EUROmediCAT: Safety of Medication Use in Pregnancy in Relation to Risk of Congenital Malformations

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06A) ANTIDEPRESSANTS

  ANTIDEPRESSANTS

  (N03) ANTIEPILEPTICS

  ANTIEPILEPTICS

  (A10) DRUGS USED IN DIABETES

  DRUGS USED IN DIABETES

  (R03) DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

  DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

  (D10AD04) isotretinoin

  isotretinoin
• Medical condition to be studied:
  Congenital cardiovascular anomaly

  Neural tube defect

  Cleft lip and palate

  Cleft palate

  Hypospadias

  Hydrocephalus

  Microcephaly

  Gastroschisis

  Renal aplasia

  Trisomy 21

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  120000

Study design details

• Main study objective:
  The central aim is to build a European system for reproductive safety evaluation, which enables us to identify systematically and comprehensively the possible adverse effects in pregnancy of a drug in humans at the earliest stage post marketing, and enables us to monitor and evaluate safety measures undertaken in Europe.
• Outcomes:
  An efficient system for methodical safety evaluation of drugs during pregnancy, based on an existing network of congenital anomalies registers in Europe and healthcare databases.A quantified risk of congenital anomaly related to new antiepileptics, insulin analogues, anti-asthmatics and SSRIs. A framework to evaluate the efficacy of pregnancy-related drug safety measures.
• Data analysis plan:
  Workpackages 4,5: For three classes of medication (antiepileptics, antidepressants, antiashtmatics) we will analyse the specificity of association between specific medications and specific malformation types, using odds ratios, from a case-malformed control design.Workpackage 4: For insulin analogs, we will use a cohort design and relative risk of malformation.For Workpackage 6, a drug utilisation study, we will use prevalence of medication use during pregnancy.For Workpackage 7 concerning internet use by pregnant women, qualitative and survey methods.