Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)

Study Overview
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Brief Summary
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The main objective of this study is to compare pelvimetric measurements performed by Magnetic Resonance Imaging (MRI) and by the EOS imaging system.

Detailed Description
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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.

Official Title
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Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)

Conditions
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Breech Fetal Presentation

Intervention / Treatment
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* Other: Pelvimetric measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvimetry group<br>The participants oh this group will successively perform MRI pelvimetry and EOS imaging. | Other: Pelvimetric measurements<br>* The patients in this group are pregnant women after failure of external manual version (EMV) in case of breech fetal presentation. The participants will successively perform MRI pelvimetry (conventional management) and EOS imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of the reliability of pelvimetric measurements using Transverse Inlet Diameter measurement | Transverse Inlet Diameter Measurement obtained by EOS® system versus MRI is evaluated in millimeters. | Up to 1 day | 
| Estimation of the reliability of pelvimetric measurements using ante posterior diameter measurement | Ante posterior diameter of the pelvic inlet obtained by using EOS® system versus MRI is evaluated in millimeters. | Up to 1 day | 
| Estimation of the reliability of pelvimetric measurements using BiSpinous Diameter measurement | BiSpinous Diameter obtained by EOS® system versus MRI is evaluated in millimeters. | Up to 1 day | 
| Estimation of the reliability of pelvimetric measurements using Bi-ischiatic mesurement | Bi-ischiatic measurement obtained by EOS® system versus MRI is evaluated in millimeters. | Up to 1 day | 
| Estimation of the reliability of pelvimetric measurements using Magin's Index calculation | Magnin's Index calculation obtained by using EOS® system versus MRI is evaluated in millimeters. | Up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvis morphological description using Cadwell and Moloy classification | Caldwell and Moloy classification (scale) obtained by MRI and EOS® system is qualified. | Up to 1 day | 
| Pelvis morphological description using subpubic angle measurement | The measurement of the subpubic angle (in degree) obtained by MRI and EOS® system is qualified. | Up to 1 day | 
| Pelvis morphological description using obturating holes appearance | The appearance of the obturating holes (descriptive analysis) obtained by MRI and EOS® system is qualified. | Up to 1 day | 
| Characterization of radiation doses received by EOS® system. | Estimation of irradiation | Up to 1 day | 
| Evaluation of the intra and inter-observer reproducibility for radiological interpretation | Blind independent reading of MRI and EOS® images by two radiologists on two different days. | 4 days | 
| Evaluation of the intra and inter-observer reproducibility for clinical interpretation | Blind independent reading of MRI and EOS® images by two independent clinician on two different days with conclusion on the mode of delivery. | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breech Fetal Presentation, MRI, EOS imaging system, Pelvimetric measurements