Antiphospholipid Antibodies and Fetal Growth Restriction

NCT01538134 | Unknown

• 1 other identifier: MHST2012-01B
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Growth Restriction; Antiphospholipid Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Lupus anticoagulant

  Number of cases positive for Lupus Anticoagulant.

  8 months

• Anticardiolipin antibodies

  Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.

  10 months

• B2 Glycoprotein I

  Number of cases with levels of B2 Glycoprotein I \> 99%

  10 months

Study Arms (2)

Cases

Patients with ultrasonographic diagnosis of fetal growth restriction.

Control

Patients with normal pregnancies at term.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients admitted for fetal growth restriction (cases) and normal patients in labor at term (controls).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Fetal Growth Retardation; Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Autoimmune Diseases; Immune System Diseases

Study Officials

• Osvaldo 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: Coordinator of Research & Development

Study Record Dates

• First Submitted: February 19, 2012
• First Posted: February 23, 2012
• Study Start: June 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 5, 2015

Record last verified: 2015-01

Locations

PA (1)