TAK-555-5002: Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Prucalopride during Pregnancy

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:
  Other
• Non-interventional study design, other:
  Prescription event monitoring, case-series

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A06AX05) prucalopride

  prucalopride
• Medical condition to be studied:
  Constipation

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The objective is to study to assess risk of major congenital malformations in relation to first trimester exposure to prucalopride.
• Outcomes:
  Percentage of Infants With Major Congenital Malformations, 1.Percentage of Participants With Spontaneous Abortions 2.Percentage of Participants With Stillbirths 3.Percentage of Participants With Preterm Delivery 4.Percentage of Infants With Small for Gestational Age 5.Percentage of Infants With Neonatal Intensive Care Unit Admission
• Data analysis plan:
  Source population and different subcohorts of interest (i.e. women with constipation on different treatment strategies) will be characterized. Patterns of constipation medications throughout pregnancy will be described to understand utilization.The primary analysis will estimate the relative risk of pre-specified outcomes for pregnancies exposed to prucalopride compared to other laxatives or no exposure to any prescription medications for constipation.