Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multiple Sclerosis (MS) is most prevalent among women of childbearing age. The post-partum (PP) period is a critical phase in MS patients, during which a recrudescence of disease activity is expected. Different strategies have been assessed in the prevention of post-partum relapse. High dose methylprednisolone was evaluated in a case control study with historical controls but the positive results have not been confirmed.
In this study, the main objective will be to compare the risk of relapse in the 6 months PP period between patients treated systematically by high dose methylprednisolone after delivery compared to patients who didn't receive a systematic treatment.
The second objective will be focused on the comparison of the disease activity and disability progression in patients who have resumed early a Disease Modifying Drug (DMD) after delivery vs patients who haven't.
Even if two small case control studies underlined the positive effect of high dose methylprednisolone on the relapse risk in the PP period in MS, these data have to be confirmed by a larger study. The impact of such a strategy remains also uncertain concerning the risk of long term disability. In this project, the investigators will also analyze the influence of the delay of DMD reintroduction after delivery on the relapse risk but also on the risk of disability. The results will have an important role in the therapeutic management of the post-partum period in MS patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with corticosteroids | Patients who have systematically been treated by high-dose corticosteroids after the delivery | ||
| Patients without corticosteroids | Patients who haven't been systematically treated by high-dose corticosteroids after the delivery. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Difference of the proportion of patients with >= 1 relapse between the two groups | proportion of patients with >= 1 relapse during the six-month period after delivery between the patients who have systematically been treated by high-dose corticosteroids after the delivery; and patients who haven't been systematically treated by high-dose corticosteroids. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of the proportion of patients with >= 1 relapse | proportion of patients with >= 1 relapse during the six-month period after delivery between patients who have resumed a DMD early after the delivery (during the first two months) compared to a delayed reintroduction, or an absence of reintroduction | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Study of Preventive use of COrticosteroids during the Post-Partum
relapsing MS patients with at least one full pregnancy with live birth between 01/2007 and 01/2017 after the beginning of the MS diagnosis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laure MICHEL, Dr | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital LAENNEC | Saint-Herblain | Nantes | 44800 | France | ||
| CHU Lyon |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Difference of the annualized relapse rate |
Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD |
| 6 months |
| Difference of the annualized relapse rate | Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD | 1 year |
| Difference of the annualized relapse rate | Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD | two years |
| Difference of the time to first relapse | Time to first relapse after delivery between corticosteroids or not and between early DMD vs delayed DMD | Date of delivery |
| Difference of the disability progression | Score of Expanded Disability Status Scale (EDSS) (from 0=no disability, to 10= Death / No sub scales) between corticosteroids or not and between early DMD vs delayed DMD | 6 months |
| Difference of the disability progression | Score of Expanded Disability Status Scale (EDSS) (from 0=no disability, to 10= Death / No sub scales) between corticosteroids or not and between early DMD vs delayed DMD | 1 year |
| Difference of the disability progression | Score of Expanded Disability Status Scale (EDSS) (from 0=no disability, to 10= Death / No sub scales) between corticosteroids or not and between early DMD vs delayed DMD | 2 years |
| Difference of percentage of with Gadolinium enhancing lesions | Difference of percentage of with Gadolinium enhancing lesions during the 6-month period after the delivery between corticosteroids or not and between early DMD vs delayed DMD | 6 months |
| Difference of the number of Gadolinium enhancing lesions | compare the number of Gadolinium enhancing lesions during the 6-month period after the delivery between corticosteroids or not and between early DMD vs delayed DMD | 6 months |
| Lyon |
| France |
| Hôpital Pasteur 2 - CHU Nice | Nice | 06000 | France |
| CHU Rennes | Rennes | 35033 | France |
| CHU Strasbourg | Strasbourg | 67098 | France |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |