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

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
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.