Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Safety study (incl. comparative)
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

  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)

Estimated number of subjects

100
Study design details

Main study objective

The objective is to study to assess relative 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 Terminations (Discontinuation of Pregnancy) 3. Percentage of Participants With Stillbirths 4. Percentage of Participants With Preterm Delivery 5.Percentage of Infants With Small for Gestational Age 6. Percentage of Infants With Neonatal Intensive Care Unit Admission. 7. Percentage of Infants With Hospitalizations 8. Percentage of Participants With Poor Growth and Developmental Delays or Disorders.

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 constipation drugs or no exposure to any prescription medications for constipation.