Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study

作者：José Villar, Constanza P. Soto Conti, Robert B. Gunier, Shabina Ariff, Rachel Craik, Paolo Ivo Cavoretto, Stephen Rauch, Serena Gandino, Ricardo Nieto, Adele Winsey, Camilla Menis, Gabriel B Rodriguez, Valeria Savasi, Niyazi Tuğ, Sonia Deantoni, Marta Fabre, Begoña Martínez de Tejada, M.J. Rodriguez‐Sibaja, Stefania Livio, R. Napolitano, Nerea Maíz, Helena Sobrero, Ashley Peterson, Philippe Deruelle, Carolina Giudice, Jagjit S. Teji, Roberto Casale, Laurent Salomon, Federico Prefumo, Leila Cheikh Ismail, Michael G. Gravett, Marynéa Silva do Vale, Valéria Hernández, Loı̈c Sentilhes, Sarah Rae Easter, Carola Capelli, Emily Marler, Daniela M Cáceres, Guadalupe Albornoz Crespo, Ernawati Ernawati, Michal Lipschuetz, Ken Takahashi, Carmen Vecchiarelli, Teresa Hubka, Satoru Ikenoue, Gabriela Tavchioska, Babagana Bako, Adejumoke Idowu Ayede, Brenda Eskenazi, Jim Thornton, Zulfiqar A Bhutta, Stephen Kennedy, Aris T. Papageorghiou · 发表于：The Lancet · 年份：2023 · DOI：10.1016/s0140-6736(22)02467-9 · 被引用次数：174 · 研究领域：COVID-19 Impact on Reproduction、SARS-CoV-2 and COVID-19 Research、Vaccine Coverage and Hesitancy

BACKGROUND: In 2021, we showed an increased risk associated with COVID-19 in pregnancy. Since then, the SARS-CoV-2 virus has undergone genetic mutations. We aimed to examine the effects on maternal and perinatal outcomes of COVID-19 during pregnancy, and evaluate vaccine effectiveness, when omicron (B.1.1.529) was the variant of concern. METHODS: INTERCOVID-2022 is a large, prospective, observational study, involving 41 hospitals across 18 countries. Each woman with real-time PCR or rapid test, laboratory-confirmed COVID-19 in pregnancy was compared with two unmatched women without a COVID-19 diagnosis who were recruited concomitantly and consecutively in pregnancy or at delivery. Mother and neonate dyads were followed until hospital discharge. Primary outcomes were maternal morbidity and mortality index (MMMI), severe neonatal morbidity index (SNMI), and severe perinatal morbidity and mortality index (SPMMI). Vaccine effectiveness was estimated, adjusted by maternal risk profile. FINDINGS: We enrolled 4618 pregnant women from Nov 27, 2021 (the day after WHO declared omicron a variant of concern), to June 30, 2022: 1545 (33%) women had a COVID-19 diagnosis (median gestation 36·7 weeks [IQR 29·0-38·9]) and 3073 (67%) women, with similar demographic characteristics, did not have a COVID-19 diagnosis. Overall, women with a diagnosis had an increased risk for MMMI (relative risk [RR] 1·16 [95% CI 1·03-1·31]) and SPMMI (RR 1·21 [95% CI 1·00-1·46]). Women with a diagnosis, compared...