Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women

Not yet recruiting

• Conditions: Focus Health Pregancy Women
• Interventions: Diagnostic Test: Draw blood

• Registration Number: NCT05883189
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-20
• Study First Submitted: 2023-05-20
• Study First Submitted QC: 2023-05-20
• Last Update Submitted: 2023-05-20
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31
• Primary Completion: 2023-10-07
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1: non-pregancy health women.	Draw blood	-
Group 2:Pregancy health women.	Draw blood	-
Group 3: Diagnosed Antiphospholipid syndrome patients	Draw blood	-

Primary Outcome Measures

Name	Time	Method
95th and 99th pencentile data of pregancy and non-pregancy women	Oct. 2023	95th and 99th pencentile data of pregancy and non-pregancy women, and the prevalence of aPLs