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

NCT ID: NCT04849975

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-09

Study Completion Date

2023-07-24

Brief Summary

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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

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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.

Conditions

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Breech Fetal Presentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pelvimetry group

The participants oh this group will successively perform MRI pelvimetry and EOS imaging.

Group Type EXPERIMENTAL

Pelvimetric measurements

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didier R RIETHMULLER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Pr Riethmuller Didier

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 29567122 (View on PubMed)

Other Identifiers

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38RC21.001

Identifier Type: -

Identifier Source: org_study_id

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