Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design.

Autor: Metz TD; Department of Obstetrics and Gynecology, University of Utah Health Hospitals and Clinics, Salt Lake City, UT, United States of America., Clifton RG; Biostatistics Center, The George Washington University, Washington, DC, United States of America., Gallagher R; Department of Child and Adolescent Psychiatry, NYU Grossman School of Medicine, New York, NY, United States of America., Gross RS; Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, United States of America., Horwitz LI; Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States of America., Jacoby VL; Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, United States of America., Martin-Herz SP; Department of Pediatrics, Division of Developmental Medicine, University of California, San Francisco, San Francisco, CA, United States of America., Peralta-Carcelen M; Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States of America., Reeder HT; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, United States of America., Beamon CJ; Department of Maternal Fetal Medicine, WakeMed Health and Hospitals, Raleigh, NC, United States of America., Chan J; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, United States of America., Chang AA; Women's Health Research Clinical Center, University of California, San Francisco, San Francisco, CA, United States of America., Costantine MM; Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America., Fitzgerald ML; Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States of America., Foulkes AS; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, United States of America., Gibson KS; Department of Obstetrics and Gynecology, The MetroHealth System, Cleveland, OH, United States of America., Güthe N; Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States of America., Habli M; Division Maternal Fetal Medicine, Trihealth Good Samaritan Hospital Maternal Fetal Medicine, Cincinnati, OH, United States of America., Hackney DN; Department of Obstetrics and Gynecology, University Hospitals Cleveland Medical Center: UH Cleveland Medical Center, Cleveland, OH, United States of America., Hoffman MK; Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE, United States of America., Hoffman MC; Department of Obstetrics & Gynecology, University of Colorado School of Medicine, Aurora, CO, United States of America., Hughes BL; Department of Obstetrics and Gynecology, Duke University, Durham, NC, United States of America., Katz SD; Department of Medicine, New York University School of Medicine, New York City, NY, United States of America., Laleau V; Department of Pediatrics, University of California, San Francisco, San Francisco, CA, United States of America., Mallett G; Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America., Mendez-Figueroa H; Department of Obstetrics, Gynecology and Reproductive Sciences, University of Texas McGovern Medical School: The University of Texas Health Science Center at Houston John P. and Katherine G. McGovern Medical School, Houston, TX, United States of America., Monzon V; Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, United States of America., Palatnik A; Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI, United States of America., Palomares KTS; Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Saint Peter's University Hospital, New Brunswick, NJ, United States of America., Parry S; Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, United States of America., Pettker CM; Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, United States of America., Plunkett BA; Department of Obstetrics and Gynecology, NorthShore University HealthSystem, Evanston, IL, United States of America., Poppas A; Division of Cardiology, Brown University Warren Alpert Medical School, Providence, RI, United States of America., Reddy UM; Department of Obstetrics and Gynecology, Columbia University, New York City, NY, United States of America., Rouse DJ; Department of Obstetrics and Gynecology, Brown University, Providence, RI, United States of America., Saade GR; Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, TX, United States of America., Sandoval GJ; Biostatistics Center, The George Washington University, Rockville, MD, United States of America., Schlater SM; Huntsman Cancer Institute, University of Utah Health, Salt Lake City, UT, United States of America., Sciurba FC; Department of Medicine, Division of Pulmonary Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, United States of America., Simhan HN; Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America., Skupski DW; Department of Obstetrics and Gynecology, Weill Cornell Medicine, New York, NY, United States of America., Sowles A; Department of Obstetrics and Gynecology, University of Utah Health Hospitals and Clinics, Salt Lake City, UT, United States of America., Thaweethai T; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, United States of America., Thomas GL; Clinical and Translational Science Collaborative of Cleveland, Case Western Reserve University, Cleveland, OH, United States of America., Thorp JM Jr; Department of Obstetrics and Gynecology, UNC: The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America., Tita AT; Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL, United States of America., Weiner SJ; Biostatistics Center, The George Washington University, Washington, DC, United States of America., Weigand S; Department of Obstetrics and Gynecology, Wright State University Boonshoft School of Medicine, Dayton, OH, United States of America., Yee LM; Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America., Flaherman VJ; Department of Pediatrics, University of California, San Francisco, San Francisco, CA, United States of America.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 Dec 21; Vol. 18 (12), pp. e0285351. Date of Electronic Publication: 2023 Dec 21 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0285351
Abstrakt: Importance: Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads.
Methods: RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators.
Discussion: RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero.
Clinical Trials.gov Identifier: Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.
Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Metz reports personal fees from Pfizer for her role as a medical consultant for a SARS-CoV-2 vaccination in pregnancy study, grants from Pfizer for role as a site PI for SARS-CoV-2 vaccination in pregnancy study, grants from Pfizer for role as a site PI for RSV vaccination in pregnancy study, and grants from Gestvision for role as a site PI for a preeclampsia study outside the submitted work. Dr. Horwitz reported serving as a member of the National Academy of Medicine Committee on the Long-Term Health Effects Stemming from COVID-19 and Implications for the Social Security Administration. Dr. Costantine reported receiving grant support for work not related to this paper from Baxter International and Siemens Healthcare and personal consulting fees not related to this paper from Progenity and Siemens Healthcare. These disclosures do not alter our adherence to PLOS ONE policies on sharing data and materials.
(Copyright: © 2023 Metz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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