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

Public Deposited
Analytics

Downloadable Content

Download PDF
Request Version for Screen Reader
Creator
  • Metz T.D.
    • Other Affiliation: University of Utah Health Hospitals and Clinics
  • Clifton R.G.
    • Other Affiliation: The George Washington University
  • Gallagher R.
    • Other Affiliation: NYU Grossman School of Medicine
  • Gross R.S.
    • Other Affiliation: NYU Grossman School of Medicine
  • Horwitz L.I.
    • Other Affiliation: NYU Grossman School of Medicine
  • Jacoby V.L.
    • Other Affiliation: University of California, San Francisco
  • Martin-Herz S.P.
    • Other Affiliation: University of California, San Francisco
  • Peralta-Carcelen M.
    • Other Affiliation: University of Alabama at Birmingham
  • Reeder H.T.
    • Other Affiliation: Massachusetts General Hospital
  • Beamon C.J.
    • Other Affiliation: WakeMed Health and Hospitals
  • Chan J.
    • Other Affiliation: Massachusetts General Hospital
  • Chang A.A.
    • Other Affiliation: University of California, San Francisco
  • Costantine M.M.
    • Other Affiliation: The Ohio State University Wexner Medical Center
  • Fitzgerald M.L.
    • Other Affiliation: New York University Grossman School of Medicine
  • Foulkes A.S.
    • Other Affiliation: Massachusetts General Hospital
  • Gibson K.S.
    • Other Affiliation: The MetroHealth System
  • Güthe N.
    • Other Affiliation: New York University Grossman School of Medicine
  • Habli M.
    • Other Affiliation: Trihealth Good Samaritan Hospital Maternal Fetal Medicine
  • Hackney D.N.
    • Other Affiliation: UH Cleveland Medical Center
  • Hoffman M.K.
    • Other Affiliation: Christiana Care Health System
  • Hoffman M.C.
    • Other Affiliation: University of Colorado School of Medicine
  • Hughes B.L.
    • Other Affiliation: Duke University
  • Katz S.D.
    • Other Affiliation: New York University School of Medicine
  • Laleau V.
    • Other Affiliation: University of California, San Francisco
  • Mallett G.
    • Other Affiliation: Northwestern University Feinberg School of Medicine
  • Mendez-Figueroa H.
    • Other Affiliation: The University of Texas Health Science Center at Houston John P. and Katherine G. McGovern Medical School
  • Monzon V.
    • Other Affiliation: University of California, San Francisco
  • Palatnik A.
    • Other Affiliation: Medical College of Wisconsin
  • Palomares K.T.S.
    • Other Affiliation: Saint Peter's University Hospital
  • Parry S.
    • Other Affiliation: University of Pennsylvania
  • Pettker C.M.
    • Other Affiliation: Yale University School of Medicine
  • Plunkett B.A.
    • Other Affiliation: NorthShore University HealthSystem
  • Poppas A.
    • Other Affiliation: Brown University Warren Alpert Medical School
  • Reddy U.M.
    • Other Affiliation: Columbia University
  • Rouse D.J.
    • Other Affiliation: Brown University
  • Saade G.R.
    • Other Affiliation: The University of Texas Medical Branch at Galveston
  • Sandoval G.J.
    • Other Affiliation: The George Washington University
  • Schlater S.M.
    • Other Affiliation: University of Utah Health
  • Sciurba F.C.
    • Other Affiliation: University of Pittsburgh
  • Simhan H.N.
    • Other Affiliation: University of Pittsburgh School of Medicine
  • Skupski D.W.
    • Other Affiliation: Weill Cornell Medicine
  • Sowles A.
    • Other Affiliation: University of Utah Health Hospitals and Clinics
  • Thaweethai T.
    • Other Affiliation: Massachusetts General Hospital
  • Thomas G.L.
    • Other Affiliation: Case Western Reserve University
  • Thorp J.M., Jr.
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
  • Tita A.T.
    • Other Affiliation: University of Alabama at Birmingham
  • Weiner S.J.
    • Other Affiliation: The George Washington University
  • Weigand S.
    • Other Affiliation: Wright State University Boonshoft School of Medicine
  • Yee L.M.
    • Other Affiliation: Northwestern University Feinberg School of Medicine
  • Flaherman V.J.
    • Other Affiliation: University of California, San Francisco
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.
Date of publication
Keyword
DOI
Identifier
Resource type
  • Article
Rights statement
  • In Copyright
License
  • Attribution 4.0 International
Journal title
  • PLoS ONE
Journal volume
  • 18
Journal issue
  • 12-Dec
Language
  • English
Version
  • Publisher
Funder
  • National Institutes of Health, NIH, (OT2HL156812, OT2HL161847, OTA OT2HL161841)
ISSN
  • 1932-6203
Publisher
  • Public Library of Science

Relations

Parents:

This work has no parents.

In Collection:

Items

Thumbnail Title Date Uploaded Visibility Actions
file details journal.pone.0285351.pdf 2024-01-03 Public Download