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

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

Study Overview

• Status: Completed
• Conditions: Breech Fetal Presentation
• Intervention / Treatment: Other: Pelvimetric measurements

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle Boudry, PhD; Phone Number: +33476766645; Email: iboudry@chu-grenoble.fr
• Study Contact Backup: Name: Didier R RIETHMULLER, MD, PhD; Phone Number: +33476765400; Email: driethmuller@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Pr Riethmuller Didier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelvimetry group; The participants oh this group will successively perform MRI pelvimetry and EOS imaging.	Other: Pelvimetric measurements; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Didier R RIETHMULLER, MD, PhD, University Hospital, Grenoble

Publications and helpful links

General Publications

• Aubry S, Padoin P, Petegnief Y, Vidal C, Riethmuller D, Delabrousse E. Can three-dimensional pelvimetry using low-dose stereoradiography replace low-dose CT pelvimetry? Diagn Interv Imaging. 2018 Sep;99(9):569-576. doi: 10.1016/j.diii.2018.02.008. Epub 2018 Mar 19.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): July 24, 2023
• Study Completion (Actual): July 24, 2023

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Breech Fetal Presentation; EOS imaging system; Pelvimetric measurements
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breech Presentation
• Other Study ID Numbers: 38RC21.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No