NCT04849975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

November 9, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

March 11, 2021

Last Update Submit

August 24, 2023

Conditions

Breech Fetal Presentation

Keywords

Breech Fetal PresentationMRIEOS imaging systemPelvimetric measurements

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Pelvis morphological description using Cadwell and Moloy classification

    Up to 1 day

  • Pelvis morphological description using subpubic angle measurement

    Up to 1 day

  • Pelvis morphological description using obturating holes appearance

    Up to 1 day

  • Characterization of radiation doses received by EOS® system.

    Up to 1 day

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

    4 days

  • +1 more secondary outcomes

Study Arms (1)

Pelvimetry group

EXPERIMENTAL

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

Other: Pelvimetric measurements

Interventions

Pelvimetric measurementsOTHER

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.

Pelvimetry group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pr Riethmuller Didier

Grenoble, 38043, France

Location

Related Publications (1)

  • 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.

    PMID: 29567122BACKGROUND

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Didier R RIETHMULLER, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

April 20, 2021

Study Start

November 9, 2021

Primary Completion

July 24, 2023

Study Completion

July 24, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)