Primary Outcome Measures:
- Negative birth outcomes, including spontaneous abortions and birth defects. [ Time Frame: During pregnancy up to 12 weeks post-delivery ] [ Designated as safety issue: Yes ]
The Tecfidera (dimethyl fumarate) Pregnancy Registry is a prospective, observational registry designed to evaluate pregnancy outcomes in women with multiple sclerosis (MS) who were exposed to dimethyl fumarate (DMF) since the first day of their last menstrual period prior to conception or at any time during pregnancy. Women of childbearing potential are a considerable segment of the patient population affected by MS and are likely to be exposed to DMF around the time of conception and during pregnancy. Although the data are very limited, there is currently no evidence of increased risk of fetal abnormalities or adverse pregnancy outcomes associated with gestational exposure to DMF during the first trimester. Therefore, it is important to evaluate, in a global pregnancy registry, how DMF exposure may affect pregnancy and infant outcomes. Data will be collected on prospective pregnancies (i.e.enrollment prior to knowledge of outcome) at time of enrollment, 6 to 7 months gestation, and approximately 4 and 12 weeks after estimated date of delivery. The prevalence of spontaneous abortions, birth defects, and other pregnancy and infant outcomes will be calculated and compared to background rates from external sources such as the European Surveillance of Congenital Anomalies.