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

Autor:	Villar J; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK; Oxford Maternal and Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, UK., Soto Conti CP; Division Neonatología, Hospital Materno Infantil Ramón Sarda, Buenos Aires, Argentina., Gunier RB; Center for Environmental Research and Community Health (CERCH), School of Public Health, University of California, Berkeley, CA, USA., Ariff S; Department of Paediatrics and Child Health, The Aga Khan University Hospital, Karachi, Pakistan., Craik R; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK., Cavoretto PI; Vita-Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Obstetrics and Gynaecology Department, Milan, Italy., Rauch S; Center for Environmental Research and Community Health (CERCH), School of Public Health, University of California, Berkeley, CA, USA., Gandino S; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK., Nieto R; Division Neonatología, Hospital Materno Infantil Ramón Sarda, Buenos Aires, Argentina., Winsey A; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK., Menis C; Department of Clinical Sciences and Community Health, University of Milan, NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Rodriguez GB; Oxford Maternal and Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, UK., Savasi V; Unit of Obstetrics and Gynecology, L- Sacco Hospital ASST Fatebenefratelli Sacco, Department of Biological and Clinical Sciences, University of Milan, Milan, Italy., Tug N; Department of Obstetrics and Gynecology, Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital, University of Health Sciences, Istanbul, Türkiye., Deantoni S; Neonatal Care Unit, Department of Public Health and Pediatrics, School of Medicine, University of Turin, Turin, Italy., Fabre M; Instituto de Investigación Sanitario de Aragón (IIS Aragon), Hospital Clínico Universitario Lozano Blesa Zaragoza, Zaragoza, Spain., Martinez de Tejada B; Department of Pediatrics, Gynecology & Obstetrics, Hôpitaux Universitaires de Genève, Geneva, Switzerland., Rodriguez-Sibaja MJ; Instituto Nacional de Perinatología Isidro Espinosa de los Reyes, Mexico City, Mexico., Livio S; Children's Hospital V Buzzi, ASST Fatebenefratelli Sacco, Milan, Italy., Napolitano R; Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK; Fetal Medicine Unit, University College London Hospitals NHS Foundation Trust, London, UK., Maiz N; Maternal-Fetal Medicine Unit, Department of Obstetrics and Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron, Barcelona Hospital Campus, Universitat Autonoma de Barcelona, Barcelona, Spain., Sobrero H; Centro Hospitalario Pereira Rossell, Montevideo, Uruguay., Peterson A; Tufts Medical Center, Boston, MA, USA., Deruelle P; Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France., Giudice C; Servicio de Neonatologia, Hospital Italiano de Buenos Aires, Instituto Universitario Hospital Italiano, Buenos Aires, Argentina., Teji JS; Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, IL, USA., Casale RA; Maternal and Child Department, Hospital Nacional Profesor Alejandro Posadas, Buenos Aires, Argentina., Salomon LJ; Hôpital Universitaire Necker-Enfants Malades, Paris, France., Prefumo F; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy., Cheikh Ismail L; Department of Clinical Nutrition and Dietetics, College of Health Sciences, University of Sharjah, Sharjah, United Arab Emirates., Gravett MG; Department of Obstetrics and Gynecology and Department of Global Health, University of Washington, Seattle, WA, USA., Vale M; Hospital Universitário da Universidade Federal do Maranhão, São Luís, Maranhão, Brazil., Hernández V; Facultad de Ciencias Médicas, Universidad Nacional de Córdoba, Córdoba, Argentina., Sentilhes L; Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France., Easter SR; Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Capelli C; Servicio de Neonatología del Departamento Materno Infantil, Hospital Universitario Austral, Buenos Aires, Argentina., Marler E; St George's University Hospitals NHS Foundation Trust, London, UK., Cáceres DM; Hospital Julio C Perrando, Resistencia, Chaco, Argentina., Albornoz Crespo G; Clínica y Maternidad Suizo Argentina, Buenos Aires, Argentina., Ernawati E; Medical Faculty Universitas Airlangga - Dr Soetomo General Academic Hospital, Surabaya, Indonesia., Lipschuetz M; Obstetrics and Gynecology Division- Hadassah Medical Center Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel., Takahashi K; Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan., Vecchiarelli C; Sanatorio Otamendi, Buenos Aires, Argentina., Hubka T; Ascension-Resurrection Medical Center, Chicago, Illinois, USA., Ikenoue S; Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan., Tavchioska G; General Hospital With Extended Activity Prilep, Prilep, North Macedonia., Bako B; Department of Obstetrics and Gynaecology, College of Medical Sciences, Gombe State University, Gombe, Nigeria., Ayede AI; College of Medicine, University of Ibadan and University College Hospital, Ibadan, Nigeria., Eskenazi B; Center for Environmental Research and Community Health (CERCH), School of Public Health, University of California, Berkeley, CA, USA., Thornton JG; University of Nottingham Medical School, University of Nottingham, Nottingham, UK., Bhutta ZA; Department of Paediatrics and Child Health, The Aga Khan University Hospital, Karachi, Pakistan; Center for Global Child Health, Hospital for Sick Children, Toronto, ON, Canada., Kennedy SH; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK; Oxford Maternal and Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, UK., Papageorghiou AT; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK; Oxford Maternal and Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, UK; St George's University Hospitals NHS Foundation Trust, London, UK. Electronic address: aris.papageorghiou@wrh.ox.ac.uk.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2023 Feb 11; Vol. 401 (10375), pp. 447-457. Date of Electronic Publication: 2023 Jan 17.
DOI:	10.1016/S0140-6736(22)02467-9
Abstrakt:	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 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% CI 6·67-20·97]). Severe COVID-19 symptoms in unvaccinated women increased the risk of MMMI (RR 2·88 [95% CI 2·02-4·12]) and referral, ICU admission, or death (RR 20·82 [95% CI 10·44-41·54]). 2886 (63%) of 4618 total participants had at least a single dose of any vaccine, and 2476 (54%) of 4618 had either complete or booster doses. Vaccine effectiveness (all vaccines combined) for severe complications of COVID-19 for all women with a complete regimen was 48% (95% CI 22-65) and 76% (47-89) after a booster dose. For women with a COVID-19 diagnosis, vaccine effectiveness of all vaccines combined for women with a complete regimen was 74% (95% CI 48-87) and 91% (65-98) after a booster dose. Interpretation: COVID-19 in pregnancy, during the first 6 months of omicron as the variant of concern, was associated with increased risk of severe maternal morbidity and mortality, especially among symptomatic and unvaccinated women. Women with complete or boosted vaccine doses had reduced risk for severe symptoms, complications, and death. Vaccination coverage among pregnant women remains a priority. Funding: None. Competing Interests: Declaration of interests LS has been a consultant for Dilafor and Ferring Pharmaceuticals and has received payment in the past for presentations and educational events from Bayer, GlaxoSmithKline, Ferring Pharmaceuticals, and Sigvaris. BMdT received a research grant from the General Health Direction of Geneva, has participated on an advisory board of Effik and Pierre Favre, and has received medical equipment from Pregnolia, Hologic, and PeriLynx. All other authors declare no competing interests. (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu