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Pregnancy Outcomes in Congenital Myasthenie Syndrome (POCoMS)

This study has been completed.
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Laurent Servais, M.D., Institut de Myologie, France
ClinicalTrials.gov Identifier:
NCT01474980
First received: November 16, 2011
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

This is a retrospective study that follows the clinical evolution, the pregnancy and the post-partum perioad of female patients with Congenital Myasthenic Syndrome.


Condition
Congenital Myasthenic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study :Describe the Changes of the Disease in Many Cases Likely to Aggravate.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut de Myologie, France:

Enrollment: 25
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The aim of this study is to better understand the action of hormonal factors that are presumably incriminated for the fluctuation of the disease. The investigators would also like to better adress the issues of women with Congenital Myasthenic Syndrome, who desire a pregnancy : the possibility of decompensation, the problems that can arise during the course of the childbearing, the risk of foetal malformations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with Congenital Myasthenie Syndrome

Criteria

Inclusion criteria:

  • Adult women
  • Congenital myastenic syndrome genetically confirmed or with clinical compatible and electrophysiological evidence
  • Written consent

Exclusion Criteria:

  • Neurological or general pathology occurs significantly with the initiation and conduct of a pregnancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474980

Sponsors and Collaborators
Institut de Myologie, France
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent SERVAIS, MD, PhD institut myologie
  More Information

No publications provided

Responsible Party: Laurent Servais, M.D., Laurent SERVAIS MD, PhD, Institut de Myologie, France
ClinicalTrials.gov Identifier: NCT01474980     History of Changes
Other Study ID Numbers: 2010-A00495-34
Study First Received: November 16, 2011
Last Updated: November 17, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut de Myologie, France:
Congenital Myasthenic Syndrome
Pregnancy
Outcome

Additional relevant MeSH terms:
Lambert-Eaton Myasthenic Syndrome
Myasthenic Syndromes, Congenital
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 16, 2013