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Antiphospholipid Antibodies and Early Severe Preeclampsia.

This study is not yet open for participant recruitment.
Verified December 2012 by Saint Thomas Hospital, Panama
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01538121
First received: February 19, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes

February 19, 2012
December 3, 2012
December 2012
March 2013   (final data collection date for primary outcome measure)
  • 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%
Same as current
Complete list of historical versions of study NCT01538121 on ClinicalTrials.gov Archive Site
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Antiphospholipid Antibodies and Early Severe Preeclampsia.
Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.

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.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Pregnant patients admitted for severe preeclampsia between 24-34 weeks pf gestation (cases) and normal patients in labor at term (controls).
  • Severe Preeclampsia
  • Antiphospholipid Syndrome
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  • Cases-Early Severe Preeclampsia
    Patients with severe preeclampsia before 34 weeks of gestation
  • Controls
    Patients with normal pregnancies at term.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
310
April 2013
March 2013   (final data collection date for primary outcome measure)

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.
Female
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No
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Panama
 
NCT01538121
MHST2012-01A
No
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
Not Provided
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP