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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01538134
Other study ID # MHST2012-01B
Secondary ID
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


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
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