Antiphospholipid Antibodies and Fetal Growth Restriction
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.
Fetal Growth Restriction
|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.|
- 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%
|Study Start Date:||June 2015|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Patients with ultrasonographic diagnosis of fetal growth restriction.
Patients with normal pregnancies at term.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538134
|Saint Thomas Maternity Hospital|
|Principal Investigator:||Osvaldo Reyes, MD||Saint Thomas Hospital, Panama|