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临床试验/NCT01954095
NCT01954095已完成不适用

Determining the Pharmacodynamic Impact of Vaginal and IM Progestins on the Cervix

University of Pittsburgh4 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2013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
89
试验地点
4
主要终点
Biomarkers

研究概览

简要总结

The purpose of this study is to analyze how the body handles and responds to progesterone treatment in parous and nulliparous women at risk of pre-term birth.

详细描述

17-hydroxyprogesterone caproate (17-OHPC) has recently been shown to reduce the rate of recurrent preterm birth while intravaginal progesterone has been shown to reduce the rate of preterm birth in women with short cervix. While these interventions have reduced the rate of preterm birth, the mechanisms of action of these medications are unknown. The objective of this study is to collect and analyze blood and cervicovaginal fluids from pregnant women receiving these medications or other interventions such as cerclage, pessary, NSAIDs, and combinations thereof. The goal of the analyses is to assess the impact of these interventions on the cervical proteome, cervical cytokines and cervical structure and to identify potential biomarkers of response and non-response thus providing insights into the mechanisms of action of these drugs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Biomarkers

时间窗: 2 Weeks

Proteins in the cervicovaginal fluid with expression changes two-fold or greater between day 0 and week 2 of either vaginal or IM progestin therapy.

次要结局

  • Cervical sonographic changes(8 Weeks)
  • Protein Expression(8 Weeks)
  • Cervical cytokines(8 Weeks)
  • Individual cytokines(8 Weeks)
  • Cervical MMPs(8 Weeks)
  • Single nucleotide polymorphisms(8 Weeks)
  • Biomarkers(8 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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The Impact of Vaginal and IM Progestins on the Cervix | 临床试验