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

NCT05224908 | Completed

• 2 other identifiers: RBHP 2021 CHAUVEAU2021-A01752-39
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

EOS; Pregnancy Related; Fetus Fetus; Breech Fetal Presentation

Outcome Measures

Primary Outcomes (1)

• 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.

  through the completion of studies, an average of 2 year

Secondary Outcomes (3)

• Successful completion of the VME

  through the completion of studies, an average of 2 year

• Intention to deliver vaginally if breech presentation persists

  through the completion of studies, an average of 2 year

• Measurement of fetal cervical flexion by measuring the craniospinal hinge angle.

  through the completion of studies, an average of 2 year

Study Arms (1)

pregnant women with a breech fetus

EXPERIMENTAL

pregnant women with a breech fetus performing standing and sitting EOS pelvimetry

Device: EOS

Interventions

EOS DEVICE

pelvimetry by EOS in standing and sitting position

pregnant women with a breech fetus

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: pregnant women with a breech fetus
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Fetus-in-Fetu; Breech Presentation

Condition Hierarchy (Ancestors)

Twins, Conjoined; Abnormalities, Severe Teratoid; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Benoit Chauveau

  University Hospital, Clermont-Ferrand

  STUDY DIRECTOR

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: December 14, 2021
• First Posted: February 4, 2022
• Study Start: January 26, 2022
• Primary Completion: February 8, 2025
• Study Completion: February 8, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

FR (1)