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Item Community based weighing of newborns and use of mobile phones by village elders in rural settings in Kenya: a decentralised approach to health care provision(Springer Nature, 2012-03-19) Gisore, Peter; Shipala, Evelyn; Otieno, Kevin; Rono, Betsy; Marete, Irene; Tenge, Constance; Mabeya, Hillary; Bucher, Sherri; Moore, Janet; Liechty, Edward; Esamai, Fabian; Pediatrics, School of MedicineBackground: Identifying every pregnancy, regardless of home or health facility delivery, is crucial to accurately estimating maternal and neonatal mortality. Furthermore, obtaining birth weights and other anthropometric measurements in rural settings in resource limited countries is a difficult challenge. Unfortunately for the majority of infants born outside of a health care facility, pregnancies are often not recorded and birth weights are not accurately known. Data from the initial 6 months of the Maternal and Neonatal Health (MNH) Registry Study of the Global Network for Women and Children's Health study area in Kenya revealed that up to 70% of newborns did not have exact weights measured and recorded by the end of the first week of life; nearly all of these infants were born outside health facilities. Methods: To more completely obtain accurate birth weights for all infants, regardless of delivery site, village elders were engaged to assist in case finding for pregnancies and births. All elders were provided with weighing scales and mobile phones as tools to assist in subject enrollment and data recording. Subjects were instructed to bring the newborn infant to the home of the elder as soon as possible after birth for weight measurement.The proportion of pregnancies identified before delivery and the proportion of births with weights measured were compared before and after provision of weighing scales and mobile phones to village elders. Primary outcomes were the percent of infants with a measured birth weight (recorded within 7 days of birth) and the percent of women enrolled before delivery. Results: The recorded birth weight increased from 43 ± 5.7% to 97 ± 1.1. The birth weight distributions between infants born and weighed in a health facility and those born at home and weighed by village elders were similar. In addition, a significant increase in the percent of subjects enrolled before delivery was found. Conclusions: Pregnancy case finding and acquisition of birth weight information can be successfully shifted to the community level.Item Corrigendum to The impact of risk factors on aspirin's efficacy for the prevention of preterm birth. American Journal of Obstetrics & Gynecology MFM. Volume 5, Issue 10, October 2023, 101095(Elsevier, 2024) Nuss, Emily E.; Hoffman, Matthew K.; Goudar, Shivaprasad S.; Kavi, Avinash; Metgud, Mrityunjay; Somannavar, Manjunath; Okitawutshu, Jean; Lokangaka, Adrien; Tshefu, Antoinette; Bauserman, Melissa; Tembo, Abigail Mwapule; 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.; Patel, Archana; Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas Study Group; Pediatrics, School of MedicineThe authors regret that the originally published manuscript erroneously excluded a contributing author Archana Patel MD, PhD. The authors would like to apologise for any inconvenience caused.Item Cost-effectiveness of low-dose aspirin for the prevention of preterm birth: a prospective study of the Global Network for Women's and Children's Health Research(Elsevier, 2023) Patterson, Jackie K.; Neuwahl, Simon; Goco, Norman; Moore, Janet; Goudar, Shivaprasad S.; Derman, Richard J.; Hoffman, Matthew; Metgud, Mrityunjay; Somannavar, Manjunath; Kavi, Avinash; Okitawutshu, Jean; Lokangaka, Adrien; Tshefu, Antoinette; Bose, Carl L.; Mwapule, Abigail; Mwenechanya, Musaku; Chomba, Elwyn; Carlo, Waldemar A.; Chicuy, Javier; Figueroa, Lester; Krebs, Nancy F.; Jessani, Saleem; Saleem, Sarah; Goldenberg, Robert L.; Kurhe, Kunal; Das, Prabir; Patel, Archana; Hibberd, Patricia L.; Achieng, Emmah; Nyongesa, Paul; Esamai, Fabian; Bucher, Sherri; Liechty, Edward A.; Bresnahan, Brian W.; Koso-Thomas, Marion; McClure, Elizabeth M.; Pediatrics, School of MedicineBackground: Premature birth is associated with an increased risk of mortality and morbidity, and strategies to prevent preterm birth are few in number and resource intensive. In 2020, the ASPIRIN trial showed the efficacy of low-dose aspirin (LDA) in nulliparous, singleton pregnancies for the prevention of preterm birth. We sought to investigate the cost-effectiveness of this therapy in low-income and middle-income countries. Methods: In this post-hoc, prospective, cost-effectiveness study, we constructed a probabilistic decision tree model to compare the benefits and costs of LDA treatment compared with standard care using primary data and published results from the ASPIRIN trial. In this analysis from a health-care sector perspective, we considered the costs and effects of LDA treatment, pregnancy outcomes, and neonatal health-care use. We did sensitivity analyses to understand the effect of the price of the LDA regimen, and the effectiveness of LDA in reducing both preterm birth and perinatal death. Findings: In model simulations, LDA was associated with 141 averted preterm births, 74 averted perinatal deaths, and 31 averted hospitalisations per 10 000 pregnancies. The reduction in hospitalisation resulted in a cost of US$248 per averted preterm birth, $471 per averted perinatal death, and $15·95 per disability-adjusted life year. Interpretation: LDA treatment in nulliparous, singleton pregnancies is a low-cost, effective treatment to reduce preterm birth and perinatal death. The low cost per disability-adjusted life year averted strengthens the evidence in support of prioritising the implementation of LDA in publicly funded health care in low-income and middle-income countries.Item Evaluating the effect of care around labor and delivery practices on early neonatal mortality in the Global Network's Maternal and Newborn Health Registry(Springer Nature, 2020-11-30) Patel, Archana B.; Simmons, Elizabeth M.; Rao, Sowmya R.; Moore, Janet; Nolen, Tracy L.; Goldenberg, Robert L.; Goudar, Shivaprasad S.; Somannavar, Manjunath S.; Esamai, Fabian; Nyongesa, Paul; Garces, Ana L.; Chomba, Elwyn; Mwenechanya, Musaku; Saleem, Sarah; Naqvi, Farnaz; Bauserman, Melissa; Bucher, Sherri; Krebs, Nancy F.; Derman, Richard J.; Carlo, Waldemar A.; Koso‑ThomasMcClure, Marion Elizabeth M.; Hibberd, Patricia L.; Pediatrics, School of MedicineBackground: Neonatal deaths in first 28-days of life represent 47% of all deaths under the age of five years globally and are a focus of the United Nation's (UN's) Sustainable Development Goals. Pregnant women are delivering in facilities but that does not indicate quality of care during delivery and the postpartum period. The World Health Organization's Essential Newborn Care (ENC) package reduces neonatal mortality, but lacks a simple and valid composite index that measures its effectiveness. Methods: Data on 5 intra-partum and 3 post-partum practices (indicators) recommended as part of ENC, routinely collected in NICHD's Global Network's (GN) Maternal Newborn Health Registry (MNHR) between 2010 and 2013, were included. We evaluated if all 8 practices (Care around Delivery - CAD), combined as an index was associated with reduced early neonatal mortality rates (days 0-6 of life). Results: A total of 150,848 live births were included in the analysis. The individual indicators varied across sites. All components were present in 19.9% births (range 0.4 to 31% across sites). Present indicators (8 components) were associated with reduced early neonatal mortality [adjusted RR (95% CI):0.81 (0.77, 0.85); p < 0.0001]. Despite an overall association between CAD and early neonatal mortality (RR < 1.0 for all early mortality): delivery by skilled birth attendant; presence of fetal heart and delayed bathing were associated with increased early neonatal mortality. Conclusions: Present indicators (8 practices) of CAD were associated with a 19% reduction in the risk of neonatal death in the diverse health facilities where delivery occurred within the GN MNHR. These indicators could be monitored to identify facilities that need to improve compliance with ENC practices to reduce preventable neonatal deaths. Three of the 8 indicators were associated with increased neonatal mortality, due to baby being sick at birth. Although promising, this composite index needs refinement before use to monitor facility-based quality of care in association with early neonatal mortality.Item Low-Dose Aspirin for the Prevention of Preterm Delivery in Nulliparous Women with a Singleton Pregnancy: A Randomised Multi-country Placebo Controlled Trial(Elsevier, 2020) Hoffman, Matthew K.; Goudar, Shivaprasad S.; Kodkany, Bhalachandra S.; Metgud, Mrityunjay; Somannavar, Manjunath; Okitawutshu, Jean; Lokangaka, Adrien; Tshefu, Antoinette; Bose, Carl L.; Mwapule, Abigail; Mwenechanya, Musaku; Chomba, Elwyn; Carlo, Waldemar A.; Chicuy, Javier; Figueroa, Lester; Garces, Ana; Krebs, Nancy F.; Jessani, Saleem; Zehra, Farnaz; Saleem, Sarah; Goldenberg, Robert L.; Kurhe, Kunal; Das, Prabir; Patel, Archana; Hibberd, Patricia L.; Achieng, Emmah; Nyongesa, Paul; Esamai, Fabian; Liechty, Edward A.; Goco, Norman; Hemingway-Foday, Jennifer; Moore, Janet; Nolen, Tracy L.; McClure, Elizabeth M.; Koso-Thomas, Marion; Miodovnik, Menachem; Silver, Robert; Derman, Richard J.; Pediatrics, School of MedicineBackground: Preterm birth remains a common cause of neonatal mortality with a disproportionate burden occurring in low and middle-income countries. Meta-analyses of low-dose aspirin to prevent preeclampsia suggest that the incidence of preterm birth may also be decreased, particularly if initiated before 16 weeks. Methods: We completed a randomised multi-country (Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan, Zambia) double masked trial of aspirin (81 mg) daily compared to placebo initiated between 6 weeks and 0 days and 13 weeks and 6 days of pregnancy in nulliparous women between14 and 40 years of age with an ultrasound confirming gestational age and singleton viable pregnancy. Randomisation (1:1) was stratified by site. The primary outcome of preterm birth, defined as delivery prior to 37 weeks gestational age, was analyzed in randomised women with pregnancy outcomes at or after 20 weeks. This study is registered with ClinicalTrials.gov, number NCT02409680, and the Clinical Trial Registry, India, number CTRI/2016/05/006970. Findings: From March 2016 through June 2018, 11,976 women were assigned to aspirin (5,990 women) or placebo (5,986 women). Amongst randomised women, an evaluable birth outcome beyond 20 weeks occurred in 5787 women who received Aspirin and 5771 women who received placebo Preterm birth occurred in 11.6% of women randomised to aspirin and 13.1% randomised to placebo (Relative Risk [RR], 0.89; 95% CI, 0.81 to 0.98; Risk Difference, −0·02; 95% CI, −0·03, −0·01). Women randomised to aspirin were less likely to experience perinatal mortality (45.7/1000 vs 53.6/1000; RR, 0.86; 95%CI, 0.73 to 1.00). Other adverse maternal/neonatal events were similar between the two groups. Interpretation: In nulliparous women with singleton pregnancies, low dose aspirin initiated between 6 weeks and 0 days and 13 weeks and 6 days results in lower rates of preterm delivery before 37 weeks and perinatal mortality.Item Predictors of Plasmodium falciparum Infection in the First Trimester Among Nulliparous Women From Kenya, Zambia, and the Democratic Republic of the Congo(Oxford University Press, 2022) Leuba, Sequoia I.; Westreich, Daniel; Bose, Carl L.; Powers, Kimberly A.; Olshan, Andy; Taylor, Steve M.; Tshefu, Antoinette; Lokangaka, Adrien; Carlo, Waldemar A.; Chomba, Elwyn; Liechty, Edward A.; Bucher, Sherri L.; Esamai, Fabian; Jessani, Saleem; Saleem, Sarah; Goldenberg, Robert L.; Moore, Janet; Nolen, Tracy; Hemingway-Foday, Jennifer; McClure, Elizabeth M.; Koso-Thomas, Marion; Derman, Richard J.; Hoffman, Matthew; Bauserman, Melissa; Pediatrics, School of MedicineBackground: Malaria can have deleterious effects early in pregnancy, during placentation. However, malaria testing and treatment are rarely initiated until the second trimester, leaving pregnancies unprotected in the first trimester. To inform potential early intervention approaches, we sought to identify clinical and demographic predictors of first-trimester malaria. Methods: We prospectively recruited women from sites in the Democratic Republic of the Congo (DRC), Kenya, and Zambia who participated in the ASPIRIN (Aspirin Supplementation for Pregnancy Indicated risk Reduction In Nulliparas) trial. Nulliparous women were tested for first-trimester Plasmodium falciparum infection by quantitative polymerase chain reaction. We evaluated predictors using descriptive statistics. Results: First-trimester malaria prevalence among 1513 nulliparous pregnant women was 6.3% (95% confidence interval [CI], 3.7%-8.8%] in the Zambian site, 37.8% (95% CI, 34.2%-41.5%) in the Kenyan site, and 62.9% (95% CI, 58.6%-67.2%) in the DRC site. First-trimester malaria was associated with shorter height and younger age in Kenyan women in site-stratified analyses, and with lower educational attainment in analyses combining all 3 sites. No other predictors were identified. Conclusions: First-trimester malaria prevalence varied by study site in sub-Saharan Africa. The absence of consistent predictors suggests that routine parasite screening in early pregnancy may be needed to mitigate first-trimester malaria in high-prevalence settings.Item The efficacy of low-dose aspirin in pregnancy among women in malaria-endemic countries(Springer, 2022-04-10) Bauserman, Melissa; Leuba, Sequoia I.; Hemingway-Foday, Jennifer; Nolen, Tracy L.; Moore, Janet; McClure, Elizabeth M.; Lokangaka, Adrien; Tsehfu, Antoinette; Patterson, Jackie; Liechty, Edward A.; Esamai, Fabian; Carlo, Waldemar A.; Chomba, Elwyn; Goldenberg, Robert L.; Saleem, Sarah; Jessani, Saleem; Koso-Thomas, Marion; Hoffman, Matthew; Derman, Richard J.; Meshnick, Steven R.; Bose, Carl L.; Pediatrics, School of MedicineBackground Low dose aspirin (LDA) is an effective strategy to reduce preterm birth. However, LDA might have differential effects globally, based on the etiology of preterm birth. In some regions, malaria in pregnancy could be an important modifier of LDA on birth outcomes and anemia. Methods This is a sub-study of the ASPIRIN trial, a multi-national, randomized, placebo controlled trial evaluating LDA effect on preterm birth. We enrolled a convenience sample of women in the ASPIRIN trial from the Democratic Republic of Congo (DRC), Kenya and Zambia. We used quantitative polymerase chain reaction to detect malaria. We calculated crude prevalence proportion ratios (PRs) for LDA by malaria for outcomes, and regression modelling to evaluate effect measure modification. We evaluated hemoglobin in late pregnancy based on malaria infection in early pregnancy. Results One thousand four hundred forty-six women were analyzed, with a malaria prevalence of 63% in the DRC site, 38% in the Kenya site, and 6% in the Zambia site. Preterm birth occurred in 83 (LDA) and 90 (placebo) women, (PR 0.92, 95% CI 0.70, 1.22), without interaction between LDA and malaria (p = 0.75). Perinatal mortality occurred in 41 (LDA) and 43 (placebo) pregnancies, (PR 0.95, 95% CI 0.63, 1.44), with an interaction between malaria and LDA (p = 0.014). Hemoglobin was similar by malaria and LDA status. Conclusions Malaria in early pregnancy did not modify the effects of LDA on preterm birth, but modified the effect of LDA on perinatal mortality. This effect measure modification deserves continued study as LDA is used in malaria endemic regions.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 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.