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

Introduction
The effects of SARS-CoV-2 in pregnancy 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 SARSCoV-2 infection in neonates associated with maternal COVID-19
Methods and analysis
Prospective cohort study using national linked datasets. We will include all women in Scotland, UK, who were pregnant on, or became pregnant after, 1st March 2020 (the date of the first confirmed case of SARS-CoV-2 infection in Scotland), and all births in Scotland from 1st March 2020 onwards. Individual-level data will be extracted from datasets 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 co-morbidities.
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
COPS is a sub-study 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.