MNHR, including participating sites, data management and quality and changes over time.Methods: Pregnant women who reside in or receive healthcare in select communities are enrolled in the MNHR of the Global Network. For each woman and her offspring, sociodemographic, health care, and the major outcomes through 42-days post-delivery are recorded. Study visits occur at enrollment during pregnancy, at delivery and at 42 days postpartum.Results: From 2010 through 2018, the Global Network MNHR sites were located in Guatemala, Belagavi and Nagpur, India, Pakistan, Democratic Republic of Congo, Kenya, and Zambia. During this period at these sites, 579,140 pregnant women were consented and enrolled in the MNHR, nearly 99% of all eligible women. Delivery data were collected for 99% of enrolled women and 42-day follow-up data for 99% of those delivered. In this supplement, the trends over time and assessment of differences across geographic regions are analyzed in a series of 18 manuscripts utilizing the MNHR data.Conclusions: Improving maternal, fetal and newborn health in countries with poor outcomes requires an understanding of the characteristics of the population, quality of health care and outcomes. Because the worst pregnancy outcomes typically occur in countries with limited health registration systems and vital records, alternative registration systems may prove to be highly valuable in providing data. The MNHR, an international, multicenter, population-based registry, assesses pregnancy outcomes over time in support of efforts to develop improved perinatal healthcare in resource-limited areas. Trial Registration The Maternal Newborn Health Registry is registered at Clinicaltrials.gov (ID# NCT01073475). Registered February 23, 2019. https://clinicaltrials.gov/ct2/show/NCT01073475

Regional trends in birth weight in low- and middle-income countries 2013-2018

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\u27sand Children\u27s 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\u27 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

Association of parity with birthweight and neonatal death in five sites: The global network\u27s maternal newborn health registry study

Background: Nulliparity has been associated with lower birth weight (BW) and other adverse pregnancy outcomes, with most of the data coming from high-income countries. In this study, we examined birth weight for gestational age z-scores and neonatal (28-day) mortality in a large prospective cohort of women dated by first trimester ultrasound from multiple sites in low and middle-income countries.Methods: Pregnant women were recruited during the first trimester of pregnancy and followed through 6 weeks postpartum from Maternal Newborn Health Registry (MNHR) sites in the Democratic Republic of Congo (DRC), Guatemala, Belagavi and Nagpur, India, and Pakistan from 2017 and 2018. Data related to the pregnancy and its outcomes were collected prospectively. First trimester ultrasound was used for determination of gestational age; (BW) was obtained in grams within 48 h of delivery and later transformed to weight for age z-scores (WAZ) adjusted for gestational age using the INTERGROWTH-21st standards.Results: 15,121 women were eligible and included. Infants of nulliparous women had lower mean BWs (males: 2676 gr, females: 2587 gr, total: 2634 gr) and gestational age adjusted weight for age z-scores (males: - 0.73, females: - 0.77, total: - 0.75,) than women with one or more previous pregnancies. The largest differences were between zero and one previous pregnancies among female infants. The associations of parity with BW and z-scores remained even after adjustment for maternal age, maternal height, maternal education, antenatal care visits, hypertensive disorders, and socioeconomic status. Nulliparous women also had a significantly higher \u3c 28-day neonatal mortality rate (27.7 per 1,000 live births) than parous women (17.2 and 20.7 for parity of 1-3 and ≥ 4 respectively). Risk of preterm birth was higher among women with ≥ 4 previous pregnancies (15.5%) compared to 11.3% for the nulliparous group and 11.8% for women with one to three previous pregnancies (p = 0.0072).Conclusions: In this large sample from diverse settings, nulliparity was independently associated with both lower BW and WAZ scores as well as higher neonatal mortality compared to multiparity