Breech Fetal Presentation
Conditions
Keywords
Breech Fetal Presentation, MRI, EOS imaging system, Pelvimetric measurements
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.
Interventions
OTHERPelvimetric 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.
Sponsors
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of the reliability of pelvimetric measurements using Transverse Inlet Diameter measurement | Up to 1 day | 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 | Up to 1 day | 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 | Up to 1 day | BiSpinous Diameter obtained by EOS® system versus MRI is evaluated in millimeters. |
| Estimation of the reliability of pelvimetric measurements using Bi-ischiatic mesurement | Up to 1 day | 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 | Up to 1 day | Magnin's Index calculation obtained by using EOS® system versus MRI is evaluated in millimeters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvis morphological description using obturating holes appearance | Up to 1 day | The appearance of the obturating holes (descriptive analysis) obtained by MRI and EOS® system is qualified. |
| Evaluation of the intra and inter-observer reproducibility for clinical interpretation | 4 days | Blind independent reading of MRI and EOS® images by two independent clinician on two different days with conclusion on the mode of delivery. |
| Characterization of radiation doses received by EOS® system. | Up to 1 day | Estimation of irradiation |
| Pelvis morphological description using Cadwell and Moloy classification | Up to 1 day | Caldwell and Moloy classification (scale) obtained by MRI and EOS® system is qualified. |
| Pelvis morphological description using subpubic angle measurement | Up to 1 day | The measurement of the subpubic angle (in degree) obtained by MRI and EOS® system is qualified. |
| Evaluation of the intra and inter-observer reproducibility for radiological interpretation | 4 days | Blind independent reading of MRI and EOS® images by two radiologists on two different days. |
Countries
France
Outcome results
None listed