Antiphospholipid Antibodies and Fetal Growth Restriction

• Conditions: Antiphospholipid Syndrome; Fetal Growth Restriction

• Registration Number: NCT01538134
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-19
• Study First Submitted QC: 2012-02-22
• 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: 2016-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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%

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama