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

Breech Fetal Presentation Clinical Trial

— CAPEOS®  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849975
• Other study ID #: 38RC21.001
• Status: Completed
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: July 24, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 24, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breech Fetal Presentation
• Breech Presentation

Intervention

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.

Locations

Country	Name	City	State
France	Pr Riethmuller Didier	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Characterization of radiation doses received by EOS® system.	Estimation of irradiation	Up to 1 day
Secondary	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
Secondary	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