Perioperative Evaluation of High Intensity Focalized Ultrasound for Adjuvant Management of Placenta Accreta: a Clinical Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Success of HIFU per-caesarean shots
研究概览
简要总结
Placental accretion during pregnancy refers to an abnormally deep insertion of the placenta into the uterus, leading to the impossibility of removing the placenta without inducting uterine or surrounding organs lesions. The management of these patients is complex, with two options during caesarean section: hysterectomy or uterine conservative surgery in which the placenta is let in the uterine cavity. These are both at risk of complications, including severe hemorrhage.
High Intensity Focused Ultrasound (HIFU) principle is based on the focusing of ultrasonic waves in a focal zone causing a rapid rise in temperature in the targeted area. This focus results in the creation of a coagulation necrosis tissue lesion. This procedure is guided in real time by an integrated ultrasound imaging cell.
The investigators hypothesized that HIFU shots would accelerate the process of placental involution when the placenta is let in the uterine cavity, increasing the chances of uterine preservation and reducing the infectious and hemorrhagic risks in the short and medium term. The aim of this study is to confirm the feasibility and safety of the use of HIFU as a per-caesarean adjuvant treatment for management of placenta accrete let in the uterus for a conservative treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman aged 18 years or older, with a suspicion of placental accretion observed with usual imaging tests (ultrasound, MRI)
- •Single pregnancy (singleton)
- •For whom a caesarean section has been scheduled
- •Wishing to try to preserve her uterus
- •Affiliated to a social security scheme or similar
- •Having signed informed consent for participation in the study
排除标准
- •Major patient protected by law, under guardianship or curatorship
- •Patient participating in other interventional research that may interfere with this research
- •Placental tumor identified in antenatal
- •Grade 3 placental calcification
- •Presence of a catheter, stent or vascular prosthesis close to the uterus
结局指标
主要结局
Success of HIFU per-caesarean shots
时间窗: Up to 30 days after procedure
Number of patients for whom: the probe is positioned in contact with the uterine serosa; and, one or more lesions of at least 1 cm each are visible on intraoperative ultrasound; and, total intervention time is 60 minutes maximum; and, no lesion are visible on the uterus; and, constants are maintained during the intervention; and, no related complication occurred during the intervention.
次要结局
- Spontaneous uterine vacuity delay(Up to 6 months after procedure)
- Ultrasound characteristics of placental lesions produced over time(Up to 6 months after procedure)
- Spontaneous uterine vacuity(Up to 6 months after procedure)
- Occurrence of a complication (hemorrhage, infection or other)(Up to 6 months after procedure)
- MRI characteristics of placental lesions produced over time(Up to 6 months after procedure)
- Characteristics of lesions produced by macroscopic and microscopic pathological examination of the placenta (only in case of hysterectomy)(Up to 6 months after procedure)