Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy
研究概览
简要总结
The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS.
To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM).
For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Pregnant patients between the ages of 18 and 45 years.
- •Diagnosis of primary APS, according to international classification criteria.
- •Pregnant patients between the ages of 18 and 45 years.
- •Patients with at least one previous full-term pregnancy.
- •No diagnosis of APS, according to international classification criteria.
排除标准
- •PMA pregnancies.
- •Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
- •Previous thrombotic event
- •Chronic renal failure not related to AD
- •Previous history of oncology
- •Pregnancy by PMA.
- •Previous history of polyabortion and/or late pregnancy complications.
- •Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
- •Previous thrombotic event
- •Previous history of oncology
结局指标
主要结局
To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy
时间窗: six month after the end of the study
To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM).
次要结局
未报告次要终点
研究者
Rovere Querini Patrizia
Associate Professor of Internal Medicine, Vita-Salute San Raffaele University Head physician, U.O. General Medicine and Continuity of Care, IRCCS San Raffaele Hospital
IRCCS San Raffaele