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

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Stock_2020_BMJOpen_COVID_19_CC.pdf (862.4Kb)
Date
26/11/2020
Author
Stock, Sarah
McAllister, David
Vasileiou, Eleftheria
Simpson, Colin R
Stagg, Helen R
Agrawal, Utkarsh
McCowan, Colin
Hopkins, Leanne
Donaghy, Jack
Ritchie, Lewis
Robertson, Chris
Sheikh, Aziz
Wood, Rachael
Keywords
RA0421 Public health. Hygiene. Preventive Medicine
RG Gynecology and obstetrics
3rd-DAS
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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.
Citation
Stock , S , McAllister , D , Vasileiou , E , Simpson , C R , Stagg , H R , Agrawal , U , McCowan , C , Hopkins , L , Donaghy , J , Ritchie , L , Robertson , C , Sheikh , A & Wood , R 2020 , ' COVID-19 in Pregnancy in Scotland (COPS) : protocol for an observational study using linked Scottish national data ' , BMJ Open , vol. 10 , no. 11 , e042813 . https://doi.org/10.1136/bmjopen-2020-042813
Publication
BMJ Open
Status
Peer reviewed
DOI
https://doi.org/10.1136/bmjopen-2020-042813
ISSN
2044-6055
Type
Journal article
Rights
Copyright © Author(s) (or their employer(s)) 2020. 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/.
Description
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).
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  • University of St Andrews Research
URI
http://hdl.handle.net/10023/21090

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