EOSPelviEOSNCT05224908
Breech Pelvimetry by EOS® Technique With Change of Maternal Position and Delivery Route
A study testing EOS in people with EOS and Pregnancy Related, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
When a patient presents with a fetus in PS after 36+0SA, after acceptance of participation in the study, pelvimetry with evaluation of the height of the fetal presentation by EOS® system in the upright and sitting position will be performed. CT pelvimetry will not be performed. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- EOS, Pregnancy Related, Fetus Fetus
- What is being tested?
- EOS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2022to 8 Feb 2025
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Major parturient with a breech fetus after 36+0SA.
- Able to give informed consent to participate in the research.
- Enrolled in a Social Security scheme.
Who cannot join
- Multiple pregnancy
- Pelvimetry by CT scan already performed
- Fetal malformation
- History of pelvic fracture
- Known uterine malformation that precludes VME (unicornuate uterus, uterine septum...)
- Contraindication to vaginal delivery (placenta previa, obstacle previa, bicatric uterus, ...)
- Patient under guardianship or legal protection
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
When a patient presents with a fetus in PS after 36+0SA, after acceptance of participation in the study, pelvimetry with evaluation of the height of the fetal presentation by EOS® system in the upright and sitting position will be performed. CT pelvimetry will not be performed. The patient may then be offered an attempt at VME, with clear, fair and appropriate information, after being informed of the data from the right standing EOS® pelvimetry (report and images). VME will be performed according to the recommendations and practice of the department. In the event of failure with a fetus that remains in PS, the choice of delivery route will be decided in consultation with the patient after clear, fair and appropriate information.
If the patient wishes to have a vaginal delivery, the pregnancy will be continued without intervention until spontaneous labour or induction in case of indication (premature rupture of membranes (PMR), over term, or intercurrent maternal or fetal pathology). The modalities of the delivery route and/or a possible induction will be discussed between the obstetric team and the patient.
If the patient wishes a caesarean delivery in case of persistent PS, the delivery will be scheduled after 39+0SA or earlier if indicated (RPM, intercurrent maternal or fetal pathology). In the case of a successful VME with a fetus that remains in cephalic presentation until labour, management will follow current recommendations. The characteristics of the dimensions and angles of the obstetric pelvis and the height of the fetal presentation in the standing and sitting positions, the performance and success of MEC, the choice of delivery route, and the final delivery route will be recorded.
Read the detailed description
The 3rd trimester ultrasound is performed between 30+0 and 35+0SA, preferably between 30+0 and 32+0SA. In case of breech presentation (PS), an ultrasound check at the Clermont-Ferrand University Hospital from 36+0SA is usually requested. If PS is confirmed, the patient will be given the information sheet concerning breech fetuses published by the Collège National des Gynécologues et Obstétriciens Français (CNGOF) in 2020 and the patient will be offered to participate in the PelviEOS study.
Information about the study will be given by the investigator or his delegates during the presentation ultrasound.
After sufficient time for reflection and consent, EOS® pelvimetry in the upright and sitting position will be performed, starting at 36+0SA, and prior to attempted external manoeuvre version (EMV). The EOS® pelvimetry will be performed in the radiology department of the Clermont-Ferrand University Hospital, Estaing site. No other irradiating examination will be carried out, such as a pelvic CT scan, which will be replaced by pelvimetry using the EOS® system.
The examination will initially be carried out in the standing position, then in the sitting position on a stool.
A marker on the floor represented by two footprints will allow the straight standing and sitting images to be taken with equivalent and reproducible angles of femoral rotation.
The parameters assessed from the images taken by the EOS® system will be in the standing and sitting positions:
- The height of the fetal presentation assessed by measuring the distance between the centre of the maternal bisecting diameter and the lowest fetal trochanter.
- The angle of fetal progression,
- The median transverse diameter (MT),
- Promonto-retro-pubic distance (PRP),
- Magnin's index,
- Measurement of the sacral cord,
- Measurement of the sacral spire,
- Bispinous diameter,
- Bischial diameter,
- Subsacro-subpubic diameter,
- Pelvic angle of incidence,
- Pelvic obliquity,
- coxofemoral angle measurement.
After having been informed of the results of the pelvimetry performed in the upright position only (report and pictures), the performance of a VME will be proposed (the results of the pelvimetry in the sitting position will be transmitted after delivery, for statistical analysis).
If the patient wishes, an attempt at VME in the maternity ward of the Clermont-Ferrand University Hospital can be programmed from 36+0SA in accordance with the recommendations.
In the event of a successful MVA with a fetus that remains in cephalic presentation until labour begins, management will follow current recommendations.
In the event of refusal or failure of VME, the different delivery options will again be explained to the patient in accordance with the recommendations.
If the patient wishes to have a vaginal delivery, the pregnancy will be continued without intervention until spontaneous labour or induction if indicated (premature rupture of membranes (PMR), overdue delivery, intercurrent maternal or fetal pathology). The modalities of the delivery route and/or a possible induction will be discussed between the obstetric team and the patient.
If the patient wishes a caesarean delivery in case of persistent PS, the delivery will be scheduled from 39+0SA or earlier in case of indication (RPM, intercurrent maternal or fetal pathology).
The characteristics of the dimensions and angles of the obstetrical pelvis and the height of the fetal presentation in the standing and sitting positions, the performance and success of a VME, the choice of the delivery route and the actual delivery route will be recorded.
- Conditions
- EOS, Pregnancy Related, Fetus Fetus, Breech Fetal Presentation
- Being tested
- EOS
- Medical subject headings
- Fetus-in-Fetu, Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOSDevice
pelvimetry by EOS in standing and sitting position
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with a breech fetus | Experimental | pregnant women with a breech fetus performing standing and sitting EOS pelvimetry Receives: Device: EOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real way of delivery for women with a fetus in PS after 36+0SA.
To compare pelvimetry data (different radiographic characteristics of the obstetrical pelvis and height of the fetal presentation (in centimeter) ) recorded by the EOS® system in the standing and sitting positions between cases with a caesarean delivery and cases with a vaginal delivery in pregnant women with a breech fetus after 36+0SA.
Measured: through the completion of studies, an average of 2 year
Secondary outcomes (3)
Successful completion of the VME
To compare pelvimetry data (different radiographic characteristics of the obstetric pelvis and height of fetal presentation (in centimeter)) from the EOS® system in the standing and sitting positions between successful and unsuccessful VME in pregnant women with breech fetuses after 36+0SA.
Measured: through the completion of studies, an average of 2 year
Intention to deliver vaginally if breech presentation persists
To compare pelvimetry data (different radiographic features of the obstetric pelvis and height of fetal presentation (in centimeter)) in pregnant women with breech fetuses after 36+0SA using EOS® in the standing and sitting positions between cases referred for caesarean delivery and cases referred for vaginal delivery.
Measured: through the completion of studies, an average of 2 year
Measurement of fetal cervical flexion by measuring the craniospinal hinge angle.
To study the feasibility of measuring fetal neck flexion (in degrees).
Measured: through the completion of studies, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start26 Jan 2022
- Primary completion8 Feb 2025
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EOSStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Chauveau, Study director, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224908
- Sponsor's protocol ID
- RBHP 2021 CHAUVEAU
- Other IDs
- 2021-A01752-39
- Acronym
- PelviEOS
- Status last verified
- May 2025
- First submitted
- 14 Dec 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breech Pelvimetry by EOS® Technique With Change of Maternal Position and Delivery Route
- ClinicalTrials.gov ID
- NCT05224908
- Acronym / sponsor ID
- PelviEOS / RBHP 2021 CHAUVEAU
- Conditions
- EOS, Pregnancy Related, Fetus Fetus, Breech Fetal Presentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 8 Feb 2025 (actual)
- Study completion
- 8 Feb 2025 (actual)
- First posted
- 4 Feb 2022 (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.
When a patient presents with a fetus in PS after 36+0SA, after acceptance of participation in the study, pelvimetry with evaluation of the height of the fetal presentation by EOS® system in the upright and sitting position will be performed. CT pelvimetry will not be performed. The patient may then be offered an attempt at VME, with clear, fair and appropriate information, after being informed of the data from the right standing EOS® pelvimetry (report and images). VME will be performed according to the recommendations and practice of the department. In the event of failure with a fetus that remains in PS, the choice of delivery route will be decided in consultation with the patient after clear, fair and appropriate information.
If the patient wishes to have a vaginal delivery, the pregnancy will be continued without intervention until spontaneous labour or induction in case of indication (premature rupture of membranes (PMR), over term, or intercurrent maternal or fetal pathology). The modalities of the delivery route and/or a possible induction will be discussed between the obstetric team and the patient.
If the patient wishes a caesarean delivery in case of persistent PS, the delivery will be scheduled after 39+0SA or earlier if indicated (RPM, intercurrent maternal or fetal pathology). In the case of a successful VME with a fetus that remains in cephalic presentation until labour, management will follow current recommendations. The characteristics of the dimensions and angles of the obstetric pelvis and the height of the fetal presentation in the standing and sitting positions, the performance and success of MEC, the choice of delivery route, and the final delivery route will be recorded.
Detailed description
The 3rd trimester ultrasound is performed between 30+0 and 35+0SA, preferably between 30+0 and 32+0SA. In case of breech presentation (PS), an ultrasound check at the Clermont-Ferrand University Hospital from 36+0SA is usually requested. If PS is confirmed, the patient will be given the information sheet concerning breech fetuses published by the Collège National des Gynécologues et Obstétriciens Français (CNGOF) in 2020 and the patient will be offered to participate in the PelviEOS study.
Information about the study will be given by the investigator or his delegates during the presentation ultrasound.
After sufficient time for reflection and consent, EOS® pelvimetry in the upright and sitting position will be performed, starting at 36+0SA, and prior to attempted external manoeuvre version (EMV). The EOS® pelvimetry will be performed in the radiology department of the Clermont-Ferrand University Hospital, Estaing site. No other irradiating examination will be carried out, such as a pelvic CT scan, which will be replaced by pelvimetry using the EOS® system.
The examination will initially be carried out in the standing position, then in the sitting position on a stool.
A marker on the floor represented by two footprints will allow the straight standing and sitting images to be taken with equivalent and reproducible angles of femoral rotation.
The parameters assessed from the images taken by the EOS® system will be in the standing and sitting positions:
- The height of the fetal presentation assessed by measuring the distance between the centre of the maternal bisecting diameter and the lowest fetal trochanter.
- The angle of fetal progression,
- The median transverse diameter (MT),
- Promonto-retro-pubic distance (PRP),
- Magnin's index,
- Measurement of the sacral cord,
- Measurement of the sacral spire,
- Bispinous diameter,
- Bischial diameter,
- Subsacro-subpubic diameter,
- Pelvic angle of incidence,
- Pelvic obliquity,
- coxofemoral angle measurement.
After having been informed of the results of the pelvimetry performed in the upright position only (report and pictures), the performance of a VME will be proposed (the results of the pelvimetry in the sitting position will be transmitted after delivery, for statistical analysis).
If the patient wishes, an attempt at VME in the maternity ward of the Clermont-Ferrand University Hospital can be programmed from 36+0SA in accordance with the recommendations.
In the event of a successful MVA with a fetus that remains in cephalic presentation until labour begins, management will follow current recommendations.
In the event of refusal or failure of VME, the different delivery options will again be explained to the patient in accordance with the recommendations.
If the patient wishes to have a vaginal delivery, the pregnancy will be continued without intervention until spontaneous labour or induction if indicated (premature rupture of membranes (PMR), overdue delivery, intercurrent maternal or fetal pathology). The modalities of the delivery route and/or a possible induction will be discussed between the obstetric team and the patient.
If the patient wishes a caesarean delivery in case of persistent PS, the delivery will be scheduled from 39+0SA or earlier in case of indication (RPM, intercurrent maternal or fetal pathology).
The characteristics of the dimensions and angles of the obstetrical pelvis and the height of the fetal presentation in the standing and sitting positions, the performance and success of a VME, the choice of the delivery route and the actual delivery route will be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women with a breech fetus | Experimental | Device: EOSpregnant women with a breech fetus performing standing and sitting EOS pelvimetry |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Major parturient with a breech fetus after 36+0SA.
- Able to give informed consent to participate in the research.
- Enrolled in a Social Security scheme.
Key exclusion criteria (8 listed)
- Multiple pregnancy
- Pelvimetry by CT scan already performed
- Fetal malformation
- History of pelvic fracture
- Known uterine malformation that precludes VME (unicornuate uterus, uterine septum...)
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 |
|---|---|---|
| EOSpelvimetry by EOS in standing and sitting position | Device | pregnant women with a breech fetus |
Primary outcome
Real way of delivery for women with a fetus in PS after 36+0SA.
Time frame: through the completion of studies, an average of 2 year
To compare pelvimetry data (different radiographic characteristics of the obstetrical pelvis and height of the fetal presentation (in centimeter) ) recorded by the EOS® system in the standing and sitting positions between cases with a caesarean delivery and cases with a vaginal delivery in pregnant women with a breech fetus after 36+0SA.
3 secondary outcomes
Successful completion of the VME
Time frame: through the completion of studies, an average of 2 year
Intention to deliver vaginally if breech presentation persists
Time frame: through the completion of studies, an average of 2 year
Measurement of fetal cervical flexion by measuring the craniospinal hinge angle.
Time frame: through the completion of studies, an average of 2 year
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 22 May 2025.
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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.
Benoit Chauveau study director
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOS in people with EOS and Pregnancy Related, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 8 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 22 May 2025. 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?
Real way of delivery for women with a fetus in PS after 36+0SA. (time frame: through the completion of studies, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2025.