跳至主要内容
临床试验/NCT02675179
NCT02675179已完成不适用

EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor: Comparative Single-center Prospective Study - PELVIC-EOS.

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2016年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
117
试验地点
2
主要终点
Diameter of the basin

研究概览

简要总结

The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS and the spiral CT in women having had an obstructed delivery. If this concordance is demonstrated, it would allow the use of this new technique of imagery, to realize a pelvimetry during the pregnancy less irradiating for the mother, and the fetus.

详细描述

The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS and the spiral CT in women having had an obstructed delivery. If this concordance is demonstrated, it would allow the use of this new technique of imagery, to realize a pelvimetry during the pregnancy less irradiating for the mother, and the fetus.

To answer this objective, the study will be a prospective, monocentric, open clinical trial, comparing the radio-pelvimetry realized with EOS technique, to the spiral CT. Measures are performed in the 3 months following the obstructed delivery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Patients who gave birth at the CHU Saint-Etienne
  • Patients having an indication of pelvimetry
  • Patients who delivered singleton pregnancy in cephalic presentation at term
  • Patients affiliated to a social security scheme

排除标准

  • Patients with no wish of further pregnancy
  • Patients with another cause of dystocia during labor
  • Patients with a significant number (>2) of radiological examinations in the year before

结局指标

主要结局

Diameter of the basin

时间窗: Day 1

The aim of this study is to compare the measures of the basins with two different techniques : the usual one spiral CT technique, and the new one : the EOS technique that is less irradiating than the older one. If these two techniques give the same measures, researchers would be able in the future to use the new technique less invasive for the mother and the fetus, as a routine technique.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验