Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.

Autor: Smith ER; Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America., Oakley E; Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America., He S; Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America., Zavala R; Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America., Ferguson K; Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America., Miller L; Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America., Grandner GW; Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America., Abejirinde IO; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., Afshar Y; Division of Maternal Fetal Medicine, University of California Los Angeles, Los Angeles, CA, United States of America., Ahmadzia H; Division of Maternal-Fetal Medicine, The George Washington University School of Medicine and Health Sciences, Washington, D.C., United States of America., Aldrovandi G; Department of Pediatrics, University of California Los Angeles, Los Angeles, CA, United States of America., Akelo V; US Centers for Disease Control and Prevention, Kisumu, Kenya., Tippett Barr BA; US Centers for Disease Control and Prevention, Kisumu, Kenya., Bevilacqua E; Department of Women and Child Health, Women Health Area, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy., Brandt JS; Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, United States of America., Broutet N; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., Fernández Buhigas I; Department of Obstetrics and Gynecology, Hospital Universitario de Torrejón, Torrejón de Ardoz, Madrid, Spain.; School of Medicine, Universidad Francisco de Vitoria, Pozuelo de Alarcón, Madrid, Spain., Carrillo J; Departmento de Obstetricia y Ginecologia, Clinica Alemana de Santiago, Facultad de Medicina Clinica Alemana-Universidad del Desarrollo, Santiago, Chile., Clifton R; Biostatistics Center, The George Washington University, Washington, DC, United States of America., Conry J; OBGYN, The International Federation of Gynecology and Obstetrics, London, United Kingdom., Cosmi E; Department of Woman's and Child's Health, Obstetrics and Gynecologic Clinic, University of Padua, Padua, Italy., Delgado-López C; Surveillance for Emerging Threats to Mothers and Babies, Puerto Rico Department of Health, San Juan, Puerto Rico., Divakar H; Asian Research and Training Institute for Skill Transfer (ARTIST), Bengaluru, India., Driscoll AJ; Center for Vaccine Development and Global Health, University of Maryland, School of Medicine, Baltimore, MD, United States of America., Favre G; Materno-fetal and Obstetrics Research Unit, Department 'Femme-Mère-Enfant', University Hospital, Lausanne, Switzerland., Flaherman V; Department of Pediatrics, University of California San Francisco, San Francisco, CA, United States of America., Gale C; Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom., Gil MM; Department of Obstetrics and Gynecology, Hospital Universitario de Torrejón, Torrejón de Ardoz, Madrid, Spain.; School of Medicine, Universidad Francisco de Vitoria, Pozuelo de Alarcón, Madrid, Spain., Godwin C; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.; Global Health Research, FHI 360, Durham, NC, United States of America., Gottlieb S; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., Hernandez Bellolio O; Gynecology and Obstetrics, Felix Bulnes Hospital and RedSalud Clinic, Santiago, Chile., Kara E; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., Khagayi S; Kenya Medical Research Institute-Center for Global Health Research, Kisumu, Kenya., Kim CR; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., Knight M; National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom., Kotloff K; Center for Vaccine Development and Global Health, University of Maryland, School of Medicine, Baltimore, MD, United States of America.; Department of Metabolism, Digestion, and Reproduction, Imperial College London, of London, United Kingdom., Lanzone A; Department of Women and Child Health, Women Health Area, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy.; Catholic University of Sacred Hearth, Rome, Italy., Le Doare K; Medical Research Council /Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit, Entebbe, Uganda.; Pediatric Infectious Diseases Research Group, St. George's University of London, of London, United Kingdom., Lees C; Department of Metabolism, Digestion, and Reproduction, Imperial College London, of London, United Kingdom., Litman E; Division of Maternal-Fetal Medicine, The George Washington University School of Medicine and Health Sciences, Washington, D.C., United States of America., Lokken EM; Department of Obstetrics and Gynecology, School of Medicine, University of Washington, Washington, DC, United States of America.; Department of Global Health, School of Public Health, University of Washington, Washington, DC, United States of America., Laurita Longo V; Catholic University of Sacred Hearth, Rome, Italy., Magee LA; Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.; Institute of Women and Children's Health, King's College Hospital, London, United Kingdom., Martinez-Portilla RJ; Clinical Research Division, National Institute of Perinatology, Mexico City, Mexico.; ABC Medical Center, Fetal Surgery Clinic, Mexico City, Mexico., McClure E; Division of Statistics and Epidemiology, RTI International, Chapel Hill, NC, United States of America., Metz TD; University of Utah Health, Salt Lake City, UT, United States of America., Money D; Department of Obstetrics and Gynecology, The University of British Columbia, Vancouver, Canada., Mullins E; Department of Metabolism, Digestion, and Reproduction, Imperial College London, of London, United Kingdom., Nachega JB; Department of Epidemiology and Center for Global Health, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, United States of America.; Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.; Departments of Epidemiology and International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America., Panchaud A; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.; Service of Pharmacy, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland., Playle R; Center for Trials Research, Cardiff University, Wales, United Kingdom., Poon LC; Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Shatin, Hong Kong., Raiten D; Pediatric Growth and Nutrition Branch, National Institute of Health, Bethesda, MD, United States of America., Regan L; Federation International Federation Gynaecology & Obstetrics, Imperial College London, London, United Kingdom., Rukundo G; PeriCovid (PREPARE)-Uganda Team, Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda., Sanin-Blair J; Maternal Fetal Unit, Universidad Pontificia Bolivariana, RECOGEST Study, Medellín, Colombia., Temmerman M; Centre of Excellence in Women and Child Health, Aga Khan University, Nairobi, Kenya., Thorson A; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., Thwin S; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., Tolosa JE; Maternal Fetal Unit, Universidad Pontificia Bolivariana, RECOGEST Study, Medellín, Colombia.; Department of Obstetrics and Gynecology, Maternal Fetal Medicine, Oregon Health and Science University, Portland, OR, United States of America.; St. Luke's University Health Network, Department of Obstetrics & Gynecology, Maternal Fetal Medicine, Bethlehem, PA, United States of America., Townson J; Center for Trials Research, Cardiff University, Wales, United Kingdom., Valencia-Prado M; Children with Special Medical Needs Division, Puerto Rico Department of Health, San Juan, Puerto Rico., Visentin S; Department of Woman's and Child's Health, Obstetrics and Gynecologic Clinic, University of Padua, Padua, Italy., von Dadelszen P; Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.; Global Health Institute, King's College London, London, United Kingdom., Adams Waldorf K; Department of Obstetrics and Gynecology, School of Medicine, University of Washington, Washington, DC, United States of America.; Department of Global Health, School of Public Health, University of Washington, Washington, DC, United States of America., Whitehead C; Department of Maternal Fetal Medicine, University of Melbourne, Royal Women's Hospital, Parkville, VIC, Australia., Yang H; Health Science Center, Peking University, Beijing, China., Thorlund K; Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada., Tielsch JM; Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2022 Jun 16; Vol. 17 (6), pp. e0270150. Date of Electronic Publication: 2022 Jun 16 (Print Publication: 2022).
DOI: 10.1371/journal.pone.0270150
Abstrakt: We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.
Competing Interests: Clare Whitehead declares a a relationship with the following entities, Ferring Pharmaceuticals COVID19 Investigational, Grant, NHMRC Fellowship (salary support). Edward Mullins declares a relationship with the following entities National Institute for Health Research (Project grant for PAN COVID study). Deborah Money declares a relationship with the following entities, Canadian Institutes of Health Research (payments to my institution only), Public Health Agency of Canada (payments to institution only), BC Women’s Foundation (payments to institution only) and is a Member of the COVID-19 Immunity Task Force sponsored by the Canadian government. Torri D. Metz declares a relationship with the following entities, Pfizer (site Principal Investigator for SARS-CoV-2 vaccination in pregnancy study, money paid to institution and member of Medical Advisory Board for SARS-CoV-2 vaccination in pregnancy study, money paid to me), NICHD (subcommittee Chair for the NICHD Maternal-Fetal Medicine Units Network Gestational Research Assessments of COVID-19 (GRAVID) study), and Society for Maternal-Fetal Medicine (board member). Erica Lokken declares a relationship with the following entity, US NIH (paid institution). Karen L. Kotloff declares a relationship with the following entity, Bill and Melinda Gates Foundation. Siran He declares a relationship with the following entity, Bill and Melinda Gates Foundtion (payments made to institution). Valerie Flaherman declares a relationship with the following entities, Bill and Melinda Gates Foundation (payments to institution), Yellow Chair Foundation (payments to institution), Robert Woods Johnson Foundation (payments to institution), CDC Foundation, California Health Care Foundation (payments to institution), Tara Health Foundation (payments to institution), UCSF Women’s Health Center of Excellence (payments to institution) and California Department of Health Care Services (payments made to institution). Jose Sanin-Blair declares a relationship with the following entity, Ferring Pharmaceuticals which gave a grant ($10,000) for the expenses of RECOGEST trial and is a part of the Columbian Federation of Perinatology. Yalda Afshar declares a relationship with the following entities, Bill and Melinda Gates Foundation (payments made to institution), CDC Foundation (payments made to my institution), Robert Woods Johnson Foundation (payments made to institution), and UCLA Dean’s Office COVID-19 research (payments made to institution). Rebecca Clifton declares a relationship with the following entity, NIH HD36801 (MFMU Network DCC). Alice Panchaud declared a relationship with the European Medicines Agency (research grant to institution) and the Federal Office of Public Health Switzerland (research grant to institution).
Databáze: MEDLINE
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