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临床试验/NCT01868308
NCT01868308已完成不适用

Screening To Obviate Preterm Birth

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 589 人开始时间: 2013年1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
589
试验地点
1
主要终点
Preterm birth

研究概览

简要总结

Our objective is to investigate the predictive value of a panel of biomarkers associated with two biologically plausible pathways of preterm birth: membrane breakdown and cervical remodeling. The investigators will obtain cervical length, cervicovaginal fetal fibronectin, and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm birth in an effort to better risk stratify this cohort.

详细描述

Preterm Birth is a complex syndrome for which several different biologically plausible pathways have been proposed, including mechanical uterine distension, abruption, inflammation, and/or activation of the fetal hypothalamic-pituitary-axis. However, despite our knowing the complexity of this syndrome and the different pathways involved, there is a paucity of clinical studies investigating whether detection of more than one of these pathways in a single patient might enhance the identification of those at greatest risk for preterm birth. We propose investigating the predictive value of a panel of biomarkers associated with two biological plausible pathways - membrane breakdown and cervical remodeling - that must be involved in the pathogenesis of preterm birth. Specifically, we propose measuring cervical length and collecting cervicovaginal fetal fibronectin as well as a panel of novel cervicovaginal biomarkers that reflect molecular pathways involved in cervical remodeling in a prospectively collected cohort of symptomatic women with singleton fetuses at high risk for preterm birth. Through this study we hope improve risk stratification of this high risk cohort.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy between 22- 33 6/7 weeks of gestational age.
  • Must be experiencing one ore more of the following symptoms including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, or light vaginal bleeding.

排除标准

  • Women with a multi-fetal pregnancy
  • Intra uterine fetal demise
  • Preterm premature rupture of membranes
  • Overt chorioamnionitis

结局指标

主要结局

Preterm birth

时间窗: Enrollment through delivery

The primary outcome is preterm birth defined as delivery before 37 weeks.

次要结局

  • Early preterm birth(Enrollment through delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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