COVID-19 in Pregnancy in Scotland (COPS)

The COVID-19 in Pregnancy in Scotland (COPS) study aims to find out how COVID-19 infection during pregnancy affects mothers and babies.

Summary (Research in a nutshell)

Very little is known about the effects of COVID-19 infection in pregnancy at the moment. As far as we can tell just now, pregnant women do not appear to be at substantially higher risk of developing severe COVID-19.  However, there are suggestions that COVID-19 in pregnancy may increase the risk of pregnancy complications such as preterm birth. Effects on other rarer pregnancy complications have not been researched.

COPS will address these uncertainties by providing population-based information for the whole of Scotland on the incidence of, and outcomes following, COVID-19 infection in pregnancy.

Who is leading the COPS study?

COPS is co-led by researchers from the University of Edinburgh and Public Health Scotland and uses healthcare data from across Scotland. The COPS project is linked to EAVE II (Early Assessment of COVID-19 epidemiology and Vaccine/anti-viral Effectiveness).  The COPS study will support EAVE II by providing detailed information on how common COVID-19 infection is in pregnancy, and whether it impacts the health of mothers or babies.

Find out more about EAVE-II on the study website

What does the COPS study involve?

In COPS we will link together healthcare datasets which include information on pregnancy. These come from General Practitioners (GPs) and hospitals across Scotland and include information on all pregnancies including early pregnancy losses (e.g. miscarriage, ectopic pregnancy), terminations of pregnancy, live and stillbirths and neonatal health records. These pregnancy records will then be linked to COVID-19 test results to mothers and babies with COVID-19 (confirmed, probable & suspected cases).

The COPS study will identify all women in Scotland who were pregnant on, or became pregnant after, 1^st March 2020 and all live births in Scotland from 1^st March 2020 onwards. The 1^st March 2020 is important as this was the date of the first confirmed COVID-19 case in Scotland.

We will use these healthcare records to describe how many pregnant women had COVID-19. We will also find out if COVID-19 increases the risk of miscarriage, stillbirth, congenital anomalies, low birthweight, preterm birth, need for specialist baby care (admission to a neonatal unit) or baby death.

The healthcare record linkage and analysis will take place within Public Health Scotland. The study dataset will be ‘pseudonymised’ before analysis. Pseudonymised or 'de-personalised' data is information that does not contain items that directly identify individuals, such as name and address or unique patient number. However, pseudonymised information is still about individuals and so needs to be handled with care. It might, in theory, be possible to recognise or re-identify individuals from pseudonymised data, for example if individuals have very rare pregnancy complications, or if the pseudonymised data was combined with different sources of information, for example from news reports. For this reason, Public Health Scotland will treat the COPS study data very carefully, using well established and strict controls to keep the data safe.

Public Health Scotland Privacy Notice

Read more about identifiable versus anonymous data on the 'What does 'anonymised' mean?' page on the 'Understanding Patient Data' website

How will COPS benefit the public?

Understanding the effects of COVID-19 at different stages during the maternity journey from conception through to birth will help inform policy on shielding strategies, and advice to pregnant women and those considering pregnancy.

It is also essential for immunisation strategies when vaccines are available, as different approaches may be needed in pregnancy.  For example, immunisation in early pregnancy may help protect against complications in the baby such as preterm birth. By contrast, immunisation in later pregnancy may help to provide protection to the baby after birth  (as antibodies can be passed to the baby via the placenta before the baby is born).

How will results from COPS be used?

The results of the COPS study will be used by Public Health Scotland and the Scottish Government to inform ongoing control of the COVID-19 pandemic. We will share results with pregnant women and their families, through links with pregnancy charities and through our website. Findings will be published in international journals and presented at meetings so other countries can learn from the Scottish findings.

Who has approved COPS?

The COPS study has been approved by the Public Benefit and Privacy Panel for Health and Social Care

The study also has full ethical approval from the National Research Ethics Service Committee, South East Scotland 02

Key people

Contact

sarah.stock@ed.ac.uk

Key publications

Stock SJE et al. COVID-19 in Pregnancy in Scotland (COPS): protocol for an observational study using linked Scottish national data (In press BMJ Open)

Key Collaborations

David McAllister, Public Health Scotland, UK. University of Glasgow, Glasgow, UK, ORCID ID 0000-0003-3550-1764

Eleftheria Vasileiou, Usher Institute, University of Edinburgh, Edinburgh, UK ORCID ID 0000-0001-6850-7578

Colin R Simpson, School of Health, Wellington Faculty of Health, Victoria University of Wellington, Wellington, New Zealand; Usher Institute, University of Edinburgh, Edinburgh, UK ORCID ID 0000-0002-5194-8083

Helen R Stagg, Usher Institute, University of Edinburgh, Edinburgh, UK ORCID ID 0000-0003-4022-3447

Utkarsh Agrawal, School of Medicine, University of St Andrews, St Andrews, UK ORCID ID 0000-0001-5181-6120

Colin McCowan, School of Medicine, University of St Andrews, St Andrews, UK ORCID ID 0000-0002-9466-833X

Leanne Hopkins, Public Health Scotland, UK ORCID ID 0000-0002-7487-4363

Jack Donaghy, Public Health Scotland, UK ORCID ID 0000-0002-6137-1601

Lewis Ritchie, Institute of Applied Health Sciences, University of Aberdeen, UK ORCID ID 0000-0002-9380-7641

Chris Robertson, Public Health Scotland, UK. Department of Mathematics and Statistics, University of Strathclyde, Glasgow, UK ORCID ID 0000-0001-6848-5241

Aziz Sheikh, Usher Institute, University of Edinburgh, Edinburgh, UK ORCID ID 0000-0001-7022-3056

Jennifer Bishop, Statistician/Information Consultant, Public Health Scotland

Sharon Kennedy, Statistician/Principal Information Analyst, Public Health Scotland

Emily Moore, Statistician/Senior Information Analyst, Public Health Scotland

David Caldwell, Senior Information Analyst, Public Health Scotland

Ciara Gribben, Senior Information Analyst, Public Health Scotland

Cheryl Denny, Principal Information Analyst, Public Health Scotland

Anna Goulding, Senior Information Analyst, Public Health Scotland

Partners and Funders

COPS is funded by Tommy’s charity (1060508; SC039280).

SJS is supported by Wellcome Trust (209560/Z/17/Z).

EAVE II is 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.

Timeline

July 2020 - Sept 2021