Wegovy® (Semaglutide) Database Study: A Population-based 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
- 2,701
- 试验地点
- 2
- 主要终点
- Number of Infants with Major Congenital Malformation (MCM)
研究概览
简要总结
This is an observational cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a reference population not exposed to Wegovy, so that participants and healthcare providers can make informed treatment decisions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Evidence of a pregnancy end event on a medical claim (example, live birth, stillbirth, or spontaneous abortion) during the pregnancy identification period (that is, 04 June 2021 - 17 February 2034).
- •Date of conception between 04 June 2021 and 06 May 2033 (that is last menstrual period (LMP) 43 weeks prior to the latest pregnancy end date).
- •Aged 15-50 and female on the date of the LMP.
- •Continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of conception through 42 days after the pregnancy end date.
- •Among the pregnancies that meet the inclusion criteria, four main cohorts and two sub cohorts of interest will be identified (two Wegovy-exposed cohorts and two comparison cohorts):
- •Wegovy-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated date of conception to end of pregnancy. Two mutually exclusive cohorts will be identified based on first Wegovy exposure during pregnancy.
- •Wegovy injection-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy.
- •Wegovy tablet-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy.
- •Other AOM-exposed- greater than or equal to1 day of phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone exposure, defined as the following:
- •Benzphetamine, diethylpropion, orlistat, or phendimetrazine exposure from one day prior to estimated conception date to end of pregnancy.
- •Phentermine or bupropion/naltrexone exposure from five days prior to estimated conception date to end of pregnancy.
- •Cohort with Overweight/Obesity and at least one weight related comorbid condition-
- •Greater than or equal to 1 diagnosis code for obesity or BMI greater than or equal to 30 kilogram per meter square (kg/m^2) on a medical claim during the six month pre-pregnancy period.
- •Greater than or equal to 1 diagnosis code for BMI greater than or equal to 27 kg/m^2 or less than 30 kg/m^2 on a medical claim and greater than or equal to 1 non-diagnostic medical claim for dyslipidemia, type 2 diabetes mellitus, or hypertension during the six month pre-pregnancy period.
- •No exposure to Wegovy or other AOM during the defined exposure window in pregnancy.
- •Among Wegovy-exposed and Other AOM-exposed pregnancies, the subset with first trimester exposures will be identified as those with greater than or equal to 1 days of exposure at less than 14 WGA.
排除标准
- •Pregnancies exposed to other glucagon-like peptide-1 receptor agonist (GLP-1 RA) during the exposure identification window (that is, 35 days prior to estimated conception date through pregnancy end date).
- •Pregnancies with exposure to both Wegovy and other AOM during the exposure identification window (estimated conception date - 35 days through pregnancy end date).
- •Pregnancies resulting in multiple infants will be excluded from the analysis of infant outcomes.
研究组 & 干预措施
Participants Exposed to Anti-obesity Medication (AOM)
Pregnant participants exposed to other Anti-obesity Medication (AOM) (phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone) during the first trimester (start of exposure identification window based on five times the half-life of each AOM through <14 WGA) and their linked infants will be observed in this observational study.
干预措施: No Intervention (Other)
Participants Exposed to Wegovy injection or Wegovy tablet
Pregnant participants exposed to Wegovy injection or Wegovy tablet during the first trimester (T1) (that is, 35 days prior to the estimated conception date through <14 weeks gestational age [wGA]) and their linked infants will be observed in this observational study.
干预措施: No Intervention (Other)
Overweight/Obese Participants
Pregnant participants with obesity or overweight and at least one weight-related comorbid condition without exposure to Wegovy injection or tablet or other AOM during pregnancy will be observed in this 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: Birth up to 1 year of age
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 infants with Developmental Delay(Birth up to 1 year of age)
- Number of Pregnant Participants Experiencing Stillbirth(up to 37 weeks of gestational age)
- Number of Pregnant Participants With Pre-eclampsia/eclampsia(Up to 37 weeks of gestational age)
- Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB)(up to 37 weeks of gestational age)
- Number of Infants Experiencing Small for Gestational Age (SGA) Birth(Birth up to 1 year of age)
- Number of Infants With Postnatal Growth Deficiency(Birth up to 1 year of age)
- Number of Pregnant Participants With Preterm Delivery(Up to 37 weeks of gestational age)