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Идёт набор NCT03900221

French Registry for Monitoring Pregnancies for Multiple Sclerosis

— Наблюдательное Sclerosis, Multiple Neuromyelitis Optica Spectrum Disorder Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders Pregnancy Abnormal

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No intervention.
Кому может быть актуально
Состояния в реестре: Sclerosis, Multiple, Neuromyelitis Optica Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders, Pregnancy Abnormal. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция, Martinique
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort

Обзор

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…)

Подробное описание

METHODOLOGY Prospective, observational, multicentric and national epidemiological study, within the scope of the OFSEP, including all groups of patients eligible to participate in the Observatoire Français de la Sclérose en Plaque (OFSEP) (definite MS, radiologically isolated syndromes, clinically isolated syndromes, neuromyelitis optica (NMO) and NMO spectrum disorders), with no age limit and an ongoing pregnancy. Women will be followed during pregnancy and in the year after and their children until 6 years of age.

STATISTICAL ANALYSIS To be determined for each specific question. EXPECTED RESULTS Interactions between pregnancy and MS course have been well characterized before the therapeutic era. Neurologists and patients are lacking information to weigh benefits and risks of DMDs used immediately before or during pregnancy, including short and long-term risks to the mother and to the child, but also after delivery. This study should help provide better answers to those questions as well as to still controversial questions about locoregional analgesia and breastfeeding. By following these patients within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, the investigator will also have access to a comprehensive description of MS before pregnancy but also in the long term.

Вмешательства

  • Другое No intervention
    No intervention

Первичные конечные точки

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during pregnancy period [Срок оценки: up to 2 years]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during post-partum period [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

  • All groups of patients eligible to participate to the Observatoire Français de la Sclérose en Plaque (OFSEP), including :
  • Definite Multiple sclerosis (MS) according to McDonald criteria
  • Whatever the clinical course (single attack MS, relapsing-remitting MS, secondary progressive MS, primary progressive MS)
  • Radiologically Isolated Syndromes (RIS) (will be validated by the RIS expert group)
  • Clinically Isolated Syndromes (CIS)
  • Neuromyelitis optica (NMO) and NMO spectrum disorders (will be validated by the "Neuro-optico-myélite aiguë de Devic et des syndromes neurologiques apparentés" (NOMADMUS) expert group)
  • No age limit (patients under the age of 18 might be included, provided informed consent is obtained from the parents)
  • Ongoing pregnancy: there will be no limit in the gestational age at inclusion. Women can be included at any time before delivery, but the gestational age at inclusion will be recorded and introduced in the analyses whenever pertinent. However, neurologists and patients will be encouraged to start the study as soon as pregnancy is diagnosed.
  • Able to give informed consent
  • Able to read and/or understand French

Критерии исключения

  • None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 47 центров
  • Chu D'Amiens — Amiens
  • Centre Hospitalier Annecy Genevois — Annecy
  • Centre Hospitalier d'Avignon — Avignon
  • Hopital Jean Minjoz — Besançon
  • Hopital Pellegrin — Bordeaux
  • Hôpital de Brive — Brive-la-Gaillarde
  • Hôpital Neurologique Pierre Wertheimer — Bron
  • Hopital Cote de Nacre — Caen
  • … и ещё 39 центров
Martinique · 1 центр
  • Hopital P. Zobda-Quitman — Fort-de-France

Идентификаторы

NCT: NCT03900221 · 69HCL18_0631 · 2018-A02552-53

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗