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

Pregnancy Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675179
• Other study ID #: 1508108
• Secondary ID: 2015-A01876-43
• Status: Completed
• Phase: N/A
• Start date: May 27, 2016
• Est. completion date: August 6, 2021

Study information

• Verified date: November 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: August 6, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dystocia
• Pregnancy

Intervention

Device:
• EOS
Pelvimetry will be performed with the new EOS technique of diagnosis to measure the diameter of the basin.
• Spiral CT pelvimetry
Pelvimetry will be performed with the spiral CT technique. It is the technique usually used.

Locations

Country	Name	City	State
France	Chu Saint Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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