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PELVI-EOS: EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor.

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT02675179
Collaborator
(none)
117
Enrollment
1
Location
1
Arm
62.3
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS and the spiral CT in women having had an obstructed delivery. If this concordance is demonstrated, it would allow the use of this new technique of imagery, to realize a pelvimetry during the pregnancy less irradiating for the mother, and the fetus.

Condition or Disease Intervention/Treatment Phase
  • Device: EOS
  • Device: Spiral CT pelvimetry
 N/A

Detailed Description

The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS and the spiral CT in women having had an obstructed delivery. If this concordance is demonstrated, it would allow the use of this new technique of imagery, to realize a pelvimetry during the pregnancy less irradiating for the mother, and the fetus.

To answer this objective, the study will be a prospective, monocentric, open clinical trial, comparing the radio-pelvimetry realized with EOS technique, to the spiral CT. Measures are performed in the 3 months following the obstructed delivery.

Study Design

Study Type:
Interventional
Actual Enrollment :
117 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor: Comparative Single-center Prospective Study - PELVIC-EOS.
Actual Study Start Date :
May 27, 2016
Actual Primary Completion Date :
Jul 12, 2021
Actual Study Completion Date :
Aug 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: EOS + Spiral CT pelvimetry

Women with an indication of pelvimetry will be included in this study. They will be their own control because they will benefit from the two methods of diagnosis : EOS new technique, and spiral CT (usual technique).

Device: EOS
Pelvimetry will be performed with the new EOS technique of diagnosis to measure the diameter of the basin.
Other Names:
  • Pelvimetry

    • Device: Spiral CT pelvimetry
    Pelvimetry will be performed with the spiral CT technique. It is the technique usually used.
    Other Names:
  • Pelvimetry

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diameter of the basin [Day 1]

      The aim of this study is to compare the measures of the basins with two different techniques : the usual one spiral CT technique, and the new one : the EOS technique that is less irradiating than the older one. If these two techniques give the same measures, researchers would be able in the future to use the new technique less invasive for the mother and the fetus, as a routine technique.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who gave birth at the CHU Saint-Etienne

    • Patients having an indication of pelvimetry

    • Patients who delivered singleton pregnancy in cephalic presentation at term

    • Patients affiliated to a social security scheme

    Exclusion Criteria:

    • Patients with no wish of further pregnancy

    • Patients with another cause of dystocia during labor

    • Patients with a significant number (>2) of radiological examinations in the year before

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Saint Etienne Saint-etienne France 42100

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Saint Etienne

    Investigators

    • Principal Investigator: Céline CHAULEUR, MD, CHU SAINT ETIENNE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Saint Etienne
    ClinicalTrials.gov Identifier:
    NCT02675179
    Other Study ID Numbers:
    • 1508108
    • 2015-A01876-43
    First Posted:
    Feb 5, 2016
    Last Update Posted:
    Nov 29, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dystocia

    Study Results

    No Results Posted as of Nov 29, 2021