Antiphospholipid Antibodies and Fetal Growth Restriction

Antiphospholipid Antibodies and Early Fetal Growth Restriction (<34 Weeks of Gestation). A Case Control Study.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01538134

Enrollment

Registered

2012-02-23

Start date

2015-06-30

Completion date

2016-03-31

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, Fetal Growth Restriction

Keywords

Antibodies, anticardiolipin, Antibodies, B2 Glycoprotein I, Lupus Anticoagulant, Fetal Growth Restriction

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 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Gestational age between 24-34 weeks. * Ultrasonographic evidence of fetal growth restriction * Abdominal circumference \< 3rd percentile. * Doppler with increase of placental resistance.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Lupus anticoagulant	8 months	Number of cases positive for Lupus Anticoagulant.
Anticardiolipin antibodies	10 months	Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.
B2 Glycoprotein I	10 months	Number of cases with levels of B2 Glycoprotein I \> 99%

Countries

Panama

Outcome results