Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International))

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Medicines to treat COVID-19 in pregnant women

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1000000

Study design details

• Main study objective:
  Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies with two key objectives 1) Use of medicines to treat COVID-19 in pregnancy 2) Effects of medicines used to treat COVID-19 in pregnancy on maternal, pregnancy and perinatal outcomes.
• Outcomes:
  Maternal, pregnancy and neonatal outcomes
• Data analysis plan:
  CONSIGN International will focus on two key objectives: 1) & 2) as stated. The aim of our international meta-analysis is to describe the use of medicines to treat COVID-19 disease by trimester of pregnancy and the effects of medicines used to treat COVID-19 on maternal, pregnancy and neonatal outcomes and to pool as much data available around the world with similar protocols and settings. To pool the available data, we will conduct two meta-analyses including prospective and retrospective data collection with reliable data on the different classes of these medicines and associated perinatal outcomes in a real-world clinical setting: the first combining population-based health care data sources (meta-analysis 1) and the second combining case-based registries compiled by health care professionals (meta-analysis 2). For further details regarding the data analysis we refer to our CONSIGN international meta-analysis protocol and statistical analysis plan.