The PRIDE-Asthma cohort: insight into the short- and long-term effects of asthma and asthma medication during pregnancy

Study type

• Study topic:
  Disease /health condition

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

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  1) To design and validate a questionnaire to assess adherence to asthma medication use during pregnancy. 2) To assess reasons for self-initiated discontinuation of asthma medication and changes in asthma medication use during pregnancy. 3) To enable future studies on the short- and long-term effects of maternal asthma and the use of asthma medication during pregnancy.
• Outcomes:
  1) Level of adherence to asthma medication and factors associated with adherence. 2) Trajectories of level of asthma control throughout pregnancy, 1) Common pregnancy complications 2) Common adverse birth outcomes 3) Child respiratory health until the age of 6 years
• Data analysis plan:
  Evaluation of novel scale to assess adherence: validity analysis (PCA), reliability analysis (internal consistency), construct validity. Associations with factors related to adherence: univariable and multivariable linear and logistic regression analyses. Trajectories of level of asthma control: unsupervised clustering methods. Short- and long term effects of asthma and asthma medication use during pregnancy: risk estimation.