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

Purpose

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.

Condition
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:

MedlinePlus related topics: Blood Thinners

U.S. FDA Resources

Further study details as provided by Saint Thomas Hospital, Panama:

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:	310
Study Start Date:	December 2012
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cases-Early Severe Preeclampsia Patients with severe preeclampsia before 34 weeks of gestation
Controls Patients with normal pregnancies at term.

Eligibility

Genders 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).

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538121

Locations

Panama
Saint Thomas Maternity Hospital
Panama, Panama

Sponsors and Collaborators

Saint Thomas Hospital, Panama

Investigators

Principal Investigator:

Osvaldo A Reyes, MD

Saint Thomas Hospital, Panama

More Information

No publications provided

Responsible Party:	Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:	NCT01538121 History of Changes
Other Study ID Numbers:	MHST2012-01A
Study First Received:	February 19, 2012
Last Updated:	December 3, 2012
Health Authority:	Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:

Antibodies, anticardiolipin
Antibodies, B2 Glycoprotein I
Lupus Anticoagulant
Severe Preeclampsia

Additional relevant MeSH terms:

Antiphospholipid Syndrome
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Autoimmune Diseases
Immune System Diseases
Antibodies

Immunoglobulins
Antibodies, Antiphospholipid
Antibodies, Anticardiolipin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

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