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Item Association of hemoglobin levels in the first trimester and at 26 to 30 weeks with fetal and neonatal outcomes: A secondary analyses of the Global Network for Women’s and Children’s Health’s ASPIRIN Trial(Wiley, 2021) Jessani, Saleem; Saleem, Sarah; Hoffman, Matthew K.; Goudar, Shivaprasad S.; Derman, Richard J.; Moore, Janet L.; Garces, Ana; Figueroa, Lester; Krebs, Nancy F.; Okitawutshu, Jean; Tshefu, Antoinette; Bose, Carl L.; Mwenechanya, Musaku; Chomba, Elwyn; Carlo, Waldemar A.; Das, Prabir Kumar; Patel, Archana; Hibberd, Patricia L.; Esamai, Fabian; Liechty, Edward A.; Bucher, Sherri; Nolen, Tracy L.; Koso-Thomas, Marion; Miodovnik, Menachem; McClure, Elizabeth M.; Goldenberg, Robert L.; Social and Behavioral Sciences, School of Public HealthObjective: Limited data are available from low- and middle-income countries (LMICs) on the relationship of haemoglobin levels to adverse outcomes at different times during pregnancy. We evaluated the association of haemoglobin levels in nulliparous women at two times in pregnancy with pregnancy outcomes. Design: ASPIRIN Trial data were used to study the association between haemoglobin levels measured at 6+0 -13+6 weeks and 26+0 -30+0 weeks of gestation with fetal and neonatal outcomes. Setting: Obstetric care facilities in Pakistan, India, Kenya, Zambia, The Democratic Republic of the Congo and Guatemala. Population: A total of 11 976 pregnant women. Methods: Generalised linear models were used to obtain adjusted relative risks and 95% CI for adverse outcomes. Main outcome measures: Preterm birth, stillbirth, neonatal death, small for gestational age (SGA) and birthweight <2500 g. Results: The mean haemoglobin levels at 6+0 -13+6 weeks and at 26-30 weeks of gestation were 116 g/l (SD 17) and 107 g/l (SD 15), respectively. In general, pregnancy outcomes were better with increasing haemoglobin. At 6+0 -13+6 weeks of gestation, stillbirth, SGA and birthweight <2500 g, were significantly associated with haemoglobin of 70-89 g/l compared with haemoglobin of 110-129 g/l The relationships of adverse pregnancy outcomes with various haemoglobin levels were more marked at 26-30 weeks of gestation. Conclusions: Both lower and some higher haemoglobin concentrations are associated with adverse fetal and neonatal outcomes at 6+0 -13+6 weeks and at 26-30 weeks of gestation, although the relationship with low haemoglobin levels appears more consistent and generally stronger.Item Communities, birth attendants and health facilities: a continuum of emergency maternal and newborn care (the global network's EmONC trial)(BMC, 2010-12-14) Pasha, Omrana; Goldenberg, Robert L.; McClure, Elizabeth M.; Saleem, Sarah; Goudar, Shivaprasad S.; Althabe, Fernando; Patel, Archana; Esamai, Fabian; Garces, Ana; Chomba, Elwyn; Mazariegos, Manolo; Kodkany, Bhala; Belizan, Jose M.; Derman, Richard J.; Hibberd, Patricia L.; Carlo, Waldemar A.; Liechty, Edward A.; Hambidge, K. Michael Michael; Buekens, Pierre; Wallace, Dennis; Howard-Grabman, Lisa; Stalls, Suzanne; Koso-Thomas, Marion; Jobe, Alan H.; Wright, Linda L.; Pediatrics, School of MedicineBackground Maternal and newborn mortality rates remain unacceptably high, especially where the majority of births occur in home settings or in facilities with inadequate resources. The introduction of emergency obstetric and newborn care services has been proposed by several organizations in order to improve pregnancy outcomes. However, the effectiveness of emergency obstetric and neonatal care services has never been proven. Also unproven is the effectiveness of community mobilization and community birth attendant training to improve pregnancy outcomes. Methods/Design We have developed a cluster-randomized controlled trial to evaluate the impact of a comprehensive intervention of community mobilization, birth attendant training and improvement of quality of care in health facilities on perinatal mortality in low and middle-income countries where the majority of births take place in homes or first level care facilities. This trial will take place in 106 clusters (300-500 deliveries per year each) across 7 sites of the Global Network for Women's and Children's Health Research in Argentina, Guatemala, India, Kenya, Pakistan and Zambia. The trial intervention has three key elements, community mobilization, home-based life saving skills for communities and birth attendants, and training of providers at obstetric facilities to improve quality of care. The primary outcome of the trial is perinatal mortality. Secondary outcomes include rates of stillbirth, 7-day neonatal mortality, maternal death or severe morbidity (including obstetric fistula, eclampsia and obstetrical sepsis) and 28-day neonatal mortality. Discussion In this trial, we are evaluating a combination of interventions including community mobilization and facility training in an attempt to improve pregnancy outcomes. If successful, the results of this trial will provide important information for policy makers and clinicians as they attempt to improve delivery services for pregnant women and newborns in low-income countries.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 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 Maternal age extremes and adverse pregnancy outcomes in low-resourced settings(Frontiers Media, 2023-11-28) Nyongesa, Paul; Ekhaguere, Osayame A.; Marete, Irene; Tenge, Constance; Kemoi, Milsort; Bann, Carla M.; Bucher, Sherri L.; Patel, Archana B.; Hibberd, Patricia L.; Naqvi, Farnaz; Saleem, Sarah; Goldenberg, Robert L.; Goudar, Shivaprasad S.; Derman, Richard J.; Krebs, Nancy F.; Garces, Ana; Chomba, Elwyn; Carlo, Waldemar A.; Mwenechanya, Musaku; Lokangaka, Adrien; Tshefu, Antoinette K.; Bauserman, Melissa; Koso-Thomas, Marion; Moore, Janet L.; McClure, Elizabeth M.; Liechty, Edward A.; Esamai, Fabian; Pediatrics, School of MedicineIntroduction: Adolescent (<20 years) and advanced maternal age (>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. Objective: To describe the prevalence and adverse pregnancy (maternal, perinatal, and neonatal) outcomes associated with extremes of maternal age across six countries. Patients and methods: We 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 (<20, 20-24, 25-29, 30-35, and >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. Results: We 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 <18 and 18-19 age groups. Conclusion: The maternal mortality ratio in the LMICs assessed is high and increased with advancing maternal age groups. While less prevalent, AMA was associated with a higher risk of adverse maternal mortality and, like adolescence, was associated with adverse perinatal mortality with little regional variation.Item Postpartum contraceptive use and unmet need for family planning in five low-income countries(Springer (Biomed Central Ltd.), 2015) Pasha, Omrana; Goudar, Shivaprasad S.; Patel, Archana; Garces, Ana; Esamai, Fabian; Chomba, Elwyn; Moore, Janet L.; Kodkany, Bhalchandra S.; Saleem, Sarah; Derman, Richard J.; Liechty, Edward A.; Hibberd, Patricia L.; Hambidge, K. Michael; Krebs, Nancy F.; Carlo, Waldemar A.; McClure, Elizabeth M.; Koso-Thomas, Marion; Goldenberg, Robert L.; Department of Pediatrics, IU School of MedicineBACKGROUND: During the post-partum period, most women wish to delay or prevent future pregnancies. Despite this, the unmet need for family planning up to a year after delivery is higher than at any other time. This study aims to assess fertility intention, contraceptive usage and unmet need for family planning amongst women who are six weeks postpartum, as well as to identify those at greatest risk of having an unmet need for family planning during this period. METHODS: Using the NICHD Global Network for Women's and Children's Health Research's multi-site, prospective, ongoing, active surveillance system to track pregnancies and births in 100 rural geographic clusters in 5 countries (India, Pakistan, Zambia, Kenya and Guatemala), we assessed fertility intention and contraceptive usage at day 42 post-partum. RESULTS: We gathered data on 36,687 women in the post-partum period. Less than 5% of these women wished to have another pregnancy within the year. Despite this, rates of modern contraceptive usage varied widely and unmet need ranged from 25% to 96%. Even amongst users of modern contraceptives, the uptake of the most effective long-acting reversible contraceptives (intrauterine devices) was low. Women of age less than 20 years, parity of two or less, limited education and those who deliver at home were at highest risk for having unmet need. CONCLUSIONS: Six weeks postpartum, almost all women wish to delay or prevent a future pregnancy. Even in sites where early contraceptive adoption is common, there is substantial unmet need for family planning. This is consistently highest amongst women below the age of 20 years. Interventions aimed at increasing the adoption of effective contraceptive methods are urgently needed in the majority of sites in order to reduce unmet need and to improve both maternal and infant outcomes, especially amongst young women. STUDY REGISTRATION: Clinicaltrials.gov (ID# NCT01073475).Item A pre-post study of a multi-country scale up of resuscitation training of facility birth attendants: does Helping Babies Breathe training save lives?(BioMed Central, 2016) Bellad, Roopa M.; Bang, Akash; Carlo, Waldemar; McClure, Elizabeth M.; Meleth, Sreelatha; Goco, Norman; Goudar, Shivaprasad S.; Derman, Richard J.; Hibberd, Patricia L.; Patel, Archana; Esamai, Fabian; Bucher, Sherri; Gisore, Peter; Wright, Linda L.; Department of Pediatrics, IU School of MedicineBackground Whether facility-based implementation of Helping Babies Breathe (HBB) reduces neonatal mortality at a population level in low and middle income countries (LMIC) has not been studied. Therefore, we evaluated HBB implementation in this context where our study team has ongoing prospective outcome data on all pregnancies regardless of place of delivery. Methods We compared outcomes of birth cohorts in three sites in India and Kenya pre-post implementation of a facility-based intervention, using a prospective, population-based registry in 52 geographic clusters. Our hypothesis was that HBB implementation would result in a 20 % decrease in the perinatal mortality rate (PMR) among births ≥1500 g. Results We enrolled 70,704 births during two 12-month study periods. Births within each site did not differ pre-post intervention, except for an increased proportion of <2500 g newborns and deliveries by caesarean section in the post period. There were no significant differences in PMR among all registry births; however, a post-hoc analysis stratified by birthweight documented improvement in <2500 g mortality in Belgaum in both registry and in HBB-trained facility births. No improvement in <2500 g mortality measures was noted in Nagpur or Kenya and there was no improvement in normal birth weight survival. Conclusions Rapid scale up of HBB training of facility birth attendants in three diverse sites in India and Kenya was not associated with consistent improvements in mortality among all neonates ≥1500 g; however, differential improvements in <2500 g survival in Belgaum suggest the need for careful implementation of HBB training with attention to the target population, data collection, and ongoing quality monitoring activities.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 Safety of daily low-dose aspirin use during pregnancy in low-income and middle-income countries(Elsevier, 2021) Short, Vanessa L.; Hoffman, Matthew; Metgud, Mrityunjay; Kavi, Avinash; Goudar, Shivaprasad S.; Okitawutshu, Jean; Tshefu, Antoinette; Bose, Carl L.; Mwenechanya, Musaku; Chomba, Elwyn; Carlo, Waldemar A.; Figueroa, Lester; Garces, Ana; Krebs, Nancy F.; Jessani, Saleem; Saleem, Sarah; Goldenberg, Robert L.; Das, Prabir Kumar; Patel, Archana; Hibberd, Patricia L.; Achieng, Emmah; Nyongesa, Paul; Esamai, Fabian; Bucher, Sherri; Nowak, Kayla J.; Goco, Norman; Nolen, Tracy L.; McClure, Elizabeth M.; Koso-Thomas, Marion; Miodovnik, Menachem; Derman, Richard J.; Medicine, School of MedicineBACKGROUND The daily use of low-dose aspirin may be a safe, widely available, and inexpensive intervention for reducing the risk of preterm birth. Data on the potential side effects of low-dose aspirin use during pregnancy in low- and middle-income countries are needed. OBJECTIVE This study aimed to assess differences in unexpected emergency medical visits and potential maternal side effects from a randomized, double-blind, multicountry, placebo-controlled trial of low-dose aspirin use (81 mg daily, from 6 to 36 weeks’ gestation). STUDY DESIGN This study was a secondary analysis of data from the Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas trial, a trial of the Global Network for Women's and Children's Health conducted in India (2 sites), Pakistan, Guatemala, Democratic Republic of the Congo, Kenya, and Zambia. The outcomes for this analysis were unexpected emergency medical visits and the occurrence of the following potential side effects—overall and separately—nausea, vomiting, rash or hives, diarrhea, gastritis, vaginal bleeding, allergic reaction, and any other potential side effects. Analyses were performed overall and by geographic region. RESULTS Between the aspirin (n=5943) and placebo (n=5936) study groups, there was no statistically significant difference in the risk of unexpected emergency medical visits or the risk of any potential side effect (overall). Of the 8 potential side effects assessed, only 1 (rash or hives) presented a different risk by treatment group (4.2% in the aspirin group vs 3.5% in the placebo group; relative risk, 1.20; 95% confidence interval, 1.01–1.43; P=.042). CONCLUSION The daily use of low-dose aspirin seems to be a safe intervention for reducing the risk of preterm birth and well tolerated by nulliparous pregnant women between 6 and 36 weeks’ gestation in low- and middle-income countries.