177 results on '"Edward A. Liechty"'
Search Results
2. Maternal age extremes and adverse pregnancy outcomes in low-resourced settings
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Paul Nyongesa, Osayame A. Ekhaguere, Irene Marete, Constance Tenge, Milsort Kemoi, Carla M. Bann, Sherri L. Bucher, Archana B. Patel, Patricia L. Hibberd, Farnaz Naqvi, Sarah Saleem, Robert L. Goldenberg, Shivaprasad S. Goudar, Richard J. Derman, Nancy F. Krebs, Ana Garces, Elwyn Chomba, Waldemar A. Carlo, Musaku Mwenechanya, Adrien Lokangaka, Antoinette K. Tshefu, Melissa Bauserman, Marion Koso-Thomas, Janet L. Moore, Elizabeth M. McClure, Edward A. Liechty, and Fabian Esamai
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pregnancy outcomes ,low-and middle-income country ,adolescent pregnancy ,advanced maternal age pregnancy ,maternal mortality ratio ,neonatal mortality ,Gynecology and obstetrics ,RG1-991 ,Women. Feminism ,HQ1101-2030.7 - Abstract
IntroductionAdolescent (35 years) pregnancies carry adverse risks and warrant a critical review in low- and middle-income countries where the burden of adverse pregnancy outcomes is highest.ObjectiveTo describe the prevalence and adverse pregnancy (maternal, perinatal, and neonatal) outcomes associated with extremes of maternal age across six countries.Patients and methodsWe performed a historical cohort analysis on prospectively collected data from a population-based cohort study conducted in the Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan, and Zambia between 2010 and 2020. We included pregnant women and their neonates. We describe the prevalence and adverse pregnancy outcomes associated with pregnancies in these maternal age groups (35 years). Relative risks and 95% confidence intervals of each adverse pregnancy outcome comparing each maternal age group to the reference group of 20–24 years were obtained by fitting a Poisson model adjusting for site, maternal age, parity, multiple gestations, maternal education, antenatal care, and delivery location. Analysis by region was also performed.ResultsWe analyzed 602,884 deliveries; 13% (78,584) were adolescents, and 5% (28,677) were advanced maternal age (AMA). The overall maternal mortality ratio (MMR) was 147 deaths per 100,000 live births and increased with advancing maternal age: 83 in the adolescent and 298 in the AMA group. The AMA groups had the highest MMR in all regions. Adolescent pregnancy was associated with an adjusted relative risk (aRR) of 1.07 (1.02–1.11) for perinatal mortality and 1.13 (1.06–1.19) for neonatal mortality. In contrast, AMA was associated with an aRR of 2.55 (1.81 to 3.59) for maternal mortality, 1.58 (1.49–1.67) for perinatal mortality, and 1.30 (1.20–1.41) for neonatal mortality, compared to pregnancy in women 20–24 years. This pattern was overall similar in all regions, even in the
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- 2023
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3. Birth weight and gestational age distributions in a rural Kenyan population
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Sherri Bucher, Kayla Nowak, Kevin Otieno, Constance Tenge, Irene Marete, Faith Rutto, Millsort Kemboi, Emmah Achieng, Osayame A. Ekhaguere, Paul Nyongesa, Fabian O. Esamai, and Edward A. Liechty
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Birthweight ,Sub-Saharan Africa ,Kenya ,Gestational age ,Obstetrical ultrasound ,Fetal growth ,Pediatrics ,RJ1-570 - Abstract
Abstract Background With the increased availability of access to prenatal ultrasound in low/middle-income countries, there is opportunity to better characterize the association between fetal growth and birth weight across global settings. This is important, as fetal growth curves and birthweight charts are often used as proxy health indicators. As part of a randomized control trial, in which ultrasonography was utilized to establish accurate gestational age of pregnancies, we explored the association between gestational age and birthweight among a cohort in Western Kenya, then compared our results to data reported by the INTERGROWTH-21st study. Methods This study was conducted in 8 geographical clusters across 3 counties in Western Kenya. Eligible subjects were nulliparous women carrying singleton pregnancies. An early ultrasound was performed between 6 + 0/7 and 13 + 6/7 weeks gestational age. At birth, infants were weighed on platform scales provided either by the study team (community births), or the Government of Kenya (public health facilities). The 10th, 25th, median, 75th, and 90th BW percentiles for 36 to 42 weeks gestation were determined; resulting percentile points were plotted, and curves determined using a cubic spline technique. A signed rank test was used to quantify the comparison of the percentiles generated in the rural Kenyan sample with those of the INTERGROWTH-21st study. Results A total of 1291 infants (of 1408 pregnant women randomized) were included. Ninety-three infants did not have a measured birth weight. The majority of these were due to miscarriage (n = 49) or stillbirth (n = 27). No significant differences were found between subjects who were lost to follow-up. Signed rank comparisons of the observed median of the Western Kenya data at 10th, 50th, and 90th birthweight percentiles, as compared to medians reported in the INTERGROWTH-21st distributions, revealed close alignment between the two datasets, with significant differences at 36 and 37 weeks. Limitations of the current study include small sample size, and detection of potential digit preference bias. Conclusions A comparison of birthweight percentiles by gestational age estimation, among a sample of infants from rural Kenya, revealed slight differences as compared to those from the global population (INTERGROWTH-21st). Trial registration This is a single site sub-study of data collected in conjunction with the Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN) Trial, which is listed at ClinicalTrials.gov , NCT02409680 (07/04/2015).
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- 2023
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4. The efficacy of low-dose aspirin in pregnancy among women in malaria-endemic countries
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Melissa Bauserman, Sequoia I. Leuba, Jennifer Hemingway-Foday, Tracy L. Nolen, Janet Moore, Elizabeth M. McClure, Adrien Lokangaka, Antoinette Tsehfu, Jackie Patterson, Edward A. Liechty, Fabian Esamai, Waldemar A. Carlo, Elwyn Chomba, Robert L. Goldenberg, Sarah Saleem, Saleem Jessani, Marion Koso-Thomas, Matthew Hoffman, Richard J. Derman, Steven R. Meshnick, and Carl L. Bose
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Malaria ,Pregnancy ,Premature birth ,Perinatal mortality ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract 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.
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- 2022
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5. Development of the Global Network for Women’s and Children’s Health Research’s socioeconomic status index for use in the network’s sites in low and lower middle-income countries
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Archana B. Patel, Carla M. Bann, Ana L. Garces, Nancy F. Krebs, Adrien Lokangaka, Antoinette Tshefu, Carl L. Bose, Sarah Saleem, Robert L. Goldenberg, Shivaprasad S. Goudar, Richard J. Derman, Elwyn Chomba, Waldemar A. Carlo, Fabian Esamai, Edward A. Liechty, Marion Koso-Thomas, Elizabeth M. McClure, and Patricia L. Hibberd
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Socioeconomic status ,Disparities ,Determinants of health ,Global health ,Lower and middle income countries (LMIC) ,Global Network for Women’ and Children’s Health Research ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background 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
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- 2020
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6. Institutional deliveries and stillbirth and neonatal mortality in the Global Network's Maternal and Newborn Health Registry
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Shivaprasad S. Goudar, Norman Goco, Manjunath S. Somannavar, Avinash Kavi, Sunil S. Vernekar, Antoinette Tshefu, Elwyn Chomba, Ana L. Garces, Sarah Saleem, Farnaz Naqvi, Archana Patel, Fabian Esamai, Carl L. Bose, Waldemar A. Carlo, Nancy F. Krebs, Patricia L. Hibberd, Edward A. Liechty, Marion Koso-Thomas, Tracy L. Nolen, Janet Moore, Pooja Iyer, Elizabeth M. McClure, Robert L. Goldenberg, and Richard J. Derman
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Institutional deliveries ,Facility births ,Stillbirths ,Neonatal mortality ,Global network ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background Few studies have shown how the move toward institutional delivery in low and middle-income countries (LMIC) impacts stillbirth and newborn mortality. Objectives The study evaluated trends in institutional delivery in research sites in Belagavi and Nagpur India, Guatemala, Kenya, Pakistan, and Zambia from 2010 to 2018 and compared them to changes in the rates of neonatal mortality and stillbirth. Methods We analyzed data from a nine-year interval captured in the Global Network (GN) Maternal Newborn Health Registry (MNHR). Mortality rates were estimated from generalized estimating equations controlling for within-cluster correlation. Cluster-level analyses were performed to assess the association between institutional delivery and mortality rates. Results From 2010 to 2018, a total of 413,377 deliveries in 80 clusters across 6 sites in 5 countries were included in these analyses. An increase in the proportion of institutional deliveries occurred in all sites, with a range in 2018 from 57.7 to 99.8%. In 2010, the stillbirth rates ranged from 19.3 per 1000 births in the Kenyan site to 46.2 per 1000 births in the Pakistani site and by 2018, ranged from 9.7 per 1000 births in the Belagavi, India site to 40.8 per 1000 births in the Pakistani site. The 2010 neonatal mortality rates ranged from 19.0 per 1000 live births in the Kenyan site to 51.3 per 1000 live births in the Pakistani site with the 2018 neonatal mortality rates ranging from 9.2 per 1000 live births in the Zambian site to 50.2 per 1000 live births in the Pakistani site. In multivariate modeling, in some but not all sites, the reductions in stillbirth and neonatal death were significantly associated with an increase in the institutional deliveries. Conclusions There was an increase in institutional delivery rates in all sites and a reduction in stillbirth and neonatal mortality rates in some of the GN sites over the past decade. The relationship between institutional delivery and a decrease in mortality was significant in some but not all sites. However, the stillbirth and neonatal mortality rates remain at high levels. Understanding the relationship between institutional delivery and stillbirth and neonatal deaths in resource-limited environments will enable development of targeted interventions for reducing the mortality burden. Trial registration The study is registered at clinicaltrials.gov . ClinicalTrial.gov Trial Registration: NCT01073475 .
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- 2020
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7. Maternal mortality in six low and lower-middle income countries from 2010 to 2018: risk factors and trends
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Melissa Bauserman, Vanessa R. Thorsten, Tracy L. Nolen, Jackie Patterson, Adrien Lokangaka, Antoinette Tshefu, Archana B. Patel, Patricia L. Hibberd, Ana L. Garces, Lester Figueroa, Nancy F. Krebs, Fabian Esamai, Paul Nyongesa, Edward A. Liechty, Waldemar A. Carlo, Elwyn Chomba, Shivaprasad S. Goudar, Avinash Kavi, Richard J. Derman, Sarah Saleem, Saleem Jessani, Sk Masum Billah, Marion Koso-Thomas, Elizabeth M. McClure, Robert L. Goldenberg, and Carl Bose
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Low-resource countries ,Maternal mortality ,Sustainable development goals ,Global network ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract 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 .
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- 2020
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8. Rates and risk factors for preterm birth and low birthweight in the global network sites in six low- and low middle-income countries
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Yamini V. Pusdekar, Archana B. Patel, Kunal G. Kurhe, Savita R. Bhargav, Vanessa Thorsten, Ana Garces, Robert L. Goldenberg, Shivaprasad S. Goudar, Sarah Saleem, Fabian Esamai, Elwyn Chomba, Melissa Bauserman, Carl L. Bose, Edward A. Liechty, Nancy F. Krebs, Richard J. Derman, Waldemar A. Carlo, Marion Koso-Thomas, Tracy L. Nolen, Elizabeth M. McClure, and Patricia L. Hibberd
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Preterm ,Low birth weight ,Low and middle-income countries ,Global network ,Risk factors ,India ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract 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.
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- 2020
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9. Why are the Pakistani maternal, fetal and newborn outcomes so poor compared to other low and middle-income countries?
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Aleha Aziz, Sarah Saleem, Tracy L. Nolen, Nousheen Akber Pradhan, Elizabeth M. McClure, Saleem Jessani, Ana L. Garces, Patricia L. Hibberd, Janet L. Moore, Shivaprasad S. Goudar, Sangappa M. Dhaded, Fabian Esamai, Constance Tenge, Archana B. Patel, Elwyn Chomba, Musaku Mwenechanya, Carl L. Bose, Edward A. Liechty, Nancy F. Krebs, Richard J. Derman, Waldemar A. Carlo, Antoinette Tshefu, Marion Koso-Thomas, Sameen Siddiqi, and Robert L. Goldenberg
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Pakistan ,Pregnancy outcomes ,Maternal mortality ,Stillbirth ,Neonatal mortality ,Risk factors ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background Pakistan has among the poorest pregnancy outcomes worldwide, significantly worse than many other low-resource countries. The reasons for these differences are not clear. In this study, we compared pregnancy outcomes in Pakistan to other low-resource countries and explored factors that might help explain these differences. Methods The Global Network (GN) Maternal Newborn Health Registry (MNHR) is a prospective, population-based observational study that includes all pregnant women and their pregnancy outcomes in defined geographic communities in six low-middle income countries (India, Pakistan, Democratic Republic of Congo, Guatemala, Kenya, Zambia). Study staff enroll women in early pregnancy and follow-up soon after delivery and at 42 days to ascertain delivery, neonatal, and maternal outcomes. We analyzed the maternal mortality ratios (MMR), neonatal mortality rates (NMR), stillbirth rates, and potential explanatory factors from 2010 to 2018 across the GN sites. Results From 2010 to 2018, there were 91,076 births in Pakistan and 456,276 births in the other GN sites combined. The MMR in Pakistan was 319 per 100,000 live births compared to an average of 124 in the other sites, while the Pakistan NMR was 49.4 per 1,000 live births compared to 20.4 in the other sites. The stillbirth rate in Pakistan was 53.5 per 1000 births compared to 23.2 for the other sites. Preterm birth and low birthweight rates were also substantially higher than the other sites combined. Within weight ranges, the Pakistani site generally had significantly higher rates of stillbirth and neonatal mortality than the other sites combined, with differences increasing as birthweights increased. By nearly every measure, medical care for pregnant women and their newborns in the Pakistan sites was worse than at the other sites combined. Conclusion The Pakistani pregnancy outcomes are much worse than those in the other GN sites. Reasons for these poorer outcomes likely include that the Pakistani sites' reproductive-aged women are largely poorly educated, undernourished, anemic, and deliver a high percentage of preterm and low-birthweight babies in settings of often inadequate maternal and newborn care. By addressing the issues highlighted in this paper there appears to be substantial room for improvements in Pakistan’s pregnancy outcomes.
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- 2020
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10. Cesarean birth in the Global Network for Women’s and Children’s Health Research: trends in utilization, risk factors, and subgroups with high cesarean birth rates
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Margo S. Harrison, Ana L. Garces, Shivaprasad S. Goudar, Sarah Saleem, Janet L. Moore, Fabian Esamai, Archana B. Patel, Elwyn Chomba, Carl L. Bose, Edward A. Liechty, Nancy F. Krebs, Richard J. Derman, Patricia L. Hibberd, Waldemar A. Carlo, Antoinette Tshefu, Marion Koso-Thomas, Elizabeth M. McClure, and Robert L. Goldenberg
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Cesarean birth ,Low- and middle-income countries ,Trends ,Risk factors ,Vaginal birth after cesarean ,Robson classification ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background 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
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- 2020
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11. Neonatal deaths in infants born weighing ≥ 2500 g in low and middle-income countries
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Sarah Saleem, Farnaz Naqvi, Elizabeth M. McClure, Kayla J. Nowak, Shiyam Sunder Tikmani, Ana L. Garces, Patricia L. Hibberd, Janet L. Moore, Tracy L. Nolen, Shivaprasad S. Goudar, Yogesh Kumar, Fabian Esamai, Irene Marete, Archana B. Patel, Elwyn Chomba, Musaku Mwenechanya, Carl L. Bose, Edward A. Liechty, Nancy F. Krebs, Richard J. Derman, Waldemar A. Carlo, Antoinette Tshefu, Marion Koso-Thomas, Sameen Siddiqi, and Robert L. Goldenberg
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Neonatal mortality ,≥ 2500 g neonatal mortality ,Low and middle-income countries ,Global network ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background Babies born weighing ≥ 2500 g account for more than 80% of the births in most resource-limited locations and for nearly 50% of the 28-day neonatal deaths. In contrast, in high-resource settings, 28-day neonatal mortality among this group represents only a small fraction of the neonatal deaths. Yet mortality risks for birth weight of ≥ 2500 g is limited. Knowledge regarding the factors associated with mortality in these babies will help in identifying interventions that can reduce mortality. Methods The Global Network’s Maternal Newborn Health Registry (MNHR) is a prospective, population-based observational study that includes all pregnant women and their pregnancy outcomes in defined geographic communities that has been conducted in research sites in six low-middle income countries (India, Pakistan, Democratic Republic of Congo, Guatemala, Kenya and Zambia). Study staff enroll all pregnant women as early as possible during pregnancy and conduct follow-up visits to ascertain delivery and 28-day neonatal outcomes. We analyzed the neonatal mortality rates (NMR) and risk factors for deaths by 28 days among all live-born babies with a birthweight ≥ 2500 g from 2010 to 2018 across the Global Network sites. Results Babies born in the Global Network sites from 2010 to 2018 with a birthweight ≥ 2500 g accounted for 84.8% of the births and 45.4% of the 28-day neonatal deaths. Among this group, the overall NMR was 13.1/1000 live births. The overall 28-day NMR for ongoing clusters was highest in Pakistan (29.7/1000 live births) and lowest in the Zambian/Kenyan sites (9.3/1000) for ≥ 2500 g infants. ≥ 2500 g NMRs declined for Zambia/Kenya and India. For Pakistan and Guatemala, the NMR remained almost unchanged over the period. The ≥ 2500 g risks related to maternal, delivery and newborn characteristics varied by site. Maternal factors that increased risk and were common for all sites included nulliparity, hypertensive disease, previous stillbirth, maternal death, obstructed labor, severe postpartum hemorrhage, and abnormal fetal presentation. Neonatal characteristics including resuscitation, hospitalization, congenital anomalies and male sex, as well as lower gestational ages and birthweights were also associated with increased mortality. Conclusions Nearly half of neonatal deaths in the Global Network sites occurred in infants born weighing ≥ 2500 g. The NMR for those infants was 13.1 per 1000 live births, much higher than rates usually seen in high-income countries. The changes in NMR over time varied across the sites. Even among babies born ≥ 2500 g, lower gestational age and birthweight were largely associated with increased risk of mortality. Since many of these deaths should be preventable, attention to preventing mortality in these infants should have an important impact on overall NMR. Trial registration: https://ClinicalTrials.gov Identifier: NCT01073475
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- 2020
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12. The relationship between birth intervals and adverse maternal and neonatal outcomes in six low and lower-middle income countries
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Melissa Bauserman, Kayla Nowak, Tracy L. Nolen, Jackie Patterson, Adrien Lokangaka, Antoinette Tshefu, Archana B. Patel, Patricia L. Hibberd, Ana L. Garces, Lester Figueroa, Nancy F. Krebs, Fabian Esamai, Edward A. Liechty, Waldemar A. Carlo, Elwyn Chomba, Musaku Mwenechanya, Shivaprasad S. Goudar, Umesh Ramadurg, Richard J. Derman, Sarah Saleem, Saleem Jessani, Marion Koso-Thomas, Elizabeth M. McClure, Robert L. Goldenberg, and Carl Bose
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Birth intervals ,Developing countries ,Maternal mortality ,Neonatal mortality ,Low birthweight ,Global network ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract 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 .
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- 2020
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13. The Global Network Maternal Newborn Health Registry: a multi-country, community-based registry of pregnancy outcomes
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Elizabeth M. McClure, Ana L. Garces, Patricia L. Hibberd, Janet L. Moore, Shivaprasad S. Goudar, Sarah Saleem, Fabian Esamai, Archana Patel, Elwyn Chomba, Adrien Lokangaka, Antoinette Tshefu, Rashidul Haque, Carl L. Bose, Edward A. Liechty, Nancy F. Krebs, Richard J. Derman, Waldemar A. Carlo, William Petri, Marion Koso-Thomas, and Robert L. Goldenberg
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Registry ,Perinatal mortality ,Neonatal mortality ,Stillbirth ,Maternal mortality ,Global network ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background 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
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- 2020
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14. Stillbirth 2010–2018: a prospective, population-based, multi-country study from the Global Network
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Elizabeth M. McClure, Sarah Saleem, Shivaprasad S. Goudar, Ana Garces, Ryan Whitworth, Fabian Esamai, Archana B. Patel, Shiyam Sunder Tikmani, Musaku Mwenechanya, Elwyn Chomba, Adrien Lokangaka, Carl L. Bose, Sherri Bucher, Edward A. Liechty, Nancy F. Krebs, S. Yogesh Kumar, Richard J. Derman, Patricia L. Hibberd, Waldemar A. Carlo, Janet L. Moore, Tracy L. Nolen, Marion Koso-Thomas, and Robert L. Goldenberg
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Stillbirth ,Low-middle income countries ,Obstetric care ,Global Network ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background Stillbirth rates are high and represent a substantial proportion of the under-5 mortality in low and middle-income countries (LMIC). In LMIC, where nearly 98% of stillbirths worldwide occur, few population-based studies have documented cause of stillbirths or the trends in rate of stillbirth over time. Methods We undertook a prospective, population-based multi-country research study of all pregnant women in defined geographic areas across 7 sites in low-resource settings (Kenya, Zambia, Democratic Republic of Congo, India, Pakistan, and Guatemala). Staff collected demographic and health care characteristics with outcomes obtained at delivery. Cause of stillbirth was assigned by algorithm. Results From 2010 through 2018, 573,148 women were enrolled with delivery data obtained. Of the 552,547 births that reached 500 g or 20 weeks gestation, 15,604 were stillbirths; a rate of 28.2 stillbirths per 1000 births. The stillbirth rates were 19.3 in the Guatemala site, 23.8 in the African sites, and 33.3 in the Asian sites. Specifically, stillbirth rates were highest in the Pakistan site, which also documented a substantial decrease in stillbirth rates over the study period, from 56.0 per 1000 (95% CI 51.0, 61.0) in 2010 to 44.4 per 1000 (95% CI 39.1, 49.7) in 2018. The Nagpur, India site also documented a substantial decrease in stillbirths from 32.5 (95% CI 29.0, 36.1) to 16.9 (95% CI 13.9, 19.9) per 1000 in 2018; however, other sites had only small declines in stillbirth over the same period. Women who were less educated and older as well as those with less access to antenatal care and with vaginal assisted delivery were at increased risk of stillbirth. The major fetal causes of stillbirth were birth asphyxia (44.0% of stillbirths) and infectious causes (22.2%). The maternal conditions that were observed among those with stillbirth were obstructed or prolonged labor, antepartum hemorrhage and maternal infections. Conclusions Over the study period, stillbirth rates have remained relatively high across all sites. With the exceptions of the Pakistan and Nagpur sites, Global Network sites did not observe substantial changes in their stillbirth rates. Women who were less educated and had less access to antenatal and obstetric care remained at the highest burden of stillbirth. Study registration Clinicaltrials.gov (ID# NCT01073475).
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- 2020
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15. Looking beyond the numbers: quality assurance procedures in the Global Network for Women’s and Children’s Health Research Maternal Newborn Health Registry
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Ana Garces, Emily MacGuire, Holly L. Franklin, Norma Alfaro, Gustavo Arroyo, Lester Figueroa, Shivaprasad S. Goudar, Sarah Saleem, Fabian Esamai, Archana Patel, Elwyn Chomba, Antoinette Tshefu, Rashidul Haque, Jacquelyn K. Patterson, Edward A. Liechty, Richard J. Derman, Waldemar A. Carlo, William Petri, Marion Elizabeth M. Koso-ThomasMcClure, Robert L. Goldenberg, Patricia Hibberd, and Nancy F. Krebs
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Quality assurance ,Training for research studies ,Adult learning ,Quality control ,Public health training ,Global network ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background 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.
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- 2020
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16. Oligohydramnios: a prospective study of fetal, neonatal and maternal outcomes in low-middle income countries
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Lester Figueroa, Elizabeth M. McClure, Jonathan Swanson, Robert Nathan, Ana L. Garces, Janet L. Moore, Nancy F. Krebs, K. Michael Hambidge, Melissa Bauserman, Adrien Lokangaka, Antoinette Tshefu, Waseem Mirza, Sarah Saleem, Farnaz Naqvi, Waldemar A. Carlo, Elwyn Chomba, Edward A. Liechty, Fabian Esamai, David Swanson, Carl L. Bose, and Robert L. Goldenberg
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Oligohydramnios ,Low and middle-income countries ,Ultrasound ,Pregnancy outcomes ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract 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
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- 2020
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17. Polyhydramnios among women in a cluster-randomized trial of ultrasound during prenatal care within five low and low-middle income countries: a secondary analysis of the first look study
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Melissa Bauserman, Robert Nathan, Adrien Lokangaka, Elizabeth M. McClure, Janet Moore, Daniel Ishoso, Antoinette Tshefu, Lester Figueroa, Ana Garces, Margo S. Harrison, Dennis Wallace, Sarah Saleem, Waseem Mirza, Nancy Krebs, Michael Hambidge, Waldemar Carlo, Elwyn Chomba, Menachem Miodovnik, Marion Koso-Thomas, Edward A. Liechty, Fabian Esamai, Jonathan Swanson, David Swanson, Robert L. Goldenberg, and Carl Bose
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Polyhydramnios ,Low-income country ,Global health ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract 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.
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- 2019
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18. Factors influencing referrals for ultrasound-diagnosed complications during prenatal care in five low and middle income countries
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Holly L. Franklin, Waseem Mirza, David L. Swanson, Jamie E. Newman, Robert L. Goldenberg, David Muyodi, Lester Figueroa, Robert O. Nathan, Jonathan O. Swanson, Nicole Goldsmith, Nancy Kanaiza, Farnaz Naqvi, Irma Sayury Pineda, Walter López-Gomez, Dorothy Hamsumonde, Victor Lokomba Bolamba, Elizabeth V. Fogleman, Sarah Saleem, Fabian Esamai, Edward A. Liechty, Ana L. Garces, Nancy F. Krebs, K. Michael Hambidge, Elwyn Chomba, Musaku Mwenechanya, Waldemar A. Carlo, Antoinette Tshefu, Adrien Lokangaka, Carl L. Bose, Marion Koso-Thomas, Menachem Miodovnik, and Elizabeth M. McClure
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Ultrasound ,Antenatal care ,Low-middle income countries ,Pregnancy complication ,Hospital referral ,Delivery ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background Ultrasound during antenatal care (ANC) is proposed as a strategy for increasing hospital deliveries for complicated pregnancies and improving maternal, fetal, and neonatal outcomes. The First Look study was a cluster-randomized trial conducted in the Democratic Republic of Congo, Guatemala, Kenya, Pakistan and Zambia to evaluate the impact of ANC-ultrasound on these outcomes. An additional survey was conducted to identify factors influencing women with complicated pregnancies to attend referrals for additional care. Methods Women who received referral due to ANC ultrasound findings participated in structured interviews to characterize their experiences. Cochran-Mantel-Haenszel statistics were used to examine differences between women who attended the referral and women who did not. Sonographers’ exam findings were compared to referred women’s recall. Results Among 700 referred women, 510 (71%) attended the referral. Among referred women, 97% received a referral card to present at the hospital, 91% were told where to go in the hospital, and 64% were told that the hospital was expecting them. The referred women who were told who to see at the hospital (88% vs 66%), where to go (94% vs 82%), or what should happen, were more likely to attend their referral (68% vs 56%). Barriers to attending referrals were cost, transportation, and distance. Barriers after reaching the hospital were substantial. These included not connecting with an appropriate provider, not knowing where to go, and being told to return later. These barriers at the hospital often led to an unsuccessful referral. Conclusions Our study found that ultrasound screening at ANC alone does not adequately address barriers to referrals. Better communication between the sonographer and the patient increases the likelihood of a completed referral. These types of communication include describing the ultrasound findings, including the reason for the referral, to the mother and staff; providing a referral card; describing where to go in the hospital; and explaining the procedures at the hospital. Thus, there are three levels of communication that need to be addressed to increase completion of appropriate referrals-communication between the sonographer and the woman, the sonographer and the clinic staff, and the sonographer and the hospital. Trial registration NCT01990625.
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- 2018
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19. Trends and determinants of stillbirth in developing countries: results from the Global Network’s Population-Based Birth Registry
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Sarah Saleem, Shiyam Sunder Tikmani, Elizabeth M. McClure, Janet L. Moore, Syed Iqbal Azam, Sangappa M. Dhaded, Shivaprasad S. Goudar, Ana Garces, Lester Figueroa, Irene Marete, Constance Tenge, Fabian Esamai, Archana B. Patel, Sumera Aziz Ali, Farnaz Naqvi, Musaku Mwenchanya, Elwyn Chomba, Waldemar A. Carlo, Richard J. Derman, Patricia L. Hibberd, Sherri Bucher, Edward A. Liechty, Nancy Krebs, K. Michael Hambidge, Dennis D. Wallace, Marion Koso-Thomas, Menachem Miodovnik, and Robert L. Goldenberg
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Stillbirth ,Low-middle income countries ,Rates of decline ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background Stillbirth rates remain high, especially in low and middle-income countries, where rates are 25 per 1000, ten-fold higher than in high-income countries. The United Nations’ Every Newborn Action Plan has set a goal of 12 stillbirths per 1000 births by 2030 for all countries. Methods From a population-based pregnancy outcome registry, including data from 2010 to 2016 from two sites each in Africa (Zambia and Kenya) and India (Nagpur and Belagavi), as well as sites in Pakistan and Guatemala, we evaluated the stillbirth rates and rates of annual decline as well as risk factors for 427,111 births of which 12,181 were stillbirths. Results The mean stillbirth rates for the sites were 21.3 per 1000 births for Africa, 25.3 per 1000 births for India, 56.9 per 1000 births for Pakistan and 19.9 per 1000 births for Guatemala. From 2010 to 2016, across all sites, the mean stillbirth rate declined from 31.7 per 1000 births to 26.4 per 1000 births for an average annual decline of 3.0%. Risk factors for stillbirth were similar across the sites and included maternal age 35 years. Compared to parity 1–2, zero parity and parity > 3 were both associated with increased stillbirth risk and compared to women with any prenatal care, women with no prenatal care had significantly increased risk of stillbirth in all sites. Conclusions At the current rates of decline, stillbirth rates in these sites will not reach the Every Newborn Action Plan goal of 12 per 1000 births by 2030. More attention to the risk factors and treating the causes of stillbirths will be required to reach the Every Newborn Action Plan goal of stillbirth reduction. Trial registration NCT01073475.
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- 2018
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20. A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study
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Matthew K. Hoffman, Shivaprasad S. Goudar, Bhalachandra S. Kodkany, Norman Goco, Marion Koso-Thomas, Menachem Miodovnik, Elizabeth M. McClure, Dennis D. Wallace, Jennifer J. Hemingway-Foday, Antoinette Tshefu, Adrien Lokangaka, Carl L. Bose, Elwyn Chomba, Musaku Mwenechanya, Waldemar A. Carlo, Ana Garces, Nancy F. Krebs, K. Michael Hambidge, Sarah Saleem, Robert L. Goldenberg, Archana Patel, Patricia L. Hibberd, Fabian Esamai, Edward A. Liechty, Robert Silver, and Richard J. Derman
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Prematurity ,Preterm birth ,Low dose Aspirin ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) may substantially reduce the rate of PTB. Methods Hypothesis: LDA initiated in the first trimester reduces the risk of preterm birth. Study Design Type: Prospective randomized, placebo-controlled, double-blinded multi-national clinical trial conducted in seven low and middle income countries. Trial will be individually randomized with one-to-one ratio (intervention/control) Population: Nulliparous women between the ages of 14 and 40, with a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin. Intervention: Daily administration of low dose (81 mg) aspirin, initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA, compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly. Outcomes Primary outcome: Incidence of PTB (birth prior to 37 0/7 weeks GA). Secondary outcomes Incidence of preeclampsia/eclampsia, small for gestational age and perinatal mortality. Discussion This study is unique as it will examine the impact of LDA early in pregnancy in low-middle income countries with preterm birth as a primary outcome. The importance of developing low-cost, high impact interventions in low-middle income countries is magnified as they are often unable to bear the financial costs of treating illness. Trial registration ClinicalTrials.gov identifier: NCT02409680 Date: March 30, 2015
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- 2017
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21. A New Machine Learning-Based Complementary Approach for Screening of NAFLD (Hepatic Steatosis).
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Suranjan Panigrahi, Ridhi Deo, and Edward A. Liechty
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- 2021
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22. Cost-effectiveness of low-dose aspirin for the prevention of preterm birth: a prospective study of the Global Network for Women's and Children's Health Research
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Jackie K Patterson, Simon Neuwahl, Norman Goco, Janet Moore, Shivaprasad S Goudar, Richard J Derman, Matthew Hoffman, Mrityunjay Metgud, Manjunath Somannavar, Avinash Kavi, Jean Okitawutshu, Adrien Lokangaka, Antoinette Tshefu, Carl L Bose, Abigail Mwapule, Musaku Mwenechanya, Elwyn Chomba, Waldemar A Carlo, Javier Chicuy, Lester Figueroa, Nancy F Krebs, Saleem Jessani, Sarah Saleem, Robert L Goldenberg, Kunal Kurhe, Prabir Das, Archana Patel, Patricia L Hibberd, Emmah Achieng, Paul Nyongesa, Fabian Esamai, Sherri Bucher, Edward A Liechty, Brian W Bresnahan, Marion Koso-Thomas, and Elizabeth M McClure
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General Medicine - Published
- 2023
23. Health care in pregnancy during the <scp>COVID</scp> ‐19 pandemic and pregnancy outcomes in six <scp>low‐ and‐middle‐income</scp> countries: Evidence from a prospective, observational registry of the Global Network for Women’s and Children’s Health
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Seemab Naqvi, Farnaz Naqvi, Sarah Saleem, Vanessa R. Thorsten, Lester Figueroa, Manolo Mazariegos, Ana Garces, Archana Patel, Prabir Das, Avinash Kavi, Shivaprasad S. Goudar, Fabian Esamai, Musaku Mwenchanya, Elwyn Chomba, Adrien Lokangaka, Antoinette Tshefu, Sana Yousuf, Melissa Bauserman, Carl L. Bose, Edward A. Liechty, Nancy F. Krebs, Richard J. Derman, Waldemar A. Carlo, Patricia L. Hibberd, Sk Masum Billah, Nalini Peres‐da‐Silva, Rashidul Haque, William A. Petri, Marion Koso‐Thomas, Tracy Nolen, Elizabeth M. McClure, and Robert L. Goldenberg
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Obstetrics and Gynecology - Published
- 2022
24. Predictors of Plasmodium falciparum Infection in the First Trimester Among Nulliparous Women From Kenya, Zambia, and the Democratic Republic of the Congo
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Sequoia I Leuba, Daniel Westreich, Carl L Bose, Kimberly A Powers, Andy Olshan, Steve M Taylor, Antoinette Tshefu, Adrien Lokangaka, Waldemar A Carlo, Elwyn Chomba, Edward A Liechty, Sherri L Bucher, Fabian Esamai, Saleem Jessani, Sarah Saleem, Robert L Goldenberg, Janet Moore, Tracy Nolen, Jennifer Hemingway-Foday, Elizabeth M McClure, Marion Koso-Thomas, Richard J Derman, Matthew Hoffman, and Melissa Bauserman
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Aspirin ,Plasmodium falciparum ,Zambia ,Kenya ,Malaria ,Major Articles and Brief Reports ,Pregnancy Trimester, First ,Infectious Diseases ,Pregnancy ,parasitic diseases ,Democratic Republic of the Congo ,Prevalence ,Humans ,Immunology and Allergy ,Female ,Malaria, Falciparum - Abstract
Background Malaria can have deleterious effects early in pregnancy, during placentation. However, malaria testing and treatment are rarely initiated until the second trimester, leaving pregnancies unprotected in the first trimester. To inform potential early intervention approaches, we sought to identify clinical and demographic predictors of first-trimester malaria. Methods We prospectively recruited women from sites in the Democratic Republic of the Congo (DRC), Kenya, and Zambia who participated in the ASPIRIN (Aspirin Supplementation for Pregnancy Indicated risk Reduction In Nulliparas) trial. Nulliparous women were tested for first-trimester Plasmodium falciparum infection by quantitative polymerase chain reaction. We evaluated predictors using descriptive statistics. Results First-trimester malaria prevalence among 1513 nulliparous pregnant women was 6.3% (95% confidence interval [CI], 3.7%–8.8%] in the Zambian site, 37.8% (95% CI, 34.2%–41.5%) in the Kenyan site, and 62.9% (95% CI, 58.6%–67.2%) in the DRC site. First-trimester malaria was associated with shorter height and younger age in Kenyan women in site-stratified analyses, and with lower educational attainment in analyses combining all 3 sites. No other predictors were identified. Conclusions First-trimester malaria prevalence varied by study site in sub-Saharan Africa. The absence of consistent predictors suggests that routine parasite screening in early pregnancy may be needed to mitigate first-trimester malaria in high-prevalence settings.
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- 2021
25. COVID-19 antibody positivity over time and pregnancy outcomes in seven low-and-middle-income countries: A prospective, observational study of the Global Network for Women's and Children's Health Research
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Robert L. Goldenberg, Sarah Saleem, Sk Masum Billah, Jean Kim, Janet L. Moore, Najia Karim Ghanchi, Rashidul Haque, Lester Figueroa, Alejandra Ayala, Adrien Lokangaka, Antoinette Tshefu, Shivaprasad S. Goudar, Avinash Kavi, Manjunath Somannavar, Fabian Esamai, Musaku Mwenechanya, Elwyn Chomba, Archana Patel, Prabir Das, Wilfred Injera Emonyi, Samuel Edidi, Madhavi Deshmukh, Biplob Hossain, Shahjahan Siraj, Manolo Mazariegos, Ana L. Garces, Melissa Bauserman, Carl L. Bose, William A. Petri, Nancy F. Krebs, Richard J. Derman, Waldemar A. Carlo, Edward A. Liechty, Patricia L. Hibberd, Marion Koso‐Thomas, Nalini Peres‐da‐Silva, Tracy L. Nolen, and Elizabeth M. McClure
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Obstetrics and Gynecology - Abstract
To determine COVID-19 antibody positivity rates over time and relationships to pregnancy outcomes in low- and middle-income countries (LMICs).With COVID-19 antibody positivity at delivery as the exposure, we performed a prospective, observational cohort study in seven LMICs during the early COVID-19 pandemic.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 (two sites), and Guatemala.Pregnant women enrolled in an ongoing pregnancy registry at study sites.From October 2020 to October 2021, standardised COVID-19 antibody testing was performed at delivery among women enrolled in MNHR. Trained staff masked to COVID-19 status obtained pregnancy outcomes, which were then compared with COVID-19 antibody results.Antibody status, stillbirth, neonatal mortality, maternal mortality and morbidity.At delivery, 26.0% of women were COVID-19 antibody positive. Positivity increased over the four time periods across all sites: 13.8%, 15.4%, 21.0% and 40.9%. In the final period, positivity rates were: DRC 27.0%, Kenya 33.1%, Pakistan 32.8%, Guatemala 37.0%, Zambia 37.8%, Bangladesh 47.2%, Nagpur, India 57.4% and Belagavi, India 62.4%. Adjusting for site and maternal characteristics, stillbirth, neonatal mortality, low birthweight and preterm birth were not significantly associated with COVID-19. The adjusted relative risk (aRR) for stillbirth was 1.27 (95% CI 0.95-1.69). Postpartum haemorrhage was associated with antibody positivity (aRR 1.44; 95% CI 1.01-2.07).In pregnant populations in LMICs, COVID-19 antibody positivity has increased. However, most adverse pregnancy outcomes were not significantly associated with antibody positivity.
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- 2022
26. Birth weight and gestational age distributions in a rural Kenyan population
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Sherri Bucher, Kayla Nowak, Kevin Otieno, Constance Tenge, Irene Marete, Faith Rutto, Millsort Kemboi, Emmah Achieng, Osayame A. Ekhaguere, Paul Nyongesa, Fabian O. Esamai, and Edward A. Liechty
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Pediatrics, Perinatology and Child Health - Abstract
Background With the increased availability of access to prenatal ultrasound in low/middle-income countries, there is opportunity to better characterize the association between fetal growth and birth weight across global settings. This is important, as fetal growth curves and birthweight charts are often used as proxy health indicators. As part of a randomized control trial, in which ultrasonography was utilized to establish accurate gestational age of pregnancies, we explored the association between gestational age and birthweight among a cohort in Western Kenya, then compared our results to data reported by the INTERGROWTH-21st study. Methods This study was conducted in 8 geographical clusters across 3 counties in Western Kenya. Eligible subjects were nulliparous women carrying singleton pregnancies. An early ultrasound was performed between 6 + 0/7 and 13 + 6/7 weeks gestational age. At birth, infants were weighed on platform scales provided either by the study team (community births), or the Government of Kenya (public health facilities). The 10th, 25th, median, 75th, and 90th BW percentiles for 36 to 42 weeks gestation were determined; resulting percentile points were plotted, and curves determined using a cubic spline technique. A signed rank test was used to quantify the comparison of the percentiles generated in the rural Kenyan sample with those of the INTERGROWTH-21st study. Results A total of 1291 infants (of 1408 pregnant women randomized) were included. Ninety-three infants did not have a measured birth weight. The majority of these were due to miscarriage (n = 49) or stillbirth (n = 27). No significant differences were found between subjects who were lost to follow-up. Signed rank comparisons of the observed median of the Western Kenya data at 10th, 50th, and 90th birthweight percentiles, as compared to medians reported in the INTERGROWTH-21st distributions, revealed close alignment between the two datasets, with significant differences at 36 and 37 weeks. Limitations of the current study include small sample size, and detection of potential digit preference bias. Conclusions A comparison of birthweight percentiles by gestational age estimation, among a sample of infants from rural Kenya, revealed slight differences as compared to those from the global population (INTERGROWTH-21st). Trial registration This is a single site sub-study of data collected in conjunction with the Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN) Trial, which is listed at ClinicalTrials.gov, NCT02409680 (07/04/2015).
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- 2022
27. Plasma Amino Acid Concentrations in Children With Severe Malaria Are Associated With Mortality and Worse Long-term Kidney and Cognitive Outcomes
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Andrea L Conroy, Tuan M Tran, Caitlin Bond, Robert O Opoka, Dibyadyuti Datta, Edward A Liechty, Paul Bangirana, Ruth Namazzi, Richard Idro, Sarah Cusick, John M Ssenkusu, and Chandy C John
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Aftercare ,Acute Kidney Injury ,Kidney ,Patient Discharge ,Malaria ,Infectious Diseases ,Methionine ,Cognition ,Child, Preschool ,Major Article ,Immunology and Allergy ,Humans ,Amino Acids ,Renal Insufficiency, Chronic ,Child - Abstract
Background Global changes in amino acid levels have been described in severe malaria (SM), but the relationship between amino acids and long-term outcomes in SM has not been evaluated. Methods We measured enrollment plasma concentrations of 20 amino acids using high-performance liquid chromatography in 500 Ugandan children aged 18 months to 12 years, including 122 community children and 378 children with SM. The Kidney Disease: Improving Global Outcomes criteria were used to define acute kidney injury (AKI) at enrollment and chronic kidney disease (CKD) at 1-year follow-up. Cognition was assessed over 2 years of follow-up. Results Compared to laboratory-defined, age-specific reference ranges, there were deficiencies in sulfur-containing amino acids (methionine, cysteine) in both community children and children with SM. Among children with SM, global changes in amino acid concentrations were observed in the context of metabolic complications including acidosis and AKI. Increases in threonine, leucine, and valine were associated with in-hospital mortality, while increases in methionine, tyrosine, lysine, and phenylalanine were associated with postdischarge mortality and CKD. Increases in glycine and asparagine were associated with worse attention in children Conclusions Among children with SM, unique amino acid profiles are associated with mortality, CKD, and worse attention.
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- 2022
28. Institutional deliveries and stillbirth and neonatal mortality in the Global Network's Maternal and Newborn Health Registry
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Pooja Iyer, Patricia L. Hibberd, Tracy L. Nolen, Elwyn Chomba, Farnaz Naqvi, Richard J. Derman, Fabian Esamai, Janet Moore, Norman Goco, Elizabeth M. McClure, Carl L. Bose, Robert L. Goldenberg, Archana B. Patel, Marion Koso-Thomas, Sunil S Vernekar, Waldemar A. Carlo, Manjunath S Somannavar, Avinash Kavi, Shivaprasad S. Goudar, Ana Garces, Nancy F. Krebs, Antoinette Tshefu, Edward A. Liechty, and Sarah Saleem
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Adult ,Male ,medicine.medical_specialty ,Kenya ,Reproductive medicine ,Institutional deliveries ,lcsh:Gynecology and obstetrics ,Pregnancy ,Infant Mortality ,Medicine ,Humans ,Infant Health ,Registries ,Generalized estimating equation ,Neonatal mortality ,lcsh:RG1-991 ,Facility births ,business.industry ,Public health ,Mortality rate ,Research ,Infant, Newborn ,Obstetrics and Gynecology ,Infant ,Targeted interventions ,Stillbirth ,Delivery, Obstetric ,Global network ,Reproductive Medicine ,Female ,Health Facilities ,Neonatal death ,business ,Stillbirths ,Demography ,Maternal Age - Abstract
Background Few studies have shown how the move toward institutional delivery in low and middle-income countries (LMIC) impacts stillbirth and newborn mortality. Objectives The study evaluated trends in institutional delivery in research sites in Belagavi and Nagpur India, Guatemala, Kenya, Pakistan, and Zambia from 2010 to 2018 and compared them to changes in the rates of neonatal mortality and stillbirth. Methods We analyzed data from a nine-year interval captured in the Global Network (GN) Maternal Newborn Health Registry (MNHR). Mortality rates were estimated from generalized estimating equations controlling for within-cluster correlation. Cluster-level analyses were performed to assess the association between institutional delivery and mortality rates. Results From 2010 to 2018, a total of 413,377 deliveries in 80 clusters across 6 sites in 5 countries were included in these analyses. An increase in the proportion of institutional deliveries occurred in all sites, with a range in 2018 from 57.7 to 99.8%. In 2010, the stillbirth rates ranged from 19.3 per 1000 births in the Kenyan site to 46.2 per 1000 births in the Pakistani site and by 2018, ranged from 9.7 per 1000 births in the Belagavi, India site to 40.8 per 1000 births in the Pakistani site. The 2010 neonatal mortality rates ranged from 19.0 per 1000 live births in the Kenyan site to 51.3 per 1000 live births in the Pakistani site with the 2018 neonatal mortality rates ranging from 9.2 per 1000 live births in the Zambian site to 50.2 per 1000 live births in the Pakistani site. In multivariate modeling, in some but not all sites, the reductions in stillbirth and neonatal death were significantly associated with an increase in the institutional deliveries. Conclusions There was an increase in institutional delivery rates in all sites and a reduction in stillbirth and neonatal mortality rates in some of the GN sites over the past decade. The relationship between institutional delivery and a decrease in mortality was significant in some but not all sites. However, the stillbirth and neonatal mortality rates remain at high levels. Understanding the relationship between institutional delivery and stillbirth and neonatal deaths in resource-limited environments will enable development of targeted interventions for reducing the mortality burden. Trial registration The study is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475.
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- 2020
29. Rates and risk factors for preterm birth and low birthweight in the global network sites in six low- and low middle-income countries
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Tracy L. Nolen, Carl L. Bose, Robert L. Goldenberg, Melissa Bauserman, Elizabeth M. McClure, Waldemar A. Carlo, Patricia L. Hibberd, Elwyn Chomba, Yamini Pusdekar, Archana B. Patel, Marion Koso-Thomas, Fabian Esamai, Savita Bhargav, Shivaprasad S. Goudar, Ana Garces, Vanessa Thorsten, Richard J. Derman, Kunal Kurhe, Edward A. Liechty, Nancy F. Krebs, and Sarah Saleem
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medicine.medical_specialty ,Population ,Reproductive medicine ,India ,lcsh:Gynecology and obstetrics ,Birth rate ,Pregnancy ,Preterm ,Epidemiology ,medicine ,Birth Weight ,Humans ,education ,Developing Countries ,lcsh:RG1-991 ,education.field_of_study ,business.industry ,Obstetrics ,Research ,Public health ,Infant, Newborn ,Infant ,Obstetrics and Gynecology ,Gestational age ,Infant, Low Birth Weight ,Guatemala ,medicine.disease ,Low birth weight ,Global network ,Reproductive Medicine ,Risk factors ,Africa ,Premature Birth ,Low and middle-income countries ,Female ,medicine.symptom ,business - Abstract
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.
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- 2020
30. Why are the Pakistani maternal, fetal and newborn outcomes so poor compared to other low and middle-income countries?
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Archana B. Patel, Carl L. Bose, Tracy L. Nolen, Edward A. Liechty, Robert L. Goldenberg, Sarah Saleem, Constance Tenge, Sameen Siddiqi, Nousheen Akber Pradhan, Nancy F. Krebs, Marion Koso-Thomas, Aleha Aziz, Antoinette Tshefu, Saleem Jessani, Shivaprasad S. Goudar, Janet Moore, Ana Garces, Richard J. Derman, Sangappa M. Dhaded, Elizabeth M. McClure, Musaku Mwenechanya, Elwyn Chomba, Waldemar A. Carlo, Patricia L. Hibberd, and Fabian Esamai
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Adult ,Maternal mortality ,medicine.medical_specialty ,Population ,Reproductive medicine ,Much Worse ,lcsh:Gynecology and obstetrics ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Infant Mortality ,medicine ,Humans ,Maternal fetal ,Pakistan ,Prospective Studies ,030212 general & internal medicine ,Pregnancy outcomes ,education ,Developing Countries ,Neonatal mortality ,lcsh:RG1-991 ,education.field_of_study ,030219 obstetrics & reproductive medicine ,business.industry ,Research ,Public health ,Infant, Newborn ,Pregnancy Outcome ,Infant ,Obstetrics and Gynecology ,Stillbirth ,Global network ,Reproductive Medicine ,Risk factors ,Premature Birth ,Female ,Observational study ,business ,Demography - Abstract
Background Pakistan has among the poorest pregnancy outcomes worldwide, significantly worse than many other low-resource countries. The reasons for these differences are not clear. In this study, we compared pregnancy outcomes in Pakistan to other low-resource countries and explored factors that might help explain these differences. Methods The Global Network (GN) Maternal Newborn Health Registry (MNHR) is a prospective, population-based observational study that includes all pregnant women and their pregnancy outcomes in defined geographic communities in six low-middle income countries (India, Pakistan, Democratic Republic of Congo, Guatemala, Kenya, Zambia). Study staff enroll women in early pregnancy and follow-up soon after delivery and at 42 days to ascertain delivery, neonatal, and maternal outcomes. We analyzed the maternal mortality ratios (MMR), neonatal mortality rates (NMR), stillbirth rates, and potential explanatory factors from 2010 to 2018 across the GN sites. Results From 2010 to 2018, there were 91,076 births in Pakistan and 456,276 births in the other GN sites combined. The MMR in Pakistan was 319 per 100,000 live births compared to an average of 124 in the other sites, while the Pakistan NMR was 49.4 per 1,000 live births compared to 20.4 in the other sites. The stillbirth rate in Pakistan was 53.5 per 1000 births compared to 23.2 for the other sites. Preterm birth and low birthweight rates were also substantially higher than the other sites combined. Within weight ranges, the Pakistani site generally had significantly higher rates of stillbirth and neonatal mortality than the other sites combined, with differences increasing as birthweights increased. By nearly every measure, medical care for pregnant women and their newborns in the Pakistan sites was worse than at the other sites combined. Conclusion The Pakistani pregnancy outcomes are much worse than those in the other GN sites. Reasons for these poorer outcomes likely include that the Pakistani sites' reproductive-aged women are largely poorly educated, undernourished, anemic, and deliver a high percentage of preterm and low-birthweight babies in settings of often inadequate maternal and newborn care. By addressing the issues highlighted in this paper there appears to be substantial room for improvements in Pakistan’s pregnancy outcomes.
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- 2020
31. Stillbirth 2010–2018: a prospective, population-based, multi-country study from the Global Network
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Ryan Whitworth, Tracy L. Nolen, Patricia L. Hibberd, S. Yogesh Kumar, Elizabeth M. McClure, Elwyn Chomba, Sarah Saleem, Waldemar A. Carlo, Sherri Bucher, Shiyam Sunder Tikmani, Nancy F. Krebs, Carl L. Bose, Robert L. Goldenberg, Richard J. Derman, Musaku Mwenechanya, Adrien Lokangaka, Marion Koso-Thomas, Archana B. Patel, Edward A. Liechty, Shivaprasad S. Goudar, Ana Garces, Janet Moore, and Fabian Esamai
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Male ,medicine.medical_specialty ,Population ,Reproductive medicine ,India ,Zambia ,lcsh:Gynecology and obstetrics ,Obstetric care ,Pregnancy ,Health care ,medicine ,Humans ,Pakistan ,Prospective Studies ,Global Network ,education ,Developing Countries ,reproductive and urinary physiology ,lcsh:RG1-991 ,Asphyxia ,education.field_of_study ,Antepartum hemorrhage ,business.industry ,Public health ,Research ,Infant, Newborn ,Obstetrics and Gynecology ,Stillbirth ,Delivery, Obstetric ,Guatemala ,Kenya ,female genital diseases and pregnancy complications ,Obstetric Labor Complications ,Reproductive Medicine ,Population Surveillance ,Gestation ,population characteristics ,Female ,medicine.symptom ,Low-middle income countries ,business ,Demography - Abstract
Background Stillbirth rates are high and represent a substantial proportion of the under-5 mortality in low and middle-income countries (LMIC). In LMIC, where nearly 98% of stillbirths worldwide occur, few population-based studies have documented cause of stillbirths or the trends in rate of stillbirth over time. Methods We undertook a prospective, population-based multi-country research study of all pregnant women in defined geographic areas across 7 sites in low-resource settings (Kenya, Zambia, Democratic Republic of Congo, India, Pakistan, and Guatemala). Staff collected demographic and health care characteristics with outcomes obtained at delivery. Cause of stillbirth was assigned by algorithm. Results From 2010 through 2018, 573,148 women were enrolled with delivery data obtained. Of the 552,547 births that reached 500 g or 20 weeks gestation, 15,604 were stillbirths; a rate of 28.2 stillbirths per 1000 births. The stillbirth rates were 19.3 in the Guatemala site, 23.8 in the African sites, and 33.3 in the Asian sites. Specifically, stillbirth rates were highest in the Pakistan site, which also documented a substantial decrease in stillbirth rates over the study period, from 56.0 per 1000 (95% CI 51.0, 61.0) in 2010 to 44.4 per 1000 (95% CI 39.1, 49.7) in 2018. The Nagpur, India site also documented a substantial decrease in stillbirths from 32.5 (95% CI 29.0, 36.1) to 16.9 (95% CI 13.9, 19.9) per 1000 in 2018; however, other sites had only small declines in stillbirth over the same period. Women who were less educated and older as well as those with less access to antenatal care and with vaginal assisted delivery were at increased risk of stillbirth. The major fetal causes of stillbirth were birth asphyxia (44.0% of stillbirths) and infectious causes (22.2%). The maternal conditions that were observed among those with stillbirth were obstructed or prolonged labor, antepartum hemorrhage and maternal infections. Conclusions Over the study period, stillbirth rates have remained relatively high across all sites. With the exceptions of the Pakistan and Nagpur sites, Global Network sites did not observe substantial changes in their stillbirth rates. Women who were less educated and had less access to antenatal and obstetric care remained at the highest burden of stillbirth. Study registration Clinicaltrials.gov (ID# NCT01073475).
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- 2020
32. Factors associated with neonatal coding knowledge: results of a national survey
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Sheri L, Nemerofsky, Ellen Johnson, Silver, Edward A, Liechty, Stephen A, Pearlman, and Deborah, Campbell
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Intensive Care Units, Neonatal ,Neonatal Nursing ,Surveys and Questionnaires ,Infant, Newborn ,Humans - Published
- 2022
33. Knowledge, attitude and practices of pregnant women related to COVID-19 infection: A cross_sectional survey in seven countries from the Global Network for Women's and Children's Health
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Farnaz Naqvi, Seemab Naqvi, Sk Masum Billah, Sarah Saleem, Elizabeth Fogleman, Nalini Peres‐da‐Silva, Lester Figueroa, Manolo Mazariegos, Ana L. Garces, Archana Patel, Prabir Das, Avinash Kavi, Shivaprasad S. Goudar, Fabian Esamai, Elwyn Chomba, Adrien Lokangaka, Antoinette Tshefu, Rashidul Haque, Shahjahan Siraj, Sana Yousaf, Melissa Bauserman, Edward A. Liechty, Nancy F. Krebs, Richard J. Derman, Waldemar A. Carlo, William A. Petri, Patricia L. Hibberd, Marion Koso‐Thomas, Carla M. Bann, Elizabeth M. McClure, and Robert L. Goldenberg
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Coronavirus ,Health Knowledge, Attitudes, Practice ,Cross-Sectional Studies ,Pregnancy ,Child Health ,Humans ,Women's Health ,Obstetrics and Gynecology ,COVID-19 ,Female ,Pregnant Women ,Child - Abstract
Objective We sought to understand knowledge, attitudes and practices (KAP) regarding COVID-19 in pregnant women in seven low and middle-income countries (LMIC). Design Population-based prospective, observational study. Settings Study sites in DRC, Kenya, Zambia, Bangladesh, India (two sites), Pakistan and Guatemala. Population and sample Pregnant women in the Global Network's Maternal and Neonatal Health Registry (MNHR). Methods A KAP questionnaire was administered in face-to-face interviews with pregnant women from September 2020 through October 2021 in the MNHR. Main outcome measures KAP regarding COVID-19 during pregnancy. Results In all, 25 260 women completed the survey. Overall, 56.8% of women named ≥3 COVID-19 symptoms, 34.3% knew ≥2 transmission modes, 51.3% knew ≥3 preventive measures and 79.7% named at least one high-risk condition. Due to COVID-19 exposure concerns, 23.8% had avoided prenatal care and 7.5% planned to avoid hospital delivery. Over half the women in the Guatemalan site and 40% in the Pakistan site reduced care seeking due to COVID-19 exposure concerns. Of the women, 24.0% were afraid of getting COVID-19 from healthcare providers. Overall, 63.3% reported wearing a mask and 29.1% planned to stay at home to reduce COVID-19 exposure risk. Conclusions We found a decrease in planned antenatal and delivery care use due to COVID-19 concerns. The clinical implications of potential decreases in care are unclear, but decline in essential healthcare utilisation during pregnancy and delivery could pose challenges for maternal and newborn health. More research is needed to address the impact of COVID-19 on routine pregnancy and delivery care.
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- 2022
34. Knowledge, attitudes, and practices of pregnant women regarding COVID-19 vaccination in pregnancy in 7 low- and middle-income countries: An observational trial from the Global Network for Women and Children’s Health Research
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Seemab Naqvi, Sarah Saleem, Farnaz Naqvi, Sk Masum Billah, Eleanor Nielsen, Elizabeth Fogleman, Nalini Peres‐da‐Silva, Lester Figueroa, Manolo Mazariegos, Ana L. Garces, Archana Patel, Prabir Das, Avinash Kavi, Shivaprasad S. Goudar, Fabian Esamai, Elwyn Chomba, Adrien Lokangaka, Antoinette Tshefu, Rashidul Haque, Shahjahan Siraj, Sana Yousaf, Melissa Bauserman, Edward A. Liechty, Nancy F. Krebs, Richard J. Derman, Waldemar A. Carlo, William A. Petri, Patricia L. Hibberd, Marion Koso‐Thomas, Vanessa Thorsten, Elizabeth M. McClure, and Robert L. Goldenberg
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Health Knowledge, Attitudes, Practice ,Vaccines ,COVID-19 Vaccines ,Vaccination ,Child Health ,Infant, Newborn ,Obstetrics and Gynecology ,COVID-19 ,Pregnancy ,Humans ,Female ,Pregnant Women ,Prospective Studies ,Child ,Developing Countries - Abstract
Objectives: We sought to determine the knowledge, attitudes and practices of pregnant women regarding COVID-19 vaccination in pregnancy in seven low- and middle-income countries (LMIC). Design: Prospective, observational, population-based study. Settings: Study areas in seven LMICs: Bangladesh, India, Pakistan, Guatemala, Democratic Republic of the Congo (DRC), Kenya and Zambia. Population: Pregnant women in an ongoing registry. Methods: COVID-19 vaccine questionnaires were administered to pregnant women in the Global Network's Maternal Newborn Health Registry from February 2021 through November 2021 in face-to-face interviews. Main outcome measures: Knowledge, attitude and practice regarding vaccination during pregnancy; vaccination status. Results: No women were vaccinated except for small proportions in India (12.9%) and Guatemala (5.5%). Overall, nearly half the women believed the COVID-19 vaccine is very/somewhat effective and a similar proportion believed that the COVID-19 vaccine is safe for pregnant women. With availability of vaccines, about 56.7% said they would get the vaccine and a 34.8% would refuse. Of those who would not get vaccinated, safety, fear of adverse effects, and lack of trust predicted vaccine refusal. Those with lower educational status were less willing to be vaccinated. Family members and health professionals were the most trusted source of information for vaccination. Conclusions: This COVID-19 vaccine survey in seven LMICs found that knowledge about the effectiveness and safety of the vaccine was generally low but varied. Concerns about vaccine safety and effectiveness among pregnant women is an important target for educational efforts to increase vaccination rates.
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- 2022
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35. Health Care in Pregnancy During the COVID-19 Pandemic and Pregnancy Outcomes in Six Low-and-Middle-Income Countries: Evidence from a Prospective, Observational Registry of the Global Network for Women's and Children's Health
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Seemab, Naqvi, Farnaz, Naqvi, Sarah, Saleem, Vanessa R, Thorsten, Lester, Figueroa, Manolo, Mazariegos, Ana, Garces, Archana, Patel, Prabir, Das, Avinash, Kavi, Shivaprasad S, Goudar, Fabian, Esamai, Musaku, Mwenchanya, Elwyn, Chomba, Adrien, Lokangaka, Antoinette, Tshefu, Sana, Yousuf, Melissa, Bauserman, Carl L, Bose, Edward A, Liechty, Nancy F, Krebs, Richard J, Derman, Waldemar A, Carlo, Patricia L, Hibberd, Sk Masum, Billah, Nalini, Peres-da-Silva, Rashidul, Haque, William A, Petri, Marion, Koso-Thomas, Tracy, Nolen, Elizabeth M, McClure, and Robert L, Goldenberg
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Child Health ,Infant, Newborn ,Pregnancy Outcome ,Infant ,COVID-19 ,Stillbirth ,Coronavirus ,Pregnancy ,Birth Weight ,Humans ,Premature Birth ,Women's Health ,Female ,Prospective Studies ,Registries ,Child ,Delivery of Health Care ,Developing Countries ,Pandemics - 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.Prospective, population-based study.Communities in Kenya, Zambia, the Democratic Republic of the Congo, Pakistan, India and Guatemala.Pregnant women enrolled in the Global Network for Women's and Children's Health's Maternal and Newborn Health Registry.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).Stillbirth, neonatal mortality, preterm birth, low birthweight and maternal mortality.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.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.
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- 2022
36. The efficacy of low-dose aspirin in pregnancy among women in malaria-endemic countries
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Tracy L. Nolen, Steve Meshnick, Carl L. Bose, Robert L. Goldenberg, Melissa Bauserman, Janet Moore, Elizabeth M. McClure, Sequoia I. Leuba, Wally Carlo, Fabian Esamai, Adrien Lokangaka, Antoinette Tsehfu, Matthew K. Hoffman, Sarah Saleem, Jennifer Hemingway-Foday, Richard J. Derman, Jackie Patterson, Saleem Jesani, Elwyn Chomba, Marion Koso-Thomas, and Edward A. Liechty
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medicine.medical_specialty ,Anemia ,Perinatal Death ,Prevalence ,Placebo-controlled study ,Placebo ,Informed consent ,Pregnancy ,parasitic diseases ,medicine ,Humans ,Perinatal Mortality ,Aspirin ,Obstetrics ,business.industry ,Infant, Newborn ,Pregnancy Outcome ,Obstetrics and Gynecology ,medicine.disease ,Malaria ,Clinical trial ,Premature Birth ,Female ,business - Abstract
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. Findings: 1,446 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. Interpretation: 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. Clinical Trial Registration Details: This is a sub-study of the ASPIRIN trial, a multi-national, randomized, placebo controlled trial evaluating LDA effect on preterm birthThe ASPIRIN trial was registered in clinicaltrials.gov (NCT02409680). Funding Information: NICHD (UG1HD076465, UG1HD078437, UG1HD076461). Declaration of Interests: We declare no competing interests. Ethics Approval Statement: This study was approved by the relevant ethics committees at the institutions conducting the study at each site prior to the initiation of study activities. The study was also approved by the ethics committees at the partner U.S.-based institutions (University of North Carolina at Chapel Hill, Columbia University, University of Alabama at Birmingham and Indiana University) and by RTI International, the data coordinating center. All women provided informed consent prior to their participation in the sub-study.
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- 2021
37. Cost estimation alongside a multi-regional, multi-country randomized trial of antenatal ultrasound in five low-and-middle-income countries
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Janet Moore, David A. Swanson, Elwyn Chomba, Sherri Bucher, Joseph B. Babigumira, B. M. Chitah, Elizabeth M. McClure, Robert O. Nathan, Waldemar A. Carlo, Edward A. Liechty, Sarah Saleem, Antoinette Tshefu, Louis P. Garrison, Elisabeth Vodicka, Adrien Lokangaka, H. Chavez, Z. Bauer, Ana Garces, A. M. Malik, F. Yego, Fabian Esamai, Jonathan O. Swanson, Brian W. Bresnahan, Carl L. Bose, Robert L. Goldenberg, and Melissa Bauserman
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medicine.medical_specialty ,Cost estimate ,Cost ,Psychological intervention ,Antenatal care ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Pregnancy ,law ,Environmental health ,Epidemiology ,medicine ,Humans ,030212 general & internal medicine ,Child ,Low-and-middle-income countries ,Developing Countries ,Poverty ,health care economics and organizations ,030219 obstetrics & reproductive medicine ,Health economics ,Cesarean Section ,business.industry ,Public health ,Public Health, Environmental and Occupational Health ,International health ,Prenatal Care ,Female ,Pregnant Women ,Maternal health ,Public aspects of medicine ,RA1-1270 ,Biostatistics ,business ,Delivery ,Research Article - Abstract
Background Improving maternal health has been a primary goal of international health agencies for many years, with the aim of reducing maternal and child deaths and improving access to antenatal care (ANC) services, particularly in low-and-middle-income countries (LMICs). Health interventions with these aims have received more attention from a clinical effectiveness perspective than for cost impact and economic efficiency. Methods We collected data on resource use and costs as part of a large, multi-country study assessing the use of routine antenatal screening ultrasound (US) with the aim of considering the implications for economic efficiency. We assessed typical antenatal outpatient and hospital-based (facility) care for pregnant women, in general, with selective complication-related data collection in women participating in a large maternal health registry and clinical trial in five LMICs. We estimated average costs from a facility/health system perspective for outpatient and inpatient services. We converted all country-level currency cost estimates to 2015 United States dollars (USD). We compared average costs across countries for ANC visits, deliveries, higher-risk pregnancies, and complications, and conducted sensitivity analyses. Results Our study included sites in five countries representing different regions. Overall, the relative cost of individual ANC and delivery-related healthcare use was consistent among countries, generally corresponding to country-specific income levels. ANC outpatient visit cost estimates per patient among countries ranged from 15 to 30 USD, based on average counts for visits with and without US. Estimates for antenatal screening US visits were more costly than non-US visits. Costs associated with higher-risk pregnancies were influenced by rates of hospital delivery by cesarean section (mean per person delivery cost estimate range: 25–65 USD). Conclusions Despite substantial differences among countries in infrastructures and health system capacity, there were similarities in resource allocation, delivery location, and country-level challenges. Overall, there was no clear suggestion that adding antenatal screening US would result in either major cost savings or major cost increases. However, antenatal screening US would have higher training and maintenance costs. Given the lack of clinical effectiveness evidence and greater resource constraints of LMICs, it is unlikely that introducing antenatal screening US would be economically efficient in these settings--on the demand side (i.e., patients) or supply side (i.e., healthcare providers). Trial registration Trial number: NCT01990625 (First posted: November 21, 2013 on https://clinicaltrials.gov).
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- 2021
38. Place of delivery and perinatal mortality in Kenya
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Sherri Bucher, Elizabeth M. McClure, Irene Marete, Fabian Esamai, Janet Moore, Rachel C. Vreeman, Edward A. Liechty, Melissa Kunkel, and Erika R Cheng
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Adult ,Perinatal Death ,Population ,Developing country ,Midwifery ,Health Services Accessibility ,Odds ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,030225 pediatrics ,Environmental health ,Humans ,Medicine ,Maternal Health Services ,Prospective Studies ,education ,Home Childbirth ,education.field_of_study ,030219 obstetrics & reproductive medicine ,business.industry ,Perinatal mortality ,Infant, Newborn ,Infant ,Obstetrics and Gynecology ,medicine.disease ,Kenya ,Observational Studies as Topic ,Neonatal outcomes ,Pediatrics, Perinatology and Child Health ,Female ,Observational study ,Medicine, Traditional ,business - Abstract
Background: Increasing access to skilled birth attendants is a key goal in reducing perinatal mortality. In Kenya, where 40% of births occur at home, efforts toward this goal have focused on providing free maternity services in government facilities and discouraging home births. Purpose: To identify trends in facility deliveries and determine the association between delivery location and PM in Kenya. Methods: We utilized data on 36,375 deliveries from the Kenya site of the Global Network for Women's and Children's Health Research, which maintains a prospective, population-based observational study of pregnancy and neonatal outcomes. We identified temporal trends in facility utilization and perinatal mortality. We then assessed associations between delivery location and PM using generalized linear mixed equations. Results: The percentage of facility births increased from 38.4% in 2009 to 47.6% in 2013, with no change in perinatal mortality. Infants delivered in a facility had a higher risk of perinatal mortality than infants delivered at home (aOR = 1.41, p = 0.005). In stratified analyses, hospital deliveries had a higher adjusted odds of perinatal mortality than home and health center deliveries, with no difference between health center and home deliveries. Conclusion: The increase in facility deliveries between 2009 and 2013 was not associated with a decline in perinatal mortality. Infants born in facilities had a 41% greater risk of perinatal mortality than infants born at home. Further research is needed to assess possible explanations for this finding, including delays in referring and caring for complicated pregnancies, higher risk infants delivering at facilities, and poor quality of care in facilities.
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- 2019
39. Including ultrasound scans in antenatal care in low-resource settings: Considering the complementarity of obstetric ultrasound screening and maternity waiting homes in strengthening referral systems in low-resource, rural settings
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Carl L. Bose, Robert L. Goldenberg, Melissa Bauserman, Lester Figueroa, Elwyn Chomba, Nancy Kanaiza, Waseem Mirza, Sherri Bucher, Fabian Esamai, David L. Swanson, Edward A. Liechty, David Muyodi, Farnaz Naqvi, Holly L. Franklin, Nicole Goldsmith, Antoinette Tshefu, Jonathan O. Swanson, Elizabeth M. McClure, Elizabeth V. Fogleman, K. Michael Hambidge, Robert O. Nathan, Victor Lokomba Bolamba, Walter López-Gomez, Musaku Mwenechanya, Ana Garces, Nancy F. Krebs, Waldemar A. Carlo, Adrien Lokangaka, Jamie E. Newman, Irma Sayury Pineda, Dorothy Hamsumonde, and Sarah Saleem
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Adult ,Rural Population ,Referral ,Low resource ,Ultrasound scan ,Midwifery ,World health ,Article ,Ultrasonography, Prenatal ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,030225 pediatrics ,medicine ,Continuum of care ,Humans ,Maternal Health Services ,Developing Countries ,Referral and Consultation ,030219 obstetrics & reproductive medicine ,business.industry ,Pregnancy risk screening ,Referral systems ,Obstetrics and Gynecology ,Prenatal Care ,Obstetric ultrasound ,Task shifting ,Continuity of Patient Care ,medicine.disease ,Hybrid approach ,Complementarity (physics) ,Pregnancy Complications ,Health Care Surveys ,Pediatrics, Perinatology and Child Health ,Maternity waiting home ,Female ,Medical emergency ,Descriptive research ,business ,Delivery of Health Care - Abstract
Recent World Health Organization (WHO) antenatal care recommendations include an ultrasound scan as a part of routine antenatal care. The First Look Study, referenced in the WHO recommendation, subsequently shows that the routine use of ultrasound during antenatal care in rural, low-income settings did not improve maternal, fetal or neonatal mortality, nor did it increase women's use of antenatal care or the rate of hospital births. This article reviews the First Look Study, reconsidering the assumptions upon which it was built in light of these results, a supplemental descriptive study of interviews with patients and sonographers that participated in the First Look study intervention, and a review of the literature. Two themes surface from this review. The first is that focused emphasis on building the pregnancy risk screening skills of rural primary health care personnel may not lead to adaptations in referral hospital processes that could benefit the patient accordingly. The second is that agency to improve the quality of patient reception at referral hospitals may need to be manufactured for obstetric ultrasound screening, or remote pregnancy risk screening more generally, to have the desired impact. Stemming from the literature, this article goes on to examine the potential for complementarity between obstetric ultrasound screening and another approach encouraged by the WHO, the maternity waiting home. Each approach may address existing shortcomings in how the other is currently understood. This paper concludes by proposing a path toward developing and testing such a hybrid approach.
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- 2019
40. Development of the Global Network for Women’s and Children’s Health Research’s socioeconomic status index for use in the network’s sites in low and lower middle-income countries
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Marion Koso-Thomas, Patricia L. Hibberd, Antoinette Tshefu, Waldemar A. Carlo, Shivaprasad S. Goudar, Carl L. Bose, Robert L. Goldenberg, Elizabeth M. McClure, Ana Garces, Elwyn Chomba, Carla M. Bann, Fabian Esamai, Richard J. Derman, Edward A. Liechty, Nancy F. Krebs, Sarah Saleem, Adrien Lokangaka, and Archana B. Patel
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medicine.medical_specialty ,Social Determinants of Health ,Maternal Health ,Population ,Global health ,Global Network for Women’ and Children’s Health Research ,Disparities ,Determinants of health ,Lower and middle income countries (LMIC) ,lcsh:Gynecology and obstetrics ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Surveys and Questionnaires ,Environmental health ,medicine ,Humans ,030212 general & internal medicine ,Social determinants of health ,Healthcare Disparities ,Child ,education ,Developing Countries ,Socioeconomic status ,lcsh:RG1-991 ,education.field_of_study ,030219 obstetrics & reproductive medicine ,Research ,Public health ,Child Health ,Infant, Newborn ,Reproducibility of Results ,Obstetrics and Gynecology ,Human development (humanity) ,Social Class ,Reproductive Medicine ,Household income ,Female ,Rural area ,Psychology - Abstract
Background 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 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.
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- 2020
41. Maternal mortality in six low and lower-middle income countries from 2010 to 2018: risk factors and trends
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Nancy F. Krebs, Paul Nyongesa, Carl L. Bose, Elwyn Chomba, Robert L. Goldenberg, Adrien Lokangaka, Lester Figueroa, Jackie Patterson, Melissa Bauserman, Tracy L. Nolen, Archana B. Patel, Sk Masum Billah, Sarah Saleem, Edward A. Liechty, Antoinette Tshefu, Patricia L. Hibberd, Avinash Kavi, Fabian Esamai, Richard J. Derman, Marion Koso-Thomas, Saleem Jessani, Shivaprasad S. Goudar, Ana Garces, Vanessa Thorsten, Waldemar A. Carlo, and Elizabeth M. McClure
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Maternal mortality ,medicine.medical_specialty ,Maternal Health ,Reproductive medicine ,Sustainable development goals ,Global Health ,lcsh:Gynecology and obstetrics ,Pregnancy ,Risk Factors ,Humans ,Medicine ,Child ,Developing Countries ,lcsh:RG1-991 ,Antepartum hemorrhage ,business.industry ,Research ,Public health ,Infant, Newborn ,Pregnancy Outcome ,Attendance ,Obstetrics and Gynecology ,Puerperal Disorders ,Sustainable Development ,Delivery, Obstetric ,Health indicator ,Pregnancy Complications ,Global network ,Standardized mortality ratio ,Reproductive Medicine ,Relative risk ,Maternal Death ,Female ,Low-resource countries ,Parity (mathematics) ,business ,Demography - Abstract
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.
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- 2020
42. Looking beyond the numbers: quality assurance procedures in the Global Network for Women’s and Children’s Health Research Maternal Newborn Health Registry
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Edward A. Liechty, Elwyn Chomba, Robert L. Goldenberg, William A. Petri, Marion Elizabeth M. Koso-ThomasMcClure, Fabian Esamai, Lester Figueroa, Holly L. Franklin, Shivaprasad S. Goudar, Ana Garces, Waldemar A. Carlo, Norma Alfaro, Gustavo Arroyo, Patricia L. Hibberd, Sarah Saleem, Antoinette Tshefu, Nancy F. Krebs, Rashidul Haque, Richard J. Derman, Emily MacGuire, Archana Patel, and Jacquelyn Patterson
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medicine.medical_specialty ,Quality Assurance, Health Care ,Training for research studies ,Maternal Health ,Population ,Certification ,Adult learning ,lcsh:Gynecology and obstetrics ,Pregnancy ,Humans ,Medicine ,Infant Health ,Registries ,Child ,education ,lcsh:RG1-991 ,Multiple choice ,Protocol (science) ,education.field_of_study ,Data collection ,business.industry ,Research ,Public health ,Child Health ,Infant, Newborn ,Quality control ,Obstetrics and Gynecology ,medicine.disease ,Quality assurance ,Global network ,Reproductive Medicine ,Data quality ,Female ,Public Health ,Medical emergency ,business ,Public health training - Abstract
Background 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.
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- 2020
43. Neonatal deaths in infants born weighing ≥ 2500 g in low and middle-income countries
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Musaku Mwenechanya, Antoinette Tshefu, Elwyn Chomba, Fabian Esamai, Farnaz Naqvi, Richard J. Derman, Janet Moore, Sameen Siddiqi, Nancy F. Krebs, Carl L. Bose, Robert L. Goldenberg, Shiyam Sunder Tikmani, Yogesh Kumar, Sarah Saleem, Marion Koso-Thomas, Archana B. Patel, Kayla Nowak, Patricia L. Hibberd, Edward A. Liechty, Shivaprasad S. Goudar, Ana Garces, Waldemar A. Carlo, Irene Marete, Elizabeth M. McClure, and Tracy L. Nolen
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Adult ,Male ,medicine.medical_specialty ,Perinatal Death ,Birth weight ,Population ,Reproductive medicine ,lcsh:Gynecology and obstetrics ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Infant Mortality ,medicine ,Humans ,≥ 2500 g neonatal mortality ,Prospective Studies ,030212 general & internal medicine ,education ,Developing Countries ,Neonatal mortality ,lcsh:RG1-991 ,education.field_of_study ,030219 obstetrics & reproductive medicine ,business.industry ,Research ,Public health ,Infant, Newborn ,Infant ,Obstetrics and Gynecology ,Gestational age ,Infant, Low Birth Weight ,medicine.disease ,Global network ,Reproductive Medicine ,Low and middle-income countries ,Gestation ,Female ,Maternal death ,business ,Demography - Abstract
Background Babies born weighing ≥ 2500 g account for more than 80% of the births in most resource-limited locations and for nearly 50% of the 28-day neonatal deaths. In contrast, in high-resource settings, 28-day neonatal mortality among this group represents only a small fraction of the neonatal deaths. Yet mortality risks for birth weight of ≥ 2500 g is limited. Knowledge regarding the factors associated with mortality in these babies will help in identifying interventions that can reduce mortality. Methods The Global Network’s Maternal Newborn Health Registry (MNHR) is a prospective, population-based observational study that includes all pregnant women and their pregnancy outcomes in defined geographic communities that has been conducted in research sites in six low-middle income countries (India, Pakistan, Democratic Republic of Congo, Guatemala, Kenya and Zambia). Study staff enroll all pregnant women as early as possible during pregnancy and conduct follow-up visits to ascertain delivery and 28-day neonatal outcomes. We analyzed the neonatal mortality rates (NMR) and risk factors for deaths by 28 days among all live-born babies with a birthweight ≥ 2500 g from 2010 to 2018 across the Global Network sites. Results Babies born in the Global Network sites from 2010 to 2018 with a birthweight ≥ 2500 g accounted for 84.8% of the births and 45.4% of the 28-day neonatal deaths. Among this group, the overall NMR was 13.1/1000 live births. The overall 28-day NMR for ongoing clusters was highest in Pakistan (29.7/1000 live births) and lowest in the Zambian/Kenyan sites (9.3/1000) for ≥ 2500 g infants. ≥ 2500 g NMRs declined for Zambia/Kenya and India. For Pakistan and Guatemala, the NMR remained almost unchanged over the period. The ≥ 2500 g risks related to maternal, delivery and newborn characteristics varied by site. Maternal factors that increased risk and were common for all sites included nulliparity, hypertensive disease, previous stillbirth, maternal death, obstructed labor, severe postpartum hemorrhage, and abnormal fetal presentation. Neonatal characteristics including resuscitation, hospitalization, congenital anomalies and male sex, as well as lower gestational ages and birthweights were also associated with increased mortality. Conclusions Nearly half of neonatal deaths in the Global Network sites occurred in infants born weighing ≥ 2500 g. The NMR for those infants was 13.1 per 1000 live births, much higher than rates usually seen in high-income countries. The changes in NMR over time varied across the sites. Even among babies born ≥ 2500 g, lower gestational age and birthweight were largely associated with increased risk of mortality. Since many of these deaths should be preventable, attention to preventing mortality in these infants should have an important impact on overall NMR. Trial registration: https://ClinicalTrials.gov Identifier: NCT01073475
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- 2020
44. The relationship between birth intervals and adverse maternal and neonatal outcomes in six low and lower-middle income countries
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Elwyn Chomba, Musaku Mwenechanya, Shivaprasad S. Goudar, Carl L. Bose, Robert L. Goldenberg, Melissa Bauserman, Sarah Saleem, Ana Garces, Waldemar A. Carlo, Kayla Nowak, Adrien Lokangaka, Patricia L. Hibberd, Richard J. Derman, Elizabeth M. McClure, Antoinette Tshefu, Fabian Esamai, Edward A. Liechty, Marion Koso-Thomas, Archana B. Patel, Saleem Jessani, Umesh Ramadurg, Lester Figueroa, Tracy L. Nolen, Jackie Patterson, and Nancy F. Krebs
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Adult ,Birth intervals ,Maternal mortality ,medicine.medical_specialty ,Low birthweight ,Reproductive medicine ,Developing country ,Logistic regression ,lcsh:Gynecology and obstetrics ,Developing countries ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Infant Mortality ,medicine ,Humans ,030212 general & internal medicine ,lcsh:RG1-991 ,Neonatal mortality ,030219 obstetrics & reproductive medicine ,Obstetrics ,business.industry ,Public health ,Research ,Infant, Newborn ,Pregnancy Outcome ,Obstetrics and Gynecology ,Infant ,Infant, Low Birth Weight ,medicine.disease ,Delivery, Obstetric ,Low birth weight ,Global network ,Reproductive Medicine ,Neonatal outcomes ,Population Surveillance ,Maternal Death ,Maternal death ,Female ,medicine.symptom ,business - Abstract
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.
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- 2020
45. Oligohydramnios: a prospective study of fetal, neonatal and maternal outcomes in low-middle income countries
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Elizabeth M. McClure, K. Michael Hambidge, Janet Moore, Edward A. Liechty, Lester Figueroa, Robert O. Nathan, Sarah Saleem, Carl L. Bose, Robert L. Goldenberg, Melissa Bauserman, Waseem Mirza, Antoinette Tshefu, Adrien Lokangaka, David L. Swanson, Ana Garces, Farnaz Naqvi, Waldemar A. Carlo, Fabian Esamai, Jonathan O. Swanson, Elwyn Chomba, and Nancy F. Krebs
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Adult ,Male ,medicine.medical_specialty ,Birth weight ,Reproductive medicine ,Zambia ,Oligohydramnios ,lcsh:Gynecology and obstetrics ,Ultrasonography, Prenatal ,Young Adult ,Fetus ,Pregnancy ,Infant Mortality ,Ultrasound ,medicine ,Humans ,Pakistan ,Prospective Studies ,Amniotic fluid index ,Prospective cohort study ,Developing Countries ,lcsh:RG1-991 ,Pregnancy outcomes ,Obstetrics ,business.industry ,Research ,Incidence (epidemiology) ,Infant, Newborn ,Pregnancy Outcome ,Infant ,Obstetrics and Gynecology ,Prenatal Care ,Infant, Low Birth Weight ,Guatemala ,medicine.disease ,Low birth weight ,Reproductive Medicine ,Low and middle-income countries ,Female ,medicine.symptom ,business - Abstract
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 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.
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- 2020
46. Cesarean birth in the Global Network for Women’s and Children’s Health Research: trends in utilization, risk factors, and subgroups with high cesarean birth rates
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Waldemar A. Carlo, Margo S. Harrison, Nancy F. Krebs, Elwyn Chomba, Carl L. Bose, Robert L. Goldenberg, Janet Moore, Antoinette Tshefu, Elizabeth M. McClure, Richard J. Derman, Marion Koso-Thomas, Patricia L. Hibberd, Sarah Saleem, Fabian Esamai, Shivaprasad S. Goudar, Ana Garces, Edward A. Liechty, and Archana B. Patel
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Adult ,medicine.medical_specialty ,Population ,Reproductive medicine ,Southeast asian ,lcsh:Gynecology and obstetrics ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Pregnancy ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,education ,Birth Rate ,Child ,lcsh:RG1-991 ,reproductive and urinary physiology ,education.field_of_study ,030219 obstetrics & reproductive medicine ,Low- and middle-income countries ,Antepartum hemorrhage ,business.industry ,Obstetrics ,Cesarean Section ,Public health ,Research ,Child Health ,Infant, Newborn ,Obstetrics and Gynecology ,medicine.disease ,Vaginal Birth after Cesarean ,female genital diseases and pregnancy complications ,Robson classification ,Parity ,Cesarean birth ,Cesarean Birth ,Reproductive Medicine ,Risk factors ,Population Surveillance ,Female ,Trends ,Parity (mathematics) ,business - Abstract
Background 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 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.
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- 2020
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47. Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial
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Matthew K Hoffman, Shivaprasad S Goudar, Bhalachandra S Kodkany, Mrityunjay Metgud, Manjunath Somannavar, Jean Okitawutshu, Adrien Lokangaka, Antoinette Tshefu, Carl L Bose, Abigail Mwapule, Musaku Mwenechanya, Elwyn Chomba, Waldemar A Carlo, Javier Chicuy, Lester Figueroa, Ana Garces, Nancy F Krebs, Saleem Jessani, Farnaz Zehra, Sarah Saleem, Robert L Goldenberg, Kunal Kurhe, Prabir Das, Archana Patel, Patricia L Hibberd, Emmah Achieng, Paul Nyongesa, Fabian Esamai, Edward A Liechty, Norman Goco, Jennifer Hemingway-Foday, Janet Moore, Tracy L Nolen, Elizabeth M McClure, Marion Koso-Thomas, Menachem Miodovnik, R Silver, Richard J Derman, Melissa Bauserman, Carl Bose, Sherri Bucher, Waldemar Carlo, Umesh S Charantimath, Richard Derman, MS Ganachari, Noman Goco, Robert Goldenberg, Shivaprasad Goudar, Patricia Hibberd, Matthew Hoffman, Narayan V Honnungar, Avinash Kavi, Bhalachandra Kodkany, Nancy Krebs, Yogesh Kumar Shashikanth, Edward Liechty, Emily MacGuire, Ashalata A Mallapur, Elizabeth McClure, Farnaz Naqvi, Seemab Naqvi, Robert Nathan, Tracy Nolen, Suchita Parepalli, Umesh Y Ramadurg, Robert Silver, Zahid Soomro, Sunil S Vernekar, and Dennis Wallace
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Adult ,medicine.medical_specialty ,Adolescent ,Placebo-controlled study ,Blood Pressure ,Placebo ,Young Adult ,Double-Blind Method ,Pre-Eclampsia ,Pregnancy ,medicine ,Humans ,Developing Countries ,Aspirin ,Eclampsia ,Obstetrics ,business.industry ,Pregnancy Outcome ,Gestational age ,General Medicine ,medicine.disease ,Delivery, Obstetric ,Gestation ,Premature Birth ,Maternal death ,Female ,business ,medicine.drug - Abstract
Preterm birth remains a common cause of neonatal mortality, with a disproportionately high burden in low-income and middle-income countries. Meta-analyses of low-dose aspirin to prevent pre-eclampsia suggest that the incidence of preterm birth might also be decreased, particularly if initiated before 16 weeks of gestation.ASPIRIN was a randomised, multicountry, double-masked, placebo-controlled trial of low-dose aspirin (81 mg daily) initiated between 6 weeks and 0 days of pregnancy, and 13 weeks and 6 days of pregnancy, in nulliparous women with an ultrasound confirming gestational age and a singleton viable pregnancy. Participants were enrolled at seven community sites in six countries (two sites in India and one site each in the Democratic Republic of the Congo, Guatemala, Kenya, Pakistan, and Zambia). Participants were randomly assigned (1:1, stratified by site) to receive aspirin or placebo tablets of identical appearance, via a sequence generated centrally by the data coordinating centre at Research Triangle Institute International (Research Triangle Park, NC, USA). Treatment was masked to research staff, health providers, and patients, and continued until 36 weeks and 7 days of gestation or delivery. The primary outcome of incidence of preterm birth, defined as the number of deliveries before 37 weeks' gestational age, was analysed in randomly assigned women with pregnancy outcomes at or after 20 weeks, according to a modified intention-to-treat (mITT) protocol. Analyses of our binary primary outcome involved a Cochran-Mantel-Haenszel test stratified by site, and generalised linear models to obtain relative risk (RR) estimates and associated confidence intervals. Serious adverse events were assessed in all women who received at least one dose of drug or placebo. This study is registered with ClinicalTrials.gov, NCT02409680, and the Clinical Trial Registry-India, CTRI/2016/05/006970.From March 23, 2016 to June 30, 2018, 14 361 women were screened for inclusion and 11 976 women aged 14-40 years were randomly assigned to receive low-dose aspirin (5990 women) or placebo (5986 women). 5780 women in the aspirin group and 5764 in the placebo group were evaluable for the primary outcome. Preterm birth before 37 weeks occurred in 668 (11·6%) of the women who took aspirin and 754 (13·1%) of those who took placebo (RR 0·89 [95% CI 0·81 to 0·98], p=0·012). In women taking aspirin, we also observed significant reductions in perinatal mortality (0·86 [0·73-1·00], p=0·048), fetal loss (infant death after 16 weeks' gestation and before 7 days post partum; 0·86 [0·74-1·00], p=0·039), early preterm delivery (34 weeks; 0·75 [0·61-0·93], p=0·039), and the incidence of women who delivered before 34 weeks with hypertensive disorders of pregnancy (0·38 [0·17-0·85], p=0·015). Other adverse maternal and neonatal events were similar between the two groups.In populations of nulliparous women with singleton pregnancies from low-income and middle-income countries, low-dose aspirin initiated between 6 weeks and 0 days of gestation and 13 weeks and 6 days of gestation resulted in a reduced incidence of preterm delivery before 37 weeks, and reduced perinatal mortality.Eunice Kennedy Shriver National Institute of Child Health and Human Development.
- Published
- 2019
48. Trends and determinants of stillbirth in developing countries: results from the Global Network’s Population-Based Birth Registry
- Author
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Elizabeth M. McClure, K. Michael Hambidge, Lester Figueroa, Farnaz Naqvi, Janet Moore, Syed Iqbal Azam, Robert L. Goldenberg, Irene Marete, Shiyam Sunder Tikmani, Nancy F. Krebs, Waldemar A. Carlo, Edward A. Liechty, Menachem Miodovnik, Elwyn Chomba, Constance Tenge, Patricia L Hibberd, Richard J. Derman, Sumera Aziz Ali, Archana B. Patel, Marion Koso-Thomas, Fabian Esamai, Shivaprasad S. Goudar, Musaku Mwenchanya, Ana Garces, Dennis Wallace, Sarah Saleem, Sangappa M. Dhaded, and Sherri Bucher
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Adult ,medicine.medical_specialty ,Population ,Reproductive medicine ,Developing country ,Prenatal care ,lcsh:Gynecology and obstetrics ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Infant Mortality ,Humans ,Medicine ,Registries ,030212 general & internal medicine ,education ,Developing Countries ,reproductive and urinary physiology ,lcsh:RG1-991 ,Reproductive health ,education.field_of_study ,030219 obstetrics & reproductive medicine ,business.industry ,Research ,Infant, Newborn ,Pregnancy Outcome ,Infant ,Obstetrics and Gynecology ,Stillbirth ,medicine.disease ,female genital diseases and pregnancy complications ,Reproductive Medicine ,Rates of decline ,population characteristics ,Female ,Low-middle income countries ,business ,Parity (mathematics) ,Risk assessment ,Maternal Age ,Demography - Abstract
Background Stillbirth rates remain high, especially in low and middle-income countries, where rates are 25 per 1000, ten-fold higher than in high-income countries. The United Nations’ Every Newborn Action Plan has set a goal of 12 stillbirths per 1000 births by 2030 for all countries. Methods From a population-based pregnancy outcome registry, including data from 2010 to 2016 from two sites each in Africa (Zambia and Kenya) and India (Nagpur and Belagavi), as well as sites in Pakistan and Guatemala, we evaluated the stillbirth rates and rates of annual decline as well as risk factors for 427,111 births of which 12,181 were stillbirths. Results The mean stillbirth rates for the sites were 21.3 per 1000 births for Africa, 25.3 per 1000 births for India, 56.9 per 1000 births for Pakistan and 19.9 per 1000 births for Guatemala. From 2010 to 2016, across all sites, the mean stillbirth rate declined from 31.7 per 1000 births to 26.4 per 1000 births for an average annual decline of 3.0%. Risk factors for stillbirth were similar across the sites and included maternal age 35 years. Compared to parity 1–2, zero parity and parity > 3 were both associated with increased stillbirth risk and compared to women with any prenatal care, women with no prenatal care had significantly increased risk of stillbirth in all sites. Conclusions At the current rates of decline, stillbirth rates in these sites will not reach the Every Newborn Action Plan goal of 12 per 1000 births by 2030. More attention to the risk factors and treating the causes of stillbirths will be required to reach the Every Newborn Action Plan goal of stillbirth reduction. Trial registration NCT01073475.
- Published
- 2018
49. A prospective cause of death classification system for maternal deaths in low and middle-income countries: results from the Global Network Maternal Newborn Health Registry
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Shivaprasad S. Goudar, Ana Garces, Sangappa M. Dhaded, Antoinette Tshefu, Elizabeth M. McClure, Janet Moore, Ashlesha Patel, Elwyn Chomba, Patricia L. Hibberd, Shiyam Sunder Tikmani, Edward A. Liechty, Lester Figueroa, Adrien Lokangaka, Constance Tenge, Menachem Miodovnik, K. M. Hambidge, Bhalchandra S. Kodkany, Marion Koso-Thomas, Fabian Esamai, Omrana Pasha, Nancy F. Krebs, Musaku Mwenechanya, Carl L. Bose, Robert L. Goldenberg, Melissa Bauserman, Sarah Saleem, Dennis Wallace, Waldemar A. Carlo, and Richard J. Derman
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Pediatrics ,medicine.medical_specialty ,Population ,Black People ,India ,Zambia ,Global Health ,Article ,White People ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Cause of Death ,Environmental health ,medicine ,Humans ,Infant Health ,Pakistan ,Prospective Studies ,Registries ,030212 general & internal medicine ,education ,Developing Countries ,Cause of death ,education.field_of_study ,030219 obstetrics & reproductive medicine ,Eclampsia ,business.industry ,Public health ,Infant, Newborn ,Obstetrics and Gynecology ,Guatemala ,medicine.disease ,Kenya ,Pregnancy Complications ,Maternal Mortality ,Cohort ,Democratic Republic of the Congo ,Income ,Maternal Death ,Female ,Maternal death ,Observational study ,business - Abstract
Objective To describe the causes of maternal death in a population-based cohort in six low- and middle-income countries using a standardised, hierarchical, algorithmic cause of death (COD) methodology. Design A population-based, prospective observational study. Setting Seven sites in six low- to middle-income countries including the Democratic Republic of the Congo (DRC), Guatemala, India (two sites), Kenya, Pakistan and Zambia. Population All deaths among pregnant women resident in the study sites from 2014 to December 2016. Methods For women who died, we used a standardised questionnaire to collect clinical data regarding maternal conditions present during pregnancy and delivery. These data were analysed using a computer-based algorithm to assign cause of maternal death based on the International Classification of Disease-Maternal Mortality system (trauma, termination of pregnancy-related, eclampsia, haemorrhage, pregnancy-related infection and medical conditions). We also compared the COD results to healthcare-provider-assigned maternal COD. Main outcome measures Assigned causes of maternal mortality. Results Among 158 205 women, there were 221 maternal deaths. The most common algorithm-assigned maternal COD were obstetric haemorrhage (38.6%), pregnancy-related infection (26.4%) and pre-eclampsia/eclampsia (18.2%). Agreement between algorithm-assigned COD and COD assigned by healthcare providers ranged from 75% for haemorrhage to 25% for medical causes coincident to pregnancy. Conclusions The major maternal COD in the Global Network sites were haemorrhage, pregnancy-related infection and pre-eclampsia/eclampsia. This system could allow public health programmes in low- and middle-income countries to generate transparent and comparable data for maternal COD across time or regions. Tweetable abstract An algorithmic system for determining maternal cause of death in low-resource settings is described.
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- 2018
50. No Intensive Admit Code for Infants Older than 28 Days
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Edward A. Liechty
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Computer science ,Programming language ,Code (cryptography) ,computer.software_genre ,computer - Published
- 2020
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