NCT02834897

Brief Summary

The purpose of this study and demonstrate the reliability of EOS imaging system in the measurement of internal diameters of obstetrical pelvis versus "Goldstandard current "that is the pelviscanner.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

July 13, 2016

Last Update Submit

July 17, 2018

Conditions

RadiationObstetric Labor ComplicationsPregnancy Complications

Keywords

EOS imagery

Outcome Measures

Primary Outcomes (1)

  • Measurement reliability index Magnin with EOS cab relative to the CT measurements

    one months

Study Arms (1)

EOS and CT Exam

EXPERIMENTAL

EOS and CT Examen for pregnant women in the 8th month of pregnancy

Radiation: EOS and CT Exam

Interventions

EOS and CT ExamRADIATION

EOS and CT Examen for pregnant women in the 8th month of pregnancy

EOS and CT Exam

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pelviscanner indication in women

You may not qualify if:

  • In the disqualification of another study or under the "national register of volunteers."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Obstetric Labor ComplicationsPregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • sebastien AUBRY, MD

    Centre Hospitalier Universitaire de Besancon

    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

July 13, 2016

First Posted

July 15, 2016

Study Start

May 1, 2015

Primary Completion

February 12, 2016

Study Completion

February 12, 2016

Last Updated

July 18, 2018

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)