Breech Pelvimetry by EOS® Technique With Change of Maternal Position and Delivery Route (PelviEOS)

May 21, 2025 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pregnant women with a breech fetus
pregnant women with a breech fetus performing standing and sitting EOS pelvimetry
Device: EOS
pelvimetry by EOS in standing and sitting position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through the completion of studies, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful completion of the VME
Time Frame: through the completion of studies, an average of 2 year
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.
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
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.
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
To study the feasibility of measuring fetal neck flexion (in degrees).
through the completion of studies, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Study Director: Benoit Chauveau, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2022

Primary Completion (Actual)

February 8, 2025

Study Completion (Actual)

February 8, 2025

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2021 CHAUVEAU
  • 2021-A01752-39 (Other Identifier: 2021-A01752-39)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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