Breech Fetal PresentationCAPEOS®NCT04849975
Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)
A study testing Pelvimetric measurements in people with Breech Fetal Presentation, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective of this study is to compare pelvimetric measurements performed by Magnetic Resonance Imaging (MRI) and by the EOS imaging system. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breech Fetal Presentation
- What is being tested?
- Pelvimetric measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2021to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age
- Patient requiring pelvimetry (breech fetus)
- Gestation > 36 SA (weeks of amenorrhea)
- Patients with BMI < 35
- Affiliated to social security or similarly regime
- Patients who gave their consent to participate in the study (Patient having agreed to perform both examinations: MRI and EOS system)
Who cannot join
- Patient with a contraindication to MRI (claustrophobia, pace-maker, intracorporeal metallic element)
- Patient with a contraindication to performing EOS® (person not standing alone)
- Patient who are in exlusion period of another interventiionnal study
- Person deprived of freedom by judicial or administrative decision; person hospitalized for psychitric care; person under legal protection measure.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to compare pelvimetric measurements performed by Magnetic Resonance Imaging (MRI) and by the EOS imaging system.
Read the detailed description
During pregnancy, after failure of External Manual Version (EMV) in case of breech fetal presentation, a radiological pelvimetry is performed to evaluate the measurements of the pelvis and decide on the appropriate mode of delivery.
Several imaging modalities are used, including pelvic computed tomography (CT),and magnetic resonance imaging (MRI) of the pelvis.
CT scan has the disadvantage of maternal irradiation and MRI has the disadvantage of an inaccurate morphological analysis.The EOS® system is an imaging tool used in radiopediatric to allow precise morphological analysis of bone masses with minimal irradiation.
The quality of the morphological analysis and measurements provided by the EOS® imaging system is the reason for proposing this study comparing the pelvimetric measurements obtained by MRI and by the EOS® imaging system.
- Conditions
- Breech Fetal Presentation
- Being tested
- Pelvimetric measurements
- Keywords
- Breech Fetal Presentation, MRI, EOS imaging system, Pelvimetric measurements
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvimetric measurementsOther
The patients in this group are pregnant women after failure of external manual version (EMV) in case of breech fetal presentation. The participants will successively perform MRI pelvimetry (conventional management) and EOS imaging.
| Study group | Role | What they receive |
|---|---|---|
| Pelvimetry group | Experimental | The participants oh this group will successively perform MRI pelvimetry and EOS imaging. Receives: Other: Pelvimetric measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the reliability of pelvimetric measurements using Transverse Inlet Diameter measurement
Transverse Inlet Diameter Measurement obtained by EOS® system versus MRI is evaluated in millimeters.
Measured: Up to 1 day
Estimation of the reliability of pelvimetric measurements using ante posterior diameter measurement
Ante posterior diameter of the pelvic inlet obtained by using EOS® system versus MRI is evaluated in millimeters.
Measured: Up to 1 day
Estimation of the reliability of pelvimetric measurements using BiSpinous Diameter measurement
BiSpinous Diameter obtained by EOS® system versus MRI is evaluated in millimeters.
Measured: Up to 1 day
Estimation of the reliability of pelvimetric measurements using Bi-ischiatic mesurement
Bi-ischiatic measurement obtained by EOS® system versus MRI is evaluated in millimeters.
Measured: Up to 1 day
Estimation of the reliability of pelvimetric measurements using Magin's Index calculation
Magnin's Index calculation obtained by using EOS® system versus MRI is evaluated in millimeters.
Measured: Up to 1 day
Secondary outcomes (6)
Pelvis morphological description using Cadwell and Moloy classification
Caldwell and Moloy classification (scale) obtained by MRI and EOS® system is qualified.
Measured: Up to 1 day
Pelvis morphological description using subpubic angle measurement
The measurement of the subpubic angle (in degree) obtained by MRI and EOS® system is qualified.
Measured: Up to 1 day
Pelvis morphological description using obturating holes appearance
The appearance of the obturating holes (descriptive analysis) obtained by MRI and EOS® system is qualified.
Measured: Up to 1 day
Characterization of radiation doses received by EOS® system.
Estimation of irradiation
Measured: Up to 1 day
Evaluation of the intra and inter-observer reproducibility for radiological interpretation
Blind independent reading of MRI and EOS® images by two radiologists on two different days.
Measured: 4 days
Evaluation of the intra and inter-observer reproducibility for clinical interpretation
Blind independent reading of MRI and EOS® images by two independent clinician on two different days with conclusion on the mode of delivery.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start9 Nov 2021
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breech Fetal PresentationStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier R RIETHMULLER, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849975
- Sponsor's protocol ID
- 38RC21.001
- Acronym
- CAPEOS®
- Status last verified
- Aug 2023
- First submitted
- 11 Mar 2021
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aubry S, Padoin P, Petegnief Y, Vidal C, Riethmuller D, Delabrousse E. Can three-dimensional pelvimetry using low-dose stereoradiography replace low-dose CT pelvimetry? Diagn Interv Imaging. 2018 Sep;99(9):569-576. doi: 10.1016/j.diii.2018.02.008. Epub 2018 Mar 19.
PubMed 29567122
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)
- ClinicalTrials.gov ID
- NCT04849975
- Acronym / sponsor ID
- CAPEOS® / 38RC21.001
- Conditions
- Breech Fetal Presentation
- Keywords
- Breech Fetal Presentation, MRI, EOS imaging system, Pelvimetric measurements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to compare pelvimetric measurements performed by Magnetic Resonance Imaging (MRI) and by the EOS imaging system.
Detailed description
During pregnancy, after failure of External Manual Version (EMV) in case of breech fetal presentation, a radiological pelvimetry is performed to evaluate the measurements of the pelvis and decide on the appropriate mode of delivery.
Several imaging modalities are used, including pelvic computed tomography (CT),and magnetic resonance imaging (MRI) of the pelvis.
CT scan has the disadvantage of maternal irradiation and MRI has the disadvantage of an inaccurate morphological analysis.The EOS® system is an imaging tool used in radiopediatric to allow precise morphological analysis of bone masses with minimal irradiation.
The quality of the morphological analysis and measurements provided by the EOS® imaging system is the reason for proposing this study comparing the pelvimetric measurements obtained by MRI and by the EOS® imaging system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvimetry group | Experimental | Other: Pelvimetric measurementsThe participants oh this group will successively perform MRI pelvimetry and EOS imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients > 18 years of age
- Patient requiring pelvimetry (breech fetus)
- Gestation > 36 SA (weeks of amenorrhea)
- Patients with BMI < 35
- Affiliated to social security or similarly regime
Key exclusion criteria (4 listed)
- Patient with a contraindication to MRI (claustrophobia, pace-maker, intracorporeal metallic element)
- Patient with a contraindication to performing EOS® (person not standing alone)
- Patient who are in exlusion period of another interventiionnal study
- Person deprived of freedom by judicial or administrative decision; person hospitalized for psychitric care; person under legal protection measure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvimetric measurementsThe patients in this group are pregnant women after failure of external manual version (EMV) in case of breech fetal presentation. The participants will successively perform MRI pelvimetry (conventional management) and EOS imaging. | Other | Pelvimetry group |
Primary outcome
Estimation of the reliability of pelvimetric measurements using Transverse Inlet Diameter measurement
Time frame: Up to 1 day
Transverse Inlet Diameter Measurement obtained by EOS® system versus MRI is evaluated in millimeters.
Estimation of the reliability of pelvimetric measurements using ante posterior diameter measurement
Time frame: Up to 1 day
Ante posterior diameter of the pelvic inlet obtained by using EOS® system versus MRI is evaluated in millimeters.
Estimation of the reliability of pelvimetric measurements using BiSpinous Diameter measurement
Time frame: Up to 1 day
BiSpinous Diameter obtained by EOS® system versus MRI is evaluated in millimeters.
Estimation of the reliability of pelvimetric measurements using Bi-ischiatic mesurement
Time frame: Up to 1 day
Bi-ischiatic measurement obtained by EOS® system versus MRI is evaluated in millimeters.
Estimation of the reliability of pelvimetric measurements using Magin's Index calculation
Time frame: Up to 1 day
Magnin's Index calculation obtained by using EOS® system versus MRI is evaluated in millimeters.
6 secondary outcomes
Pelvis morphological description using Cadwell and Moloy classification
Time frame: Up to 1 day
Pelvis morphological description using subpubic angle measurement
Time frame: Up to 1 day
Pelvis morphological description using obturating holes appearance
Time frame: Up to 1 day
Characterization of radiation doses received by EOS® system.
Time frame: Up to 1 day
Evaluation of the intra and inter-observer reproducibility for radiological interpretation
Time frame: 4 days
Evaluation of the intra and inter-observer reproducibility for clinical interpretation
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Background: PubMed 29567122Aubry S, Padoin P, Petegnief Y, Vidal C, Riethmuller D, Delabrousse E. Can three-dimensional pelvimetry using low-dose stereoradiography replace low-dose CT pelvimetry? Diagn Interv Imaging. 2018 Sep;99(9):569-576. doi: 10.1016/j.diii.2018.02.008. Epub 2018 Mar 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier R RIETHMULLER, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvimetric measurements in people with Breech Fetal Presentation, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the reliability of pelvimetric measurements using Transverse Inlet Diameter measurement (time frame: Up to 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04849975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.