Clinical trial NCT05872022: A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy
Official title: Wegovy® (Semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pregnancy
Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 728
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant participants exposed to Wegovy during pregnancy, and pregnant participants who were not exposed to Wegovy or other GLP-1 RAs at any time during pregnancy but who may be exposed to other products for weight management with obesity and overweight were to be observed prospectively.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Infants with Major Congenital Malformation (MCM)
timeFrame: From date of conception (DOC) to pregnancy outcome for foetal losses or 12 months of infant age for live births
Secondary outcomes:
measure: Number of Infants with Minor Congenital Malformation
timeFrame: From DOC to pregnancy outcome for foetal losses or 12 months of infant age for live births
measure: Number of Pregnant Participants With Pre-eclampsia
timeFrame: From 20 0/7 gestational weeks to 6 weeks
measure: Number of Pregnant Participants With Eclampsia
timeFrame: From 20 0/7 gestational weeks to 6 weeks
measure: Number of Pregnant Participants Experiencing Spontaneous Abortion
timeFrame: From date of conception to 19 6/7 gestational weeks
measure: Number of Pregnant Participants Experiencing Stillbirth
timeFrame: From 20 0/7 gestational weeks to pregnancy outcome (week 40)
measure: Number of Pregnant Participants With Elective Termination
timeFrame: From date of conception to pregnancy outcome (week 40)
measure: Number of Pregnant Participants With Preterm Delivery
timeFrame: From date of conception to 37 gestational weeks (week 37)
measure: Number of Infants Experiencing Small for Gestational Age (SGA) Birth
timeFrame: At delivery of live birth
measure: Number of Infants With Postnatal Growth Deficiency
timeFrame: At 4 and 12 months of infant age
measure: Number of infants with Developmental Delay
timeFrame: At 4 and 12 months of infant age
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: