Clinical trial NCT04849975: Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)
Official title: Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breech Fetal Presentation
Keywords: Breech Fetal Presentation
MRI
EOS imaging system
Pelvimetric measurements
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Estimation of the reliability of pelvimetric measurements using Transverse Inlet Diameter measurement
timeFrame: Up to 1 day
measure: Estimation of the reliability of pelvimetric measurements using ante posterior diameter measurement
timeFrame: Up to 1 day
measure: Estimation of the reliability of pelvimetric measurements using BiSpinous Diameter measurement
timeFrame: Up to 1 day
measure: Estimation of the reliability of pelvimetric measurements using Bi-ischiatic mesurement
timeFrame: Up to 1 day
measure: Estimation of the reliability of pelvimetric measurements using Magin's Index calculation
timeFrame: Up to 1 day
Secondary outcomes:
measure: Pelvis morphological description using Cadwell and Moloy classification
timeFrame: Up to 1 day
measure: Pelvis morphological description using subpubic angle measurement
timeFrame: Up to 1 day
measure: Pelvis morphological description using obturating holes appearance
timeFrame: Up to 1 day
measure: Characterization of radiation doses received by EOS® system.
timeFrame: Up to 1 day
measure: Evaluation of the intra and inter-observer reproducibility for radiological interpretation
timeFrame: 4 days
measure: Evaluation of the intra and inter-observer reproducibility for clinical interpretation
timeFrame: 4 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Pr Riethmuller Didier
Study officials:
affiliation: University Hospital, Grenoble
name: Didier R RIETHMULLER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.