Antiphospholipid Antibodies and Early Severe Preeclampsia.

• Conditions: Severe Preeclampsia; Antiphospholipid Syndrome

• Registration Number: NCT01538121
• Lead Sponsor: 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 severe preeclampsia before 34 weeks of gestation, but this was done without solid evidence of a relation between the two. Our study will try to add information to this particular point.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-19
• Study First Submitted QC: 2012-02-19
• Study First Posted: 2012-02-23
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-01
• Last Update Posted: 2015-01-05
• Study Start: 2015-06
• Primary Completion: 2016-07
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 310

Inclusion Criteria

• Gestational age between 24-34 weeks
• Diagnosis of severe preeclampsia

Exclusion Criteria

• Known antiphospholipid syndrome.
• Known presence of antiphospholipid antibodies.
• Patients with systemic lupus erythematosus.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anticardiolipin antibodies	15 months	Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.
Lupus anticoagulant	15 months	Number of cases positive for Lupus Anticoagulant.
B2 Glycoprotein I	15 months	Number of cases with levels of B2 Glycoprotein 1 \> 99%

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama