Wegovy® (Semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 728
- 试验地点
- 3
- 主要终点
- Number of Infants with Major Congenital Malformation (MCM)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Participants Exposed to Wegovy
Pregnant women who are exposed to Wegovy at any time during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition will be observed in this prospective observational study.
干预措施: No Intervention (Other)
Participants Unexposed to Wegovy or Other GLP-1 RAs
Pregnant women who have overweight with at least one weight-related comorbid condition or who have obesity at conception and who are 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 will be observed in this prospective observational study.
干预措施: No Intervention (Other)
结局指标
主要结局
Number of Infants with Major Congenital Malformation (MCM)
时间窗: 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.
次要结局
- Number of Pregnant Participants With Pre-eclampsia(From 20 0/7 gestational weeks to 6 weeks)
- Number of Pregnant Participants With Preterm Delivery(From date of conception to 37 gestational weeks (week 37))
- Number of Pregnant Participants With Elective Termination(From date of conception to pregnancy outcome (week 40))
- Number of Infants Experiencing Small for Gestational Age (SGA) Birth(At delivery of live birth)
- Number of Infants with Minor Congenital Malformation(From DOC to pregnancy outcome for foetal losses or 12 months of infant age for live births)
- Number of Infants With Postnatal Growth Deficiency(At 4 and 12 months of infant age)
- Number of Pregnant Participants With Eclampsia(From 20 0/7 gestational weeks to 6 weeks)
- Number of Pregnant Participants Experiencing Spontaneous Abortion(From date of conception to 19 6/7 gestational weeks)
- Number of Pregnant Participants Experiencing Stillbirth(From 20 0/7 gestational weeks to pregnancy outcome (week 40))
- Number of infants with Developmental Delay(At 4 and 12 months of infant age)