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

Not Applicable

Completed

• Conditions: Breech Fetal Presentation

• Registration Number: NCT04849975
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-20
• Study Start: 2021-11-09
• Primary Completion: 2023-07-24
• Study Completion: 2023-07-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Estimation of the reliability of pelvimetric measurements using ante posterior diameter measurement	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	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	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	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	Up to 1 day	Magnin's Index calculation obtained by using EOS® system versus MRI is evaluated in millimeters.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pr Riethmuller Didier; 🇫🇷 Grenoble, France