COVID-19 infections and medicines in pregnancy- the INOSS collaboration (INOSS CONSIGN)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Medical condition to be studied:
  Acute respiratory distress syndrome
• Additional medical condition(s):
  Maternal and neonatal respiratory support

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:
  2500

Study design details

• Main study objective:
  Primary objectives: To determine: I. The incidence frequency of hospitalisation with COVID-19 disease in pregnancy across multiple EU and non-EU nations. II. The COVID-related outcomes of hospitalisation with COVID-19 disease in pregnancy for mother and infant. III. Medication use in COVID-19 positive pregnant women admitted to hospital.
• Outcomes:
  Maternal and neonatal Intensive care unit admission, need for ventilatory support, maternal or perinatal death including stillbirth, delivery by cesarean section, preterm delivery (<37 gestational weeks), infant with severe growth restriction (birth weight <10 percentile according to Intergrowth standards)
• Data analysis plan:
  To estimate the associations between medicines use during a hospitalization for COVID-19 in pregnant women and pregnancy, maternal and neonatal outcomes, nested case control analyses will be conducted. Cases will be the women with completed pregnancies with adverse outcomes, controls are women with completed pregnancies without the adverse outcome. Characteristics of cases (separately for each outcome) and controls will be described and tested utilizing logistic regression analysis. The effect of medicines use will be estimated utilizing logistic regression, adjustments will be made for all factors that change the effect estimate with more than 10%. For metaanalysis we use a two-stage hybrid approach for pooling case-control data from study sites. Random effects meta-analyses will be performed overall and stratified by subgroups. Descriptive analyses of characteristics and distribution of outcomes and by analysing crude and adjusted odds ratios.