A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention.
- Who it may be relevant to
- Registry conditions: Pregnancy, Obesity, Overweight. Basic parameters: 15 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Wegovy® (Semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy
Overview
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.
Interventions
- Other No Intervention
This is a non-interventional study, therefore no intervention is used.
Primary outcome measures
- Number of Infants with Major Congenital Malformation (MCM) [Time frame: From date of conception (DOC) to pregnancy outcome for foetal losses or 12 months of infant age for live births]
Secondary outcome measures (10)
- Number of Infants with Minor Congenital Malformation [Time frame: From DOC to pregnancy outcome for foetal losses or 12 months of infant age for live births]
- Number of Pregnant Participants With Pre-eclampsia [Time frame: From 20 0/7 gestational weeks to 6 weeks]
- Number of Pregnant Participants With Eclampsia [Time frame: From 20 0/7 gestational weeks to 6 weeks]
- Number of Pregnant Participants Experiencing Spontaneous Abortion [Time frame: From date of conception to 19 6/7 gestational weeks]
- Number of Pregnant Participants Experiencing Stillbirth [Time frame: From 20 0/7 gestational weeks to pregnancy outcome (week 40)]
- Number of Pregnant Participants With Elective Termination [Time frame: From date of conception to pregnancy outcome (week 40)]
- Number of Pregnant Participants With Preterm Delivery [Time frame: From date of conception to 37 gestational weeks (week 37)]
- Number of Infants Experiencing Small for Gestational Age (SGA) Birth [Time frame: At delivery of live birth]
- Number of Infants With Postnatal Growth Deficiency [Time frame: At 4 and 12 months of infant age]
- Number of infants with Developmental Delay [Time frame: At 4 and 12 months of infant age]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Novo Nordisk Investigational Site — Princeton
Spain · 1 center
- Novo Nordisk Investigational Site — Madrid
United Kingdom · 1 center
- Novo Nordisk Investigational Site — London
Identifiers
NCT: NCT05872022 · NN9536-4937 · U1111-1273-4336