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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 Building Comprehensive and Sustainable Health Informatics Institutions in Developing Countries: Moi University Experience(IOS, 2015) Were, Martin C.; Siika, Abraham; Ayuo, Paul O.; Atwoli, Lukoye; Esamai, Fabian; Department of Medicine, IU School of MedicineCurrent approaches for capacity building in Health Informatics (HI) in developing countries mostly focus on training, and often rely on support from foreign entities. In this paper, we describe a comprehensive and multidimensional capacity-building framework by Lansang & Dennis, and its application for HI capacity building as implemented in a higher-education institution in Kenya. This framework incorporates training, learning-by-doing, partnerships, and centers of excellence. At Moi University (Kenya), the training dimensions include an accredited Masters in HI Program, PhD in HI, and HI short courses. Learning-by-doing occurs through work within MOH facilities at the AMPATH care and treatment program serving 3 million people. Moi University has formed strategic HI partnerships with Regenstrief Institute, Inc. (USA), University of Bergen (Norway), and Makerere University (Uganda), among others. The University has also created an Institute of Biomedical Informatics to serve as an HI Center of Excellence in the region. This Institute has divisions in Training, Research, Service and Administration. The HI capacity-building approach by Moi provides a model for adoption by other institutions in resource-limited settings.Item Caesarean birth by maternal request: a poorly understood phenomenon in low- and middle-income countries(Oxford University Press, 2021-01-14) Harrison, Margo S.; Garces, Ana; Figueroa, Lester; Esamai, Fabian; Bucher, Sherri; Bose, Carl; Goudar, Shivaprasad; Derman, Richard; Patel, Archana; Hibberd, Patricia L.; Chomba, Elwyn; Mwenechanya, Miusaku; Hambidge, Michael; Krebs, Nancy F.; Medicine, School of MedicineBackground: While trends in caesarean birth by maternal request in low- and middle-income countries are unclear, age, education, multiple gestation and hypertensive disease appear associated with the indication when compared with caesarean birth performed for medical indications. Methods: We performed a secondary analysis of a prospectively collected population-based study of home and facility births using descriptive statistics, bivariate comparisons and multilevel mixed-effects logistic regression. Results: Of 28 751 patients who underwent caesarean birth and had a documented primary indication for the surgery, 655 (2%) were attributed to caesarean birth by maternal request. The remaining 98% were attributed to maternal and foetal indications and prior caesarean birth. In a multilevel mixed effects logistic regression adjusted for site and cluster of birth, when compared with caesareans performed for medical indications, caesarean birth performed for maternal request had a higher odds of being performed among women ≥35 y of age, with a university or higher level of education, with multiple gestations and with pregnancies complicated by hypertension (P < 0.01). Caesarean birth by maternal request was associated with a two-times increased odds of breastfeeding within 1 h of delivery, but no adverse outcomes (when compared with women who underwent caesarean birth for medical indications; P < 0.01). Conclusion: Caesarean performed by maternal request is more common in older and more educated women and those with multifoetal gestation or hypertensive disease. It is also associated with higher rates of breastfeeding within 1 h of delivery.Item Can the date of last menstrual period be trusted in the first trimester? Comparisons of gestational age measures from a prospective cohort study in six low-income to middle-income countries(BMJ, 2023-09-20) Patel, Archana; Bann, Carla M.; Thorsten, Vanessa R.; Rao, Sowmya R.; Lokangaka, Adrien; Tshefu Kitoto, Antoinette; Bauserman, Melissa; Figueroa, Lester; Krebs, Nancy F.; Esamai, Fabian; Bucher, Sherri; Saleem, Sarah; Goldenberg, Robert L.; Chomba, Elwyn; Carlo, Waldemar A.; Goudar, Shivaprasad; Derman, Richard; Koso-Thomas, Marion; McClure, Elizabeth; Hibberd, Patricia L.; Pediatrics, School of MedicineObjectives: We examined gestational age (GA) estimates for live and still births, and prematurity rates based on last menstrual period (LMP) compared with ultrasonography (USG) among pregnant women at seven sites in six low-resource countries. Design: Prospective cohort study SETTING AND PARTICIPANTS: This study included data from the Global Network's population-based Maternal and Newborn Health Registry which follows pregnant women in six low-income and middle-income countries (Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan and Zambia). Participants in this analysis were 42 803 women, including their 43 230 babies, who registered for the study in their first trimester based on GA estimated either by LMP or USG and had a live or stillbirth with an estimated GA of 20-42 weeks. Outcome measures: GA was estimated in weeks and days based on LMP and/or USG. Prematurity was defined as GA of 20 weeks+0 days through 36 weeks+6 days, calculated by both USG and LMP. Results: Overall, average GA varied ≤1 week between LMP and USG. Mean GA for live births by LMP was lower than by USG (adjusted mean difference (95% CI) = -0.23 (-0.29 to -0.17) weeks). Among stillbirths, a higher GA was estimated by LMP than USG (adjusted mean difference (95% CI)= 0.42 (0.11 to 0.72) weeks). Preterm birth rates for live births were significantly higher when dated by LMP (adjusted rate difference (95% CI)= 4.20 (3.56 to 4.85)). There was no significant difference in preterm birth rates for stillbirths. Conclusion: The small differences in GA for LMP versus USG in the Guatemalan and Indian sites suggest that LMP may be a useful alternative to USG for GA dating during the first trimester until availability of USG improves in those areas. Further research is needed to assess LMP for first-trimester GA dating in other regions with limited access to USG.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 Design and development of an integrated mHealth platform to improve kangaroo mother care in Kenya(APHA 2021 Annual Meeting and Expo, 2021-10) Padmanaban, Priya Geetha; Joshi, Siddhi Hareshkumar; Purkayastha, Saptarshi; Ekhaguere, Osayame; Linnes, Jacqueline C.; Esamai, Fabian; Bucher, SherriBackground and Significance: There are 15 million preterm births a year. Premature babies suffer the highest rates of newborn mortality, occurring primarily in low/middle-income countries (LMICs). Neonatal hypothermia (low body temperature) is a life-threatening complication, which is prevented by Kangaroo Mother Care (KMC), but in Kenya, a profound shortage of health workers and lack of resources are barriers to KMC. Our international team has developed an integrated platform (educational and data collection apps + biomedical device) to improve the implementation of KMC in health facilities. Methods: From August 2020 – February 2021, a multi-disciplinary team from the United States and Kenya utilized agile development (weekly scrum meetings) and human-and user-centered design techniques to develop high-fidelity wireframes (Figma) of Android apps which are designed to integrate with a patented self-warming biomedical device (US10390630B2; NG/PT/IC/2016/053394) that utilizes wireless sensors to track KMC babies, continuously monitor infant vital signs, and display physiological data on mobile phones/tablets. Results: High-fidelity wireframes have been developed for two user interfaces of an integrated app, NeoRoo. The NeoRoo-Family app is for KMC parents; the NeoRoo-HealthWorker app is built for nurses and doctors. NeoRoo-Family provides parental caregivers with: (a) automated monitoring of key vital signs for their baby; (c) ability to alert a clinician as needed; (c) tracking of KMC metrics and goals, such as number of hours of skin-toskin care completed in a week; and (d) educational resources for evidence-based newborn care. The NeoRoo- HealthWorker app interface enables clinicians to: (a) simultaneously track breathing, heart rate, temperature, and oxygen saturation for multiple KMC infants in real-time; (b) review each infant’s past clinical history and vital signs trends; (c) receive automated and parent-generated alerts; (d) support harmonized dissemination of key educational messages to families. Conclusions: By providing education, continuous thermal support, and integrated, automated vital signs monitoring for premature babies, via the NeoRoo mHealth platform, we hope to better equip parents and health workers in Kenya to: (1) prevent hypothermia; (2) automatically monitor vital signs in newborns; (3) track key KMC metrics; (4) promote more effective task-sharing among KMC teams. On-going work includes participatory design interviews and a usability assessment.Item eHBB: a randomised controlled trial of virtual reality or video for neonatal resuscitation refresher training in healthcare workers in resource-scarce settings(BMJ, 2021) Umoren, Rachel; Bucher, Sherri; Hippe, Daniel S; Ezenwa, Beatrice Nkolika; Fajolu, Iretiola Bamikeolu; Okwako, Felicitas M; Feltner, John; Nafula, Mary; Musale, Annet; Olawuyi, Olubukola A; Adeboboye, Christianah O; Asangansi, Ime; Paton, Chris; Purkayastha, Saptarshi; Ezeaka, Chinyere Veronica; Esamai, Fabian; Pediatrics, School of MedicineObjective To assess the impact of mobile virtual reality (VR) simulations using electronic Helping Babies Breathe (eHBB) or video for the maintenance of neonatal resuscitation skills in healthcare workers in resource-scarce settings. Design Randomised controlled trial with 6-month follow-up (2018–2020). Setting Secondary and tertiary healthcare facilities. Participants 274 nurses and midwives assigned to labour and delivery, operating room and newborn care units were recruited from 20 healthcare facilities in Nigeria and Kenya and randomised to one of three groups: VR (eHBB+digital guide), video (video+digital guide) or control (digital guide only) groups before an in-person HBB course. Intervention(s) eHBB VR simulation or neonatal resuscitation video. Main outcome(s) Healthcare worker neonatal resuscitation skills using standardised checklists in a simulated setting at 1 month, 3 months and 6 months. Results Neonatal resuscitation skills pass rates were similar among the groups at 6-month follow-up for bag-and-mask ventilation (BMV) skills check (VR 28%, video 25%, control 22%, p=0.71), objective structured clinical examination (OSCE) A (VR 76%, video 76%, control 72%, p=0.78) and OSCE B (VR 62%, video 60%, control 49%, p=0.18). Relative to the immediate postcourse assessments, there was greater retention of BMV skills at 6 months in the VR group (−15% VR, p=0.10; −21% video, p<0.01, –27% control, p=0.001). OSCE B pass rates in the VR group were numerically higher at 3 months (+4%, p=0.64) and 6 months (+3%, p=0.74) and lower in the video (−21% at 3 months, p<0.001; −14% at 6 months, p=0.066) and control groups (−7% at 3 months, p=0.43; −14% at 6 months, p=0.10). On follow-up survey, 95% (n=65) of respondents in the VR group and 98% (n=82) in the video group would use their assigned intervention again. Conclusion eHBB VR training was highly acceptable to healthcare workers in low-income to middle-income countries and may provide additional support for neonatal resuscitation skills retention compared with other digital interventions.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 Iron in Micronutrient Powder Promotes an Unfavorable Gut Microbiota in Kenyan Infants(MDPI, 2017-07-19) Tang, Minghua; Frank, Daniel N.; Hendricks, Audrey E.; Ir, Diana; Esamai, Fabian; Liechty, Edward; Hambidge, K. Michael; Krebs, Nancy F.; Pediatrics, School of MedicineIron supplementation may have adverse health effects in infants, probably through manipulation of the gut microbiome. Previous research in low-resource settings have focused primarily on anemic infants. This was a double blind, randomized, controlled trial of home fortification comparing multiple micronutrient powder (MNP) with and without iron. Six-month-old, non- or mildly anemic, predominantly-breastfed Kenyan infants in a rural malaria-endemic area were randomized to consume: (1) MNP containing 12.5 mg iron (MNP+Fe, n = 13); (2) MNP containing no iron (MNP−Fe, n = 13); or (3) Placebo (CONTROL, n = 7), from 6–9 months of age. Fecal microbiota were profiled by high-throughput bacterial 16S rRNA gene sequencing. Markers of inflammation in serum and stool samples were also measured. At baseline, the most abundant phylum was Proteobacteria (37.6% of rRNA sequences). The proteobacterial genus Escherichia was the most abundant genus across all phyla (30.1% of sequences). At the end of the intervention, the relative abundance of Escherichia significantly decreased in MNP−Fe (−16.05 ± 6.9%, p = 0.05) and CONTROL (−19.75 ± 4.5%, p = 0.01), but not in the MNP+Fe group (−6.23 ± 9%, p = 0.41). The second most abundant genus at baseline was Bifidobacterium (17.3%), the relative abundance of which significantly decreased in MNP+Fe (−6.38 ± 2.5%, p = 0.02) and CONTROL (−8.05 ± 1.46%, p = 0.01), but not in MNP-Fe (−4.27 ± 5%, p = 0.4445). Clostridium increased in MNP-Fe only (1.9 ± 0.5%, p = 0.02). No significant differences were observed in inflammation markers, except for IL-8, which decreased in CONTROL. MNP fortification over three months in non- or mildly anemic Kenyan infants can potentially alter the gut microbiome. Consistent with previous research, addition of iron to the MNP may adversely affect the colonization of potential beneficial microbes and attenuate the decrease of potential pathogens.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.
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