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Item Evaluating the effect of care around labor and delivery practices on early neonatal mortality in the Global Network's Maternal and Newborn Health Registry(Springer Nature, 2020-11-30) Patel, Archana B.; Simmons, Elizabeth M.; Rao, Sowmya R.; Moore, Janet; Nolen, Tracy L.; Goldenberg, Robert L.; Goudar, Shivaprasad S.; Somannavar, Manjunath S.; Esamai, Fabian; Nyongesa, Paul; Garces, Ana L.; Chomba, Elwyn; Mwenechanya, Musaku; Saleem, Sarah; Naqvi, Farnaz; Bauserman, Melissa; Bucher, Sherri; Krebs, Nancy F.; Derman, Richard J.; Carlo, Waldemar A.; Koso‑ThomasMcClure, Marion Elizabeth M.; Hibberd, Patricia L.; Pediatrics, School of MedicineBackground: Neonatal deaths in first 28-days of life represent 47% of all deaths under the age of five years globally and are a focus of the United Nation's (UN's) Sustainable Development Goals. Pregnant women are delivering in facilities but that does not indicate quality of care during delivery and the postpartum period. The World Health Organization's Essential Newborn Care (ENC) package reduces neonatal mortality, but lacks a simple and valid composite index that measures its effectiveness. Methods: Data on 5 intra-partum and 3 post-partum practices (indicators) recommended as part of ENC, routinely collected in NICHD's Global Network's (GN) Maternal Newborn Health Registry (MNHR) between 2010 and 2013, were included. We evaluated if all 8 practices (Care around Delivery - CAD), combined as an index was associated with reduced early neonatal mortality rates (days 0-6 of life). Results: A total of 150,848 live births were included in the analysis. The individual indicators varied across sites. All components were present in 19.9% births (range 0.4 to 31% across sites). Present indicators (8 components) were associated with reduced early neonatal mortality [adjusted RR (95% CI):0.81 (0.77, 0.85); p < 0.0001]. Despite an overall association between CAD and early neonatal mortality (RR < 1.0 for all early mortality): delivery by skilled birth attendant; presence of fetal heart and delayed bathing were associated with increased early neonatal mortality. Conclusions: Present indicators (8 practices) of CAD were associated with a 19% reduction in the risk of neonatal death in the diverse health facilities where delivery occurred within the GN MNHR. These indicators could be monitored to identify facilities that need to improve compliance with ENC practices to reduce preventable neonatal deaths. Three of the 8 indicators were associated with increased neonatal mortality, due to baby being sick at birth. Although promising, this composite index needs refinement before use to monitor facility-based quality of care in association with early neonatal mortality.Item Impact of exposure to cooking fuels on stillbirths, perinatal, very early and late neonatal mortality - a multicenter prospective cohort study in rural communities in India, Pakistan, Kenya, Zambia and Guatemala(Springer (Biomed Central Ltd.), 2015) Patel, Archana B.; Meleth, Sreelatha; Pasha, Omrana; Goudar, Shivaprasad S.; Esamai, Fabian; Garces, Ana L.; Chomba, Elwyn; McClure, Elizabeth M.; Wright, Linda L.; Koso-Thomas, Marion; Moore, Janet L.; Saleem, Sarah; Liechty, Edward A.; Goldenberg, Robert L.; Derman, Richard J.; Hambidge, K. Michael; Carlo, Waldemar A.; Hibberd, Patricia L.; Department of Pediatrics, IU School of MedicineBACKGROUND: Consequences of exposure to household air pollution (HAP) from biomass fuels used for cooking on neonatal deaths and stillbirths is poorly understood. In a large multi-country observational study, we examined whether exposure to HAP was associated with perinatal mortality (stillbirths from gestation week 20 and deaths through day 7 of life) as well as when the deaths occurred (macerated, non-macerated stillbirths, very early neonatal mortality (day 0-2) and later neonatal mortality (day 3-28). Questions addressing household fuel use were asked at pregnancy, delivery, and neonatal follow-up visits in a prospective cohort study of pregnant women in rural communities in five low and lower middle income countries participating in the Global Network for Women and Children's Health's Maternal and Newborn Health Registry. The study was conducted between May 2011 and October 2012. Polluting fuels included kerosene, charcoal, coal, wood, straw, crop waste and dung. Clean fuels included electricity, liquefied petroleum gas (LPG), natural gas and biogas. RESULTS: We studied the outcomes of 65,912 singleton pregnancies, 18 % from households using clean fuels (59 % LPG) and 82 % from households using polluting fuels (86 % wood). Compared to households cooking with clean fuels, there was an increased risk of perinatal mortality among households using polluting fuels (adjusted relative risk (aRR) 1.44, 95 % confidence interval (CI) 1.30-1.61). Exposure to HAP increased the risk of having a macerated stillbirth (adjusted odds ratio (aOR) 1.66, 95%CI 1.23-2.25), non-macerated stillbirth (aOR 1.43, 95 % CI 1.15-1.85) and very early neonatal mortality (aOR 1.82, 95 % CI 1.47-2.22). CONCLUSIONS: Perinatal mortality was associated with exposure to HAP from week 20 of pregnancy through at least day 2 of life. Since pregnancy losses before labor and delivery are difficult to track, the effect of exposure to polluting fuels on global perinatal mortality may have previously been underestimated. TRIAL REGISTRATION: ClinicalTrials.gov NCT01073475.Item 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(Elsevier, 2019) Swanson, David L.; Franklin, Holly L.; Swanson, Jonathan O.; Goldenberg, Robert L.; McClure, Elizabeth M.; Mirza, Waseem; Muyodi, David; Figueroa, Lester; Goldsmith, Nicole; Kanaiza, Nancy; Naqvi, Farnaz; Pineda, Irma Sayury; López-Gomez, Walter; Hamsumonde, Dorothy; Bolamba, Victor Lokomba; Newman, Jamie E.; Fogleman, Elizabeth V.; Saleem, Sarah; Esamai, Fabian; Bucher, Sherri; Liechty, Edward A.; Garces, Ana L.; Krebs, Nancy F.; Hambidge, K. Michael; Chomba, Elwyn; Bauserman, Melissa; Mwenechanya, Musaku; Carlo, Waldemar A.; Tshefu, Antoinette; Lokangaka, Adrien; Bose, Carl L.; Nathan, Robert O.; Pediatrics, School of MedicineRecent 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.Item 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(Wiley, 2022-11) Naqvi, Seemab; Saleem, Sarah; Naqvi, Farnaz; Billah, Sk Masum; Nielsen, Eleanor; Fogleman, Elizabeth; Peres-da-Silva, Nalini; Figueroa, Lester; Mazariegos, Manolo; Garces, Ana L.; Patel, Archana; Das, Prabir; Kavi, Avinash; Goudar, Shivaprasad S.; Esamai, Fabian; Chomba, Elwyn; Lokangaka, Adrien; Tshefu, Antoinette; Haque, Rashidul; Siraj, Shahjahan; Yousaf, Sana; Bauserman, Melissa; Liechty, Edward A.; Krebs, Nancy F.; Derman, Richard J.; Carlo, Waldemar A.; Petri, William A., Jr.; Hibberd, Patricia L.; Koso-Thomas, Marion; Thorsten, Vanessa; McClure, Elizabeth M.; Goldenberg, Robert L.; Pediatrics, School of MedicineObjectives: 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.Item 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(Wiley, 2017) Pasha, Omrana; McClure, Elizabeth M.; Saleem, Sarah; Sunder, Shiyam; Lokangaka, Adrien; Tshefu, Antoinette; Bose, Carl L.; Bauserman, Melissa; Mwenechanya, Musaku; Chomba, Elwyn; Carlo, Waldemar A.; Garces, Ana L.; Figueroa, Lester; Hambidge, K. Michael; Krebs, Nancy F.; Goudar, Shivaprasad; Kodkany, Bhalachandra S.; Dhaded, Sangappa; Derman, Richard J.; Patel, Archana; Hibberd, Patricia L.; Esamai, Fabian; Tenge, Constance; Liechty, Edward A.; Moore, Janet L.; Wallace, Dennis D.; Koso-Thomas, Marion; Miodovnik, Menachem; Goldenberg, Robert L.; Pediatrics, School of MedicineObjective To describe the causes of maternal death in a population-based cohort in six low and middle-income countries using a standardized, hierarchical, algorithmic cause of death (COD) methodology. Design A population-based, prospective observational study. Setting Seven sites in six low-middle income countries including the Democratic Republic of the Congo (DRC), Guatemala, India (2), Kenya, Pakistan and Zambia. Population All deaths amongst pregnant women resident in the study sites from 2014 to December 2016. Methods For women who died, we used a standardized questionnaire to collect clinical data regarding maternal conditions present during pregnancy and delivery. These data were analyzed using a computer-based algorithm to assign cause of maternal death based on the International Classification of Disease - Maternal Mortality system (trauma, abortion-related, eclampsia, hemorrhage, pregnancy-related infection and medical conditions). We also compared the COD results to health care provider assigned maternal COD. Main Outcome Measures Assigned causes of maternal mortality. Results Amongst 158,205 women, there were 221 maternal deaths. The most common algorithm-assigned maternal COD were obstetric hemorrhage (38.6%), pregnancy-related infection (26.4%) and preeclampsia/eclampsia (18.2%). Agreement between algorithm-assigned COD and COD assigned by health care providers ranged from 75% for hemorrhage to 25% for medical causes coincident to pregnancy. Conclusions The major maternal COD in the Global Network sites were hemorrhage, pregnancy-related infection and preeclampsia/eclampsia. This system could allow public health programs in low and middle-income countries to generate transparent and comparable data for maternal COD across time or regions.Item A prospective study of maternal, fetal and neonatal outcomes in the setting of cesarean section in low- and middle-income countries(Wiley, 2017-04) Harrison, Margo S.; Pasha, Omrana; Saleem, Sarah; Ali, Sumera; Chomba, Elwyn; Carlo, Waldemar A.; Garces, Ana L.; Krebs, Nancy F.; Hambidge, K. Michael; Goudar, Shivaprasad S.; Kodkany, Bhala; Dhaded, Sangappa; Derman, Richard J.; Patel, Archana; Hibberd, Patricia L.; Esamai, Fabian; Liechty, Edward A.; Moore, Janet L.; Wallace, Dennis; McClure, Elizabeth M.; Miodovnik, Menachem; Koso-Thomas, Marion; Belizan, Jose; Tsefu, Antoinette K.; Bauserman, Melissa; Goldenberg, Robert L.; Pediatrics, School of MedicineIntroduction Cesarean section (CS) rates are increasing globally with an unclear effect on pregnancy outcomes. The study objective was to quantify maternal and perinatal morbidity and mortality associated with CS compared with vaginal delivery (VD) both within and across sites in low- and middle-income countries. Material and methods A prospective population-based study including home and facility births in 337 153 women with a VD and 47 308 women with a CS from 2010 to 2015 was performed in Guatemala, India, Kenya, Pakistan, Zambia and Democratic Republic of Congo. Women were enrolled during pregnancy; delivery and 6-week follow-up data were collected. Results Across all sites, CS rates increased from 8.6% to 15.2%, but remained low in African sites. Younger, nulliparous women were more likely to have a CS, as were women with higher education and those delivering an infant weighing 1500–2499 g. Across all sites, maternal and neonatal mortality was higher, and stillbirths were lower, in pregnancies delivered by CS. Antepartum and postpartum complications as well as obstetric interventions and treatments were more common among women who underwent CS. In stratified analyses, all outcomes were worse in women with a CS compared with VD in African compared to non-African sites. Conclusions CS rates increased across all sites during the study period, but at more pronounced rates in the non-African sites. CS was associated with reduced postpartum hemorrhage and lower rates of stillbirths in the non-African sites. In the African sites, CS was associated with an increase in all adverse outcomes. Further studies are necessary to better understand the increase in adverse outcomes with CS in the African sites.Item Regional trends in birth weight in low- and middle-income countries 2013–2018(BMC, 2020-12-17) Marete, Irene; Ekhaguere, Osayame; Bann, Carla M.; Bucher, Sherri L.; Nyongesa, Paul; Patel, Archana B.; Hibberd, Patricia L.; Saleem, Sarah; Goldenberg, Robert L.; Goudar, Shivaprasad S.; Derman, Richard J.; Garces, Ana L.; Krebs, Nancy F.; Chomba, Elwyn; Carlo, Waldemar A.; Lokangaka, Adien; Bauserman, Melissa; Koso‑Thomas, Marion; Moore, Janet L.; McClure, Elizabeth M.; Esamai, Fabian; Pediatrics, School of MedicineBackground: Birth weight (BW) is a strong predictor of neonatal outcomes. The purpose of this study was to compare BWs between global regions (south Asia, sub-Saharan Africa, Central America) prospectively and to determine if trends exist in BW over time using the population-based maternal and newborn registry (MNHR) of the Global Network for Women'sand Children's Health Research (Global Network). Methods: The MNHR is a prospective observational population-based registryof six research sites participating in the Global Network (2013-2018), within five low- and middle-income countries (Kenya, Zambia, India, Pakistan, and Guatemala) in threeglobal regions (sub-Saharan Af rica, south Asia, Central America). The birth weights were obtained for all infants born during the study period. This was done either by abstracting from the infants' health facility records or from direct measurement by the registry staff for infants born at home. After controlling for demographic characteristics, mixed-effect regression models were utilized to examine regional differences in birth weights over time. Results: The overall BW meanswere higher for the African sites (Zambia and Kenya), 3186 g (SD 463 g) in 2013 and 3149 g (SD 449 g) in 2018, ascompared to Asian sites (Belagavi and Nagpur, India and Pakistan), 2717 g (SD450 g) in 2013 and 2713 g (SD 452 g) in 2018. The Central American site (Guatemala) had a mean BW intermediate between the African and south Asian sites, 2928 g (SD 452) in 2013, and 2874 g (SD 448) in 2018. The low birth weight (LBW) incidence was highest in the south Asian sites (India and Pakistan) and lowest in the African sites (Kenya and Zambia). The size of regional differences varied somewhat over time with slight decreases in the gap in birth weights between the African and Asian sites and slight increases in the gap between the African and Central American sites. Conclusions: Overall, BWmeans by global region did not change significantly over the 5-year study period. From 2013 to 2018, infants enrolled at the African sites demonstrated the highest BW means overall across the entire study period, particularly as compared to Asian sites. The incidence of LBW was highest in the Asian sites (India and Pakistan) compared to the African and Central American sites. Trial registration The study is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475.Item The Global Network Neonatal Cause of Death algorithm for low-resource settings(Wiley, 2017) Garces, Ana L.; McClure, Elizabeth M.; Pérez, Wilton; Hambidge, K. Michael; Krebs, Nancy F.; Figueroa, Lester; Bose, Carl L.; Carlo, Waldemar A.; Tenge, Constance; Esamai, Fabian; Goudar, Shivaprasad S.; Saleem, Sarah; Patel, Archana B.; Chiwila, Melody; Chomba, Elwyn; Tshefu, Antoinette; Derman, Richard J.; Hibberd, Patricia L.; Bucher, Sherri; Liechty, Edward A.; Bauserman, Melissa; Moore, Janet L.; Koso-Thomas, Marion; Miodovnik, Menachem; Goldenberg, Robert L.; Pediatrics, School of MedicineAim: This study estimated the causes of neonatal death using an algorithm for low-resource areas, where 98% of the world's neonatal deaths occur. Methods: We enrolled women in India, Pakistan, Guatemala, the Democratic Republic of Congo, Kenya and Zambia from 2014 to 2016 and tracked their delivery and newborn outcomes for up to 28 days. Antenatal care and delivery symptoms were collected using a structured questionnaire, clinical observation and/or a physical examination. The Global Network Cause of Death algorithm was used to assign the cause of neonatal death, analysed by country and day of death. Results: One-third (33.1%) of the 3068 neonatal deaths were due to suspected infection, 30.8% to prematurity, 21.2% to asphyxia, 9.5% to congenital anomalies and 5.4% did not have a cause of death assigned. Prematurity and asphyxia-related deaths were more common on the first day of life (46.7% and 52.9%, respectively), while most deaths due to infection occurred after the first day of life (86.9%). The distribution of causes was similar to global data reported by other major studies. Conclusion: The Global Network algorithm provided a reliable cause of neonatal death in low-resource settings and can be used to inform public health strategies to reduce mortality.Item Trends of antenatal care during pregnancy in low- and middle-income countries: Findings from the global network maternal and newborn health registry(Elsevier, 2019) Tikmani, Shiyam Sunder; Ali, Sumera Aziz; Saleem, Sarah; Bann, Carla M.; Mwenechanya, Musaku; Carlo, Waldemar A.; Figueroa, Lester; Garces, Ana L.; Krebs, Nancy F.; Patel, Archana; Hibberd, Patricia L.; Goudar, Shivaprasad S.; Derman, Richard J.; Aziz, Aleha; Marete, Irene; Tenge, Constance; Esamai, Fabian; Liechty, Edward; Bucher, Sherri; Moore, Janet L.; McClure, Elizabeth M.; Goldenberg, Robert L.; Pediatrics, School of MedicineBackground: Antenatal care (ANC) is an important opportunity to diagnose and treat pregnancy-related complications and to deliver interventions aimed at improving health and survival of both mother and the infant. Multiple individual studies and national surveys have assessed antenatal care utilization at a single point in time across different countries, but ANC trends have not often been studied in rural areas of low-middle income countries (LMICs). The objective of this analysis was to study the trends of antenatal care use in LMICs over a seven-year period. Methods: Using a prospective maternal and newborn health registry study, we analyzed data collected from 2011 to 2017 across five countries (Guatemala, India [2 sites], Kenya, Pakistan, and Zambia). Utilization of any ANC along with use of select services, including vitamins/iron, tetanus toxoid vaccine and HIV testing, were assessed. We used a generalized linear regression model to examine the trends of women receiving at least one and at least four antenatal care visits by site and year, controlling for maternal age, education and parity. Results: Between January 2011 and December 2017, 313,663 women were enrolled and included in the analysis. For all six sites, a high proportion of women received at least one ANC visit across this period. Over the years, there was a trend for an increasing proportion of women receiving at least one and at least four ANC visits in all sites, except for Guatemala where a decline in ANC was observed. Regarding utilization of specific services, in India almost 100% of women reported receiving tetanus toxoid vaccine, vitamins/iron supplementation and HIV testing services for all study years. In Kenya, a small increase in the proportion of women receiving tetanus toxoid vaccine was observed, while for Zambia, tetanus toxoid use declined from 97% in 2011 to 89% in 2017. No trends for tetanus toxoid use were observed for Pakistan and Guatemala. Across all countries an increasing trend was observed for use of vitamins/iron and HIV testing. However, HIV testing remained very low (<0.1%) for Pakistan. Conclusion: In a range of LMICs, from 2011 to 2017 nearly all women received at least one ANC visit, and a significant increase in the proportion of women who received at least four ANC visits was observed across all sites except Guatemala. Moreover, there were variations regarding the utilization of preventive care services across all sites except for India where rates were generally high. More research is required to understand the quality and influences of ANC.