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Fabry's Disease and Pregnancy (PREFAB)

Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon (Other)
Overall Status
Terminated
CT.gov ID
NCT02582294
Collaborator
(none)
12
Enrollment
1
Location
32
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Fabry's disease is a progressive systemic disease X-linked which combines neurological (Fabry's pain crises), dermatologic (angiokeratomas), renal (renal failure), cardiovascular (hypertrophic cardiomyopathy, valvular disease, conduction disorder, coronary heart disease) and cerebral vascular (stroke) symptoms .

It is a glycosphingolipid metabolism disorder due to deficient or absent activity of the alpha-galactosidase A, causing accumulation of globotriaosylceramide in the lysosomes.

The incidence is estimated being 1/40 000. Some patients suffering from Fabry's disease today are of childbearing age and their multidisciplinary care (by neurologists, obstetricians and anesthetists) raises several questions.

About the anesthetic, the question of epidural block is debated in patients with neurological diseases and recommendations are not unequivocal.

Indeed one of the problems of the management in those conditions is the potential worsening of the disease because of the anesthetic procedure. In addition, the possibility of an antiplatelet and / or an anticoagulant treatment in these patients may also contre-indicate an epidural block.

The rate of epidural block achieved in patients with Fabry's disease is not currently known. Moreover, only sparse data on pregnancy outcomes in these patients are reported.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Study Design

Study Type:
Observational
Actual Enrollment :
12 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Description of Obstetrical Care, Mainly Anesthesic, in Patients With Fabry's Disease
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Outcome Measures

Primary Outcome Measures

  1. Proportion of Fabry's disease patients having had an epidural block in childbirth. [The duration of the interview for this study with women with Fabry disease's will be one hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Fabry's disease patients, aged 18 years or more, having had at least one childbirth
Exclusion Criteria:

  • Patient under a legal protection procedure

  • Patient denying to participate to the study

  • Lack of affiliation to a social security system

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe hospitalier Diaconesses Croix Saint Simon Paris Ile De France France 75020

Sponsors and Collaborators

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Groupe Hospitalier Diaconesses Croix Saint-Simon
ClinicalTrials.gov Identifier:
NCT02582294
Other Study ID Numbers:
  • OLE_2015_4
First Posted:
Oct 21, 2015
Last Update Posted:
Feb 15, 2019
Last Verified:
Feb 1, 2019
Additional relevant MeSH terms:
Fabry Disease

Study Results

No Results Posted as of Feb 15, 2019