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Antiphospholipid Antibodies and Fetal Growth Restriction

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:
NCT01538134
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 fetal growth restriction (diagnosed postpartum), but this was done without solid evidence of a relation between the two or using the most common form of fetal growth restriction diagnosis (ultrasound). Our study will try to add information to this particular point.


Condition
Fetal Growth Restriction
Antiphospholipid Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antiphospholipid Antibodies and Early Fetal Growth Restriction (<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: 8 months ] [ Designated as safety issue: No ]
    Number of cases positive for Lupus Anticoagulant.

  • Anticardiolipin antibodies [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.

  • B2 Glycoprotein I [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Number of cases with levels of B2 Glycoprotein I > 99%


Estimated Enrollment: 90
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
Patients with ultrasonographic diagnosis of fetal growth restriction.
Control
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 fetal growth restriction (cases) and normal patients in labor at term (controls).

Criteria

Inclusion Criteria:

  • Gestational age between 24-34 weeks.

  • Ultrasonographic evidence of fetal growth restriction

    • Abdominal circumference < 3rd percentile.
    • Doppler with increase of placental resistance.

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: NCT01538134

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

No publications provided

Responsible Party: Osvaldo A. Reyes T., Coordinator of Research & Development, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01538134     History of Changes
Other Study ID Numbers: MHST2012-01B
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
Fetal Growth Restriction

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
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 19, 2013