{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,16]],"date-time":"2025-05-16T04:09:12Z","timestamp":1747368552924,"version":"3.40.5"},"reference-count":50,"publisher":"Public Library of Science (PLoS)","issue":"5","license":[{"start":{"date-parts":[[2025,5,15]],"date-time":"2025-05-15T00:00:00Z","timestamp":1747267200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004897","name":"Pennsylvania Department of Health","doi-asserted-by":"publisher","award":["4100089395"],"award-info":[{"award-number":["4100089395"]}],"id":[{"id":"10.13039\/100004897","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec030\">\n<jats:title><jats:underline>Background<\/jats:underline><\/jats:title>\n<jats:p>Pregnant people are vulnerable to more severe outcomes of COVID-19 compared with their non-pregnant counterparts. Research is needed to systematically test the degree to which COVID-19 during pregnancy increases the risk for adverse maternal, perinatal, and infant health and development outcomes and whether social determinants of health or psychological\/psychosocial health outcomes confound or intensify the risk. This protocol paper describes a prospective cohort study using electronic health record (EHR) and patient-reported data from four large health systems in Pennsylvania to examine neighborhood, social, and health factors predicting COVID-19 and its severity, birth weight, gestational age, and vaccination among pregnant people to 12 months postpartum.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec031\">\n<jats:title><jats:underline>Methods<\/jats:underline><\/jats:title>\n<jats:p>Our study will be conducted with two aims. Aim 1 will combine maternal and infant clinical data and neighborhood data from four health systems in Pennsylvania participating in a PCORI-supported clinical research network. The cohort will include all people who were pregnant between June 2019 and May 2025, along with linkage to their newborn delivery records. In Aim 2, a subset of pregnant people from the Aim 1 cohort will be recruited to participate in a series of surveys from pregnancy to one year postpartum. Survey instruments will be developed to collect patient-reported health and social information as well as patient-centered outcomes depicting whether and how the COVID-19 pandemic is impacting pregnant people and their newborns. Survey data will be collected during pregnancy and at one, six, and 12 months postpartum. Survey data will be linked with data from Aim 1 for analysis.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec032\">\n<jats:title>Results<\/jats:title>\n<jats:p>Ethical approval has been obtained at all sites. Subcontracts and data use agreements have been established. EHR data across health systems are being collected and curated. Surveys have been developed and recruitment and retention procedures implemented. Recruitment for the survey aim of the study began in July 2023 and is ongoing.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec033\">\n<jats:title>Discussion<\/jats:title>\n<jats:p>This study will advance multi-site research involving pregnant people across diverse communities in a time of public health crisis. Data from this study will provide additional evidence of the impact of the COVID-19 pandemic on pregnant people and their infants. Findings will help guide future clinical and public health practices in pandemics for pregnant people.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0323891","type":"journal-article","created":{"date-parts":[[2025,5,15]],"date-time":"2025-05-15T17:32:10Z","timestamp":1747330330000},"page":"e0323891","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Maternal and infant health during the COVID-19 pandemic \u2013 A Pennsylvania Study Protocol"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9680-4497","authenticated-orcid":true,"given":"Kristin K.","family":"Sznajder","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard S.","family":"Legro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas","family":"Teti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A. Dhanya","family":"Mackeen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wadia","family":"Mulla","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hyagriv","family":"Simhan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenke","family":"Hwang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,5,15]]},"reference":[{"issue":"2","key":"pone.0323891.ref001","doi-asserted-by":"crossref","first-page":"360","DOI":"10.1097\/GRF.0b013e31816f28de","article-title":"Race, racism, and racial disparities in adverse birth outcomes","volume":"51","author":"TP Dominguez","year":"2008","journal-title":"Clin Obstet Gynecol"},{"key":"pone.0323891.ref002","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1186\/1471-2458-9-84","article-title":"Maternal care and birth outcomes among ethnic minority women in Finland","volume":"9","author":"M Malin","year":"2009","journal-title":"BMC Public Health"},{"key":"pone.0323891.ref003","volume-title":"Maternal Mortality: A US Public Health Crisis","author":"JP Gingrey","year":"2020"},{"issue":"8","key":"pone.0323891.ref004","doi-asserted-by":"crossref","first-page":"817","DOI":"10.1001\/jamapediatrics.2021.1050","article-title":"Maternal and neonatal morbidity and mortality among pregnant women with and without COVID-19 infection: the INTERCOVID Multinational Cohort Study","volume":"175","author":"J Villar","year":"2021","journal-title":"JAMA Pediatr"},{"issue":"1","key":"pone.0323891.ref005","doi-asserted-by":"crossref","first-page":"13898","DOI":"10.1038\/s41598-021-92357-y","article-title":"Maternal outcomes and risk factors for COVID-19 severity among pregnant women","volume":"11","author":"M Vouga","year":"2021","journal-title":"Sci Rep"},{"issue":"2","key":"pone.0323891.ref006","doi-asserted-by":"crossref","first-page":"596","DOI":"10.3390\/ijerph18020596","article-title":"Maternal and neonatal characteristics and outcomes of COVID-19 in pregnancy: an overview of systematic reviews","volume":"18","author":"M Papapanou","year":"2021","journal-title":"Int J Environ Res Public Health"},{"issue":"6","key":"pone.0323891.ref007","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0234187","article-title":"Maternal and neonatal outcomes associated with COVID-19 infection: a systematic review","volume":"15","author":"V Smith","year":"2020","journal-title":"PLoS One"},{"key":"pone.0323891.ref008","article-title":"Association between mode of delivery among pregnant women with COVID-19 and maternal and neonatal outcomes in Spain","author":"O Mart\u00ednez-Perez","year":"2020","journal-title":"JAMA"},{"issue":"4","key":"pone.0323891.ref009","doi-asserted-by":"crossref","DOI":"10.1001\/jamapediatrics.2016.4805","article-title":"Association between moderate and late preterm birth and neurodevelopment and social-emotional development at age 2 years","volume":"171","author":"JL Cheong","year":"2017","journal-title":"JAMA Pediatr"},{"key":"pone.0323891.ref010","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1016\/j.placenta.2017.06.009","article-title":"Child neurodevelopmental outcomes following preterm and term birth: what can the placenta tell us?","volume":"57","author":"NA Hodyl","year":"2017","journal-title":"Placenta"},{"key":"pone.0323891.ref011","volume-title":"Developmental status of NICU admitted low birth weight preterm neonates at 6 and 12 months of age using Ages and Stages Questionnaire","author":"R Fallah","year":"2011"},{"issue":"2","key":"pone.0323891.ref012","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1089\/jwh.2020.8882","article-title":"Social and structural determinants of health inequities in maternal health","volume":"30","author":"J Crear-Perry","year":"2021","journal-title":"J Womens Health (Larchmt)"},{"issue":"1","key":"pone.0323891.ref013","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1097\/GRF.0000000000000665","article-title":"Health care disparities in the COVID-19 pandemic in the United States: a focus on obstetrics","volume":"65","author":"UN Emeruwa","year":"2022","journal-title":"Clin Obstet Gynecol"},{"issue":"3","key":"pone.0323891.ref014","first-page":"394","article-title":"A critical review on the complex interplay between social determinants of health and maternal and infant mortality","volume":"9","author":"RK Dagher","year":"2022","journal-title":"Children (Basel)"},{"issue":"3","key":"pone.0323891.ref015","doi-asserted-by":"crossref","first-page":"316","DOI":"10.21106\/ijma.398","article-title":"Role of social determinants of health in widening maternal and child health disparities in the Era of Covid-19 pandemic","volume":"9","author":"D Dongarwar","year":"2020","journal-title":"Int J MCH AIDS"},{"key":"pone.0323891.ref016","volume-title":"Maternal health inequities during the COVID-19 pandemic","author":"E Burroughs","year":"2021"},{"issue":"1","key":"pone.0323891.ref017","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1055\/s-0041-1735878","article-title":"Attitudes toward COVID-19 illness and COVID-19 vaccination among pregnant women: a cross-sectional multicenter study during August-December 2020","volume":"39","author":"AN Battarbee","year":"2022","journal-title":"Am J Perinatol"},{"issue":"4","key":"pone.0323891.ref018","doi-asserted-by":"crossref","first-page":"217","DOI":"10.1097\/01.ogx.0000659584.47546.72","article-title":"What we can do about maternal mortality\u2014and how to do it quickly","volume":"75","author":"S Mann","year":"2020","journal-title":"Obstet Gynecol Survey"},{"issue":"4","key":"pone.0323891.ref019","first-page":"402","article-title":"Health effects of air pollution in worldwide countries: an ecological study","volume":"3","author":"M Soheilyzad","year":"2016","journal-title":"Int J Epidemiol Res"},{"key":"pone.0323891.ref020","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1016\/j.envint.2018.09.021","article-title":"Identifying windows of susceptibility for maternal exposure to ambient air pollution and preterm birth","volume":"121","author":"Q Wang","year":"2018","journal-title":"Environ Int"},{"issue":"4","key":"pone.0323891.ref021","doi-asserted-by":"crossref","first-page":"219","DOI":"10.3109\/0167482X.2010.518776","article-title":"Psychosocial stress during pregnancy and perinatal outcomes: a meta-analytic review","volume":"31","author":"HL Littleton","year":"2010","journal-title":"J Psychosom Obstet Gynaecol"},{"issue":"5","key":"pone.0323891.ref022","doi-asserted-by":"crossref","DOI":"10.4088\/JCP.17r12011","article-title":"Maternal anxiety during pregnancy and the association with adverse perinatal outcomes: systematic review and meta-analysis","volume":"79","author":"S Grigoriadis","year":"2018","journal-title":"J Clin Psychiatry"},{"issue":"6","key":"pone.0323891.ref023","doi-asserted-by":"crossref","first-page":"1009","DOI":"10.1007\/s00737-016-0649-x","article-title":"Multiple domains of stress predict postpartum depressive symptoms in low-income Mexican American women: the moderating effect of social support","volume":"19","author":"SS Coburn","year":"2016","journal-title":"Arch Womens Ment Health"},{"key":"pone.0323891.ref024","doi-asserted-by":"crossref","first-page":"116","DOI":"10.1016\/j.infbeh.2017.11.007","article-title":"Maternal avoidance, anxiety cognitions and interactive behaviour predicts infant development at 12 months in the context of anxiety disorders in the postpartum period","volume":"50","author":"C Reck","year":"2018","journal-title":"Infant Behav Dev"},{"key":"pone.0323891.ref025","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1016\/j.jad.2020.03.023","article-title":"Maternal perinatal mental health and infant and toddler neurodevelopment - Evidence from low and middle-income countries. a systematic review","volume":"268","author":"M Burger","year":"2020","journal-title":"J Affect Disord"},{"key":"pone.0323891.ref026","author":"AA Prather","year":"2020"},{"issue":"10","key":"pone.0323891.ref027","doi-asserted-by":"crossref","first-page":"2051","DOI":"10.3945\/jn.116.231365","article-title":"Psychological distress mediates the association between food insecurity and suboptimal sleep quality in latinos with type 2 diabetes mellitus","volume":"146","author":"A Berm\u00fadez-Mill\u00e1n","year":"2016","journal-title":"J Nutr"},{"issue":"23","key":"pone.0323891.ref028","doi-asserted-by":"crossref","DOI":"10.1097\/MD.0000000000015950","article-title":"Perceived stress and psychological distress among chinese physicians: the mediating role of coping style","volume":"98","author":"Y Wang","year":"2019","journal-title":"Medicine (Baltimore)"},{"key":"pone.0323891.ref029","doi-asserted-by":"crossref","first-page":"100107","DOI":"10.1016\/j.ajogmf.2020.100107","article-title":"Outcome of coronavirus spectrum infections (SARS, MERS, COVID 1-19) during pregnancy: a systematic review and meta-analysis","author":"D Di Mascio","year":"2020","journal-title":"Am J Obstet Gynecol MFM"},{"issue":"8","key":"pone.0323891.ref030","doi-asserted-by":"crossref","first-page":"771","DOI":"10.1111\/j.1471-0528.2004.00199.x","article-title":"A case-controlled study comparing clinical course and outcomes of pregnant and non-pregnant women with severe acute respiratory syndrome","volume":"111","author":"CM Lam","year":"2004","journal-title":"BJOG"},{"issue":"12","key":"pone.0323891.ref031","doi-asserted-by":"crossref","first-page":"1870","DOI":"10.1093\/infdis\/jiu068","article-title":"Stillbirth during infection with Middle East respiratory syndrome coronavirus","volume":"209","author":"DC Payne","year":"2014","journal-title":"J Infect Dis"},{"key":"pone.0323891.ref032","article-title":"Second-trimester miscarriage in a pregnant woman with SARS-CoV-2 infection","author":"D Baud","year":"2020","journal-title":"JAMA"},{"key":"pone.0323891.ref033","article-title":"Coronavirus disease 2019 (COVID-19) in pregnant women: a report based on 116 cases","author":"J Yan","year":"2020","journal-title":"Am J Obstet Gynecol"},{"key":"pone.0323891.ref034","first-page":"1","article-title":"Vertical transmission of coronavirus disease 19 (COVID-19) from infected pregnant mothers to neonates: a review","author":"M Karimi-Zarchi","year":"2020","journal-title":"Fetal Pediatr Pathol"},{"issue":"25","key":"pone.0323891.ref035","doi-asserted-by":"crossref","first-page":"769","DOI":"10.15585\/mmwr.mm6925a1","article-title":"Characteristics of women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status - United States, January 22-June 7, 2020","volume":"69","author":"S Ellington","year":"2020","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"pone.0323891.ref036","doi-asserted-by":"crossref","DOI":"10.15585\/mmwr.mm6938e1","article-title":"Characteristics and maternal and birth outcomes of hospitalized pregnant women with laboratory-confirmed COVID-19\u2014COVID-NET, 13 states, March 1\u2013August 22, 2020","volume":"69","author":"M Delahoy","year":"2020","journal-title":"MMWR Morb Mortal Wkly Rep"},{"issue":"4","key":"pone.0323891.ref037","doi-asserted-by":"crossref","first-page":"100649","DOI":"10.1016\/j.ajogmf.2022.100649","article-title":"The influence of structural racism, pandemic stress, and SARS-CoV-2 infection during pregnancy with adverse birth outcomes","volume":"4","author":"T Janevic","year":"2022","journal-title":"Am J Obstet Gynecol MFM"},{"issue":"5","key":"pone.0323891.ref038","doi-asserted-by":"crossref","first-page":"525","DOI":"10.1016\/j.jogn.2021.04.012","article-title":"Perinatal behavioral health, the COVID-19 pandemic, and a social determinants of health framework","volume":"50","author":"SL Ruyak","year":"2021","journal-title":"J Obstet Gynecol Neonatal Nurs"},{"issue":"4","key":"pone.0323891.ref039","doi-asserted-by":"crossref","first-page":"633","DOI":"10.1136\/amiajnl-2014-002759","article-title":"PaTH: towards a learning health system in the Mid-Atlantic region","volume":"21","author":"W Amin","year":"2014","journal-title":"J Am Med Inform Assoc"},{"key":"pone.0323891.ref040","author":"PCORnet"},{"issue":"26","key":"pone.0323891.ref041","doi-asserted-by":"crossref","first-page":"2456","DOI":"10.1056\/NEJMp1802313","article-title":"Making neighborhood-disadvantage metrics accessible - the neighborhood Atlas","volume":"378","author":"AJH Kind","year":"2018","journal-title":"N Engl J Med"},{"issue":"2","key":"pone.0323891.ref042","doi-asserted-by":"crossref","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","article-title":"Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support","volume":"42","author":"PA Harris","year":"2009","journal-title":"J Biomed Inform"},{"key":"pone.0323891.ref043","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1016\/j.jclinepi.2020.09.036","article-title":"PCORnet\u00ae 2020: current state, accomplishments, and future directions","volume":"129","author":"CB Forrest","year":"2021","journal-title":"J Clin Epidemiol"},{"issue":"1","key":"pone.0323891.ref044","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1186\/s12879-024-09076-8","article-title":"Association between SARS-CoV-2 infection and select symptoms and conditions 31 to 150 days after testing among children and adults.","volume":"24","author":"Y Zhang","year":"2024","journal-title":"BMC Infectious Dis"},{"issue":"14","key":"pone.0323891.ref045","doi-asserted-by":"crossref","first-page":"1623","DOI":"10.1002\/(SICI)1097-0258(19980730)17:14<1623::AID-SIM871>3.0.CO;2-S","article-title":"A simple method of sample size calculation for linear and logistic regression","volume":"17","author":"FY Hsieh","year":"1998","journal-title":"Statist Med"},{"key":"pone.0323891.ref046","doi-asserted-by":"crossref","DOI":"10.1201\/9781315183084","volume-title":"Sample size calculations in clinical research","author":"S Chow","year":"2017"},{"issue":"16","key":"pone.0323891.ref047","article-title":"The impact of COVID-19 on pregnancy outcomes: a systematic review and meta-analysis","volume":"193","author":"SQ Wei","year":"2021","journal-title":"CMAJ"},{"key":"pone.0323891.ref048","volume-title":"Introduction to mediation, moderation, and conditional process analysis: a regression-based approach","author":"AF Hayes","year":"2017"},{"key":"pone.0323891.ref049","article-title":"An analysis of 38 pregnant women with COVID-19, their newborn infants, and maternal-fetal transmission of SARS-CoV-2: maternal coronavirus infections and pregnancy outcomes","author":"DA Schwartz","year":"2020","journal-title":"Arch Pathol Lab Med"},{"issue":"44","key":"pone.0323891.ref050","doi-asserted-by":"crossref","first-page":"1635","DOI":"10.15585\/mmwr.mm6944e2","article-title":"Birth and Infant Outcomes Following Laboratory-Confirmed SARS-CoV-2 Infection in Pregnancy - SET-NET, 16 Jurisdictions, March 29-October 14, 2020","volume":"69","author":"KR Woodworth","year":"2020","journal-title":"MMWR Morb Mortal Wkly Rep"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0323891","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,15]],"date-time":"2025-05-15T17:32:22Z","timestamp":1747330342000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0323891"}},"subtitle":[],"editor":[{"given":"Charles M'poca","family":"Charles","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,5,15]]},"references-count":50,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2025,5,15]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0323891","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,15]]}}}