A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- argenx
- 入组人数
- 279
- 试验地点
- 5
- 主要终点
- Pregnancy outcomes
研究概览
简要总结
This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.
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
- •Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days.
- •Written/verbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written/verbal informed assent or eConsent by the pregnant minor (where applicable) and written/verbal informed consent or eConsent by the parent/legal guardian).
排除标准
- 未提供
研究组 & 干预措施
Retrospective Pregnancy
woman is no longer pregnant at time of study enrollment but was exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy
干预措施: Efgartigimod (Biological)
Prospective Pregnancy
woman is pregnant or breastfeeding at time of study enrollment.
干预措施: Efgartigimod (Biological)
结局指标
主要结局
Pregnancy outcomes
时间窗: up to 10 years
Pregnancy outcomes: Spontaneous abortion; Elective or therapeutic abortion; Fetal death/stillbirth ; Molar or ectopic pregnancy; Live birth (Preterm delivery; Fullterm delivery)
次要结局
- Congenital malformations(up to 10 years)
- The number of observed fetal growth deficiency(up to 10 years)
- The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness)(up to 10 years)
- Maternal complications of pregnancy(up to 10 years)
- Maternal infections(up to 10 years)