Study type

Study topic

Other

Study topic, other

Disease/Epidemiology study

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
Population studied

Short description of the study population

The study population comprised of pregnant women with suspected SARS-CoV-2 infection from April 2020 to April 2024.
Inclusion criteria: Pregnant women with a suspicion of infection by SARS-CoV-2
Exclusion criteria: Patients considered as minor in their jurisdiction and patients who have not given their informed consent or are not able to consent for themselves will not be considerate eligible in the registry.

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

3000
Study design details

Main study objective

i.To characterise the clinical course of SARS-CoV-2 infection during pregnancy ii.To assess the risk assessment of vertical transmission and congenital lesions iii.To quantify the risk of adverse maternal outcomes, pregnancy outcomes and neonatal outcomes iv. To identify additional risk factors and risk modifiers

Outcomes

maternal, obstetrical and neonatal outcomes

Data analysis plan

It will be evaluated for each future research question by the Registry Scientific Advisory Committee and a biomedical research Ethics committee. Interim analysis to get an early appraisal of study findings might be considered for some aims and will be submitted for approval to a biomedical research Ethics committee.