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Antiphospholipid Antibodies and Early Severe Preeclampsia.

Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01538121
Enrollment
310
Registered
2012-02-23
Start date
2015-06-30
Completion date
2016-08-31
Last updated
2015-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiphospholipid Syndrome, Severe Preeclampsia

Keywords

Antibodies, anticardiolipin, Antibodies, B2 Glycoprotein I, Lupus Anticoagulant, Severe Preeclampsia

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.

Interventions

None listed

Sponsors

Saint Thomas Hospital, Panama
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lupus anticoagulant15 monthsNumber of cases positive for Lupus Anticoagulant.
Anticardiolipin antibodies15 monthsNumber of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.
B2 Glycoprotein I15 monthsNumber of cases with levels of B2 Glycoprotein 1 \> 99%

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026