Multiple Sclerosis, Pregnancy, Prenatal Exposure Delayed Effects
Conditions
Keywords
AVONEX, Pregnancy
Brief summary
The primary objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy, where the outcome of the pregnancy was unknown prospectively and to prospectively record and analyze pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who may have been exposed to Avonex with approximately 1 week of conception or during the first trimester of pregnancy.
Interventions
Exposure to Avonex during pregnancy
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Have been exposed to AVONEX within approximately 1 week of conception or during the first trimester of pregnancy. * Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively). * Provide verbal consent to participate in the Registry. * Verbally provide contact information for herself, her HCP, and the infant's HCP (if applicable). NOTE: Other protocol defined inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Record and analyze birth defects and spontaneous fetal losses | Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy |
| Record and analyze pregnancy outcomes | Prospectively, MS women who stopped therapy, but may have been exposed to Avonex within 1 week of conception or during the first trimester of pregnancy |
Countries
United States
Outcome results
None listed