Pregistry International Pregnancy Exposure Registry (PIPER)

Study type

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

  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Pregnancy registry

Study drug and medical condition

• Medical condition to be studied:
  Pregnancy

  Drug exposure before pregnancy

  Stillbirth

  Abortion spontaneous

  Gestational hypertension

  COVID-19

Population studied

• Age groups:
  • Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  The aims of the Pregistry International Pregnancy Exposure Registry (PIPER) are to provide early signals of risk after prenatal exposure to medical products and to define boundaries of safety for medical products. The goal is to assist prescribers and study participants in weighing the potential risks of prenatal treatments on the wellbeing of mother and the unborn offspring.
• Outcomes:
  Risk of obstetric, neonatal, and infant outcomes.
• Data analysis plan:
  There are no a priori defined primary or secondary endpoints in the PIPER. The aim is to conduct surveillance of adverse events (AEs) potentially associated with prescription medical products in the United States. As described below, the analyses will include a descriptive component, a real-time disproportional reporting evaluation, a clinical assessment of similar cases, and analyses of causal inference.