TAK-555-5001: Prucalopride Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance of Prucalopride Safety in Pregnancy

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  prucalopride
• Medical condition to be studied:
  Constipation

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  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:
  616

Study design details

• Main study objective:
  The objective is to evaluate the potential effect of exposure to prucalopride in pregnancy compared with a group of disease-matched pregnant women who are not exposed to prucalopride.
• Outcomes:
  Major Structural Defects in Children, 1. Number of Participants With Spontaneous Abortion/Miscarriage 2. Number of Participants With Stillbirth 3. Number of Participants With Elective Termination/Abortion 4. Number of Participants With Premature Delivery 5. Small for Gestational Age 6. Postnatal Growth Deficiency of Live Born Children 7. Screening for Neurodevelopmental Milestones 8. Hospitalization in Live Born Children
• Data analysis plan:
  Major structural defects in children will be analyzed. The primary comparison will be the birth prevalence of major structural defects between exposed group and unexposed group among pregnancies resulting in at least one live born infant.