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  • 1
    In: Reproductive Health, Springer Science and Business Media LLC, Vol. 17, No. S2 ( 2020-11)
    Abstract: The Global Network for Women's and Children’s Health Research (Global Network) conducts clinical trials in resource-limited countries through partnerships among U.S. investigators, international investigators based in in low and middle-income countries (LMICs) and a central data coordinating center. The Global Network’s objectives include evaluating low-cost, sustainable interventions to improve women’s and children’s health in LMICs. Accurate reporting of births, stillbirths, neonatal deaths, maternal mortality, and measures of obstetric and neonatal care is critical to determine strategies for improving pregnancy outcomes. In response to this need, the Global Network developed the Maternal Newborn Health Registry (MNHR), a prospective, population-based registry of pregnant women, fetuses and neonates receiving care in defined catchment areas at the Global Network sites. This publication describes the MNHR, including participating sites, data management and quality and changes over time. Methods Pregnant women who reside in or receive healthcare in select communities are enrolled in the MNHR of the Global Network. For each woman and her offspring, sociodemographic, health care, and the major outcomes through 42-days post-delivery are recorded. Study visits occur at enrollment during pregnancy, at delivery and at 42 days postpartum. Results From 2010 through 2018, the Global Network MNHR sites were located in Guatemala, Belagavi and Nagpur, India, Pakistan, Democratic Republic of Congo, Kenya, and Zambia. During this period at these sites, 579,140 pregnant women were consented and enrolled in the MNHR, nearly 99% of all eligible women. Delivery data were collected for 99% of enrolled women and 42-day follow-up data for 99% of those delivered. In this supplement, the trends over time and assessment of differences across geographic regions are analyzed in a series of 18 manuscripts utilizing the MNHR data. Conclusions Improving maternal, fetal and newborn health in countries with poor outcomes requires an understanding of the characteristics of the population, quality of health care and outcomes. Because the worst pregnancy outcomes typically occur in countries with limited health registration systems and vital records, alternative registration systems may prove to be highly valuable in providing data. The MNHR, an international, multicenter, population-based registry, assesses pregnancy outcomes over time in support of efforts to develop improved perinatal healthcare in resource-limited areas. Trial Registration The Maternal Newborn Health Registry is registered at Clinicaltrials.gov (ID# NCT01073475). Registered February 23, 2019. https://clinicaltrials.gov/ct2/show/NCT01073475
    Type of Medium: Online Resource
    ISSN: 1742-4755
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2149029-6
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  • 2
    In: Reproductive Health, Springer Science and Business Media LLC, Vol. 17, No. S2 ( 2020-11)
    Abstract: Quality assurance (QA) is a process that should be an integral part of research to protect the rights and safety of study participants and to reduce the likelihood that the results are affected by bias in data collection. Most QA plans include processes related to study preparation and regulatory compliance, data collection, data analysis and publication of study results. However, little detailed information is available on the specific procedures associated with QA processes to ensure high-quality data in multi-site studies. Methods The Global Network for Women’s and Children’s Health Maternal Newborn Health Registy (MNHR) is a prospective population-based registry of pregnancies and deliveries that is carried out in 8 international sites. Since its inception, QA procedures have been utilized to ensure the quality of the data. More recently, a training and certification process was developed to ensure that standardized, scientifically accurate clinical definitions are used consistently across sites. Staff complete a web-based training module that reviews the MNHR study protocol, study forms and clinical definitions developed by MNHR investigators and are certified through a multiple choice examination prior to initiating study activities and every six months thereafter. A standardized procedure for supervision and evaluation of field staff is carried out to ensure that research activites are conducted according to the protocol across all the MNHR sites. Conclusions We developed standardized QA processes for training, certification and supervision of the MNHR, a multisite research registry. It is expected that these activities, together with ongoing QA processes, will help to further optimize data quality for this protocol.
    Type of Medium: Online Resource
    ISSN: 1742-4755
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2149029-6
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  • 3
    In: Reproductive Health, Springer Science and Business Media LLC, Vol. 17, No. S3 ( 2020-12)
    Abstract: Socioeconomic status (SES) is an important determinant of health globally and an important explanatory variable to assess causality in epidemiological research. The 10th Sustainable Development Goal is to reduce disparities in SES that impact health outcomes globally. It is easier to study SES in high-income countries because household income is representative of the SES. However, it is well recognized that income is poorly reported in low- and middle- income countries (LMIC) and is an unreliable indicator of SES. Therefore, there is a need for a robust index that will help to discriminate the SES of rural households in a pooled dataset from LMIC. Methods The study was nested in the population-based Maternal and Neonatal Health Registry of the Global Network for Women’s and Children’s Health Research which has 7 rural sites in 6 Asian, sub-Saharan African and Central American countries. Pregnant women enrolling in the Registry were asked questions about items such as housing conditions and household assets. The characteristics of the candidate items were evaluated using confirmatory factor analyses and item response theory analyses. Based on the results of these analyses, a final set of items were selected for the SES index. Results Using data from 49,536 households of pregnant women, we reduced the data collected to a 10-item index. The 10 items were feasible to administer, covered the SES continuum and had good internal reliability and validity. We developed a sum score-based Item Response Theory scoring algorithm which is easy to compute and is highly correlated with scores based on response patterns (r = 0.97), suggesting minimal loss of information with the simplified approach. Scores varied significantly by site (p  〈  0.001). African sites had lower mean SES scores than the Asian and Central American sites. The SES index demonstrated good internal consistency reliability (Cronbach’s alpha = 0.81). Higher SES scores were significantly associated with formal education, more education, having received antenatal care, and facility delivery (p  〈  0.001). Conclusions While measuring SES in LMIC is challenging, we have developed a Global Network Socioeconomic Status Index which may be useful for comparisons of SES within and between locations. Next steps include understanding how the index is associated with maternal, perinatal and neonatal mortality. Trial Registration NCT01073475 Plain English summary Socioeconomic status (SES) is an important determinant of health globally, and improving SES is important to reduce disparities in health outcomes. It is easier to study SES in high-income countries because it can be measured by income and what income is spent on, but this concept does not translate easily to low and middle income countries. We developed a questionnaire that includes 10 items to determine SES in low-resource settings that was added to an ongoing Maternal and Neonatal Health Registry that is funded by the National Institutes of Child Health and Human Development’s Global Network. The Registry includes sites that collect outcomes of pregnancies in women and their babies in rural areas in 6 countries in South Asia, sub-Saharan Africa and Central America. The Registry is population based and tracks women from early in pregnancy to day 42 post-partum. The questionnaire is easy to administer and has good reliability and validity. Next steps include understanding how the index is associated with maternal, fetal and neonatal mortality.
    Type of Medium: Online Resource
    ISSN: 1742-4755
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2149029-6
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  • 4
    In: Reproductive Health, Springer Science and Business Media LLC, Vol. 17, No. S2 ( 2020-11)
    Abstract: 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 .
    Type of Medium: Online Resource
    ISSN: 1742-4755
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2149029-6
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  • 5
    In: Reproductive Health, Springer Science and Business Media LLC, Vol. 17, No. S3 ( 2020-12)
    Abstract: The objectives of this analysis were to document trends in and risk factors associated with the cesarean birth rate in low- and middle-income country sites participating in the Global Network for Women’s and Children’s Health Research (Global Network). Methods This is a secondary analysis of a prospective, population-based study of home and facility births conducted in the Global Network sites. Results Cesarean birth rates increased uniformly across all sites between 2010 and 2018. Across all sites in multivariable analyses, women younger than age twenty had a reduced risk of cesarean birth (RR 0.9 [0.9, 0.9]) and women over 35 had an increased risk of cesarean birth (RR 1.1 [1.1, 1.1] ) compared to women aged 20 to 35. Compared to women with a parity of three or more, less parous women had an increased risk of cesarean (RR 1.2 or greater [1.2, 1.4]). Four or more antenatal visits (RR 1.2 [1.2, 1.3] ), multiple pregnancy (RR 1.3 [1.3, 1.4]), abnormal progress in labor (RR 1.1 [1.0, 1.1] ), antepartum hemorrhage (RR 2.3 [2.0, 2.7]), and hypertensive disease (RR 1.6 [1.5, 1.7] ) were all associated with an increased risk of cesarean birth, p  〈  0.001. For multiparous women with a history of prior cesarean birth, rates of vaginal birth after cesarean were about 20% in the Latin American and Southeast Asian sites and about 84% at the sub-Saharan African sites. In the African sites, proportions of cesarean birth in the study were highest among women without a prior cesarean and a single, cephalic, term pregnancy. In the non-African sites, groups with the greatest proportion of cesarean births were nulliparous women with a single, cephalic, term pregnancy and all multiparous women with at least one previous uterine scar with a term, cephalic pregnancy. Conclusion Cesarean birth rates continue to rise within the Global Network. The proportions of cesarean birth are higher among women with no history of cesarean birth in the African sites and among women with primary elective cesarean, primary cesarean after induction, and repeat cesarean in the non-African sites.
    Type of Medium: Online Resource
    ISSN: 1742-4755
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2149029-6
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  • 6
    In: BJOG: An International Journal of Obstetrics & Gynaecology, Wiley, Vol. 129, No. 8 ( 2022-07), p. 1298-1307
    Abstract: To assess, on a population basis, the medical care for pregnant women in specific geographic regions of six countries before and during the first year of the coronavirus disease 2019 (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 with the COVID‐19 time‐period (March 2020–February 2021). Main outcome measures Stillbirth, neonatal mortality, preterm birth, low birthweight and maternal mortality. Results Across all sites, a small but statistically significant increase in home births occurred between the pre‐COVID‐19 and COVID‐19 periods (18.9% versus 20.3%, adjusted relative risk [aRR] 1.12, 95% CI 1.05–1.19). A small but significant decrease in the mean number of antenatal care visits (from 4.1 to 4.0, p  =  〈 0.0001) was seen during the COVID‐19 period. Of outcomes evaluated, overall, a small but significant decrease in low‐birthweight infants in the COVID‐19 period occurred (15.7% versus 14.6%, aRR 0.94, 95% CI 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 antenatal care services were observed during the initial COVID‐19 period; however, there was not an increase in the stillbirth, neonatal mortality, maternal mortality, low birthweight, or preterm birth rates during the COVID‐19 period compared with the previous year. Further research should help to elucidate the relationship between access to and use of pregnancy‐related medical services and birth outcomes over an extended period.
    Type of Medium: Online Resource
    ISSN: 1470-0328 , 1471-0528
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2036469-6
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  • 7
    In: BJOG: An International Journal of Obstetrics & Gynaecology, Wiley
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1470-0328 , 1471-0528
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2036469-6
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  • 8
    In: BJOG: An International Journal of Obstetrics & Gynaecology, Wiley, Vol. 129, No. 8 ( 2022-07), p. 1289-1297
    Abstract: Pregnant women in 7 low and middle income sites often had incomplete knowledge related to COVID‐19 and practices to prevent COVID‐19 during pregnancy varied.
    Type of Medium: Online Resource
    ISSN: 1470-0328 , 1471-0528
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2036469-6
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  • 9
    In: Acta Paediatrica, Wiley, Vol. 106, No. 6 ( 2017-06), p. 904-911
    Abstract: This study estimated the causes of neonatal death using an algorithm for low‐resource areas, where 98% of the world's neonatal deaths occur. Methods We enrolled women in India, Pakistan, Guatemala, the Democratic Republic of Congo, Kenya and Zambia from 2014 to 2016 and tracked their delivery and newborn outcomes for up to 28 days. Antenatal care and delivery symptoms were collected using a structured questionnaire, clinical observation and/or a physical examination. The Global Network Cause of Death algorithm was used to assign the cause of neonatal death, analysed by country and day of death. Results One‐third (33.1%) of the 3068 neonatal deaths were due to suspected infection, 30.8% to prematurity, 21.2% to asphyxia, 9.5% to congenital anomalies and 5.4% did not have a cause of death assigned. Prematurity and asphyxia‐related deaths were more common on the first day of life (46.7% and 52.9%, respectively), while most deaths due to infection occurred after the first day of life (86.9%). The distribution of causes was similar to global data reported by other major studies. Conclusion The Global Network algorithm provided a reliable cause of neonatal death in low‐resource settings and can be used to inform public health strategies to reduce mortality.
    Type of Medium: Online Resource
    ISSN: 0803-5253 , 1651-2227
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 1492629-5
    detail.hit.zdb_id: 1501466-6
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  • 10
    In: American Journal of Perinatology, Georg Thieme Verlag KG, Vol. 36, No. 07 ( 2019-06), p. 730-736
    Abstract: Objective Few data are available on cesarean delivery and operative vaginal delivery trends in low- and middle-income countries. Our objective was to analyze a prospective population-based registry including eight sites in seven low- and middle-income countries to observe trends in operative vaginal delivery versus cesarean delivery rates over time, across sites. Study Design A prospective population-based study, including home and facility births among women enrolled from 2010 to 2016, was performed in communities in Argentina, Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan, and Zambia. Women were enrolled during pregnancy and delivery outcome data were collected. Results We analyzed 354,287 women; 4,119 (1.2%) underwent an operative vaginal delivery and 45,032 (11.2%) delivered by cesarean. Across all sites with data for 7 years, rates of operative vaginal delivery decreased from 1.6 to 0.3%, while cesarean delivery increased from 6.4 to 14.4%. Similar trends were seen when individual country data were analyzed. Operative vaginal delivery rates decreased in both hospitals and clinics, except in the hospital setting at one of the Indian sites. Conclusion In low- and middle-income countries, operative vaginal delivery is becoming less utilized while cesarean delivery is becoming an increasingly common mode of delivery.
    Type of Medium: Online Resource
    ISSN: 0735-1631 , 1098-8785
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2019
    detail.hit.zdb_id: 2042426-7
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