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NCT02582294 Clinical Trial

Fabry's Disease and Pregnancy (PREFAB)

Pregnancy Clinical Trial

— PREFAB  

Official title:
Description of Obstetrical Care, Mainly Anesthesic, in Patients With Fabry's Disease

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02582294
Other study ID # OLE_2015_4
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 2015
Est. completion date June 1, 2018

Study information
Verified date February 2019
Source Groupe Hospitalier Diaconesses Croix Saint-Simon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire

Locations
Country Name City State
France Groupe hospitalier Diaconesses Croix Saint Simon Paris Ile De France

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier Diaconesses Croix Saint-Simon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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