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

Primary Purpose

Pregnancy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EOS
Spiral CT pelvimetry
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Saint Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EOS + Spiral CT pelvimetry

Arm Description

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).

Outcomes

Primary Outcome Measures

Diameter of the basin
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.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2016
Last Updated
November 24, 2021
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02675179
Brief Title
EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor.
Acronym
PELVI-EOS
Official Title
EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor: Comparative Single-center Prospective Study - PELVIC-EOS.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 27, 2016 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
August 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EOS + Spiral CT pelvimetry
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
EOS
Other Intervention Name(s)
Pelvimetry
Intervention Description
Pelvimetry will be performed with the new EOS technique of diagnosis to measure the diameter of the basin.
Intervention Type
Device
Intervention Name(s)
Spiral CT pelvimetry
Other Intervention Name(s)
Pelvimetry
Intervention Description
Pelvimetry will be performed with the spiral CT technique. It is the technique usually used.
Primary Outcome Measure Information:
Title
Diameter of the basin
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline CHAULEUR, MD
Organizational Affiliation
CHU SAINT ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint Etienne
City
Saint-etienne
ZIP/Postal Code
42100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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