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      Maternal and Neonatal Morbidity and Mortality Among Pregnant Women With and Without COVID-19 Infection : The INTERCOVID Multinational Cohort Study

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      , MD 1 , 2 , , MD 3 , , PhD 4 , , MD 5 , , MPH 4 , , MD 6 , , PhD 7 , 8 , , PhD 9 , 10 , , MD 11 , , MD 12 , , PhD 13 , , MD 14 , , PhD 15 , , PhD 16 , , MD 17 , 18 , , MD 19 , , MD 20 , , PhD 21 , 22 , , MD 23 , , MD 24 , , MBBS 25 , , MD 26 , , MD 27 , , MD 28 , , MD 29 , 30 , , PhD 31 , , MD 32 , , MSc 33 , 34 , , PhD 35 , , MD 36 , 37 , , PhD 38 , , MD 39 , , MD 40 , , PhD 41 , 42 , , MD 43 , , MD 44 , , MD 45 ,   , PhD 46 , , PhD 47 , , MD 48 , , MD 49 , , MD 50 , 51 , , MBBS 52 , , PhD 36 , 37 , , MD 20 , , MD 8 , , PhD 53 , , MD 54 , , MD 1 , 2 , , MD 1 , 2 , 25 ,
      JAMA Pediatrics
      American Medical Association

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          Abstract

          This cohort study assesses the association between COVID-19 and maternal and neonatal outcomes in pregnant women with COVID-19 diagnosis compared with concomitantly enrolled pregnant women without COVID-19 diagnosis.

          Key Points

          Question

          To what extent does COVID-19 in pregnancy alter the risks of adverse maternal and neonatal outcomes compared with pregnant individuals without COVID-19?

          Findings

          In this multinational cohort study of 2130 pregnant women in 18 countries, women with COVID-19 diagnosis were at increased risk of a composite maternal morbidity and mortality index. Newborns of women with COVID-19 diagnosis had significantly higher severe neonatal morbidity index and severe perinatal morbidity and mortality index compared with newborns of women without COVID-19 diagnosis.

          Meaning

          This study indicates a consistent association between pregnant individuals with COVID-19 diagnosis and higher rates of adverse outcomes, including maternal mortality, preeclampsia, and preterm birth compared with pregnant individuals without COVID-19 diagnosis.

          Abstract

          Importance

          Detailed information about the association of COVID-19 with outcomes in pregnant individuals compared with not-infected pregnant individuals is much needed.

          Objective

          To evaluate the risks associated with COVID-19 in pregnancy on maternal and neonatal outcomes compared with not-infected, concomitant pregnant individuals.

          Design, Setting, and Participants

          In this cohort study that took place from March to October 2020, involving 43 institutions in 18 countries, 2 unmatched, consecutive, not-infected women were concomitantly enrolled immediately after each infected woman was identified, at any stage of pregnancy or delivery, and at the same level of care to minimize bias. Women and neonates were followed up until hospital discharge.

          Exposures

          COVID-19 in pregnancy determined by laboratory confirmation of COVID-19 and/or radiological pulmonary findings or 2 or more predefined COVID-19 symptoms.

          Main Outcomes and Measures

          The primary outcome measures were indices of (maternal and severe neonatal/perinatal) morbidity and mortality; the individual components of these indices were secondary outcomes. Models for these outcomes were adjusted for country, month entering study, maternal age, and history of morbidity.

          Results

          A total of 706 pregnant women with COVID-19 diagnosis and 1424 pregnant women without COVID-19 diagnosis were enrolled, all with broadly similar demographic characteristics (mean [SD] age, 30.2 [6.1] years). Overweight early in pregnancy occurred in 323 women (48.6%) with COVID-19 diagnosis and 554 women (40.2%) without. Women with COVID-19 diagnosis were at higher risk for preeclampsia/eclampsia (relative risk [RR], 1.76; 95% CI, 1.27-2.43), severe infections (RR, 3.38; 95% CI, 1.63-7.01), intensive care unit admission (RR, 5.04; 95% CI, 3.13-8.10), maternal mortality (RR, 22.3; 95% CI, 2.88-172), preterm birth (RR, 1.59; 95% CI, 1.30-1.94), medically indicated preterm birth (RR, 1.97; 95% CI, 1.56-2.51), severe neonatal morbidity index (RR, 2.66; 95% CI, 1.69-4.18), and severe perinatal morbidity and mortality index (RR, 2.14; 95% CI, 1.66-2.75). Fever and shortness of breath for any duration was associated with increased risk of severe maternal complications (RR, 2.56; 95% CI, 1.92-3.40) and neonatal complications (RR, 4.97; 95% CI, 2.11-11.69). Asymptomatic women with COVID-19 diagnosis remained at higher risk only for maternal morbidity (RR, 1.24; 95% CI, 1.00-1.54) and preeclampsia (RR, 1.63; 95% CI, 1.01-2.63). Among women who tested positive (98.1% by real-time polymerase chain reaction), 54 (13%) of their neonates tested positive. Cesarean delivery (RR, 2.15; 95% CI, 1.18-3.91) but not breastfeeding (RR, 1.10; 95% CI, 0.66-1.85) was associated with increased risk for neonatal test positivity.

          Conclusions and Relevance

          In this multinational cohort study, COVID-19 in pregnancy was associated with consistent and substantial increases in severe maternal morbidity and mortality and neonatal complications when pregnant women with and without COVID-19 diagnosis were compared. The findings should alert pregnant individuals and clinicians to implement strictly all the recommended COVID-19 preventive measures.

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          Most cited references42

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          World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

          (2013)
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            Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study

            Summary Background A cluster of patients with coronavirus disease 2019 (COVID-19) pneumonia caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were successively reported in Wuhan, China. We aimed to describe the CT findings across different timepoints throughout the disease course. Methods Patients with COVID-19 pneumonia (confirmed by next-generation sequencing or RT-PCR) who were admitted to one of two hospitals in Wuhan and who underwent serial chest CT scans were retrospectively enrolled. Patients were grouped on the basis of the interval between symptom onset and the first CT scan: group 1 (subclinical patients; scans done before symptom onset), group 2 (scans done ≤1 week after symptom onset), group 3 (>1 week to 2 weeks), and group 4 (>2 weeks to 3 weeks). Imaging features and their distribution were analysed and compared across the four groups. Findings 81 patients admitted to hospital between Dec 20, 2019, and Jan 23, 2020, were retrospectively enrolled. The cohort included 42 (52%) men and 39 (48%) women, and the mean age was 49·5 years (SD 11·0). The mean number of involved lung segments was 10·5 (SD 6·4) overall, 2·8 (3·3) in group 1, 11·1 (5·4) in group 2, 13·0 (5·7) in group 3, and 12·1 (5·9) in group 4. The predominant pattern of abnormality observed was bilateral (64 [79%] patients), peripheral (44 [54%]), ill-defined (66 [81%]), and ground-glass opacification (53 [65%]), mainly involving the right lower lobes (225 [27%] of 849 affected segments). In group 1 (n=15), the predominant pattern was unilateral (nine [60%]) and multifocal (eight [53%]) ground-glass opacities (14 [93%]). Lesions quickly evolved to bilateral (19 [90%]), diffuse (11 [52%]) ground-glass opacity predominance (17 [81%]) in group 2 (n=21). Thereafter, the prevalence of ground-glass opacities continued to decrease (17 [57%] of 30 patients in group 3, and five [33%] of 15 in group 4), and consolidation and mixed patterns became more frequent (12 [40%] in group 3, eight [53%] in group 4). Interpretation COVID-19 pneumonia manifests with chest CT imaging abnormalities, even in asymptomatic patients, with rapid evolution from focal unilateral to diffuse bilateral ground-glass opacities that progressed to or co-existed with consolidations within 1–3 weeks. Combining assessment of imaging features with clinical and laboratory findings could facilitate early diagnosis of COVID-19 pneumonia. Funding None.
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              Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study

              Abstract Objective To characterise the clinical features of patients admitted to hospital with coronavirus disease 2019 (covid-19) in the United Kingdom during the growth phase of the first wave of this outbreak who were enrolled in the International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) World Health Organization (WHO) Clinical Characterisation Protocol UK (CCP-UK) study, and to explore risk factors associated with mortality in hospital. Design Prospective observational cohort study with rapid data gathering and near real time analysis. Setting 208 acute care hospitals in England, Wales, and Scotland between 6 February and 19 April 2020. A case report form developed by ISARIC and WHO was used to collect clinical data. A minimal follow-up time of two weeks (to 3 May 2020) allowed most patients to complete their hospital admission. Participants 20 133 hospital inpatients with covid-19. Main outcome measures Admission to critical care (high dependency unit or intensive care unit) and mortality in hospital. Results The median age of patients admitted to hospital with covid-19, or with a diagnosis of covid-19 made in hospital, was 73 years (interquartile range 58-82, range 0-104). More men were admitted than women (men 60%, n=12 068; women 40%, n=8065). The median duration of symptoms before admission was 4 days (interquartile range 1-8). The commonest comorbidities were chronic cardiac disease (31%, 5469/17 702), uncomplicated diabetes (21%, 3650/17 599), non-asthmatic chronic pulmonary disease (18%, 3128/17 634), and chronic kidney disease (16%, 2830/17 506); 23% (4161/18 525) had no reported major comorbidity. Overall, 41% (8199/20 133) of patients were discharged alive, 26% (5165/20 133) died, and 34% (6769/20 133) continued to receive care at the reporting date. 17% (3001/18 183) required admission to high dependency or intensive care units; of these, 28% (826/3001) were discharged alive, 32% (958/3001) died, and 41% (1217/3001) continued to receive care at the reporting date. Of those receiving mechanical ventilation, 17% (276/1658) were discharged alive, 37% (618/1658) died, and 46% (764/1658) remained in hospital. Increasing age, male sex, and comorbidities including chronic cardiac disease, non-asthmatic chronic pulmonary disease, chronic kidney disease, liver disease and obesity were associated with higher mortality in hospital. Conclusions ISARIC WHO CCP-UK is a large prospective cohort study of patients in hospital with covid-19. The study continues to enrol at the time of this report. In study participants, mortality was high, independent risk factors were increasing age, male sex, and chronic comorbidity, including obesity. This study has shown the importance of pandemic preparedness and the need to maintain readiness to launch research studies in response to outbreaks. Study registration ISRCTN66726260.
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                Author and article information

                Journal
                JAMA Pediatr
                JAMA Pediatr
                JAMA Pediatr
                JAMA Pediatrics
                American Medical Association
                2168-6203
                2168-6211
                22 April 2021
                August 2021
                22 April 2021
                : 175
                : 8
                : 1-10
                Affiliations
                [1 ]Nuffield Department of Women’s & Reproductive Health, University of Oxford, Oxford, United Kingdom
                [2 ]Oxford Maternal and Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, United Kingdom
                [3 ]Department of Paediatrics and Child Health, The Aga Khan University Hospital, Karachi, Pakistan
                [4 ]School of Public Health, University of California, Berkeley, Berkeley
                [5 ]Translational Health Science and Technology Institute, Faridabad, India
                [6 ]National Medical Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russia
                [7 ]Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy
                [8 ]Department of Woman, Child and Neonate, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy
                [9 ]Division of Obstetrics and Gynecology, ASST Spedali Civili di Brescia, Brescia, Italy
                [10 ]Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy
                [11 ]Universidade Federal do Maranhão, São Luís, Brazil
                [12 ]Instituto Nacional de Perinatología Isidro Espinosa de los Reyes, Mexico City, Mexico
                [13 ]Obstetrics Department, Hospital Universitari Vall d’Hebron, Barcelona Hospital Campus, Barcelona, Spain
                [14 ]Ospedale Vittore Buzzi Children’s Hospital, Department of BioMedical and Clinical Sciences, University of Milan, Milan, Italy
                [15 ]Ospedale Luigi Sacco University Hospital, Department of BioMedical and Clinical Sciences, University of Milan, Milan, Italy
                [16 ]Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France
                [17 ]Division of Maternal-Fetal Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
                [18 ]Division of Critical Care Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
                [19 ]Hôpital Universitaire Necker-Enfants Malades, AP-HP, Université de Paris, Paris, France
                [20 ]Division Neonatología, Hospital Materno Infantil Ramón Sarda, Buenos Aires Argentina
                [21 ]Department of Obstetrics and Gynecology, Medical Faculty, Universitas Airlangga, Surabaya, Indonesia
                [22 ]Soetomo General Academic Hospital, Surabaya, Indonesia
                [23 ]Tufts Medical Center, Boston, Massachusetts
                [24 ]Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern Feinberg School of Medicine, Chicago, Illinois
                [25 ]St George’s University Hospitals NHS Foundation Trust, London, United Kingdom
                [26 ]Servicio de Neonatologia del Departamento Materno Infantil del Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina
                [27 ]S.C. Obstetrics 2U, Sant’Anna Hospital, AOU Città della Salute e della scienza di Torino, Turin, Italy
                [28 ]Fetal Medicine Unit, University College London Hospitals NHS Foundation Trust, London, United Kingdom
                [29 ]Department of Obstetrics and Gynecology, University of Washington, Seattle
                [30 ]Department of Global Health, University of Washington, Seattle
                [31 ]Obstetrics and Gynaecology Department, IRCCS San Raffaele Hospital and University, Milan, Italy
                [32 ]Fr. Thomas Alan Rooney Memorial Hospital, Asankragwa, Ghana
                [33 ]Africa Center of Excellence for Population Health and Policy, Bayero University Kano, Kano, Nigeria
                [34 ]Aminu Kano Teaching Hospital, Kano, Nigeria
                [35 ]Aragon Institute of Health Research, Obstetrics Department, Hospital Clínico Universitario Lozano Blesa Zaragoza, Zaragoza, Spain
                [36 ]College of Medicine, University of Ibadan, Ibadan, Nigeria
                [37 ]University College Hospital, Ibadan, Nigeria
                [38 ]Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France
                [39 ]Department of Obstetrics and Gynaecology, Faculty of Clinical Sciences, College of Medical Sciences, Gombe State University, Gombe, Nigeria
                [40 ]Hospital de Moron, Moron, Provincia de Buenos Aires, Argentina
                [41 ]Laboratory of Dietetics and Clinical Nutrition, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy
                [42 ]Clinical Nutrition and Dietetics Service, Unit of Internal Medicine and Endocrinology, ICS Maugeri IRCCS, University of Pavia, Pavia, Italy
                [43 ]Hospital Regional Lic. Adolfo López Mateos ISSSTE, Mexico City, Mexico
                [44 ]University of Calabar Teaching Hospital, Calabar, Nigeria
                [45 ]Maternal and Child Department, Hospital Nacional Profesor Alejandro Posadas, Buenos Aires, Argentina
                [46 ]Tropical Medicine and Infectious Diseases Department, Tanta University, Tanta, Egypt
                [47 ]Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan
                [48 ]Department of Obstetrics and Gynaecology, Abubakar Tafawa Balewa University Teaching Hospital, Bauchi, Nigeria
                [49 ]Sanatorio Otamendi, Ciudad de Buenos Aires, Argentina
                [50 ]Universidad de Buenos Aires, Buenos Aires, Argentina
                [51 ]Universidad de Moron, Moron, Argentina
                [52 ]Department of Obstetrics and Gynaecology, Muhammad Abdullahi Wase Teaching Hospital, Kano State, Nigeria
                [53 ]Center for Global Child Health, Hospital for Sick Children, Toronto, Ontario, Canada
                [54 ]Women and Health Initiative, Global Health and Population Department, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
                Author notes
                Article Information
                Corresponding Author: Aris T. Papageorghiou, MD, Nuffield Department of Women’s & Reproductive Health, University of Oxford, Women’s Centre, John Radcliffe Hospital, Headington, Oxford OX3 9DU, United Kingdom ( aris.papageorghiou@ 123456wrh.ox.ac.uk ).
                Accepted for Publication: January 21, 2021.
                Published Online: April 22, 2021. doi:10.1001/jamapediatrics.2021.1050
                Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Villar J et al. JAMA Pediatrics.
                Author Contributions: Drs Villar and Papageorghiou had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Kennedy and Papageorghiou contributed equally.
                Concept and design: Villar, Thiruvengadam, Arturo Cardona-Perez, Ayede, Bako, Duro, Langer, Kennedy, Papageorghiou.
                Acquisition, analysis, or interpretation of data: Villar, Ariff, Gunier, Thiruvengadam, Rauch, Kholin, Roggero, Prefumo, Silva do Vale, Maiz, Cetin, Savasi, Deruelle, Easter, Sichitiu, Soto Conti, Ernawati, Mhatre, Singh Teji, Liu, Capelli, Oberto, Salazar, Gravett, Cavoretto, Bizor Nachinab, Galadanci, Oros, Ayede, Sentilhes, Bako, Savorani, Cena, Garcia-May, Etuk, Casale, Abd-Elsalam, Ikenoue, Baffah Aminu, Vecchiarelli, Usman, John-Akinola, Nieto, Ferrazzi, Bhutta, Papageorghiou.
                Drafting of the manuscript: Villar, Gunier, Thiruvengadam, Rauch, Prefumo, Maiz, Singh Teji, Liu, Etuk, Kennedy, Papageorghiou.
                Critical revision of the manuscript for important intellectual content: Villar, Ariff, Thiruvengadam, Kholin, Roggero, Prefumo, Silva do Vale, Arturo Cardona-Perez, Cetin, Savasi, Deruelle, Easter, Sichitiu, Soto Conti, Ernawati, Mhatre, Singh Teji, Capelli, Oberto, Salazar, Gravett, Cavoretto, Bizor Nachinab, Galadanci, Oros, Ayede, Sentilhes, Bako, Savorani, Cena, Garcia-May, Casale, Abd-Elsalam, Ikenoue, Baffah Aminu, Vecchiarelli, Duro, Usman, John-Akinola, Nieto, Ferrazzi, Bhutta, Langer, Kennedy, Papageorghiou.
                Statistical analysis: Villar, Gunier, Rauch, Papageorghiou.
                Obtained funding: Villar, Papageorghiou.
                Administrative, technical, or material support: Villar, Ariff, Thiruvengadam, Silva do Vale, Arturo Cardona-Perez, Savasi, Easter, Sichitiu, Ernawati, Singh Teji, Liu, Galadanci, Oros, Ayede, Bako, Savorani, Garcia-May, Etuk, Baffah Aminu, John-Akinola, Papageorghiou.
                Supervision: Villar, Thiruvengadam, Kholin, Roggero, Cetin, Savasi, Ayede, Cena, Etuk, Usman, Ferrazzi, Langer, Papageorghiou.
                Conflict of Interest Disclosures: Dr Gunier reported grants from Oxford University during the conduct of the study. Dr Sentilhes reported personal, lecture, and consulting fees from Ferring Pharmaceutical and personal and lecture fees from Bayer outside the submitted work. Dr Papageorghiou reported grants from National Institute for Health Research Biomedical Research Centre and other support from Intelligent Ultrasound as director outside the submitted work. No other disclosures were reported.
                Funding/Support: The study was supported by the COVID-19 Research Response Fund from the University of Oxford (reference 0009083). Dr Papageorghiou is supported by the Oxford Partnership Comprehensive Biomedical Research Centre with funding from the National Institute for Health Research Biomedical Research Centre Biomedical Research Centre funding scheme.
                Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
                Disclaimer: The views expressed herein are those of the authors and not necessarily those of the UK National Health System, the US National Institute for Health Research Department of Health, or any of the other funders.
                Additional Contributions: We are grateful to the following colleagues for their contributions to the study: Josephine Agyeman-Duah, MSc (Nuffield Department of Women’s & Reproductive Health, University of Oxford, Oxford, UK), study coordinator, Nkawkaw, Ghana; Eric Baafi, MD (Holy Family Hospital, Nkawkaw, Ghana), data collection, Ghana; Anne Caroline Benski, MD (Hôpitaux Universitaires de Genève, Département de la Femme, de l’Enfant et de l'Adolescent, Geneva, Switzerland), data collection, Geneva, Switzerland; Rachel Craik, BSc (Nuffield Department of Women’s & Reproductive Health, University of Oxford, Oxford, UK), study coordinator (overall study); Sonia Deantoni, MD (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; Neonatal Care Unit, Department of Public Health and Pediatrics, School of Medicine, University of Turin, Italy), data collection, Oxford, UK, and data input (multiple sites); Ken Takahashi, PhD (Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan), data collection, Jikei, Japan; Gabriela Tavchioska, MSc (Department of Pediatrics, General Hospital Borka Taleski, Prilep, Republic of North Macedonia), data collection, Prilep, Republic of North Macedonia; Jim G. Thornton, MD (Division of Child Health, Obstetrics and Gynaecology, University of Nottingham, Nottingham, UK), literature reviews and study advisor; Albertina Rego, PhD (Departamento de Pediatria, Faculdade Universidade Federal de Minas Gerais, Belo Horizonte, Brazil), study coordinator, Brazil; and Adele Winsey, PhD (Nuffield Department of Women’s & Reproductive Health, University of Oxford, Oxford, UK), study coordinator (overall study). Dr Winsey and Ms Craik were supported by the COVID-19 Research Response Fund from the University of Oxford. Other contributors did not receive any compensation (eAppendix 1 in the Supplement). We also thank all the contributing institutions and local researchers involved in the study. eAppendix 2 in the Supplement contains their details as well as details of the study committees.
                Article
                poi210025
                10.1001/jamapediatrics.2021.1050
                8063132
                33885740
                58946b05-93b0-4f7c-bd2a-b17ce4caebc3
                Copyright 2021 Villar J et al. JAMA Pediatrics.

                This is an open access article distributed under the terms of the CC-BY License.

                History
                : 23 December 2020
                : 21 January 2021
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                Research
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