Browsing by Author "Mazariegos, Manolo"

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    Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth
    (Massachusetts Medical Society, 2023) Tita, Alan T. N.; Carlo, Waldemar A.; McClure, Elizabeth M.; Mwenechanya, Musaku; Chomba, Elwyn; Hemingway-Foday, Jennifer J.; Kavi, Avinash; Metgud, Mrityunjay C.; Goudar, Shivaprasad S.; Derman, Richard; Lokangaka, Adrien; Tshefu, Antoinette; Bauserman, Melissa; Bose, Carl; Shivkumar, Poonam; Waikar, Manju; Patel, Archana; Hibberd, Patricia L.; Nyongesa, Paul; Esamai, Fabian; Ekhaguere, Osayame A.; Bucher, Sherri; Jessani, Saleem; Tikmani, Shiyam S.; Saleem, Sarah; Goldenberg, Robert L.; Billah, Sk M.; Lennox, Ruth; Haque, Rashidul; Petri, William; Figueroa, Lester; Mazariegos, Manolo; Krebs, Nancy F.; Moore, Janet L.; Nolen, Tracy L.; Koso-Thomas, Marion; A-PLUS Trial Group; Pediatrics, School of Medicine
    Background: The use of azithromycin reduces maternal infection in women during unplanned cesarean delivery, but its effect on those with planned vaginal delivery is unknown. Data are needed on whether an intrapartum oral dose of azithromycin would reduce maternal and offspring sepsis or death. Methods: In this multicountry, placebo-controlled, randomized trial, we assigned women who were in labor at 28 weeks' gestation or more and who were planning a vaginal delivery to receive a single 2-g oral dose of azithromycin or placebo. The two primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis. During an interim analysis, the data and safety monitoring committee recommended stopping the trial for maternal benefit. Results: A total of 29,278 women underwent randomization. The incidence of maternal sepsis or death was lower in the azithromycin group than in the placebo group (1.6% vs. 2.4%), with a relative risk of 0.67 (95% confidence interval [CI], 0.56 to 0.79; P<0.001), but the incidence of stillbirth or neonatal death or sepsis was similar (10.5% vs. 10.3%), with a relative risk of 1.02 (95% CI, 0.95 to 1.09; P = 0.56). The difference in the maternal primary outcome appeared to be driven mainly by the incidence of sepsis (1.5% in the azithromycin group and 2.3% in the placebo group), with a relative risk of 0.65 (95% CI, 0.55 to 0.77); the incidence of death from any cause was 0.1% in the two groups (relative risk, 1.23; 95% CI, 0.51 to 2.97). Neonatal sepsis occurred in 9.8% and 9.6% of the infants, respectively (relative risk, 1.03; 95% CI, 0.96 to 1.10). The incidence of stillbirth was 0.4% in the two groups (relative risk, 1.06; 95% CI, 0.74 to 1.53); neonatal death within 4 weeks after birth occurred in 1.5% in both groups (relative risk, 1.03; 95% CI, 0.86 to 1.24). Azithromycin was not associated with a higher incidence in adverse events. Conclusions: Among women planning a vaginal delivery, a single oral dose of azithromycin resulted in a significantly lower risk of maternal sepsis or death than placebo but had little effect on newborn sepsis or death.
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    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 Medicine
    Background 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.
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    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 Medicine
    Objectives: 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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    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 Medicine
    Objective: 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.