The primary objective of the Registry was to evaluate the outcomes of pregnancy in women with Multiple Sclerosis (MS) or Crohn's Disease (CD) who were exposed to TYSABRI® at any time within 90 days prior to first day of Last Menstrual Period (LMP) or during pregnancy.
This study was conducted in coordination with the TYSABRI® Global Observational Program in Safety (TYGRIS) observational study in the United States (US), Canada, and Rest of World (ROW). The Coordinating Center (CC) monitored participants throughout their pregnancies and monitored the infants until 8 to 12 weeks of age in the US and Canada, and within 4 weeks after the Estimated Date of Delivery (EDD) in the ROW.
Study Type
OBSERVATIONAL
Enrollment
376
United BioSource Corporation
Morgantown, West Virginia, United States
Number of spontaneous abortions, fetal losses including stillbirths, and ectopic pregnancies
Time frame: Approximately 9 months
Number of elective or therapeutic pregnancy terminations
Time frame: Approximately 9 months
Number of Live Births
Time frame: 4 weeks after the estimated date of delivery
Number of Live Births with Birth Defects
Time frame: 8-12 weeks post-birth
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