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Antiphospholipid Antibodies and Early Severe Preeclampsia.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama Identifier:
First received: February 19, 2012
Last updated: January 1, 2015
Last verified: January 2015
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.

Severe Preeclampsia
Antiphospholipid Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.

Resource links provided by NLM:

Further study details as provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • Lupus anticoagulant [ Time Frame: 15 months ]
    Number of cases positive for Lupus Anticoagulant.

  • Anticardiolipin antibodies [ Time Frame: 15 months ]
    Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.

  • B2 Glycoprotein I [ Time Frame: 15 months ]
    Number of cases with levels of B2 Glycoprotein 1 > 99%

Estimated Enrollment: 310
Study Start Date: June 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: July 2016 (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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients admitted for severe preeclampsia between 24-34 weeks pf gestation (cases) and normal patients in labor at term (controls).

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.
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Please refer to this study by its identifier: NCT01538121

Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
  More Information

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama Identifier: NCT01538121     History of Changes
Other Study ID Numbers: MHST2012-01A
Study First Received: February 19, 2012
Last Updated: January 1, 2015

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Antibodies, anticardiolipin
Antibodies, B2 Glycoprotein I
Lupus Anticoagulant
Severe Preeclampsia

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Hypertension, Pregnancy-Induced
Pregnancy Complications
Autoimmune Diseases
Immune System Diseases
Antibodies, Antiphospholipid
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017