NN9536-4937 Wegovy® (semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy during Pregnancy

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SEMAGLUTIDE
• Medical condition to be studied:
  Obesity
• Additional medical condition(s):
  pregnant women with overweight or obesity

Population studied

• 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:
  728

Study design details

• Main study objective:
  The primary objective is to compare the overall prevalence of Major Congenital Malformations (MCM) between cohorts.
• Outcomes:
  Number of Infants with Major Congenital Malformation (MCM), Number of Infants with: Minor Congenital Malformation Postnatal Growth Deficiency Developmental Delay Small for Gestational Age (SGA) Birth Number of Pregnant Participants With: Pre-eclampsia Eclampsia Elective Termination Preterm Delivery Number of pregnant Participants Experiencing: Spontaneous Abortion Stillbirth
• Data analysis plan:
  Registry data will be summarised in tables and listings by study cohort, as appropriate. Comparisons of demographic and baseline characteristics and prevalence of the outcomes will be conducted between the study cohorts. In addition, the prevalence of the outcomes in the general population and/or populations of women with overweight or obesity will be used to put the registry-observed outcome prevalences into context.