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临床试验/NCT01610258
NCT01610258已完成不适用

Contribution of the Study of Maternal Plasmatic Regulator T Cells and Th17 for the Diagnosis of Acute Chorioanmionitis Among Women Hospitalized for Premature Rupture of Fetal Membranes (PPROM) Between 24 and 34 Gestation Weeks

Centre Hospitalier Universitaire Dijon4 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2013年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
4
主要终点
Evaluate the percentage of Treg in maternal blood at the time of admission

研究概览

简要总结

The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for PPROM.

详细描述

Acute chorioamnionitis is the principal antecedent of premature birth and an important contributor to specific neonatal and other complications that may extend throughout subsequent life. The PPROM is a high risk condition for developing chorioamnionitis. Available biological markers have a low prognostic value. Indeed, currently the diagnosis of intra-uterine infection relies only on placental cultures and anatomo-pathological exam after the delivery.

Moreover, pregnancy is an immunologic particular condition. Indeed an immune tolerance is required with respect to the fetus and is mediated by Treg lymphocytes, which suppressed Th17 activity.

Recent studies have shown among women with frequent miscarriages, a balance between Treg and Th17, with a decrease in Treg number and an increase in Th17 number in decidua and blood.

In case of infection, the immune pro-inflammatory response (Th17) is restored in peripheric tissues and in blood in order to limit the extention of intra-uterine infection. This restoration of this pro-inflammatory response could be due to a modification of Treg number ou tolerogenic activity.

In this context, our hypothesis is that chorioamnionitis will lead to a decrease of treg proportion and an increase of Th17 proportion in lymphocyte populations of maternal blood and placenta, with a back to values near than which is observed in beginning of pregnancy or in no pregnant women.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Informed consent signed
  • Patient affiliated with a social security scheme
  • term pregnancy betwwen 24 and 34 weeks
  • PPROM diagnosis
  • singleton pregnancy

排除标准

  • delivery occured in 1 hour after admission
  • hemorragic praevia placenta or retro-placental hematoma
  • confirmed autoimmune or inflammatory disease
  • confirmed infectious disease by VIH, VHC, and VHB

结局指标

主要结局

Evaluate the percentage of Treg in maternal blood at the time of admission

时间窗: the day of delivery or 7 days after the admission if no delivery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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