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Completed

NCT Number: NCT04849975

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pr Riethmuller Didier

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pelvimetric measurements

Other

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.

Primary outcomes

  1. Estimation of the reliability of pelvimetric measurements using Transverse Inlet Diameter measurement

    Time frame: Up to 1 day

    Transverse Inlet Diameter Measurement obtained by EOS® system versus MRI is evaluated in millimeters.

  2. Estimation of the reliability of pelvimetric measurements using ante posterior diameter measurement

    Time frame: Up to 1 day

    Ante posterior diameter of the pelvic inlet obtained by using EOS® system versus MRI is evaluated in millimeters.

  3. Estimation of the reliability of pelvimetric measurements using BiSpinous Diameter measurement

    Time frame: Up to 1 day

    BiSpinous Diameter obtained by EOS® system versus MRI is evaluated in millimeters.

  4. Estimation of the reliability of pelvimetric measurements using Bi-ischiatic mesurement

    Time frame: Up to 1 day

    Bi-ischiatic measurement obtained by EOS® system versus MRI is evaluated in millimeters.

  5. Estimation of the reliability of pelvimetric measurements using Magin's Index calculation

    Time frame: Up to 1 day

    Magnin's Index calculation obtained by using EOS® system versus MRI is evaluated in millimeters.

Secondary outcomes

  1. Pelvis morphological description using Cadwell and Moloy classification

    Time frame: Up to 1 day

    Caldwell and Moloy classification (scale) obtained by MRI and EOS® system is qualified.

  2. Pelvis morphological description using subpubic angle measurement

    Time frame: Up to 1 day

    The measurement of the subpubic angle (in degree) obtained by MRI and EOS® system is qualified.

  3. Pelvis morphological description using obturating holes appearance

    Time frame: Up to 1 day

    The appearance of the obturating holes (descriptive analysis) obtained by MRI and EOS® system is qualified.

  4. Characterization of radiation doses received by EOS® system.

    Time frame: Up to 1 day

    Estimation of irradiation

  5. Evaluation of the intra and inter-observer reproducibility for radiological interpretation

    Time frame: 4 days

    Blind independent reading of MRI and EOS® images by two radiologists on two different days.

  6. Evaluation of the intra and inter-observer reproducibility for clinical interpretation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: CAPEOS®

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2021
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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