G35
Conditions
Interventions
Group 1: Standardized telephone interviews in every remaining trimester after enrollment as well as 2, 6, and 12 months postpartum.
Sponsors
Katholisches Klinikum Bochum gGmbH, Neurologische Universitätsklinik der Ruhr Universität Bochum, St. Josef Hospital, Deutsches MS und Kinderwunschregister
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Ability to understand the purpose of the study • Provide informed consent • Pregnant at the time of enrolment • RRMS Diagnose • Consent to follow up the development of the infant up to the age of 1 year • Alemtuzumab or teriflunomide treatment during the period of 365 days prior to conception (treatment group) or • treatment with natalizumab or fingolimod prior to pregnancy, at least one relapse per year under basic treatment or at least two relapses per year without treatment prior to pregnancy (highly active control group) or • basic treatment prior to pregnancy (active control group)
Exclusion criteria
Exclusion criteria: • Unable or unwilling to provide informed consent • Contacted the German Multiple Sclerosis and Pregnancy Registry due to a relapse during pregnancy • Pregnancy outcome is already known at the time of enrolment • PPMS or SPMS Diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this study is defined as the number of women suffering from one or more relapse between LMP and date of delivery (during pregnancy). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Multiple Sclerosis disease activity (relapses and disability) prior to, during and after pregnancy a. Number of women suffering from one or more relapse during the last 365 days prior to LMP b. Number of occurred relapses during the last 365 days prior to LMP c. Relapse rate in the year prior to LMP d. Number of occurred relapses during pregnancy e. Relapse rates per trimester f. Number of women suffering from one or more relapse during the first 365 days postpartum g. Number of occurred relapses during the first 365 days postpartum h. Relapse rate in the first year postpartum i. Time to first relapse postpartum j. Number of women suffering from disability progression k. Number of women breastfeeding exclusively l. Time to first supplemental feeding • Pregnancy outcomes a. Number of live births, spontaneous abortions, elective abortions due to social reasons, elective abortions due to medical reasons, miscarriages, stillbirths, preterm births, minor congenital abnormalities and major congenital abnormalities. b. Birth weight and birth length of the newborn • Disease activity (relapses and disability) prior, during and after pregnancy, pregnancy outcomes as well as breastfeeding behavior and child development in a control group. a. Number of women suffering from one or more relapse during the last 365 days prior to LMP b. Number of occurred relapses during the last 365 days prior to LMP c. Relapse rate in the year prior to LMP d. Number of occurred relapses during pregnancy e. Relapse rates per trimester f. Number of women suffering from one or more relapse during the first 365 days postpartum g. Number of occurred relapses during the first 365 days postpartum h. Relapse rate in the first year postpartum i. Time to first relapse postpartum j. Number of women suffering from disability progression k. Number of women breastfeeding exclusively l. Time to first supplemental feeding m. Number of congenital abnormalities, chronic diseases, an | — |
Countries
Germany
Contacts
Public ContactKerstin Hellwig
Katholisches Klinikum Bochum gGmbH, Neurologische Universitätsklinik der Ruhr Universität Bochum, St. Josef Hospital, Deutsches MS und Kinderwunschregister
Outcome results
None listed