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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  20000

Study design details

• Main study objective:
  The main aim of this work is to assess the safety of receiving COVID-19 vaccines during pregnancy.
• Outcomes:
  The primary outcomes are: - Hypertensive disorders of pregnancy - Venous thromboembolism - Pregnancy-related bleeding - Maternal ICU admission or death - Miscarriage - Ectopic pregnancy - Stillbirth - Any congenital anomaly - Microcephaly - Preterm birth - Spontaneous preterm birth - Small for gestational age - Low Apgar score - Neonatal death - Extended perinatal mortality, The secondary outcomes are: - First trimester miscarriage - Second trimester miscarriage - Any non-genetic congenital anomaly - Severe microcephaly - Very preterm birth - Spontaneous very preterm birth - Very small for gestational age - Very low Apgar score
• Data analysis plan:
  Descriptive analyses will initially be conducted first exploring the key socio-demographic and clinical characteristics of the vaccinated and unvaccinated cohorts, and then calculating the number and risk of each outcome of interest in the vaccinated and unvaccinated groups. Maternal, pregnancy and neonatal outcomes in the vaccinated and unvaccinated pregnant cohorts will be compared using appropriate regression models, including accounting for competing risks where these are relevant for a particular outcome. We will adjust for potential confounders in these models. We will consider adjusting our modelling approach for rarer outcomes. Full details of the statistical analysis plan can be found here: https://github.com/Public-Health-Scotland/COPS-public/tree/main/Safety%20protocol