Betaseron Pregnancy Registry

Because informed consent is required, the Registration process must be initiated by the patient. An HCP who contacts the Registry may request an authorization for release of medical information packet or have the eligible patient contact the Registry directly. Once an eligible subject provides consent and permission to obtain information from her HCP, the Registry will contact the obstetric HCP and obtain information on demographics, history of previous pregnancies, maternal risk factors, pregnancy outcome, and neonatal health. Data will be collected from the maternal HCP at enrollment, during the second trimester (around week 20), and at outcome. Data on live born infants will be collected from the pediatrician at 4 months of age. If a birth defect is reported, targeted follow-up may be conducted.

NOTE: This study has previously been posted by Berlex, Inc. which has since been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of this pregnancy registry.

Inclusion criteria

The subjects must meet the following criteria for registration:

• Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
• Diagnosed with MS prior to or during the current pregnancy
• Exposed to Betaseron® on or after the first day of the patient's last menstrual period
• Provide verbal consent to participate in the Registry
• Verbally provide contact information for herself, her HCP, and the infant's HCP (as applicable)