Establish the Reference Range of Antiphospholipid Antibody in Healthy Preganany Women: The Prospective Studies for Antiphospholipid Syndrome Related Pregancy Loss
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- 95th and 99th pencentile data of pregancy and non-pregancy women
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Thrombosis history
- •Rheumatic immune disease
- •Use oral contraception or biological inhibitors
- •History of abortion, adverse pregnancy outcome, common high blood pressure, diabetes
结局指标
主要结局
95th and 99th pencentile data of pregancy and non-pregancy women
时间窗: Oct. 2023
95th and 99th pencentile data of pregancy and non-pregancy women, and the prevalence of aPLs
次要结局
未报告次要终点
研究者
chenhui79
Chief Physician
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University