Breech Fetal Presentation Clinical Trial
— CAPEOS®Official title:
Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)
Verified date | August 2023 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this study is to compare pelvimetric measurements performed by Magnetic Resonance Imaging (MRI) and by the EOS imaging system.
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. |
Country | Name | City | State |
---|---|---|---|
France | Pr Riethmuller Didier | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05224908 -
Breech Pelvimetry by EOS® Technique With Change of Maternal Position and Delivery Route
|
N/A |