Multiple Sclerosis, Pregnancy
Conditions
Brief summary
This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy.
Detailed description
There are no mandatory physician visits. The registry will collect pregnancy outcome data from the participants health care provider during the prenatal follow up (6-7 months gestation), pregnancy outcome (4 weeks after estimated delivery date) and finally the pediatric follow up (at 4 weeks and 12 weeks post birth).
Interventions
DRUGFampridine
As prescribed and taken after the last menstrual period prior to becoming pregnant or anytime during the pregnancy
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Documentation that the patient was exposed to prolonged-release fampridine since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy. (If exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure.) * The outcome of the pregnancy must not be known at the time of report. Key
Exclusion criteria
* None NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous abortions | < 22 weeks of gestation |
| Elective or therapeutic terminations | Up to 9 months of pregnancy |
| Ectopic pregnancy | Up to 9 months of pregnancy |
| Fetal death including still births | >22 weeks of gestation or weighing 500 grams |
| Live born infants | During delivery time ( at expected average 9 months of pregnancy) |
| Premature births | Delivered before 37 Weeks of gestation |
| Maternal death | During pregnancy, labor or delivery |
| Neonatal death | Prior to 28 days of life |
| Birth Defects | Delivery time (expected 9 months of pregnancy) |
Countries
France
Outcome results
None listed