French Registry for Monitoring Pregnancies for Multiple Sclerosis

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention: No intervention

Study summary

The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia.

To set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women/children…)

Eligibility

Primary outcome measure(s)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during pregnancy period — up to 2 years
  Description of the current neurological practice of French neurologists regarding disease modifying drugs and desire of pregnancy and evaluation of its short term impact on the risk of relapses.
• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during post-partum period — up to 2 years
  Description of the current neurological practice of French neurologists regarding disease modifying drugs and desire of pregnancy and evaluation of its short term impact on the risk of relapses.

Trial sites (48)

+ 8 more sites — see the full list on the official registry below.

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