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临床试验/NCT03211338
NCT03211338已完成不适用

Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2017年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
1
主要终点
Maturation effects of progesterone on preterm and term placentas

研究概览

简要总结

The aim of this study is to investigate the In Vitro and In Vivo effect of progesterone on immature myeloid cells (IMC), inflammation characteristics and maturation into dendritic cells (DC).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

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

  • •Placentas from term and preterm deliveries
  • •Singleton pregnancy
  • •Consent to participate

排除标准

  • •Pregnancies with obstetric complications
  • •Multiple gestation
  • •Maternal illness or fetal malformation known pre-delivery

研究组 & 干预措施

Preterm labor placentas and progesterone

Active Comparator

IMC cells taken from preterm labor placentas after delivery will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture with progesterone (Biological)

Term labor placentas and progesterone

Active Comparator

IMC cells taken from term labor placentas after delivery will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture with progesterone (Biological)

Preterm labor placentas without progesterone

Active Comparator

IMC cells taken from preterm labor placentas after delivery will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture without progesterone (Biological)

Term labor placentas without progesterone

Active Comparator

IMC cells taken from term labor placentas after delivery will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture without progesterone (Biological)

Term placentas from progesterone treated pregnancies

Active Comparator

IMC cells taken from term labor placentas from women that were treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture with growth factors (Biological)

Preterm placentas from progesterone treated pregnancies

Active Comparator

IMC cells taken from preterm labor placentas from women that were treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture with growth factors (Biological)

Term placentas not treated with progesterone in pregnancy

Active Comparator

IMC cells taken from term placentas from women who were not treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture with growth factors (Biological)

Preterm placentas not treated with progesterone in pregnancy

Active Comparator

IMC cells taken from preterm placentas from women who were not treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture with growth factors (Biological)

Term postpartum blood samples with progesterone

Active Comparator

CD-14+ monocyte cells taken from women delivering at term will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture with progesterone (Biological)

Preterm postpartum blood samples with progesterone

Active Comparator

CD-14+ monocyte cells taken from women delivering preterm will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture with progesterone (Biological)

Term postpartum blood samples without progesterone

Active Comparator

CD-14+ monocyte cells taken from women delivering at term will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture without progesterone (Biological)

Preterm postpartum blood samples without progesterone

Active Comparator

CD-14+ monocyte cells taken from women delivering preterm will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells.

干预措施: Culture without progesterone (Biological)

结局指标

主要结局

Maturation effects of progesterone on preterm and term placentas

时间窗: One year

Differences observed in maturation of IMC cells into DC cells in term and preterm placentas

Inflammation characteristic effects of progesterone on preterm and term placentas

时间窗: One year

Differences observed in cytokine profiles of IMC cells from term and preterm placentas cultured with and without progesterone

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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