A pregnancy exposure registry study to assess clinical follow-up and outcomes of pregnancies exposed to ulipristal acetate 30 mg

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-marketing, non-interventional, web-based joint pregnancy registry. Retrospective collection of pregnancy data and pregnancy outcomes.

Study drug and medical condition

• Medicinal product name:
  ULIPRISTAL
• Study drug International non-proprietary name (INN) or common name:
  ULIPRISTAL ACETATE
• Anatomical Therapeutic Chemical (ATC) code:
  (G03AD02) ulipristal

  ulipristal
• Medical condition to be studied:
  Abortion

  Ectopic pregnancy

Population studied

• Short description of the study population:
  Pregnant women of any age in all European countries where the product will be launched are concerned, as far as they were exposed to Ulipristal 30 mg: ; • during the menstrual cycle in which the pregnancy started or ; • at any time during pregnancy.
• Age groups:
  • 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:
  25

Study design details

• Study design:
  Post-marketing, non-interventional, web-based joint pregnancy registry. Retrospective collection of pregnancy data and pregnancy outcomes.
• Main study objective:
  The primary objective of this pregnancy registry is to collect all data about pregnancy and pregnancy outcome in women exposed to ulipristal acetate 30mg for any reason, e.g. unrecognized pregnancy before intake or product failure.
• Outcomes:
  “Effects on pregnancy maintenance/off-label use”, ; “Risk of incomplete abortion and heavy bleeding”, ; “Effects on foetus and newborns” and ; “Risk of ectopic pregnancy”.
• Data analysis plan:
  Descriptive statistics will be the primary approach for summarizing data from the pregnancy exposure registry. Data will be presented for all subjects enrolled in the registry. No stratified analysis is foreseen or has been planned for this study.