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

Emily R. Smith, Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America.
Erin Oakley, Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America.
Siran He, Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America.
Rebecca Zavala, Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America.
Kacey Ferguson, Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America.
Lior Miller, Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America.
Gargi Wable Grandner, Department of Global Health, George Washington University Milken Institute School of Public Health, Washington, DC, United States of America.
Ibukun-Oluwa Omolade Abejirinde, Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Yalda Afshar, Division of Maternal Fetal Medicine, University of California Los Angeles, Los Angeles, CA, United States of America.
Homa Ahmadzia, Division of Maternal-Fetal Medicine, The George Washington University School of Medicine and Health Sciences, Washington, D.C., United States of America.
Grace Aldrovandi, Department of Pediatrics, University of California Los Angeles, Los Angeles, CA, United States of America.
Victor Akelo, US Centers for Disease Control and Prevention, Kisumu, Kenya.
Beth A. Tippett Barr, US Centers for Disease Control and Prevention, Kisumu, Kenya.
Elisa Bevilacqua, Department of Women and Child Health, Women Health Area, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy.
Justin S. Brandt, 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.
Natalie Broutet, Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Irene Fernández Buhigas, Department of Obstetrics and Gynecology, Hospital Universitario de Torrejón, Torrejón de Ardoz, Madrid, Spain.
Jorge Carrillo, Departmento de Obstetricia y Ginecologia, Clinica Alemana de Santiago, Facultad de Medicina Clinica Alemana-Universidad del Desarrollo, Santiago, Chile.
Rebecca Clifton, Biostatistics Center, The George Washington University, Washington, DC, United States of America.
Jeanne Conry, OBGYN, The International Federation of Gynecology and Obstetrics, London, United Kingdom.
Erich Cosmi, Department of Woman's and Child's Health, Obstetrics and Gynecologic Clinic, University of Padua, Padua, Italy.
Camille Delgado-López, Surveillance for Emerging Threats to Mothers and Babies, Puerto Rico Department of Health, San Juan, Puerto Rico.
Hema Divakar, Asian Research and Training Institute for Skill Transfer (ARTIST), Bengaluru, India.
Amanda J. Driscoll, Center for Vaccine Development and Global Health, University of Maryland, School of Medicine, Baltimore, MD, United States of America.
Guillaume Favre, Materno-fetal and Obstetrics Research Unit, Department "Femme-Mère-Enfant", University Hospital, Lausanne, Switzerland.
Valerie Flaherman, Department of Pediatrics, University of California San Francisco, San Francisco, CA, United States of America.
Christopher Gale, Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.
Maria M. Gil, Department of Obstetrics and Gynecology, Hospital Universitario de Torrejón, Torrejón de Ardoz, Madrid, Spain.
Christine Godwin, Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Sami Gottlieb, Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Olivia Hernandez Bellolio, Gynecology and Obstetrics, Felix Bulnes Hospital and RedSalud Clinic, Santiago, Chile.
Edna Kara, Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Document Type

Journal Article

Publication Date

1-1-2022

Journal

PloS one

Volume

17

Issue

6

DOI

10.1371/journal.pone.0270150

Abstract

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.

Department

Global Health

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