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

NCT ID: NCT02675179

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-27

Study Completion Date

2021-08-06

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

EOS

Intervention Type DEVICE

Pelvimetry will be performed with the new EOS technique of diagnosis to measure the diameter of the basin.

Spiral CT pelvimetry

Intervention Type DEVICE

Pelvimetry will be performed with the spiral CT technique. It is the technique usually used.

Interventions

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EOS

Pelvimetry will be performed with the new EOS technique of diagnosis to measure the diameter of the basin.

Intervention Type DEVICE

Spiral CT pelvimetry

Pelvimetry will be performed with the spiral CT technique. It is the technique usually used.

Intervention Type DEVICE

Other Intervention Names

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Pelvimetry Pelvimetry

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Céline CHAULEUR, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Saint Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2015-A01876-43

Identifier Type: OTHER

Identifier Source: secondary_id

1508108

Identifier Type: -

Identifier Source: org_study_id