NCT05883189

Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women

Establish the Reference Range of Antiphospholipid Antibody in Healthy Preganany Women: The Prospective Studies for Antiphospholipid Syndrome Related Pregancy Loss

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study is aim to establish 95th and 99th percentile for healthy pregancy women for antiphospholipid antibodies(aPLs), such as aCL IgG/M/A, B2GP1 IgG/M/A, aPS/PT IgG/M. The outcome of the study is expected to aid Antiphospholipid syndrome patients diagnosis and managment. We also include some obstetirc Antiphospholipid syndrome(APS) patients to analysis the correlation between antiphospholipid antibodies and pregancy outcome, also want to know the prevalenc of aPLs, which can be guide for clinical application for APS diagnosis and treatment.

Conditions

• Focus Health Pregancy Women

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Draw blood	Draw blood from human body and make into serum to test

Timeline

• Start date: 2023-05-20
• Primary completion: 2023-10-07
• Completion: 2024-02-28
• First posted: 2023-05-31
• Last updated: 2023-05-31

Regulatory

• FDA-regulated device study