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

NCT02675179 | Completed

• 2 other identifiers: 15081082015-A01876-43
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EOS + Spiral CT pelvimetry

EXPERIMENTAL

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; Device: Spiral CT pelvimetry

Interventions

EOS DEVICE

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

Also known as: Pelvimetry

EOS + Spiral CT pelvimetry

Spiral CT pelvimetry DEVICE

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

Also known as: Pelvimetry

EOS + Spiral CT pelvimetry

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Interventions

Pelvimetry

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Physical Examination; Investigative Techniques

Study Officials

• Céline CHAULEUR, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 5, 2016
• Study Start: May 27, 2016
• Primary Completion: July 12, 2021
• Study Completion: August 6, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)