Breech Pelvimetry by EOS® Technique With Change of Maternal Position and Delivery Route
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Real way of delivery for women with a fetus in PS after 36+0SA.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Real way of delivery for women with a fetus in PS after 36+0SA.
时间窗: 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.
次要结局
- 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)
- Successful completion of the VME(through the completion of studies, an average of 2 year)