Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 8
- 主要终点
- Fetal/Infant Outcomes
研究概览
简要总结
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.
详细描述
This observational study will collect prospective and retrospective data in participants exposed to Ultomiris during pregnancy and/or breastfeeding to assess risk of maternal complications, adverse effects on the developing fetus, and adverse effects on the infant.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified).
- •Participant informed consent (written or e-consent per local regulations or ethics committee requirements) must be obtained prior to the participant's enrollment. If the participant is a minor, consent must be obtained from the parent or legal guardian, with assent from the minor (as locally appropriate).
- •Willing to provide contact information for the participant.
- •Willing to authorize HCP(s) to release maternal and infant medical information to the study, upon request, if applicable to current local regulations.
- •Diagnosed with an indication for which Ultomiris is approved, based on HCP or medical records.
- •Exposed to Ultomiris at any point during the defined exposure window based on HCP or medical record documentation. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester or timing of exposure [prior to conception as LMP+14 days, or during breastfeeding].)
- •Use of Ultomiris per local product information (i.e., United States Prescribing Information [USPI] or summary of product characteristics [SmPC])
排除标准
- •Participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectual disabilities) will be excluded from this study
结局指标
主要结局
Fetal/Infant Outcomes
时间窗: In utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk)
Fetal (in Utero)/infant (for Live Born Births) may include major congenital malformation (MCMs), full-term birth, preterm birth, low birth weight, size for gestational age, neonatal death, perinatal death, infant death, serious and severe infections of infants, infant hospitalization, growth delays, and abnormal postnatal growth and development
Pregnancy Complications
时间窗: Up to 4 weeks post-delivery
Pregnancy outcomes
Maternal Complications
时间窗: Up to 4 weeks post-delivery
Maternal Complications may include pre-eclampsia, eclampsia, deep-vein thrombosis (DVT), pregnancy-induced hypertension, gestational diabetes, preterm labor, placenta previa, and postpartum hemorrhage
次要结局
未报告次要终点