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Item A prospective observational description of frequency and timing of antenatal care attendance and coverage of selected interventions from sites in Argentina, Guatemala, India, Kenya, Pakistan and Zambia(Springer Nature, 2015) Bucher, Sherri; Marete, Irene; Tenge, Constance; Liechty, Edward A.; Esamai, Fabian; Patel, Archana; Goudar, Shivaprasad S.; Kodkany, Bhalchandra; Garces, Ana; Chomba, Elwyn; Althabe, Fernando; Barreuta, Mabel; Pasha, Omrana; Hibberd, Patricia; Derman, Richard J.; Otieno, Kevin; Hambidge, K. Michael; Krebs, Nancy F.; Carlo, Waldemar A.; Chemweno, Carolyne; Goldenberg, Robert L.; McClure, Elizabeth M.; Moore, Janet L.; Wallace, Dennis D.; Saleem, Sarah; Koso-Thomas, Marion; Pediatrics, School of MedicineBackground: The Global Network for Women’s and Children’s Health Research is one of the largest international networks for testing and generating evidence-based recommendations for improvement of maternal-child health in resource-limited settings. Since 2009, Global Network sites in six low and middle-income countries have collected information on antenatal care practices, which are important as indicators of care and have implications for programs to improve maternal and child health. We sought to: (1) describe the quantity of antenatal care attendance over a four-year period; and (2) explore the quality of coverage for selected preventative, screening, and birth preparedness components. Methods: The Maternal Newborn Health Registry (MNHR) is a prospective, population-based birth and pregnancy outcomes registry in Global Network sites, including: Argentina, Guatemala, India (Belgaum and Nagpur), Kenya, Pakistan, and Zambia. MNHR data from these sites were prospectively collected from January 1, 2010 – December 31, 2013 and analyzed for indicators related to quantity and patterns of ANC and coverage of key elements of recommended focused antenatal care. Descriptive statistics were generated overall by global region (Africa, Asia, and Latin America), and for each individual site. Results: Overall, 96% of women reported at least one antenatal care visit. Indian sites demonstrated the highest percentage of women who initiated antenatal care during the first trimester. Women from the Latin American and Indian sites reported the highest number of at least 4 visits. Overall, 88% of women received tetanus toxoid. Only about half of all women reported having been screened for syphilis (49%) or anemia (50%). Rates of HIV testing were above 95% in the Argentina, African, and Indian sites. The Pakistan site demonstrated relatively high rates for birth preparation, but for most other preventative and screening interventions, posted lower coverage rates as compared to other Global Network sites. Conclusions: Results from our large, prospective, population-based observational study contribute important insight into regional and site-specific patterns for antenatal care access and coverage. Our findings indicate a quality and coverage gap in antenatal care services, particularly in regards to syphilis and hemoglobin screening. We have identified site-specific gaps in access to, and delivery of, antenatal care services that can be targeted for improvement in future research and implementation efforts.Item Home birth attendants in low income countries: who are they and what do they do?(Springer Nature, 2012-05-14) Garces, Ana; McClure, Elizabeth M.; Chomba, Elwyn; Patel, Archana; Pasha, Omrana; Tshefu, Antoinette; Esamai, Fabian; Goudar, Shivaprasad; Lokangaka, Adrien; Hambidge, K. Michael; Wright, Linda L.; Koso-Thomas, Marion; Bose, Carl; Carlo, Waldemar A.; Liechty, Edward A.; Hibberd, Patricia L.; Bucher, Sherri; Whitworth, Ryan; Goldenberg, Robert L.; Pediatrics, School of MedicineBackground: Nearly half the world's babies are born at home. We sought to evaluate the training, knowledge, skills, and access to medical equipment and testing for home birth attendants across 7 international sites. Methods: Face-to-face interviews were done by trained interviewers to assess level of training, knowledge and practices regarding care during the antenatal, intrapartum and postpartum periods. The survey was administered to a sample of birth attendants conducting home or out-of-facility deliveries in 7 sites in 6 countries (India, Pakistan, Guatemala, Democratic Republic of the Congo, Kenya and Zambia). Results: A total of 1226 home birth attendants were surveyed. Less than half the birth attendants were literate. Eighty percent had one month or less of formal training. Most home birth attendants did not have basic equipment (e.g., blood pressure apparatus, stethoscope, infant bag and mask manual resuscitator). Reporting of births and maternal and neonatal deaths to government agencies was low. Indian auxilliary nurse midwives, who perform some home but mainly clinic births, were far better trained and differed in many characteristics from the birth attendants who only performed deliveries at home. Conclusions: Home birth attendants in low-income countries were often illiterate, could not read numbers and had little formal training. Most had few of the skills or access to tests, medications and equipment that are necessary to reduce maternal, fetal or 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 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 Lost to follow-up among pregnant women in a multi-site community based maternal and newborn health registry: a prospective study(Springer Nature, 2015) Marete, Irene; Tenge, Constance; Chemweno, Carolyne; Bucher, Sherri; Pasha, Omrana; Ramadurg, Umesh Y.; Mastiholi, Shivanand C.; Chiwila, Melody; Patel, Archana; Althabe, Fernando; Garces, Ana; Moore, Janet L.; Liechty, Edward A.; Derman, Richard J.; Hibberd, Patricia L.; Hambidge, K. Michael; Goldenberg, Robert L.; Carlo, Waldemar A.; Koso-Thomas, Marion; McClure, Elizabeth M.; Esamai, Fabian; Pediatrics, School of MedicineBackground: It is important when conducting epidemiologic studies to closely monitor lost to follow up (LTFU) rates. A high LTFU rate may lead to incomplete study results which in turn can introduce bias to the trial or study, threatening the validity of the findings. There is scarce information on LTFU in prospective community-based perinatal epidemiological studies. This paper reports the rates of LTFU, describes socio-demographic characteristics, and pregnancy/delivery outcomes of mothers LTFU in a large community-based pregnancy registry study. Methods: Data were from a prospective, population-based observational study of the Global Network for Women's and Children's Health Research Maternal Newborn Health Registry (MNHR). This is a multi-centre, international study in which pregnant women were enrolled in mid-pregnancy, followed through parturition and 42 days post-delivery. Risk for LTFU was calculated within a 95%CI. Results: A total of 282,626 subjects were enrolled in this study, of which 4,893 were lost to follow-up. Overall, there was a 1.7% LTFU to follow up rate. Factors associated with a higher LTFU included mothers who did not know their last menstrual period (RR 2.2, 95% CI 1.1, 4.4), maternal age of < 20 years (RR 1.2, 95% CI 1.1, 1.3), women with no formal education (RR 1.2, 95% CI 1.1, 1.4), and attending a government clinic for antenatal care (RR 2.0, 95% CI 1.4, 2.8). Post-natal factors associated with a higher LTFU rate included a newborn with feeding problems (RR 1.6, 94% CI 1.2, 2.2). Conclusions: The LTFU rate in this community-based registry was low (1.7%). Maternal age, maternal level of education, pregnancy status at enrollment and using a government facility for ANC are factors associated with being LTFU. Strategies to ensure representation and high retention in community studies are important to informing progress toward public health goals.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 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 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.