Inflammation in Intrahepatic Cholestasis of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 322
- 试验地点
- 11
- 主要终点
- Prevalence of placental chronic inflammation
研究概览
简要总结
This observational prospective study will help to determine if an immune process similar to allograft rejection is responsible for the occurrence of an intrahepatic cholestasis of pregnancy (ICP).
If so, it would suggest the potential benefit of immunomodulatory therapeutics.
详细描述
This observational study will include 322 pregnant women at delivery: 161 women diagnosed with an intrahepatic cholestasis of pregnancy, and 161 control women.
A blood test will be performed at delivery for each woman and each newborn, in order to measure several biological parameters involved in inflammation processes, allograft rejection and angiogenesis. Placenta will also be analysed. In particular, we will look for chronic inflammation in placenta.
Biological parameters and placental parameters will be compared between the two groups: cases with ICP and 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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult pregnant woman with singleton
- •For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP
排除标准
- •Women under 18 years old
- •Women under legal protection
- •Gemellar pregnancies
- •Delivery before 22 Weeks of gestation
- •Medical termination of pregnancy
- •Acute chorioamniotitis, in particular those due to the following pathogens: toxoplasmosis, rubella, CMV, herpes virus
- •Premature rupture of membranes <37SA
- •Women infected by covid-19 in the month before delivery
结局指标
主要结局
Prevalence of placental chronic inflammation
时间窗: At delivery
次要结局
- Levels of several biological parameters involved in angiogenesis(At delivery)
- Levels of several biological parameters involved in allograft rejection(At delivery)
- Levels of several biological parameters involved in inflammation processes(At delivery)