Clinical Trial: Antiphospholipid Antibodies and Fetal Growth Restriction
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Antiphospholipid Antibodies and Early Fetal Growth Restriction (<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 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.
Detailed Summary:
Sponsor: Saint Thomas Hospital, Panama
Current Primary Outcome:
- Lupus anticoagulant [ Time Frame: 8 months ]Number of cases positive for Lupus Anticoagulant.
- Anticardiolipin antibodies [ Time Frame: 10 months ]Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.
- B2 Glycoprotein I [ Time Frame: 10 months ]Number of cases with levels of B2 Glycoprotein I > 99%
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Saint Thomas Hospital, Panama
Dates:
Date Received: February 19, 2012
Date Started: June 2015
Date Completion: March 2016
Last Updated: January 1, 2015
Last Verified: January 2015
