An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden
Active, not recruiting
- Conditions
- Multiple Sclerosis (MS)
- Registration Number
- NCT06053749
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 4
Inclusion Criteria
Inclusion Criteria:<br><br> - Women with a diagnosis of MS disease, regardless of MS clinical type, recorded at<br> least once during the full study period.<br><br> - Women with at least one recorded pregnancy after the MS diagnosis (including<br> pregnancies ending in live birth, stillbirth, spontaneous abortion, ectopic<br> pregnancy, or elective termination)<br><br>Exclusion Criteria:<br><br> - None.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of pregnancies of women with MS, not allowing exposure to other MS Disease Modifying Drugs (MSDMDs);The level of precision for the risk of pre-defined adverse pregnancy outcomes in late pregnancy that can be obtained with the available number of exposed and unexposed pregnancies;The annual number of pregnancies of women with MS in the exposure groups
- Secondary Outcome Measures
Name Time Method The number of pregnancies of women with MS in Finland and Sweden in exposure groups allowing exposure to other MSDMDs;The annual number of women with MS in childbearing age, and with dispensed IFNB