COVID-19 in pregnancy in Scotland (COPS) : protocol for an observational study using linked Scottish national data

Stock, Sarah Jane and McAllister, David and Vasileiou, Eleftheria and Simpson, Colin R and Stagg, Helen R and Agrawal, Utkarsh and McCowan, Colin and Hopkins, Leanne and Donaghy, Jack and Ritchie, Lewis and Robertson, Chris and Sheikh, Aziz and Wood, Rachael (2020) COVID-19 in pregnancy in Scotland (COPS) : protocol for an observational study using linked Scottish national data. BMJ Open, 10 (11). e042813. ISSN 2044-6055 (https://doi.org/10.1136/bmjopen-2020-042813)

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Abstract

Introduction The effects of SARS-CoV-2 in pregnancy are not fully delineated. We will describe the incidence of COVID-19 in pregnancy at population level in Scotland, in a prospective cohort study using linked data. We will determine associations between COVID-19 and adverse pregnancy, neonatal and maternal outcomes and the proportion of confirmed cases of SARS-CoV-2 infection in neonates associated with maternal COVID-19. Methods and analysis Prospective cohort study using national linked data sets. We will include all women in Scotland, UK, who were pregnant on or became pregnant after, 1 March 2020 (the date of the first confirmed case of SARS-CoV-2 infection in Scotland) and all births in Scotland from 1 March 2020 onwards. Individual-level data will be extracted from data sets containing details of all livebirths, stillbirth, terminations of pregnancy and miscarriages and ectopic pregnancies treated in hospital or attending general practice. Records will be linked within the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) platform, which includes primary care records, virology and serology results and details of COVID-19 Community Hubs and Assessment Centre contacts and deaths. We will perform analyses using definitions for confirmed, probable and possible COVID-19 and report serology results (where available). Outcomes will include congenital anomaly, miscarriage, stillbirth, termination of pregnancy, preterm birth, neonatal infection, severe maternal disease and maternal deaths. We will perform descriptive analyses and appropriate modelling, adjusting for demographic and pregnancy characteristics and the presence of comorbidities. The cohort will provide a platform for future studies of the effectiveness and safety of therapeutic interventions and immunisations for COVID-19 and their effects on childhood and developmental outcomes. Ethics and dissemination COVID-19 in Pregnancy in Scotland is a substudy of EAVE II(, which has approval from the National Research Ethics Service Committee. Findings will be reported to Scottish Government, Public Health Scotland and published in peer-reviewed journals.

  • Item type:Article
    ID code:75169
    Dates:
    Date
    Event
    26 November 2020
    Published
    26 October 2020
    Accepted
    Notes:Funding Information: Funding EAVE II funded by the Medical Research Council (MR/R008345/1) with the support of BREATHE - The Health Data Research Hub for Respiratory Health (MC_ PC_19004), which is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through Health Data Research UK. Additional support has been provided through the Scottish Government DG Health and Social Care. COPS receive additional funding from Tommy’s charity (1060508; SC039280). SJS is supported by Wellcome Trust (209560/Z/17/Z) Publisher Copyright: © Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
    Subjects:Medicine
    Department:Strategic Research Themes > Health and Wellbeing
    Faculty of Science > Mathematics and Statistics
    Depositing user: Pure Administrator
    Date deposited:27 Jan 2021 09:40
    Last modified:09 Apr 2024 02:08
    Related URLs:
    URI:https://strathprints.strath.ac.uk/id/eprint/75169
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