NCT01538121

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
3.3 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 5, 2015

Status Verified

January 1, 2015

Enrollment Period

1.1 years

First QC Date

February 19, 2012

Last Update Submit

January 1, 2015

Conditions

Severe PreeclampsiaAntiphospholipid Syndrome

Keywords

Antibodies, anticardiolipinAntibodies, B2 Glycoprotein ILupus AnticoagulantSevere Preeclampsia

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Cases-Early Severe Preeclampsia

Patients with severe preeclampsia before 34 weeks of gestation

Controls

Patients with normal pregnancies at term.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Pre-EclampsiaAntiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Osvaldo A Reyes, MD

    Saint Thomas Hospital, Panama

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 19, 2012

First Posted

February 23, 2012

Study Start

June 1, 2015

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

January 5, 2015

Record last verified: 2015-01

Locations

PA(1)