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Item The impact of risk factors on aspirin's efficacy for the prevention of preterm birth(Elsevier, 2023) Nuss, Emily E.; Hoffman, Matthew K.; Goudar, Shivaprasad S.; Kavi, Avinash; Metgud, Mrityunjay; Somannavar, Manjunath; Okitawutshu, Jean; Lokangaka, Adrien; Tshefu, Antoinette; Bauserman, Melissa; Mwapule Tembo, Abigail; Chomba, Elwyn; Carlo, Waldemar A.; Figueroa, Lester; Krebs, Nancy F.; Jessani, Saleem; Saleem, Sarah; Goldenberg, Robert L.; Kurhe, Kunal; Das, Prabir; Hibberd, Patricia L.; Achieng, Emmah; Nyongesa, Paul; Esamai, Fabian; Liechty, Edward A.; Bucher, Sherri; Goco, Norman; Hemingway-Foday, Jennifer; Moore, Janet; McClure, Elizabeth M.; Silver, Robert M.; Derman, Richard J.; Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas Study Group; Pediatrics, School of MedicineBackground: The Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas trial was a landmark study that demonstrated a reduction in preterm birth and hypertensive disorders of pregnancy in nulliparous women who received low-dose aspirin. All women in the study had at least 1 moderate-risk factor for preeclampsia (nulliparity). Unlike current US Preventative Service Task Force guidelines, which recommend low-dose aspirin for ≥2 moderate-risk factors, women in this study were randomized to receive low-dose aspirin regardless of the presence or absence of an additional risk factor. Objective: This study aimed to compare how low-dose aspirin differentially benefits nulliparous women with and without additional preeclampsia risk factors for the prevention of preterm birth and hypertensive disorders of pregnancy. Study design: This was a non-prespecified secondary analysis of the Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas trial that randomized nulliparous women with singleton pregnancies from 6 low-middle-income countries to receive low-dose aspirin or placebo. Our primary exposure was having an additional preeclampsia risk factor beyond nulliparity. Our primary outcome was preterm birth before 37 weeks of gestation, and our secondary outcomes included preterm birth before 34 weeks of gestation, preterm birth before 28 weeks of gestation, hypertensive disorders of pregnancy, and perinatal mortality. Results: Among 11,558 nulliparous women who met the inclusion criteria, 66.8% had no additional risk factors. Low-dose aspirin similarly reduced the risk of preterm birth at <37 weeks of gestation in women with and without additional risk factors (relative risk: 0.75 vs 0.85; P=.35). Additionally for our secondary outcomes, low-dose aspirin similarly reduced the risk of preterm birth at <28 weeks of gestation, hypertensive disorders of pregnancy, and perinatal mortality in women with and without additional risk factors. The reduction of preterm birth at <34 weeks of gestation with low-dose aspirin was significantly greater in women without additional risk factors than those with an additional risk factor (relative risk: 0.69 vs 1.04; P=.04). Conclusion: Low-dose aspirin's ability to prevent preterm birth, hypertensive disorders of pregnancy, and perinatal mortality was similar in nulliparous women with and without additional risk factors. Professional societies should consider recommending low-dose aspirin to all nulliparous women.Item Trends and determinants of stillbirth in developing countries: results from the Global Network’s Population-Based Birth Registry(Springer Nature, 2018-06-22) Saleem, Sarah; Tikmani, Shiyam Sunder; McClure, Elizabeth M.; Moore, Janet L.; Azam, Syed Iqbal; Dhaded, Sangappa M.; Goudar, Shivaprasad S.; Garces, Ana; Figueroa, Lester; Marete, Irene; Tenge, Constance; Esamai, Fabian; Patel, Archana B.; Ali, Sumera Aziz; Naqvi, Farnaz; Mwenchanya, Musaku; Chomba, Elwyn; Carlo, Waldemar A.; Derman, Richard J.; Hibberd, Patricia L.; Bucher, Sherri; Liechty, Edward A.; Krebs, Nancy; Hambidge, K. Michael; Wallace, Dennis D.; Koso-Thomas, Marion; Miodovnik, Menachem; Goldenberg, Robert L.; Pediatrics, School of MedicineBackground: 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 < 20 years and 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.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 Rates and determinants of early initiation of breastfeeding and exclusive breast feeding at 42 days postnatal in six low and middle-income countries: A prospective cohort study(Springer Nature, 2015) Patel, Archana; Bucher, Sherri; Pusdekar, Yamini; Esamai, Fabian; Krebs, Nancy F.; Goudar, Shivaprasad S.; Chomba, Elwyn; Garces, Ana; Pasha, Omrana; Saleem, Sarah; Kodkany, Bhalachandra S.; Liechty, Edward A.; Kodkany, Bhala; Derman, Richard J.; Carlo, Waldemar A.; Hambidge, K. Michael; Goldenberg, Robert L.; Althabe, Fernando; Berrueta, Mabel; Moore, Janet L.; McClure, Elizabeth M.; Koso-Thomas, Marion; Hibberd, Patricia L.; Pediatrics, School of MedicineBackground: Early initiation of breastfeeding after birth and exclusive breastfeeding through six months of age confers many health benefits for infants; both are crucial high impact, low-cost interventions. However, determining accurate global rates of these crucial activities has been challenging. We use population-based data to describe: (1) rates of early initiation of breastfeeding (defined as within 1 hour of birth) and of exclusive breastfeeding at 42 days post-partum; and (2) factors associated with failure to initiate early breastfeeding and exclusive breastfeeding at 42 days post-partum. Methods: Prospectively collected data from women and their live-born infants enrolled in the Global Network's Maternal and Newborn Health Registry between January 1, 2010-December 31, 2013 included women-infant dyads in 106 geographic areas (clusters) at 7 research sites in 6 countries (Kenya, Zambia, India [2 sites], Pakistan, Argentina and Guatemala). Rates and risk factors for failure to initiate early breastfeeding were investigated for the entire cohort and rates and risk factors for failure to maintain exclusive breastfeeding was assessed in a sub-sample studied at 42 days post-partum. Result: A total of 255,495 live-born women-infant dyads were included in the study. Rates and determinants for the exclusive breastfeeding sub-study at 42 days post-partum were assessed from among a sub-sample of 105,563 subjects. Although there was heterogeneity by site, and early initiation of breastfeeding after delivery was high, the Pakistan site had the lowest rates of early initiation of breastfeeding. The Pakistan site also had the highest rate of lack of exclusive breastfeeding at 42 days post-partum. Across all regions, factors associated with failure to initiate early breastfeeding included nulliparity, caesarean section, low birth weight, resuscitation with bag and mask, and failure to place baby on the mother's chest after delivery. Factors associated with failure to achieve exclusive breastfeeding at 42 days varied across the sites. The only factor significant in all sites was multiple gestation. Conclusions: In this large, prospective, population-based, observational study, rates of both early initiation of breastfeeding and exclusive breastfeeding at 42 days post-partum were high, except in Pakistan. Factors associated with these key breastfeeding indicators should assist with more effective strategies to scale-up these crucial public health interventions.Item Traditional Birth Attendants and Birth Outcomes in Low-Middle Income Countries: A Review(Elsevier, 2019) Garces, Ana; McClure, Elizabeth M.; Espinoza, Leopoldo; Saleem, Sarah; Figueroa, Lester; Bucher, Sherri; Goldenberg, Robert L.; Pediatrics, School of MedicineTraditional birth attendants (TBAs) provided delivery care throughout the world prior to the development of organized systems of medical care. In 2016, an estimated 22% of pregnant women delivered with a TBA, mostly in rural or remote areas that lacked formal health services. Still active in many regions of LMICs, they provide care, including support and advice, to women during pregnancy and childbirth. Even though they generally have no formal training and are not recognized as medical practitioners, TBAs enjoy a high societal standing and many families seek them as health care providers. They are generally older women who have acquired their skills acting as apprentices of other TBAs or are self-taught. WHO and other international organizations have focused maternal mortality reduction efforts on the availability of skilled birth attendance, which excludes TBAs as providers of care. However, as countries move towards SBA, policy makers need to make the best use of TBAs while simultaneously planning for their replacement with skilled attendants. They often serve as a bridge between the community and the formal health system; once women are inside an institution, TBAs could potentially act as doulas, providing company and making women feel more comfortable in an unknown environment. In this paper, we will review who TBAs are, how many births they attend worldwide worldwide, where they provide delivery care, and finally, their relationships with the formal health care system and the communities they serve.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.Item Trends over time in the knowledge, attitude and practices of pregnant women related to COVID-19: A cross-sectional survey from seven low- and middle-income countries(Wiley, 2023) Jessani, Saleem; Saleem, Sarah; Fogleman, Elizabeth; Billah, Sk Masum; Haque, Rashidul; Figueroa, Lester; Lokangaka, Adrien; Tshefu, Antoinette; Goudar, Shivaprasad S.; Kavi, Avinash; Esamai, Fabian; Mwenchanya, Musaku; Chomba, Elwyn; Patel, Archana; Das, Prabir; Mazariegos, Manolo; Bauserman, Melissa; Petri, William A., Jr.; Krebs, Nancy F.; Derman, Richard J.; Carlo, Waldemar A.; Bucher, Sherri; Hibberd, Patricia L.; Koso-Thomas, Marion; Bann, Carla M.; McClure, Elizabeth M.; Goldenberg, Robert L.; Pediatrics, School of MedicineObjective: To understand trends in the knowledge, attitudes and practices (KAP) of pregnant women related to COVID-19 in seven low- and middle-income countries. Design: Multi-country population-based prospective observational study. Setting: Study sites in Bangladesh, the Demographic Republic of Congo (DRC), Guatemala, India (two sites), Kenya, Pakistan and Zambia. Population: Pregnant women in the Global Network's Maternal and Neonatal Health Registry (MNHR). Methods: Pregnant women enrolled in the MNHR were interviewed to assess their KAP related to COVID-19 from September 2020 through July 2022 across all study sites. Main outcome measures: Trends of COVID-19 KAP were assessed using the Cochran-Armitage test for trend. Results: A total of 52 297 women participated in this study. There were wide inter-country differences in COVID-19-related knowledge. The level of knowledge of women in the DRC was much lower than that of women in the other sites. The ability to name COVID-19 symptoms increased over time in the African sites, whereas no such change was observed in Bangladesh, Belagavi and Guatemala. All sites observed decreasing trends over time in women avoiding antenatal care visits. Conclusions: The knowledge and attitudes of pregnant women related to COVID-19 varied substantially among the Global Network sites over a period of 2 years; however, there was very little change in knowledge related to COVID-19 over time across these sites. The major change observed was that fewer women reported avoiding medical care because of COVID-19 across all sites over time.Item Stillbirth 2010-2018: a prospective, population-based, multi-country study from the Global Network(Springer Nature, 2020-11-30) McClure, Elizabeth M.; Saleem, Sarah; Goudar, Shivaprasad S.; Garces, Ana; Whitworth, Ryan; Esamai, Fabian; Patel, Archana B.; Sunder Tikmani, Shiyam; Mwenechanya, Musaku; Chomba, Elwyn; Lokangaka, Adrien; Bose, Carl L.; Bucher, Sherri; Liechty, Edward A.; Krebs, Nancy F.; Kumar, S. Yogesh; Derman, Richard J.; Hibberd, Patricia L.; Carlo, Waldemar A.; Moore, Janet L.; Nolen, Tracy L.; Koso-Thomas, Marion; Goldenberg, Robert L.; Pediatrics, School of MedicineBackground: 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.Item The Global Network COVID-19 studies: a review(Wiley, 2023) Naqvi, Seemab; Saleem, Sarah; Billah, Sk Masum; Moore, Janet; Mwenechanya, Musaku; Carlo, Waldemar A.; Esamai, Fabian; Bucher, Sherri; Derman, Richard J.; Goudar, Shivaprasad S.; Somannavar, Manjunath; Patel, Archana; Hibberd, Patricia L.; Figueroa, Lester; Krebs, Nancy F.; Petri, William A.; Lokangaka, Adrien; Bauserman, Melissa; Koso-Thomas, Marion; McClure, Elizabeth M.; Goldenberg, Robert L.; Pediatrics, School of MedicineWith the paucity of data available regarding COVID-19 in pregnancy in low- and middle-income countries (LMICs), near the start of the pandemic, the Global Network for Women's and Children's Health Research, funded by the National Institute of Child Health and Human Development (NICHD), initiated four separate studies to better understand the impact of the COVID-19 pandemic in eight LMIC sites. These sites included: four in Asia, in Bangladesh, India (two sites) and Pakistan; three in Africa, in the Democratic Republic of the Congo (DRC), Kenya and Zambia; and one in Central America, in Guatemala. The first study evaluated changes in health service utilisation; the second study evaluated knowledge, attitudes and practices of pregnant women in relationship to COVID-19 in pregnancy; the third study evaluated knowledge, attitude and practices related to COVID-19 vaccination in pregnancy; and the fourth study, using antibody status at delivery, evaluated changes in antibody status over time in each of the sites and the relationship of antibody positivity with various pregnancy outcomes. Across the Global Network, in the first year of the study there was little reduction in health care utilisation and no apparent change in pregnancy outcomes. Knowledge related to COVID-19 was highly variable across the sites but was generally poor. Vaccination rates among pregnant women in the Global Network were very low, and were considerably lower than the vaccination rates reported for the countries as a whole. Knowledge regarding vaccines was generally poor and varied widely. Most women did not believe the vaccines were safe or effective, but slightly more than half would accept the vaccine if offered. Based on antibody positivity, the rates of COVID-19 infection increased substantially in each of the sites over the course of the pandemic. Most pregnancy outcomes were not worse in women who were infected with COVID-19 during their pregnancies. We interpret the absence of an increase in adverse outcomes in women infected with COVID-19 to the fact that in the populations studied, most COVID-19 infections were either asymptomatic or were relatively mild.Item Commonly cited incentives in the community implementation of the emergency maternal and newborn care study in western Kenya(Makerere Medical School, 2013) Gisore, P.; Rono, B.; Marete, I.; Nekesa-Mangeni, J.; Tenge, C.; Shipala, E.; Mabeya, H.; Odhiambo, D.; Otieno, K.; Bucher, S.; Makokha, C.; Liechty, E.; Esamai, F.; Pediatrics, School of MedicineBackground: Mortality of mothers and newborns is an important public health problem in low-income countries. In the rural setting, implementation of community based education and mobilization are strategies that have sought to reduce these mortalities. Frequently such approaches rely on volunteers within each community. Objective: To assess the perceptions of the community volunteers in rural Kenya as they implemented the EmONC program and to identify the incentives that could result in their sustained engagement in the project. Method: A community-based cross sectional survey was administered to all volunteers involved in the study. Data were collected using a self-administered supervision tool from all the 881 volunteers. Results: 881 surveys were completed. 769 respondents requested some form of incentive; 200 (26%) were for monetary allowance, 149 (19.4%) were for a bicycle to be used for transportation, 119 (15.5%) were for uniforms for identification, 88 (11.4%) were for provision of training materials, 81(10.5%) were for training in Home based Life Saving Skills (HBLSS), 57(7.4%) were for provision of first AID kits, and 39(5%) were for provision of training more facilitators, 36(4.7%) were for provision of free medication. Conclusion: Monetary allowances, improved transportation and some sort of identification are the main incentives cited by the respondents in this context.