French Registry for Monitoring Pregnancies for Multiple Sclerosis (RESPONSE)

January 25, 2024 updated by: Hospices Civils de Lyon

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

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…)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
        • Not yet recruiting
        • CHU d'Amiens
        • Contact:
          • Abdullatif AL KHEDR
        • Principal Investigator:
          • Abdullatif AL KHEDR
      • Besançon, France, 25030
        • Not yet recruiting
        • Hopital Jean Minjoz
        • Contact:
          • Eric BERGER
        • Principal Investigator:
          • Eric BERGER
      • Bordeaux, France, 33076
        • Not yet recruiting
        • Hopital Pellegrin
        • Contact:
          • Bruno BROCHET
        • Principal Investigator:
          • Bruno BROCHET
      • Bron, France, 69677
        • Recruiting
        • Hôpital Neurologique Pierre Wertheimer
        • Contact:
        • Principal Investigator:
          • Sandra VUKUSIC
      • Caen, France, 14033
        • Not yet recruiting
        • Hôpital Côte de Nacre
        • Contact:
          • Gilles DEFER
        • Principal Investigator:
          • Gilles DEFER
      • Clermont-Ferrand, France, 63003
        • Not yet recruiting
        • Hôpital Gabriel Montpied
        • Contact:
          • Pierre CLAVELOU
        • Principal Investigator:
          • Pierre Clavelou
      • Corbeil-Essonnes, France, 91100
        • Not yet recruiting
        • Centre Hospitalier Sud Francilien
        • Contact:
          • Ivania PATRY
        • Principal Investigator:
          • Ivania PATRY
      • Créteil, France, 94010
        • Not yet recruiting
        • Hôpital Henri Mondor
        • Contact:
          • Alain CREANGE
        • Principal Investigator:
          • Alain CREANGE
      • Dijon, France, 21079
        • Not yet recruiting
        • Hopital Du Bocage
        • Contact:
          • Thibault MOREAU
        • Principal Investigator:
          • Thibault MOREAU
      • Grenoble, France, 38043
        • Not yet recruiting
        • CHU de Grenoble
        • Contact:
          • Olivier CASEZ
        • Principal Investigator:
          • Olivier CASEZ
      • Le Chesnay, France, 78157
        • Not yet recruiting
        • Centre Hospitalier de Versailles Hôpital Andre Mignot
        • Contact:
          • Chantal NIEFLE
        • Principal Investigator:
          • Chantal NIEFLE
      • Lille, France, 59037
        • Not yet recruiting
        • CHRU de Lille
        • Contact:
          • Patrick VERMERSCH
        • Principal Investigator:
          • Patrick VERMERSCH
      • Limoges, France, 87042
        • Not yet recruiting
        • Hôpital Dupuytren
        • Contact:
          • Laurent MAGY
        • Principal Investigator:
          • Laurent MAGY
      • Marseille, France, 13385
        • Not yet recruiting
        • Hopital Timone Adultes
        • Contact:
          • Jean PELLETIER
        • Principal Investigator:
          • Jean PELLETIER
      • Montpellier, France, 34295
        • Not yet recruiting
        • Hopital Gui de Chauliac
        • Contact:
          • Pierre LABAUGE
        • Principal Investigator:
          • Pierre Labauge
      • Nancy, France, 54035
        • Not yet recruiting
        • Hôpital Central
        • Contact:
          • Marc DEBOUVERIE
        • Principal Investigator:
          • Marc DEBOUVERIE
      • Nice, France, 06001
        • Not yet recruiting
        • Hôpital Pasteur
        • Contact:
          • Christine LEBRUN-FRENAY
        • Principal Investigator:
          • Christine LEBRUN-FRENAY
      • Nîmes, France, 30029
        • Not yet recruiting
        • Hopital Caremeau
        • Principal Investigator:
          • Eric THOUVENOT
        • Contact:
          • Eric THOUVENOT
      • Paris, France, 75019
        • Not yet recruiting
        • Fondation Rotschild
        • Contact:
          • Olivier GOUT
        • Principal Investigator:
          • Olivier GOUT
      • Paris, France, 75570
        • Not yet recruiting
        • Hopital Saint Antoine
        • Contact:
          • Bruno STANKOFF
        • Principal Investigator:
          • Bruno STANKOFF
      • Paris, France, 75651
        • Not yet recruiting
        • Hopital Pitie Salpetriere
        • Contact:
          • Catherine LUBETZKI
        • Principal Investigator:
          • Catherine LUBETZKI
      • Poissy, France, 78303
        • Not yet recruiting
        • Chi Poissy Saint Germain En Laye
        • Contact:
          • Olivier HEINZLEF
        • Principal Investigator:
          • Olivier Heinzlef
      • Poitiers, France, 86021
        • Not yet recruiting
        • Chr La Miletrie
        • Contact:
          • Jean-Philippe NEAU
        • Principal Investigator:
          • Jean-Philippe NEAU
      • Pontoise, France, 95300
        • Not yet recruiting
        • Hôpital René Dubos
        • Contact:
          • Corinne DUPEL-POTTIER
        • Principal Investigator:
          • Corinne DUPEL-POTTIER
      • Reims, France, 51092
        • Not yet recruiting
        • Hopital de La Maison Blanche
        • Contact:
          • Ayman TOURBAH
        • Principal Investigator:
          • Ayman TOURBAH
      • Rennes, France, 35033
        • Not yet recruiting
        • Hôpital Pontchaillou
        • Contact:
          • Gilles EDAN
        • Principal Investigator:
          • Gilles EDAN
      • Rouen, France, 76000
        • Not yet recruiting
        • Hôpital Charles-Nicolle
        • Contact:
          • Bertrand BOURRE
        • Principal Investigator:
          • Bertrand BOURRE
      • Saint-Denis, France, 93200
        • Not yet recruiting
        • Centre Hospitalier de Saint-Denis
        • Contact:
          • Thomas DEBROUCKER
        • Principal Investigator:
          • Thomas DEBROUCKER
      • Saint-Herblain, France, 44800
        • Not yet recruiting
        • Hopital G. Et R. Laennec
        • Contact:
          • David LAPLAUD
        • Principal Investigator:
          • David LAPLAUD
      • Saint-Priest-en-Jarez, France, 42277
        • Not yet recruiting
        • Hopital Nord
        • Principal Investigator:
          • Jean-Philippe CAMDESSANCHE
        • Contact:
          • Jean-Philippe CAMDESSANCHE
      • Strasbourg, France, 67098
        • Not yet recruiting
        • Hôpital Hautepierre
        • Contact:
          • Jérôme DE SEZE
        • Principal Investigator:
          • Jérôme De Sèze
      • Toulouse, France, 31059
        • Not yet recruiting
        • Hôpital Purpan
        • Contact:
          • David BRASSAT
        • Principal Investigator:
          • David BRASSAT
      • Tours, France, 37044
        • Not yet recruiting
        • CHRU de Tours Hôpital Bretonneau
        • Contact:
          • Anne-Marie GUENNOC
        • Principal Investigator:
          • Anne-Marie GUENNOC
  • Martinique
      • Fort-de-France, Martinique, 97200
        • Not yet recruiting
        • Hopital P. Zobda-Quitman
        • Contact:
          • Philippe CABRE
        • Principal Investigator:
          • Philippe CABRE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with multiple sclerosis or related neurological syndromes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women with multiple sclerosis or related neurological
Children born to women with multiple sclerosis or related neurological syndromes.
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during pregnancy period
Time Frame: 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.
up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during post-partum period
Time Frame: 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.
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sandra VUKUSIC, Prof., Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2019

Primary Completion (Estimated)

August 12, 2030

Study Completion (Estimated)

August 12, 2030

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0631
  • 2018-A02552-53 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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