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.
Study Type
OBSERVATIONAL
Enrollment
312
fingolimod 0.5 mg/day, including generic versions of fingolimod
Frequency of major malformations associated with exposure to fingolimod during pregnancy
Major malformations are defined as any structural defect with surgical, medical, or cosmetic importance recognized.
Time frame: Up to 23 months
Frequency of minor congenital malformations associated to fingolimod during pregnancy
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.
Time frame: Up to 23 months
Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy
Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy would be collected
Time frame: Up to 23 months
Number of spontaneous abortions, stillbirths and elective terminations;
Number of spontaneous abortions, stillbirths and elective terminations will be collected to characterize the nature of pregnancy and other fetal outcomes associated with exposure to fingolimod during pregnancy
Time frame: 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
Number of occurrence of physical developmental delays as well as adverse effects on immune system development in infants around one year of age associated with exposure to fingolimod during pregnancy
Time frame: Up to 23 months
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