Antiphospholipid Antibodies and Early Severe Preeclampsia.

Antiphospholipid Antibodies and Early Severe Preeclampsia (< 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 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.

Study Overview

• Status: Unknown
• Conditions: Antiphospholipid Syndrome; Severe Preeclampsia

• Study Type: Observational
• Enrollment (Anticipated): 310

Contacts and Locations

Study Locations

• Panama
  • Panama, Panama
    • Saint Thomas Maternity Hospital

Participation Criteria

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 severe preeclampsia between 24-34 weeks pf gestation (cases) and normal patients in labor at term (controls).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cases-Early Severe Preeclampsia; Patients with severe preeclampsia before 34 weeks of gestation
Controls; Patients with normal pregnancies at term.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Saint Thomas Hospital, Panama
• Investigators: Principal Investigator: Osvaldo A Reyes, MD, Saint Thomas Hospital, Panama

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: February 19, 2012
• First Submitted That Met QC Criteria: February 19, 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: Lupus Anticoagulant; Antibodies, anticardiolipin; Antibodies, B2 Glycoprotein I; Severe Preeclampsia
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Antiphospholipid Syndrome
• Other Study ID Numbers: MHST2012-01A