1. Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study.
- Author
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Villar, Jose, Villar, Jose, Soto Conti, Constanza P, Gunier, Robert B, Ariff, Shabina, Craik, Rachel, Cavoretto, Paolo I, Rauch, Stephen, Gandino, Serena, Nieto, Ricardo, Winsey, Adele, Menis, Camilla, Rodriguez, Gabriel B, Savasi, Valeria, Tug, Niyazi, Deantoni, Sonia, Fabre, Marta, Martinez de Tejada, Begoña, Rodriguez-Sibaja, Maria Jose, Livio, Stefania, Napolitano, Raffaele, Maiz, Nerea, Sobrero, Helena, Peterson, Ashley, Deruelle, Philippe, Giudice, Carolina, Teji, Jagjit S, Casale, Roberto A, Salomon, Laurent J, Prefumo, Federico, Cheikh Ismail, Leila, Gravett, Michael G, Vale, Marynéa, Hernández, Valeria, Sentilhes, Loïc, Easter, Sarah R, Capelli, Carola, Marler, Emily, Cáceres, Daniela M, Albornoz Crespo, Guadalupe, Ernawati, Ernawati, Lipschuetz, Michal, Takahashi, Ken, Vecchiarelli, Carmen, Hubka, Teresa, Ikenoue, Satoru, Tavchioska, Gabriela, Bako, Babagana, Ayede, Adejumoke I, Eskenazi, Brenda, Thornton, Jim G, Bhutta, Zulfiqar A, Kennedy, Stephen H, Papageorghiou, Aris T, INTERCOVID-2022 International Consortium, Villar, Jose, Villar, Jose, Soto Conti, Constanza P, Gunier, Robert B, Ariff, Shabina, Craik, Rachel, Cavoretto, Paolo I, Rauch, Stephen, Gandino, Serena, Nieto, Ricardo, Winsey, Adele, Menis, Camilla, Rodriguez, Gabriel B, Savasi, Valeria, Tug, Niyazi, Deantoni, Sonia, Fabre, Marta, Martinez de Tejada, Begoña, Rodriguez-Sibaja, Maria Jose, Livio, Stefania, Napolitano, Raffaele, Maiz, Nerea, Sobrero, Helena, Peterson, Ashley, Deruelle, Philippe, Giudice, Carolina, Teji, Jagjit S, Casale, Roberto A, Salomon, Laurent J, Prefumo, Federico, Cheikh Ismail, Leila, Gravett, Michael G, Vale, Marynéa, Hernández, Valeria, Sentilhes, Loïc, Easter, Sarah R, Capelli, Carola, Marler, Emily, Cáceres, Daniela M, Albornoz Crespo, Guadalupe, Ernawati, Ernawati, Lipschuetz, Michal, Takahashi, Ken, Vecchiarelli, Carmen, Hubka, Teresa, Ikenoue, Satoru, Tavchioska, Gabriela, Bako, Babagana, Ayede, Adejumoke I, Eskenazi, Brenda, Thornton, Jim G, Bhutta, Zulfiqar A, Kennedy, Stephen H, Papageorghiou, Aris T, and INTERCOVID-2022 International Consortium
- Abstract
BackgroundIn 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.MethodsINTERCOVID-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.FindingsWe 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 with those without a diagnosis, also had increased risks of SNMI (RR 1·23 [95% CI 0·88-1·71]), although the lower bounds of the 95% CI crossed unity. Unvaccinated women with a COVID-19 diagnosis had a greater risk of MMMI (RR 1·36 [95% CI 1·12-1·65]). Severe COVID-19 symptoms in the total sample increased the risk of severe maternal complications (RR 2·51 [95% CI 1·84-3·43]), perinatal complications (RR 1·84 [95% CI 1·02-3·34]), and referral, intensive care unit (ICU) admission, or death (RR 11·83 [95%
- Published
- 2023