Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,828
- 试验地点
- 1
- 主要终点
- Prevalence of major congenital malformations among infants
研究概览
简要总结
The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 49 years on date of conception
- •Date of conception between June 1, 2021 and September 1, 2030
- •Continuous medical and pharmacy coverage for a minimum of 6 months prior to date of last menstrual period through the end of the pregnancy episode
- •Diagnosis of UC during the 12 months prior to conception through the end of the first trimester
排除标准
- •• Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)
研究组 & 干预措施
Ozanimod exposed
干预措施: Ozanimod (Drug)
Conventional therapy exposed
干预措施: Conventional therapy (Drug)
Advanced therapy exposed
干预措施: Advanced therapy (Drug)
结局指标
主要结局
Prevalence of major congenital malformations among infants
时间窗: Up to 10 years
To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy.
次要结局
- Number of spontaneous abortions(Up to 10 years)
- Number of participants with pre-eclampsia(Up to 10 years)
- Number of preterm births(Up to 10 years)
- Number of infants small for gestational age(Up to 10 years)
- Number of infant postnatal growth deficiencies(Up to 10 years)
- Number of infant developmental deficiencies(Up to 10 years)
- Number of neonatal hospitalizations(Up to 10 years)
- Number of participants with eclampsia(Up to 10 years)
- Number of serious or opportunistic infections in liveborn infants up to 1 year of age(Up to 10 years)
- Number of stillbirths(Up to 10 years)
- Number of infant deaths(Up to 10 years)
- Number of neonatal deaths(Up to 10 years)
- Number of perinatal deaths(Up to 10 years)