Fabry's Disease and Pregnancy (PREFAB) (PREFAB)
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|ClinicalTrials.gov Identifier: NCT02582294|
Recruitment Status : Terminated (Difficulty in patient recruitment)
First Posted : October 21, 2015
Last Update Posted : February 15, 2019
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|
|Fabry's Disease Pregnancy||Other: Questionnaire|
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||Description of Obstetrical Care, Mainly Anesthesic, in Patients With Fabry's Disease|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||June 1, 2018|
- Proportion of Fabry's disease patients having had an epidural block in childbirth. [ Time Frame: The duration of the interview for this study with women with Fabry disease's will be one hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582294
|Groupe hospitalier Diaconesses Croix Saint Simon|
|Paris, Ile De France, France, 75020|