Antiphospholipid Antibodies and Fetal Growth Restriction

January 1, 2015 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Antiphospholipid Antibodies and Early Fetal Growth Restriction (<34 Weeks of Gestation). A Case Control Study.

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases
Patients with ultrasonographic diagnosis of fetal growth restriction.
Control
Patients with normal pregnancies at term.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lupus anticoagulant
Time Frame: 8 months
Number of cases positive for Lupus Anticoagulant.
8 months
Anticardiolipin antibodies
Time Frame: 10 months
Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.
10 months
B2 Glycoprotein I
Time Frame: 10 months
Number of cases with levels of B2 Glycoprotein I > 99%
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

February 19, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

January 5, 2015

Last Update Submitted That Met QC Criteria

January 1, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST2012-01B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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