Asthma medication during pregnancy : a cohort study in EFEMERIS

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:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03) DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

  DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Population studied

• Short description of the study population:
  Pregnant women in EFEMERIS database who delivered between July 1, 2005 and December 31, 2012.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  70000

Study design details

• Main study objective:
  The aim of the study is to describe asthma medications before and during pregnancy in France and to assess the possible association between asthma medications and adverse pregnancy outcomes.
• Outcomes:
  prescription of asthma medication, pregnancy losses, birth defects, preterm births, low birth weight.
• Data analysis plan:
  First, a description of prescription of asthma medications wil be made. Second, we will compare pregnancy outcomes and newborn health between asthmatic and non-asthmatic women.We will use multiple logistic regression to analyze risks for each outcome associated with asthma, taking into potential confounders. Unajusted and ajusted odds ratios will be presented.