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临床试验/NCT02284867
NCT02284867已完成不适用

Comparison Between Uterine Natural Killer Cells In Preterm Labor And Term Labor

Ain Shams University0 个研究点目标入组 60 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Uterine Natural Killer Cells In Preterm Labor

研究概览

简要总结

Research question:

Population of study: women diagnosed as term pregnancy in labor (control) and the other group diagnosed as preterm labor (cases).

Intervention: measuring uterine natural killer cells . Outcome: uterine natural killer cells has a role in initiation of preterm labor.

Research hypothesis:

• Are uterine Natural Killer cells involved in the initiation of preterm labor ?

Medical Application:

• Possibility of prediction of preterm labor by assessment of Natural killer cells as well as preventing preterm labor by suppressing their activity .

详细描述

Type of the Study:

This is a case control study .

Study Settings:

This clinical trial will be conducted at Ain Shams University Maternity Hospital and the laboratory work will be done at Ain Shams University histopathology Laboratory , in the period between August 2012 to August 2014 .

Study Population:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Maternal age: 18-35 years old (to decrease the incidence of preterm labor related to age factor).
  • Women who present with viable pregnancy (between 28 and 37 weeks' gestation), and having a threatened preterm labor (which is defined as ≥ 2 uterine contractions at 28-37 weeks' gestation, The onset of labor may be determined by documented uterine contractions (at least one every 10 minutes) and ruptured fetal membranes or documented cervical change with an estimated length of less than 1cm or cervical dilation of more than 2 cm. Threatened preterm labor may be diagnosed when there are documented uterine contractions but no evidence of cervical change.

排除标准

  • Multiple pregnancy.
  • Documented uterine anomalies.
  • Oligohydramnios and polyhydramnios .
  • Medical disorders as Diabetes mellitus and hypertension.
  • Preterm premature rupture of membranes.
  • Conditions that may have an influence on immune reaction e.g. history of chorioamnionitis.
  • Smoking as a risk factor for preterm labor.
  • Patients having Autoimmune disorder as it may affect Uterine NK( natural killer ) cells level .

结局指标

主要结局

Uterine Natural Killer Cells In Preterm Labor

时间窗: 2 years

Number of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample

次要结局

  • Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abass

Assistant lecturer

Ain Shams University

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