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

Torri D. Metz, Department of Obstetrics and Gynecology, University of Utah Health Hospitals and Clinics, Salt Lake City, UT, United States of America.
Rebecca G. Clifton, Biostatistics Center, The George Washington University, Washington, DC, United States of America.
Richard Gallagher, Department of Child and Adolescent Psychiatry, NYU Grossman School of Medicine, New York, NY, United States of America.
Rachel S. Gross, Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, United States of America.
Leora I. Horwitz, Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States of America.
Vanessa L. Jacoby, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, United States of America.
Susanne P. Martin-Herz, Department of Pediatrics, Division of Developmental Medicine, University of California, San Francisco, San Francisco, CA, United States of America.
Myriam Peralta-Carcelen, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States of America.
Harrison T. Reeder, Department of Biostatistics, Massachusetts General Hospital, Boston, MA, United States of America.
Carmen J. Beamon, Department of Maternal Fetal Medicine, WakeMed Health and Hospitals, Raleigh, NC, United States of America.
James Chan, Department of Biostatistics, Massachusetts General Hospital, Boston, MA, United States of America.
A Ann Chang, Women's Health Research Clinical Center, University of California, San Francisco, San Francisco, CA, United States of America.
Maged M. Costantine, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America.
Megan L. Fitzgerald, Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States of America.
Andrea S. Foulkes, Department of Biostatistics, Massachusetts General Hospital, Boston, MA, United States of America.
Kelly S. Gibson, Department of Obstetrics and Gynecology, The MetroHealth System, Cleveland, OH, United States of America.
Nick Güthe, Department of Population Health, New York University Grossman School of Medicine, New York, NY, United States of America.
Mounira Habli, Division Maternal Fetal Medicine, Trihealth Good Samaritan Hospital Maternal Fetal Medicine, Cincinnati, OH, United States of America.
David N. Hackney, Department of Obstetrics and Gynecology, University Hospitals Cleveland Medical Center: UH Cleveland Medical Center, Cleveland, OH, United States of America.
Matthew K. Hoffman, Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE, United States of America.
M Camille Hoffman, Department of Obstetrics & Gynecology, University of Colorado School of Medicine, Aurora, CO, United States of America.
Brenna L. Hughes, Department of Obstetrics and Gynecology, Duke University, Durham, NC, United States of America.
Stuart D. Katz, Department of Medicine, New York University School of Medicine, New York City, NY, United States of America.
Victoria Laleau, Department of Pediatrics, University of California, San Francisco, San Francisco, CA, United States of America.
Gail Mallett, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.
Hector Mendez-Figueroa, 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.
Vanessa Monzon, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, United States of America.
Anna Palatnik, Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI, United States of America.
Kristy T. Palomares, Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Saint Peter's University Hospital, New Brunswick, NJ, United States of America.
Samuel Parry, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, United States of America.
Christian M. Pettker, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, United States of America.
Beth A. Plunkett, Department of Obstetrics and Gynecology, NorthShore University HealthSystem, Evanston, IL, United States of America.

Document Type

Journal Article

Publication Date

1-1-2023

Journal

PloS one

Volume

18

Issue

12

DOI

10.1371/journal.pone.0285351

Abstract

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.

Department

Epidemiology

Link to Full Text

Share

COinS