Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Estimation of the reliability of pelvimetric measurements using ante posterior diameter measurement
研究概览
简要总结
The main objective of this study is to compare pelvimetric measurements performed by Magnetic Resonance Imaging (MRI) and by the EOS imaging system.
详细描述
During pregnancy, after failure of External Manual Version (EMV) in case of breech fetal presentation, a radiological pelvimetry is performed to evaluate the measurements of the pelvis and decide on the appropriate mode of delivery.
Several imaging modalities are used, including pelvic computed tomography (CT),and magnetic resonance imaging (MRI) of the pelvis.
CT scan has the disadvantage of maternal irradiation and MRI has the disadvantage of an inaccurate morphological analysis.The EOS® system is an imaging tool used in radiopediatric to allow precise morphological analysis of bone masses with minimal irradiation.
The quality of the morphological analysis and measurements provided by the EOS® imaging system is the reason for proposing this study comparing the pelvimetric measurements obtained by MRI and by the EOS® imaging system.
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
- 是
入选标准
- •Patients > 18 years of age
- •Patient requiring pelvimetry (breech fetus)
- •Gestation > 36 SA (weeks of amenorrhea)
- •Patients with BMI < 35
- •Affiliated to social security or similarly regime
- •Patients who gave their consent to participate in the study (Patient having agreed to perform both examinations: MRI and EOS system)
排除标准
- •Patient with a contraindication to MRI (claustrophobia, pace-maker, intracorporeal metallic element)
- •Patient with a contraindication to performing EOS® (person not standing alone)
- •Patient who are in exlusion period of another interventiionnal study
- •Person deprived of freedom by judicial or administrative decision; person hospitalized for psychitric care; person under legal protection measure.
结局指标
主要结局
Estimation of the reliability of pelvimetric measurements using ante posterior diameter measurement
时间窗: Up to 1 day
Ante posterior diameter of the pelvic inlet obtained by using EOS® system versus MRI is evaluated in millimeters.
Estimation of the reliability of pelvimetric measurements using Transverse Inlet Diameter measurement
时间窗: Up to 1 day
Transverse Inlet Diameter Measurement obtained by EOS® system versus MRI is evaluated in millimeters.
Estimation of the reliability of pelvimetric measurements using BiSpinous Diameter measurement
时间窗: Up to 1 day
BiSpinous Diameter obtained by EOS® system versus MRI is evaluated in millimeters.
Estimation of the reliability of pelvimetric measurements using Bi-ischiatic mesurement
时间窗: Up to 1 day
Bi-ischiatic measurement obtained by EOS® system versus MRI is evaluated in millimeters.
Estimation of the reliability of pelvimetric measurements using Magin's Index calculation
时间窗: Up to 1 day
Magnin's Index calculation obtained by using EOS® system versus MRI is evaluated in millimeters.
次要结局
- Characterization of radiation doses received by EOS® system.(Up to 1 day)
- Evaluation of the intra and inter-observer reproducibility for clinical interpretation(4 days)
- Evaluation of the intra and inter-observer reproducibility for radiological interpretation(4 days)
- Pelvis morphological description using Cadwell and Moloy classification(Up to 1 day)
- Pelvis morphological description using subpubic angle measurement(Up to 1 day)
- Pelvis morphological description using obturating holes appearance(Up to 1 day)