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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Device: EOS; Device: Spiral CT pelvimetry

• Registration Number: NCT02675179
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2016-01-29
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Study Start: 2016-05-27
• Primary Completion: 2021-07-12
• Study Completion: 2021-08-06
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EOS + Spiral CT pelvimetry	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).
EOS + Spiral CT pelvimetry	EOS	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).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chu Saint Etienne; 🇫🇷 Saint-etienne, France