COVID-19 in Pregnancy in Scotland COVID-19: vaccine safety analyses in pregnant women (COPS)

Study identification

• EU PAS number:
  EUPAS45026
• Study ID:
  45301
• Official title and acronym:
  COVID-19 in Pregnancy in Scotland COVID-19: vaccine safety analyses in pregnant women (COPS)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The main aim of this matched cohort study is to assess the safety of receiving COVID-19 vaccines during pregnancy in Scotland. This will be done using routinely collected electronic health records which provide data to identify pregnancies and their outcomes, vaccination status, any confirmed PCR test for SARS-COV-2 infection, and other covariates of interest (e.g. age, ethnicity and deprivation score). These linked data will be used to monitor whether there is evidence that risk of a series of pre-specified pregnancy, maternal and neonatal outcomes is different among women who received a COVID-19 vaccine in pregnancy compared to women who did not receive a COVID-19 vaccine in pregnancy. In our primary analysis, the vaccinated group will comprise of women who received any COVID-19 vaccine in the six weeks preceding conception or at any point between conception and the end of pregnancy between 08 December 2020 to the date of data extraction, and unvaccinated individuals will be identified from the pre-pandemic period (2015 to the start of the pandemic). Three unvaccinated women will be matched to each vaccinated women by maternal age, gestational age and season of conception. Supplementary analyses will be conducted selecting the unvaccinated comparison group from the pandemic period.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Public Health Scotland

Rachael Wood

Study timelines

Date when funding contract was signed

Planned:01/07/2020

Actual:01/07/2020

Study start date

Planned:01/01/2015

Actual:01/01/2015

Data analysis start date

Planned:17/01/2022

Date of interim report, if expected

Planned:01/03/2022

Date of final study report

Planned:30/09/2022

Sources of funding

Non-for-profit organisation (e.g. charity)

Other

More details on funding

Tommy's Charity, Wellcome Trust, Scottish Government DG Health and Social Care, Medical Research Council, UK Research and Innovation Industrial Strategy Challenge Fund

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable