Antiphospholipid Antibodies and Fetal Growth Restriction

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. Identifier: NCT01538134
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
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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 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 or disease
Fetal Growth Restriction Antiphospholipid Syndrome

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antiphospholipid Antibodies and Early Fetal Growth Restriction (<34 Weeks of Gestation). A Case Control Study.
Study Start Date : June 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Patients with ultrasonographic diagnosis of fetal growth restriction.
Patients with normal pregnancies at term.

Primary Outcome Measures :
  1. Lupus anticoagulant [ Time Frame: 8 months ]
    Number of cases positive for Lupus Anticoagulant.

  2. Anticardiolipin antibodies [ Time Frame: 10 months ]
    Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.

  3. B2 Glycoprotein I [ Time Frame: 10 months ]
    Number of cases with levels of B2 Glycoprotein I > 99%

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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 fetal growth restriction (cases) and normal patients in labor at term (controls).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01538134

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

Responsible Party: Osvaldo A. Reyes T., Coordinator of Research & Development, Saint Thomas Hospital, Panama Identifier: NCT01538134     History of Changes
Other Study ID Numbers: MHST2012-01B
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015

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

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Fetal Growth Retardation
Autoimmune Diseases
Immune System Diseases
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Antibodies, Antiphospholipid
Immunologic Factors
Physiological Effects of Drugs