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Trial record 1 of 8 for:    severe preeclampsia | Panama
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Antiphospholipid Antibodies and Early Severe Preeclampsia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01538121
Recruitment Status : Unknown
Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2012
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Tracking Information
First Submitted Date February 19, 2012
First Posted Date February 23, 2012
Last Update Posted Date January 5, 2015
Study Start Date June 2015
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2012)
  • 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%
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01538121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Antiphospholipid Antibodies and Early Severe Preeclampsia.
Official Title Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Severe Preeclampsia
  • Antiphospholipid Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • Cases-Early Severe Preeclampsia
    Patients with severe preeclampsia before 34 weeks of gestation
  • Controls
    Patients with normal pregnancies at term.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 19, 2012)
310
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Panama
Removed Location Countries  
 
Administrative Information
NCT Number NCT01538121
Other Study ID Numbers MHST2012-01A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Study Sponsor Saint Thomas Hospital, Panama
Collaborators Not Provided
Investigators
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
PRS Account Saint Thomas Hospital, Panama
Verification Date January 2015