Improving detection of associations between congenital anomalies and medicines taken in the first trimester of pregnancy, using data derived hierarchies.

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Methodological

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-only

Population studied

• 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:
  33000

Study design details

• Main study objective:
  Does the identification of groups of anomalies with similar patterns of association across several medications, and identification of groups of medications with similar patterns of association across several anomalies, improve signal detection of teratogens within the EUROmediCAT database?
• Data analysis plan:
  Suitable statistical methods to simultaneously analyse data on multiple birth defects and multiple medications within the EUROmediCAT database have been developed by searching the literature for application of similar methods in other fields of research and adapting such methods. An advisory committee containing specialists, pharmacologists and geneticists has been created to assist in model selection and interpretation of results. Chosen methods will be applied initially to a drug and anomaly blinded EUROmediCAT database, with additional information from the EUROCAT database incorporated into models where appropriate. Final model selection will be supported by the advisory team based on the simulation performance and blinded results. The chosen model(s) will then be applied to data from the EUROmediCAT and EUROCAT databases. The advisory committee will assist and support the interpretation of results, including assimilation of new signals with known teratogens.