Clinical trial

A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

Invitation only Β· Not applicable Β· 3 countries Β· Registry ID NCT05872022

Invitation onlyNot applicableObservational

What this study is about

This is an observational, prospective Wegovy (semaglutide 2.4 milligram \[mg\]) Pregnancy Registry Study. The aim of this study is to compare the maternal, foetal, and infant outcomes of pregnant women who are exposed to Wegovy during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition with outcomes in an internal comparison cohort of pregnant women with obesity or overweight with at least one weight related comorbid condition at conception and who are not exposed to Wegovy or other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) during pregnancy. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age15 Years to 50 Years
SexFemale
Healthy volunteersNot listed
ConditionPregnancy, Obesity, Overweight

Full registry criteria

Inclusion Criteria: * Signed consent obtained before any study-related activities * Female 15-50 years of age at the time of signing consent * Currently or recently pregnant * Resident of country included in the study * Authorisation for her HCP(s) to provide data to the registry * Exposed to Wegovy cohort: Exposure to at least one dose of Wegovy at any time during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition. * Unexposed to Wegovy cohort: Have obesity or overweight with at least one weight related comorbid condition at conception Exclusion Criteria: * Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation * Unexposed to Wegovy cohort: Exposure to Wegovy or other GLP-1 RA at any time during pregnancy

Treatments and study arms

No Intervention

Other

This is a non-interventional study, therefore no intervention is used.

Primary outcomes

Number of Infants with Major Congenital Malformation (MCM)From date of conception (DOC) to pregnancy outcome for foetal losses or 12 months of infant age for live births

Number of infants with MCM is defined as an abnormality of body structure or function that is present at birth; is of prenatal origin (that is, birth defect); has significant medical, social, or cosmetic consequences for the affected individual; and typically requires medical intervention.

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Novo Nordisk Investigational SiteπŸ‡ͺπŸ‡Έ Madrid, Spain
Novo Nordisk Investigational SiteπŸ‡¬πŸ‡§ London, United Kingdom
Novo Nordisk Investigational SiteπŸ‡ΊπŸ‡Έ Princeton, New Jersey, United States