@article{
 title = {Seroprevalence of SARS-CoV-2 during pregnancy and associated outcomes: results from an ongoing prospective cohort study, New York City},
 type = {article},
 year = {2021},
 websites = {https://onlinelibrary.wiley.com/doi/abs/10.1111/ppe.12812},
 id = {8871c680-8084-33cb-af14-43b7a0ebf22a},
 created = {2021-11-22T20:09:26.662Z},
 file_attached = {true},
 profile_id = {031c901b-e377-3792-995f-e5d0201f5174},
 last_modified = {2021-11-22T20:16:08.883Z},
 read = {false},
 starred = {false},
 authored = {true},
 confirmed = {true},
 hidden = {false},
 private_publication = {false},
 abstract = {Background In May-July 2020 in the New York City area, up to 16% of pregnant women had reportedly been infected with SARS-CoV-2. Prior studies found associations between SARS-CoV-2 infection during pregnancy and certain adverse outcomes (e.g., preterm birth, cesarean delivery). These studies relied on reverse transcription polymerase chain reaction (RT-PCR) testing to establish SARS-CoV-2 infection. This led to overrepresentation of symptomatic or acutely ill cases in scientific studies. Objective To expand our understanding of the effects of SARS-CoV-2 infection during pregnancy on pregnancy outcomes, regardless of symptomatology and stage of infection, by using serological tests to measure IgG antibody levels. Study Design The Generation C Study is an ongoing prospective cohort study conducted at the Mount Sinai Health System. All pregnant women receiving obstetrical care at the Mount Sinai Hospital and Mount Sinai West Hospital from April 20, 2020 onwards are eligible for participation. For the current analysis, we included participants who had given birth to a liveborn singleton infant on or before August 15, 2020. Blood was drawn as part of routine clinical care; for each woman, we tested the latest sample available to establish seropositivity using a SARS-CoV-2 serologic enzyme-linked immunosorbent assay. Additionally, RT-PCR testing was performed on a nasopharyngeal swab taken during labor and delivery. Pregnancy outcomes of interest (i.e., gestational age at delivery, birth weight, mode of delivery, Apgar score, ICU/NICU admission, and neonatal hospital length of stay) and covariates were extracted from electronic medical records. Among all Generation C participants who had given birth by August 15, 2020 (n=708), we established the SARS-CoV-2 seroprevalence. Excluding women who tested RT-PCR positive at delivery, we conducted crude and adjusted linear and logistic regression models to compare antibody positive women without RT-PCR positivity at delivery with antibody negative women without RT-PCR positivity at delivery. We stratified analyses by race/ethnicity to examine potential effect modification. Results The SARS-CoV-2 seroprevalence based on IgG measurement was 16.4% (n=116, 95% CI 13.7-19.3). Twelve women (1.7%) were SARS-CoV-2 RT-PCR positive at delivery (11 of these women were seropositive). Seropositive women were generally younger, more often Black or Hispanic, and more often had public insurance and higher pre-pregnancy BMI compared with seronegative women. SARS-CoV-2 seropositivity without RT-PCR positivity at delivery was associated with decreased odds of caesarean delivery (aOR 0.48, 95%CI 0.27; 0.84) compared with seronegative women without RT-PCR positivity at delivery. Stratified by race/ethnicity, the association between seropositivity and decreased odds of caesarean delivery remained for non-Hispanic Black/African-American and Hispanic women, but not for non-Hispanic White women. No other pregnancy outcomes differed by seropositivity, overall or stratified by race/ethnicity. Conclusion Seropositivity for SARS-CoV-2 without RT-PCR positivity at delivery, suggesting that infection occurred earlier during pregnancy, was not associated with selected adverse maternal or neonatal outcomes among live births in a cohort sample of women from New York City. While non-Hispanic Black and Latina women in our cohort had a higher rate of SARS-CoV-2 seropositivity compared with non-Hispanic White women, we found no increase in adverse maternal or neonatal outcomes among these groups due to infection. ### Competing Interest Statement Mount Sinai has licensed serological assays to commercial entities and has filed for patent protection for serological assays. D.S and F.K. are listed as inventors on the pending patent application. The other authors have nothing to report. ### Funding Statement This study is partially funded (contract 75D30120C08186) by the US Centers for Disease Control and Prevention (CDC), who also provided technical assistance related to analysis and interpretation of data and writing the report. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC. Initial assay development work in the Krammer laboratory was partially supported by the NIAID Centers of Excellence for Influenza Research and Surveillance (CEIRS) contract HHSN272201400008C (FK, for reagent generation), Collaborative Influenza Vaccine Innovation Centers (CIVIC) contract 75N93019C00051 (FK, for reagent generation), and the generous support of the JPB foundation, the Open Philanthropy Project (#2020-215611) and other philanthropic donations. These funding sources were not involved in the current study. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: All participants provided informed consent per the institutional review board (IRB)-approved study protocol (IRB at the Icahn School of Medicine at Mount Sinai, protocol IRB-20-03352, April 15, 2020). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data not publicly available. Please contact the corresponding author for data requests.},
 bibtype = {article},
 author = {Molenaar, Nina M. and Rommel, Anna-Sophie and Witte, Lotje de and Dolan, Siobhan M. and Lieb, Whitney and Ibroci, Erona and Ohrn, Sophie and Lynch, Jezelle and Capuano, Christina and Stadlbauer, Daniel and Krammer, Florian and Zapata, Lauren B. and Brody, Rachel I. and Sperling, Rhoda S. and Afzal, Omara and Missall, Mr Roy and Balbierz, Amy and Janevic, Teresa and Stone, Joanne and Howell, Elizabeth A. and Bergink, Veerle},
 doi = {10.1111/ppe.12812},
 journal = {Paediatric and Perinatal Epidemiology}
}

{"_id":"TxfWayxeeZgK4Qbhu","bibbaseid":"molenaar-rommel-witte-dolan-lieb-ibroci-ohrn-lynch-etal-seroprevalenceofsarscov2duringpregnancyandassociatedoutcomesresultsfromanongoingprospectivecohortstudynewyorkcity-2021","author_short":["Molenaar, N., M.","Rommel, A.","Witte, L., d.","Dolan, S., M.","Lieb, W.","Ibroci, E.","Ohrn, S.","Lynch, J.","Capuano, C.","Stadlbauer, D.","Krammer, F.","Zapata, L., B.","Brody, R., I.","Sperling, R., S.","Afzal, O.","Missall, M., R.","Balbierz, A.","Janevic, T.","Stone, J.","Howell, E., A.","Bergink, V."],"bibdata":{"title":"Seroprevalence of SARS-CoV-2 during pregnancy and associated outcomes: results from an ongoing prospective cohort study, New York City","type":"article","year":"2021","websites":"https://onlinelibrary.wiley.com/doi/abs/10.1111/ppe.12812","id":"8871c680-8084-33cb-af14-43b7a0ebf22a","created":"2021-11-22T20:09:26.662Z","file_attached":"true","profile_id":"031c901b-e377-3792-995f-e5d0201f5174","last_modified":"2021-11-22T20:16:08.883Z","read":false,"starred":false,"authored":"true","confirmed":"true","hidden":false,"private_publication":false,"abstract":"Background In May-July 2020 in the New York City area, up to 16% of pregnant women had reportedly been infected with SARS-CoV-2. Prior studies found associations between SARS-CoV-2 infection during pregnancy and certain adverse outcomes (e.g., preterm birth, cesarean delivery). These studies relied on reverse transcription polymerase chain reaction (RT-PCR) testing to establish SARS-CoV-2 infection. This led to overrepresentation of symptomatic or acutely ill cases in scientific studies. Objective To expand our understanding of the effects of SARS-CoV-2 infection during pregnancy on pregnancy outcomes, regardless of symptomatology and stage of infection, by using serological tests to measure IgG antibody levels. Study Design The Generation C Study is an ongoing prospective cohort study conducted at the Mount Sinai Health System. All pregnant women receiving obstetrical care at the Mount Sinai Hospital and Mount Sinai West Hospital from April 20, 2020 onwards are eligible for participation. For the current analysis, we included participants who had given birth to a liveborn singleton infant on or before August 15, 2020. Blood was drawn as part of routine clinical care; for each woman, we tested the latest sample available to establish seropositivity using a SARS-CoV-2 serologic enzyme-linked immunosorbent assay. Additionally, RT-PCR testing was performed on a nasopharyngeal swab taken during labor and delivery. Pregnancy outcomes of interest (i.e., gestational age at delivery, birth weight, mode of delivery, Apgar score, ICU/NICU admission, and neonatal hospital length of stay) and covariates were extracted from electronic medical records. Among all Generation C participants who had given birth by August 15, 2020 (n=708), we established the SARS-CoV-2 seroprevalence. Excluding women who tested RT-PCR positive at delivery, we conducted crude and adjusted linear and logistic regression models to compare antibody positive women without RT-PCR positivity at delivery with antibody negative women without RT-PCR positivity at delivery. We stratified analyses by race/ethnicity to examine potential effect modification. Results The SARS-CoV-2 seroprevalence based on IgG measurement was 16.4% (n=116, 95% CI 13.7-19.3). Twelve women (1.7%) were SARS-CoV-2 RT-PCR positive at delivery (11 of these women were seropositive). Seropositive women were generally younger, more often Black or Hispanic, and more often had public insurance and higher pre-pregnancy BMI compared with seronegative women. SARS-CoV-2 seropositivity without RT-PCR positivity at delivery was associated with decreased odds of caesarean delivery (aOR 0.48, 95%CI 0.27; 0.84) compared with seronegative women without RT-PCR positivity at delivery. Stratified by race/ethnicity, the association between seropositivity and decreased odds of caesarean delivery remained for non-Hispanic Black/African-American and Hispanic women, but not for non-Hispanic White women. No other pregnancy outcomes differed by seropositivity, overall or stratified by race/ethnicity. Conclusion Seropositivity for SARS-CoV-2 without RT-PCR positivity at delivery, suggesting that infection occurred earlier during pregnancy, was not associated with selected adverse maternal or neonatal outcomes among live births in a cohort sample of women from New York City. While non-Hispanic Black and Latina women in our cohort had a higher rate of SARS-CoV-2 seropositivity compared with non-Hispanic White women, we found no increase in adverse maternal or neonatal outcomes among these groups due to infection. ### Competing Interest Statement Mount Sinai has licensed serological assays to commercial entities and has filed for patent protection for serological assays. D.S and F.K. are listed as inventors on the pending patent application. The other authors have nothing to report. ### Funding Statement This study is partially funded (contract 75D30120C08186) by the US Centers for Disease Control and Prevention (CDC), who also provided technical assistance related to analysis and interpretation of data and writing the report. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC. Initial assay development work in the Krammer laboratory was partially supported by the NIAID Centers of Excellence for Influenza Research and Surveillance (CEIRS) contract HHSN272201400008C (FK, for reagent generation), Collaborative Influenza Vaccine Innovation Centers (CIVIC) contract 75N93019C00051 (FK, for reagent generation), and the generous support of the JPB foundation, the Open Philanthropy Project (#2020-215611) and other philanthropic donations. These funding sources were not involved in the current study. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: All participants provided informed consent per the institutional review board (IRB)-approved study protocol (IRB at the Icahn School of Medicine at Mount Sinai, protocol IRB-20-03352, April 15, 2020). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data not publicly available. Please contact the corresponding author for data requests.","bibtype":"article","author":"Molenaar, Nina M. and Rommel, Anna-Sophie and Witte, Lotje de and Dolan, Siobhan M. and Lieb, Whitney and Ibroci, Erona and Ohrn, Sophie and Lynch, Jezelle and Capuano, Christina and Stadlbauer, Daniel and Krammer, Florian and Zapata, Lauren B. and Brody, Rachel I. and Sperling, Rhoda S. and Afzal, Omara and Missall, Mr Roy and Balbierz, Amy and Janevic, Teresa and Stone, Joanne and Howell, Elizabeth A. and Bergink, Veerle","doi":"10.1111/ppe.12812","journal":"Paediatric and Perinatal Epidemiology","bibtex":"@article{\n title = {Seroprevalence of SARS-CoV-2 during pregnancy and associated outcomes: results from an ongoing prospective cohort study, New York City},\n type = {article},\n year = {2021},\n websites = {https://onlinelibrary.wiley.com/doi/abs/10.1111/ppe.12812},\n id = {8871c680-8084-33cb-af14-43b7a0ebf22a},\n created = {2021-11-22T20:09:26.662Z},\n file_attached = {true},\n profile_id = {031c901b-e377-3792-995f-e5d0201f5174},\n last_modified = {2021-11-22T20:16:08.883Z},\n read = {false},\n starred = {false},\n authored = {true},\n confirmed = {true},\n hidden = {false},\n private_publication = {false},\n abstract = {Background In May-July 2020 in the New York City area, up to 16% of pregnant women had reportedly been infected with SARS-CoV-2. Prior studies found associations between SARS-CoV-2 infection during pregnancy and certain adverse outcomes (e.g., preterm birth, cesarean delivery). These studies relied on reverse transcription polymerase chain reaction (RT-PCR) testing to establish SARS-CoV-2 infection. This led to overrepresentation of symptomatic or acutely ill cases in scientific studies. Objective To expand our understanding of the effects of SARS-CoV-2 infection during pregnancy on pregnancy outcomes, regardless of symptomatology and stage of infection, by using serological tests to measure IgG antibody levels. Study Design The Generation C Study is an ongoing prospective cohort study conducted at the Mount Sinai Health System. All pregnant women receiving obstetrical care at the Mount Sinai Hospital and Mount Sinai West Hospital from April 20, 2020 onwards are eligible for participation. For the current analysis, we included participants who had given birth to a liveborn singleton infant on or before August 15, 2020. Blood was drawn as part of routine clinical care; for each woman, we tested the latest sample available to establish seropositivity using a SARS-CoV-2 serologic enzyme-linked immunosorbent assay. Additionally, RT-PCR testing was performed on a nasopharyngeal swab taken during labor and delivery. Pregnancy outcomes of interest (i.e., gestational age at delivery, birth weight, mode of delivery, Apgar score, ICU/NICU admission, and neonatal hospital length of stay) and covariates were extracted from electronic medical records. Among all Generation C participants who had given birth by August 15, 2020 (n=708), we established the SARS-CoV-2 seroprevalence. Excluding women who tested RT-PCR positive at delivery, we conducted crude and adjusted linear and logistic regression models to compare antibody positive women without RT-PCR positivity at delivery with antibody negative women without RT-PCR positivity at delivery. We stratified analyses by race/ethnicity to examine potential effect modification. Results The SARS-CoV-2 seroprevalence based on IgG measurement was 16.4% (n=116, 95% CI 13.7-19.3). Twelve women (1.7%) were SARS-CoV-2 RT-PCR positive at delivery (11 of these women were seropositive). Seropositive women were generally younger, more often Black or Hispanic, and more often had public insurance and higher pre-pregnancy BMI compared with seronegative women. SARS-CoV-2 seropositivity without RT-PCR positivity at delivery was associated with decreased odds of caesarean delivery (aOR 0.48, 95%CI 0.27; 0.84) compared with seronegative women without RT-PCR positivity at delivery. Stratified by race/ethnicity, the association between seropositivity and decreased odds of caesarean delivery remained for non-Hispanic Black/African-American and Hispanic women, but not for non-Hispanic White women. No other pregnancy outcomes differed by seropositivity, overall or stratified by race/ethnicity. Conclusion Seropositivity for SARS-CoV-2 without RT-PCR positivity at delivery, suggesting that infection occurred earlier during pregnancy, was not associated with selected adverse maternal or neonatal outcomes among live births in a cohort sample of women from New York City. While non-Hispanic Black and Latina women in our cohort had a higher rate of SARS-CoV-2 seropositivity compared with non-Hispanic White women, we found no increase in adverse maternal or neonatal outcomes among these groups due to infection. ### Competing Interest Statement Mount Sinai has licensed serological assays to commercial entities and has filed for patent protection for serological assays. D.S and F.K. are listed as inventors on the pending patent application. The other authors have nothing to report. ### Funding Statement This study is partially funded (contract 75D30120C08186) by the US Centers for Disease Control and Prevention (CDC), who also provided technical assistance related to analysis and interpretation of data and writing the report. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC. Initial assay development work in the Krammer laboratory was partially supported by the NIAID Centers of Excellence for Influenza Research and Surveillance (CEIRS) contract HHSN272201400008C (FK, for reagent generation), Collaborative Influenza Vaccine Innovation Centers (CIVIC) contract 75N93019C00051 (FK, for reagent generation), and the generous support of the JPB foundation, the Open Philanthropy Project (#2020-215611) and other philanthropic donations. These funding sources were not involved in the current study. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: All participants provided informed consent per the institutional review board (IRB)-approved study protocol (IRB at the Icahn School of Medicine at Mount Sinai, protocol IRB-20-03352, April 15, 2020). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data not publicly available. Please contact the corresponding author for data requests.},\n bibtype = {article},\n author = {Molenaar, Nina M. and Rommel, Anna-Sophie and Witte, Lotje de and Dolan, Siobhan M. and Lieb, Whitney and Ibroci, Erona and Ohrn, Sophie and Lynch, Jezelle and Capuano, Christina and Stadlbauer, Daniel and Krammer, Florian and Zapata, Lauren B. and Brody, Rachel I. and Sperling, Rhoda S. and Afzal, Omara and Missall, Mr Roy and Balbierz, Amy and Janevic, Teresa and Stone, Joanne and Howell, Elizabeth A. and Bergink, Veerle},\n doi = {10.1111/ppe.12812},\n journal = {Paediatric and Perinatal Epidemiology}\n}","author_short":["Molenaar, N., M.","Rommel, A.","Witte, L., d.","Dolan, S., M.","Lieb, W.","Ibroci, E.","Ohrn, S.","Lynch, J.","Capuano, C.","Stadlbauer, D.","Krammer, F.","Zapata, L., B.","Brody, R., I.","Sperling, R., S.","Afzal, O.","Missall, M., R.","Balbierz, A.","Janevic, T.","Stone, J.","Howell, E., A.","Bergink, V."],"urls":{"Paper":"https://bibbase.org/service/mendeley/031c901b-e377-3792-995f-e5d0201f5174/file/08d31e56-3fed-8cc3-7aac-0c3c1bd724cb/Molenaar__Rommel_et_al_PPE_2021_Gen_C.pdf.pdf","Website":"https://onlinelibrary.wiley.com/doi/abs/10.1111/ppe.12812"},"biburl":"https://bibbase.org/service/mendeley/031c901b-e377-3792-995f-e5d0201f5174","bibbaseid":"molenaar-rommel-witte-dolan-lieb-ibroci-ohrn-lynch-etal-seroprevalenceofsarscov2duringpregnancyandassociatedoutcomesresultsfromanongoingprospectivecohortstudynewyorkcity-2021","role":"author","metadata":{"authorlinks":{}}},"bibtype":"article","biburl":"https://bibbase.org/service/mendeley/031c901b-e377-3792-995f-e5d0201f5174","dataSources":["J8fbWsdsy3xAaB3pX","ya2CyA73rpZseyrZ8","2252seNhipfTmjEBQ"],"keywords":[],"search_terms":["seroprevalence","sars","cov","during","pregnancy","associated","outcomes","results","ongoing","prospective","cohort","study","new","york","city","molenaar","rommel","witte","dolan","lieb","ibroci","ohrn","lynch","capuano","stadlbauer","krammer","zapata","brody","sperling","afzal","missall","balbierz","janevic","stone","howell","bergink"],"title":"Seroprevalence of SARS-CoV-2 during pregnancy and associated outcomes: results from an ongoing prospective cohort study, New York City","year":2021}