Pregnancy Related Clinical Trial
— PelviEOSOfficial title:
Breech Pelvimetry by EOS® Technique With Change of Maternal Position and Delivery Route
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.
Status | Recruiting |
Enrollment | 87 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU clermont-ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | through the completion of studies, an average of 2 year | |
Secondary | 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. | through the completion of studies, an average of 2 year | |
Secondary | Measurement of fetal cervical flexion by measuring the craniospinal hinge angle. | To study the feasibility of measuring fetal neck flexion (in degrees). | through the completion of studies, an average of 2 year |
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