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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01474980
Other study ID # 2010-A00495-34
Secondary ID
Status Completed
Phase N/A
First received November 16, 2011
Last updated November 17, 2011
Start date January 2010
Est. completion date October 2011

Study information

Verified date November 2011
Source Institut de Myologie, France
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date October 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Institut de Myologie, France Assistance Publique - Hôpitaux de Paris
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