Analyses of Interleukin-6, Presepsin and Pentraxin-3 in the Diagnosis and Severity of Late-onset Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia group and control group.
研究概览
简要总结
Introduction: The etiology/pathophysiology of preeclampsia remains an enigma. Cellular immunity is a key factor in the etiology of late-onset preeclampsia (L-PrE). Presepsin is split out from the phagocytes membranes after phagocytosis. To investigators knowledge, this is the first study in literature to investigate maternal blood concentrations of presepsin in preeclampsia and healthy pregnant women.
Methods: The investigators examined maternal plasma interleukin-6, presepsin and pentraxin-3 concentrations in pregnant women with (n=44) and without L-PrE (n=44). These three inflammatory markers concentrations measured using enzyme-linked immunosorbent assays were compared.
详细描述
This observational case-control study was designed at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey, in the Department of Obstetrics and Gynecology between June 2018 and January 2019. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2018/393). The study strictly adhered to the principles of the Declaration of Helsinki. All subjects included in the study gave oral and written informed consent. Eighty-eight women were enrolled in the study in two groups. All participants will gave their oral and written informed consent before their inclusion in the study.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •preeclampsia healthy pregnancy
排除标准
- •pregnant women with any systemic condition (such as chronic hypertension, inflammatory and rheumatic diseases),
- •using any kind of medication throughout pregnancy (such as acetylsalicylic acid, corticosteroids or heparin),
- •pregnant women who had fever at the time of the first admission,
- •concurrent infections (urinary tract infection, cervicitis, etc.),
- •pregnancies complicated with premature membrane rupture or chorioamnionitis,
- •history of medication for PE treatment at the time of the first admission,
- •patients who had fetal congenital abnormalities or genetic syndromes,
- •multiple gestations,
- •active labor.
结局指标
主要结局
The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia group and control group.
时间窗: 3 months
The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia and control group.
次要结局
未报告次要终点
研究者
Ali Ovayolu
Principal Investigator
Cengiz Gokcek Women's and Children's Hospital