Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design
Rattachement africain : us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design
- Date Crossref
- 21/12/2023
- Éditeur
- Public Library of Science (PLoS)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Utah Hospital pays non établi dans la noticeÉtablissement de santé
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George Washington University Biostatistics Center pays non établi dans la noticeUniversité ou école supérieure
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New York University Department of Pediatrics pays non établi dans la noticeUniversité ou école supérieure
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University of California Department of Obstetrics pays non établi dans la noticeUniversité ou école supérieure
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University of Alabama at Birmingham Department of Pediatrics pays non établi dans la noticeUniversité ou école supérieure
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Massachusetts General Hospital Department of Biostatistics pays non établi dans la noticeÉtablissement de santé
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WakeMed Department of Maternal Fetal Medicine pays non établi dans la noticeÉtablissement de santé
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The Ohio State University Wexner Medical Center Department of Obstetrics and Gynecology pays non établi dans la noticeÉtablissement de santé
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MetroHealth pays non établi dans la noticeÉtablissement de santé
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Good Samaritan Hospital Division Maternal Fetal Medicine pays non établi dans la noticeÉtablissement de santé
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University Hospitals of Cleveland pays non établi dans la noticeÉtablissement de santé
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Christiana Care Health System pays non établi dans la noticeÉtablissement de santé
University of Utah Hospital, Biostatistics Center — George Washington University et Department of Pediatrics — New York University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.