Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Focus Health Pregancy Women

Treatments: Diagnostic Test: Draw blood

Study type: Observational

Funder types: Other

Identifiers

NCT05883189

SYSKY-2022-412-01

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 120 non-pregnant healthy women, Age 18-45, with at least 1 successful pregnancy , no history of adverse pregnancy outcome, no abortion, still birth, premature delivery, preeclampsia
• 120 pregnant women, Age 18-45, follow through the pregnancy and successful delivery without any adverse pregnancy outcome during the pregnancy process, no abortion, still birth, premature delivery, preeclampsia, no drug treatment
• 60 APS pregnant patients diagnosed by clinical department

Exclusion criteria

1. Thrombosis history
2. Rheumatic immune disease
3. Use oral contraception or biological inhibitors
4. History of abortion, adverse pregnancy outcome, common high blood pressure, diabetes

Trial design

300 participants in 3 patient groups

Group1: non-pregancy health women.

Treatment:

Diagnostic Test: Draw blood

Group 2:Pregancy health women.

Treatment:

Diagnostic Test: Draw blood

Group 3: Diagnosed Antiphospholipid syndrome patients

Treatment:

Diagnostic Test: Draw blood