Antiphospholipid Antibodies and Fetal Growth Restriction

Antiphospholipid Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01538134
• Other study ID #: MHST2012-01B
• Status: Not yet recruiting
• Phase: N/A
• First received: February 19, 2012
• Last updated: January 1, 2015
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: January 2015
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Fetal Growth Restriction
• Fetal Growth Retardation

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lupus anticoagulant	Number of cases positive for Lupus Anticoagulant.	8 months	No
Primary	Anticardiolipin antibodies	Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.	10 months	No
Primary	B2 Glycoprotein I	Number of cases with levels of B2 Glycoprotein I > 99%	10 months	No