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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Pregnancy

Treatments: Device: Spiral CT pelvimetry; Device: EOS

Study type: Interventional

Funder types: Other

Identifiers

NCT02675179

2015-A01876-43 (Other Identifier)

1508108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

117 participants in 1 patient group

EOS + Spiral CT pelvimetry

Experimental group

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).

Treatment:

Device: EOS

Device: Spiral CT pelvimetry