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临床试验/NCT01007513
NCT01007513已完成不适用

Cervical Assessment by Supracervical, Cervical and Vaginal Markers: Simultaneous Transvaginal Ultrasound and Inflammatory Proteins Detection

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年6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
100
试验地点
1
主要终点
Preterm birth < 34 gestational weeks among patient with presence of supracervical factor at ultrasound study.

研究概览

简要总结

Preterm birth rate is 7.2% in Quebec, it's risen worldwide in the past decade and it's the leading cause of perinatal mortality and morbidity. Preterm birth is a major public health problem. Preterm labor leading to preterm birth is difficult to diagnose and prediction of preterm birth is a medical challenge. In the past years, research found that transvaginal ultrasound to assess the cervix of the uterus and vaginal detection of inflammatory protein, specific bacteria and fetal fibronectin can help to detect women at increase risk of preterm delivery. The investigators believe that a combination of these tests can lead to a better prediction of preterm delivery. The investigators want to conduct a study among women judged at increase risk of preterm delivery by their physician (having contractions, modified cervix, past-history of preterm delivery or multiple pregnancy) and assess their cervix by ultrasound and sample their vaginal secretion. The investigators want to analyze the vaginal sampling and look for inflammatory proteins. The objective of this study is to prove the feasibility of this assessment method and elaborate a better predictive test that the investigators can easily use in obstetrics clinics and hospitals.

详细描述

Preterm birth rate in Quebec is 7.2% and, despite extensive research, the rate of preterm birth has risen worldwide over the past decades. Preterm birth is, all over the world, the first cause of perinatal mortality and morbidity. Spontaneous preterm birth (sPTB) groups premature births with intact and ruptured membranes and represents 70% of preterm delivery. The two conditions associated with sPTB share a common physiopathology and a progressive cascade of events. Extensive evidence supports a central role for the production of prostaglandins, inflammatory cytokines and matrix metalloproteinases (MMP) in the cervix and decidua to promote cervical ripening and decidual and fetal membrane activation but, the exact progression of events remains unclear. Several factors were described as risk factor for sPTB like bacterial vaginosis, inflammatory cytokines and fetal fibronectin in vaginal secretions. The transvaginal ultrasound of the cervix (TVUS), which estimates the length and the aspect of the cervix, can be used as predictive factor of preterm birth. To date, no study has addressed the supra-cervical region by transvaginal ultrasound. This region may be an important key of the inflammatory process leading to sPTB. The assessment of this region by ultrasound can be a predictive marker of sPTB. We want to prove the feasibility of this new approach of sPTB prediction : the transvaginal ultrasound assessment of the supracervical and cervical region associated with detection of vaginal inflammation.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Live singleton or multiple pregnancy
  • Clinical risk of preterm delivery
  • Pregnancy between 20 and 34 gestational weeks

排除标准

  • Delivery on the day of the ultrasound
  • Major fetal anomaly
  • Previa placentation

结局指标

主要结局

Preterm birth < 34 gestational weeks among patient with presence of supracervical factor at ultrasound study.

时间窗: December 2009

次要结局

  • Presence of inflammatory proteins in vaginal secretion of patient with presence of supracervical factors at transvaginal ultrasound.(December 2009)
  • Neonatal morbidity of preterm infant.(December 2009)

研究者

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

Jean-Charles Pasquier

Dr

Université de Sherbrooke

研究点 (1)

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