Antiphospholipid Syndrome Clinical Trial
Official title:
Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.
Verified date | January 2015 |
Source | Saint Thomas Hospital, Panama |
Contact | n/a |
Is FDA regulated | No |
Health authority | Panama: Ministry of Health |
Study type | Observational |
The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of severe preeclampsia before 34 weeks of gestation, but this was done without solid evidence of a relation between the two. Our study will try to add information to this particular point.
Status | Not yet recruiting |
Enrollment | 310 |
Est. completion date | August 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Gestational age between 24-34 weeks - Diagnosis of severe preeclampsia Exclusion Criteria: - Known antiphospholipid syndrome. - Known presence of antiphospholipid antibodies. - Patients with systemic lupus erythematosus. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Panama | Saint Thomas Maternity Hospital | Panama |
Lead Sponsor | Collaborator |
---|---|
Saint Thomas Hospital, Panama |
Panama,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lupus anticoagulant | Number of cases positive for Lupus Anticoagulant. | 15 months | No |
Primary | Anticardiolipin antibodies | Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies. | 15 months | No |
Primary | B2 Glycoprotein I | Number of cases with levels of B2 Glycoprotein 1 > 99% | 15 months | No |
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