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临床试验/NCT02862886
NCT02862886已完成不适用

Study of the Effect of Beta-3 Adrenergic Receptor Agonists on Oxidative Stress and Signalling Pathways Implicated in Remodelling of the Uteroplacental Space: Experimental in Vitro Approach on Myometrial Tissue Explants

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2010年7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
55
试验地点
2
主要终点
simultaneous assays of 4-amino-5-methylamino-2,7-difluorescein (DAF) / Dihydroethidium (DHE) markers by the technique of high pressure liquid chromatography

研究概览

简要总结

CHRONOLOGICAL DESCRIPTION OF THE STUDY

  1. Information provided to study participants
  2. Collection of written informed consent
  3. Harvesting of myometrial biopsies
  4. Creation of tissue explants using myometrial biopsies
  5. Stimulation of the explants with LPS
  6. Study of the effect of SAR150640 (beta3-adrenergic agonist) on LPS-induced oxidative stress Moreover, demonstrating the ability of beta3-adrenergic receptor agonists to prevent the appearance of oxidative stress and its consequences on tissues, as a complement to previous studies, is an additional argument for the clinical development of this class of pharmaceuticals in the management of threatened premature delivery and labour induction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Signed informed consent
  • Patients with national health insurance cover
  • Patients with a normal pregnancy requiring a caesarean section for obstetrical reasons
  • No obvious infectious context

排除标准

  • Obvious inflammatory or autoimmune diseases
  • Suspected or confirmed infectious context, including HIV, HCV HBV
  • Coagulation disorders
  • Preexisting or gestational diabetes

结局指标

主要结局

simultaneous assays of 4-amino-5-methylamino-2,7-difluorescein (DAF) / Dihydroethidium (DHE) markers by the technique of high pressure liquid chromatography

时间窗: The biopsy of myometrium is done specifically for this study in a surgical unit after delivery of the child, in women with a normal pregnancy but requiring a caesarean

In vitro measurement of the ability of SAR150640 to prevent the release of free radicals (oxidative stress) induced by an inflammatory stimulus on tissue explants of the human myometrium. The level of oxidative stress will be determined using simultaneous assays of DAF/DHE using HPLC. This reference technique for the overall evaluation of oxidative stress is perfectly mastered at the LPPCE (Laboratoire de Physiopathologie et Pharmacologie Cardiovasculaire et Experimentales)

次要结局

  • Characterization of signalling pathways induced by oxidative stress during inflammation(The biopsy of myometrium is done specifically for this study in a surgical unit after delivery of the child, in women with a normal pregnancy but requiring a caesarean)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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