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OpenTrials
Completed

NCT Number: NCT02675179

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint Etienne

Saint-Etienne, 42100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOS

Device

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

Other names: Pelvimetry

Spiral CT pelvimetry

Device

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

Other names: Pelvimetry

Primary outcomes

  1. Diameter of the basin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor: Comparative Single-center Prospective Study - PELVIC-EOS.

Acronym: PELVI-EOS

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2016
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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