The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Number of Fetal Deaths or Stillbirths
研究概览
简要总结
The Xolair® Pregnancy Registry is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair®. Women exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their pregnancies. The evaluation of infants will be conducted at birth and at 6-month intervals until the infants are 12 months old. Follow-up of the infant will be extended until the infant is 18 months old, if the woman continues Xolair® treatment while breastfeeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have been exposed to at least one dose of Xolair® (whether inadvertent or deliberate) within 8 weeks prior to conception or during pregnancy
排除标准
- •Women not currently pregnant
- •Women exposed to Xolair® not during pregnancy but only while breastfeeding
- •Re-enrollment of women who are pregnant for second (or more) time is not allowed
研究组 & 干预措施
Pregnant Women Exposed to Xolair®
Women who are exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their pregnancies.
干预措施: Xolair® (Drug)
结局指标
主要结局
Number of Fetal Deaths or Stillbirths
时间窗: At Delivery (up to approximately 9 months after enrollment)
Number of Live Births
时间窗: At Delivery (up to approximately 9 months after enrollment)
Number of Elective Terminations
时间窗: At Delivery (up to approximately 9 months after enrollment)
Number of Congenital Birth Anomalies
时间窗: At Delivery (up to approximately 9 months after enrollment)
次要结局
- Gestational Age of Neonates/Infants(Up to approximately 9 months after enrollment)
- Weight of Neonates/Infants(At Delivery (up to approximately 9 months after enrollment))
- Number of Delivery Complications or Abnormalities(At Delivery (up to approximately 9 months after enrollment))
- Number of Infant Illnesses or Infections(Delivery (up to approximately 9 months after enrollment) to 18 months)
- Number of Spontaneous Abortions(At Delivery (up to approximately 9 months after enrollment))
- Number of Pregnancy Complications or Abnormalities(Up to approximately 9 months after enrollment)
- Head Circumference of Neonates/Infants(At Delivery (up to approximately 9 months after enrollment))
- Length of Neonates/Infants(At Delivery (up to approximately 9 months after enrollment))
- Apgar Score of Neonates/Infants(Delivery (up to approximately 9 months after enrollment) to 18 months)
- Neonatal Platelet Count(Delivery (up to approximately 9 months after enrollment) to 18 months)