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

EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor: Comparative Single-center Prospective Study - PELVIC-EOS.

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: EOS; Device: Spiral CT pelvimetry

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 Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42100
    • CHU Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Céline CHAULEUR, MD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2016
• Primary Completion (Actual): July 12, 2021
• Study Completion (Actual): August 6, 2021

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Dystocia
• Other Study ID Numbers: 1508108; 2015-A01876-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No