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

Primary Purpose

Breech Fetal Presentation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pelvimetric measurements
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breech Fetal Presentation focused on measuring Breech Fetal Presentation, MRI, EOS imaging system, Pelvimetric measurements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Pr Riethmuller Didier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pelvimetry group

Arm Description

The participants oh this group will successively perform MRI pelvimetry and EOS imaging.

Outcomes

Primary Outcome Measures

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.
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.
Estimation of the reliability of pelvimetric measurements using BiSpinous Diameter measurement
BiSpinous Diameter obtained by EOS® system versus MRI is evaluated in millimeters.
Estimation of the reliability of pelvimetric measurements using Bi-ischiatic mesurement
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
Magnin's Index calculation obtained by using EOS® system versus MRI is evaluated in millimeters.

Secondary Outcome Measures

Pelvis morphological description using Cadwell and Moloy classification
Caldwell and Moloy classification (scale) obtained by MRI and EOS® system is qualified.
Pelvis morphological description using subpubic angle measurement
The measurement of the subpubic angle (in degree) obtained by MRI and EOS® system is qualified.
Pelvis morphological description using obturating holes appearance
The appearance of the obturating holes (descriptive analysis) obtained by MRI and EOS® system is qualified.
Characterization of radiation doses received by EOS® system.
Estimation of irradiation
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.
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.

Full Information

First Posted
March 11, 2021
Last Updated
August 24, 2023
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT04849975
Brief Title
Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)
Acronym
CAPEOS®
Official Title
Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
July 24, 2023 (Actual)
Study Completion Date
July 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Fetal Presentation
Keywords
Breech Fetal Presentation, MRI, EOS imaging system, Pelvimetric measurements

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvimetry group
Arm Type
Experimental
Arm Description
The participants oh this group will successively perform MRI pelvimetry and EOS imaging.
Intervention Type
Other
Intervention Name(s)
Pelvimetric measurements
Intervention Description
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.
Primary Outcome Measure Information:
Title
Estimation of the reliability of pelvimetric measurements using Transverse Inlet Diameter measurement
Description
Transverse Inlet Diameter Measurement obtained by EOS® system versus MRI is evaluated in millimeters.
Time Frame
Up to 1 day
Title
Estimation of the reliability of pelvimetric measurements using ante posterior diameter measurement
Description
Ante posterior diameter of the pelvic inlet obtained by using EOS® system versus MRI is evaluated in millimeters.
Time Frame
Up to 1 day
Title
Estimation of the reliability of pelvimetric measurements using BiSpinous Diameter measurement
Description
BiSpinous Diameter obtained by EOS® system versus MRI is evaluated in millimeters.
Time Frame
Up to 1 day
Title
Estimation of the reliability of pelvimetric measurements using Bi-ischiatic mesurement
Description
Bi-ischiatic measurement obtained by EOS® system versus MRI is evaluated in millimeters.
Time Frame
Up to 1 day
Title
Estimation of the reliability of pelvimetric measurements using Magin's Index calculation
Description
Magnin's Index calculation obtained by using EOS® system versus MRI is evaluated in millimeters.
Time Frame
Up to 1 day
Secondary Outcome Measure Information:
Title
Pelvis morphological description using Cadwell and Moloy classification
Description
Caldwell and Moloy classification (scale) obtained by MRI and EOS® system is qualified.
Time Frame
Up to 1 day
Title
Pelvis morphological description using subpubic angle measurement
Description
The measurement of the subpubic angle (in degree) obtained by MRI and EOS® system is qualified.
Time Frame
Up to 1 day
Title
Pelvis morphological description using obturating holes appearance
Description
The appearance of the obturating holes (descriptive analysis) obtained by MRI and EOS® system is qualified.
Time Frame
Up to 1 day
Title
Characterization of radiation doses received by EOS® system.
Description
Estimation of irradiation
Time Frame
Up to 1 day
Title
Evaluation of the intra and inter-observer reproducibility for radiological interpretation
Description
Blind independent reading of MRI and EOS® images by two radiologists on two different days.
Time Frame
4 days
Title
Evaluation of the intra and inter-observer reproducibility for clinical interpretation
Description
Blind independent reading of MRI and EOS® images by two independent clinician on two different days with conclusion on the mode of delivery.
Time Frame
4 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier R RIETHMULLER, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pr Riethmuller Didier
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29567122
Citation
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.
Results Reference
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Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)

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