An interventional study of Pelvimetric measurements in Breech Fetal Presentation, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Diagnostic
The main objective of this study is to compare pelvimetric measurements performed by Magnetic Resonance Imaging (MRI) and by the EOS imaging system.
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.
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's enrollment of 35 is below the median of 119 across 31 interventional studies indexed under Breech Presentation.
Browse Breech Presentation studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 day
Pelvis morphological description using Cadwell and Moloy classification
Caldwell and Moloy classification (scale) obtained by MRI and EOS® system is qualified.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 day
Characterization of radiation doses received by EOS® system.
Estimation of irradiation
Time frame: 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.
Time frame: 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.
Time frame: 4 days
Plan to share: No
Ran from Nov 2021 to primary completion in Jul 2023, 20 months.
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