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

Torri D Metz; Rebecca G Clifton; Richard Gallagher; Rachel S Gross; Leora I Horwitz; Vanessa L Jacoby; Susanne P Martin-Herz; Myriam Peralta-Carcelen; Harrison T Reeder; Carmen J Beamon; Marie-Abele Bind; James Chan; A Ann Chang; Lori B Chibnik; Maged M Costantine; Megan L Fitzgerald; Andrea S Foulkes; Kelly S Gibson; Nick Güthe; Mounira Habli; David N Hackney; Matthew K Hoffman; M Camille Hoffman; Brenna L Hughes; Stuart D Katz; Victoria Laleau; Gail Mallett; Hector Mendez-Figueroa; Vanessa Monzon; Anna Palatnik; Kristy T S Palomares; Samuel Parry; Myriam Peralta-Carcelen; Christian M Pettker; Beth A Plunkett; Athena Poppas; Uma M Reddy; Dwight J Rouse; George R Saade; Grecio J Sandoval; Shannon M Schlater; Frank C Sciurba; Hyagriv N Simhan; Daniel W Skupski; Amber Sowles; Tanayott Thaweethai; Gelise L Thomas; John M Thorp Jr; Alan T Tita; Steven J Weiner; Samantha Weigand; Lynn M Yee; Valerie J Flaherman

doi:10.1101/2023.04.24.23289025

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

medRxiv [Preprint]. 2023 Apr 24:2023.04.24.23289025. doi: 10.1101/2023.04.24.23289025.

Authors

Torri D Metz¹, Rebecca G Clifton², Richard Gallagher³, Rachel S Gross⁴, Leora I Horwitz⁵, Vanessa L Jacoby⁶, Susanne P Martin-Herz⁷, Myriam Peralta-Carcelen⁸, Harrison T Reeder⁹, Carmen J Beamon¹⁰, Marie-Abele Bind⁹, James Chan⁹, A Ann Chang¹¹, Lori B Chibnik⁹, Maged M Costantine¹², Megan L Fitzgerald⁵, Andrea S Foulkes⁹, Kelly S Gibson¹³, Nick Güthe⁵, Mounira Habli¹⁴, David N Hackney¹⁵, Matthew K Hoffman¹⁶, M Camille Hoffman¹⁷, Brenna L Hughes¹⁸, Stuart D Katz¹⁹, Victoria Laleau²⁰, Gail Mallett²¹, Hector Mendez-Figueroa²², Vanessa Monzon⁶, Anna Palatnik²³, Kristy T S Palomares²⁴, Samuel Parry²⁵, Myriam Peralta-Carcelen⁸, Christian M Pettker²⁶, Beth A Plunkett²⁷, Athena Poppas²⁸, Uma M Reddy²⁹, Dwight J Rouse³⁰, George R Saade³¹, Grecio J Sandoval³², Shannon M Schlater³³, Frank C Sciurba³⁴, Hyagriv N Simhan³⁵, Daniel W Skupski³⁶, Amber Sowles¹, Tanayott Thaweethai⁹, Gelise L Thomas³⁷, John M Thorp Jr³⁸, Alan T Tita³⁹, Steven J Weiner², Samantha Weigand⁴⁰, Lynn M Yee²¹, Valerie J Flaherman²⁰

Affiliations

¹ Department of Obstetrics and Gynecology, University of Utah Health Hospitals and Clinics, Salt Lake City, UT, USA.
² Biostatistics Center, The George Washington University, Washington, DC, USA.
³ Department of Child and Adolescent Psychiatry, NYU Grossman School of Medicine, New York, NY, USA.
⁴ Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.
⁵ Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA.
⁶ Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, USA.
⁷ Department of Pediatrics, Division of Developmental Medicine, University of California San Francisco, San Francisco, CA, San Francisco, CA, USA.
⁸ Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.
⁹ Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA.
¹⁰ Department of Maternal Fetal Medicine, WakeMed Health and Hospitals, Raleigh, NC, USA.
¹¹ Women's Health Research Clinical Center, University of California San Francisco, San Francisco, CA, USA.
¹² Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
¹³ Department of Obstetrics and Gynecology, The MetroHealth System, Cleveland, OH, USA.
¹⁴ Division Maternal Fetal Medicine, Trihealth Good Samaritan Hospital Maternal Fetal Medicine, Cincinnati, OH, USA.
¹⁵ Department of Obstetrics and Gynecology, University Hospitals Cleveland Medical Center: UH Cleveland Medical Center, Cleveland, OH, USA.
¹⁶ Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE, USA.
¹⁷ Department of Obstetrics & Gynecology, University of Colorado School of Medicine, Aurora, CO, USA.
¹⁸ Department of Obstetrics and Gynecology, Duke University, Durham, NC, USA.
¹⁹ Department of Medicine, New York University School of Medicine, New York City, NY, USA.
²⁰ Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.
²¹ Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
²² 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, USA.
²³ Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI, USA.
²⁴ Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Saint Peter's University Hospital, New Brunswick, NJ, USA.
²⁵ Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, USA.
²⁶ Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, USA.
²⁷ Department of Obstetrics and Gynecology, NorthShore University HealthSystem, Evanston, IL, USA.
²⁸ Division of Cardiology, Brown University Warren Alpert Medical School, PROVIDENCE, RI, USA.
²⁹ Department of Obstetrics and Gynecology, Columbia University, New York City, NY, USA.
³⁰ Department of Obstetrics and Gynecology, Brown University, Providence, RI, USA.
³¹ Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, TX, USA.
³² Biostatistics Center, The George Washington University, Rockville, MD, USA.
³³ Huntsman Cancer Institute, University of Utah Health, Salt Lake City, UT, USA.
³⁴ Department of Medicine, Division of Pulmonary Allergy and Critical Care Medicine, University of Pittsburgh, pittsburgh, PA, USA.
³⁵ Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
³⁶ Department of Obstetrics and Gynecology, Weill Cornell Medicine, New York, NY, USA.
³⁷ Clinical and Translational Science Collaborative of Cleveland, Case Western Reserve University, Cleveland, Ohio, Cleveland, OH, USA.
³⁸ Department of Obstetrics and Gynecology, UNC: The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
³⁹ Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL, USA.
⁴⁰ Department of Obstetrics and Gynecology, Wright State University Boonshoft School of Medicine, Dayton, OH, USA.

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.

Registration: NCT05172024.

Publication types

Preprint

Associated data

ClinicalTrials.gov/NCT05172024

Abstract

Publication types

Associated data

Grants and funding