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Pregnancy and Neonatal Outcomes in COVID-19: Study protocol for a global registry of women with suspected or confirmed SARS-CoV-2 infection in pregnancy and their neonates, understanding natural history to guide treatment and prevention

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Title: Pregnancy and Neonatal Outcomes in COVID-19: Study protocol for a global registry of women with suspected or confirmed SARS-CoV-2 infection in pregnancy and their neonates, understanding natural history to guide treatment and prevention
Authors: Banerjee, J
Mullins, E
Townson, J
Playle, R
Shaw, C
Kirby, N
Munnery, K
Bourne, T
Teoh, TG
Dhanjal, M
Poon, L
Wright, A
Lees, C
Item Type: Journal Article
Abstract: Introduction: Previous novel coronavirus pandemics, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), observed an association of infection in pregnancy with pre-term delivery, stillbirth and increased maternal mortality. Coronavirus disease2019(COVID-19), caused by SARS-CoV-2 infection, is the largest pandemic in living memory. Rapid accrual of robust case data on women in pregnancy and their babies affected by suspectedCOVID-19or confirmed SARS-CoV-2 infection will inform clinical management and preventative strategies in the current pandemic and future outbreaks. Methods and analysis: The Pregnancy And Neonatal outcomes in COVID-19 (PAN-COVID) registry is an observational study collecting focussed data on outcomes of pregnant mothers who have had suspected COVID-19 in pregnancy or confirmed SARS-CoV-2 infection and their neonatesvia a web-portal. Amongst the women recruited to the PAN-COVID registry, the study will evaluate the incidence of:1. Miscarriage and pregnancy loss2. FGR and stillbirth 3. Pre-term delivery 4. Vertical transmission(suspected or confirmed) and early-onset neonatal SARS-CoV-2 infection Data will be centre based and collected on individual women and their babies. Verbal consent will be obtained, to reduce face-to-face contact in the pandemic whilst allowing identifiable data collection for linkage. Statistical analysis of the data will be carried out on a pseudonymised dataset by the study statistician. Regular reports will be distributed to collaborators on the study research questions. Ethics and dissemination: This study has received research ethics approval in the UK. For international centres, evidence of appropriate local approval will be required to participate, prior to entry of data to the database. The reports will be published regularly. The outputs of the study will be regularly disseminated to 4participants and collaborators on the study website (https://pan-covid.org)and social media channels as well as dissemination to scientific meetings and journals.
Issue Date: 29-Jan-2021
Date of Acceptance: 2-Dec-2020
URI: http://hdl.handle.net/10044/1/85386
DOI: 10.1136/bmjopen-2020-041247
ISSN: 2044-6055
Publisher: BMJ Journals
Start Page: 1
End Page: 6
Journal / Book Title: BMJ Open
Volume: 11
Issue: 1
Copyright Statement: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Sponsor/Funder: Medical Research Council (MRC)
Funder's Grant Number: MC_PC 19066
Keywords: infectious diseases
neonatology
obstetrics
public health
Humans
Pregnancy Complications, Infectious
Abortion, Spontaneous
Premature Birth
Pregnancy Outcome
Registries
Maternal Mortality
Pregnancy
Research Design
Infant, Newborn
Female
Infectious Disease Transmission, Vertical
Global Health
United Kingdom
COVID-19
SARS-CoV-2
1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status: Published
Online Publication Date: 2021-01-29
Appears in Collections:Department of Metabolism, Digestion and Reproduction
Faculty of Medicine
Imperial College London COVID-19



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