Trial record 17 of 32 for:
Antiphospholipid Antibodies and Early Severe Preeclampsia.
This study is not yet open for participant recruitment.
Verified June 2013 by Saint Thomas Hospital, Panama
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
First received: February 19, 2012
Last updated: June 30, 2013
Last verified: June 2013
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.
Primary Outcome Measures:
- Lupus anticoagulant [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Number of cases positive for Lupus Anticoagulant.
- Anticardiolipin antibodies [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.
- B2 Glycoprotein I [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Number of cases with levels of B2 Glycoprotein 1 > 99%
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
Cases-Early Severe Preeclampsia
Patients with severe preeclampsia before 34 weeks of gestation
Patients with normal pregnancies at term.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Pregnant patients admitted for severe preeclampsia between 24-34 weeks pf gestation (cases) and normal patients in labor at term (controls).
- Gestational age between 24-34 weeks
- Diagnosis of severe preeclampsia
- Known antiphospholipid syndrome.
- Known presence of antiphospholipid antibodies.
- Patients with systemic lupus erythematosus.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538121
|Saint Thomas Maternity Hospital
|Panama, Panama |
Saint Thomas Hospital, Panama
||Osvaldo A Reyes, MD
||Saint Thomas Hospital, Panama
No publications provided
||Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 19, 2012
||June 30, 2013
||Panama: Ministry of Health
Keywords provided by Saint Thomas Hospital, Panama:
Antibodies, B2 Glycoprotein I
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2013
Immune System Diseases
Physiological Effects of Drugs