Asthma treatment in pregnancy and the frequency of adverse pregnancy outcomes (WEUSRTP4850)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• 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
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Females with asthma who had asthma related medical code recorded anytime before the pregnancy start date and at least one prescription for an asthma medicine in the 6 months before the pregnancy start date or during pregnancy and no asthma related Read medical code but at least 6 prescriptions for an asthma; medicine in their record before the pregnancy start date, including one in the 6 months before the pregnancy start date or during pregnancy.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  30000

Study design details

• Main study objective:
  To evaluate the safety profile of fluticasone propionate compared with exposure to all other inhaled corticosteroids, with all major congenital malformations combined as the primary endpoint, whilst taking into account potential confounders and exposure to other asthma medicines. This will be carried out separately for FP alone and in combination. If appropriate the 2 groups will be combined.
• Outcomes:
  The primary outcome of interest will be all major congenital malformations (MCMs) combined. MCMs will be defined according to the EUROCAT (European network of population-based registers for the epidemiological surveillance of congenital anomalies) classification scheme. MCMs will exclude all chromosomal defects and congenital malformations known to be of a genetic origin. 1. Spontaneous pregnancy losses2. Pre-term births3. Stillbirths at >24 weeks gestation4. Neonatal deaths occurring in the first 4 weeks of life
• Data analysis plan:
  The absolute risk of a pregnancy outcome with a major congenital malformation (MCM) will be calculated for the fluticasone propionate exposure groups, other inhaled corticosteroid (ICS) exposure group and the entire asthma cohort stratified by asthma activity level.The relative risk of an MCM following first trimester exposure to fluticasone propionate compared to all other ICS will be calculated stratified by asthma activity level during the 1st trimester.The prevalence of different types of MCMs identified in the fluticasone propionate exposure groups, other ICS exposure group and the entire asthma cohort will be calculated.The risk of a spontaneous pregnancy loss, a pre-term delivery and a stillbirth will be calculated separately for the entire asthma cohort stratified by asthma activity level. Comparisons will be made between women classed as having ‘considerable to severe’ asthma activity and ‘moderate’ asthma activity to those with ‘mild’ asthma activity.