The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Frequency of major malformations associated with exposure to fingolimod during pregnancy
研究概览
简要总结
The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.
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
- •Any woman with a diagnosis of MS
- •Any woman currently pregnant
- •Exposure to fingolimod during pregnancy or up to 8 weeks before LMP
- •Signed informed consent
排除标准
- •There are no specific exclusion criteria for this registry.
研究组 & 干预措施
fingolimod
prescribed fingolimod 0.5 mg/day, including generic versions of fingolimod
干预措施: Fingolimod (Drug)
结局指标
主要结局
Frequency of major malformations associated with exposure to fingolimod during pregnancy
时间窗: Up to 23 months
Major malformations are defined as any structural defect with surgical, medical, or cosmetic importance recognized.
Frequency of minor congenital malformations associated to fingolimod during pregnancy
时间窗: Up to 23 months
Minor congenital malformations: * Minor anomalies, i.e., anomalies with no serious medical or cosmetic consequence to the child. * Positional deformities, i.e., a positional deformity that usually normalizes spontaneously after about 3 months of age, e.g., abnormal head shape, torticollis. * Features of pre-maturity. * Chromosome abnormalities. * Genetic disorders.
次要结局
- Number of spontaneous abortions, stillbirths and elective terminations;(Up to 23 months)
- Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy(Up to 23 months)
- Number of occurrence of physical developmental delays as well as adverse effects on immune system development in infants around one year of age(Up to 23 months)