Pregnancy Clinical Trial
— PREFABOfficial title:
Description of Obstetrical Care, Mainly Anesthesic, in Patients With Fabry's Disease
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 |
Verified date | February 2019 |
Source | Groupe Hospitalier Diaconesses Croix Saint-Simon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Groupe hospitalier Diaconesses Croix Saint Simon | Paris | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Diaconesses Croix Saint-Simon |
France,
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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