Clinical trial NCT04003428: Feasibility of HIFU for Management of Placenta Accreta (HIFU-ACCRETA)
Official title: Perioperative Evaluation of High Intensity Focalized Ultrasound for Adjuvant Management of Placenta Accreta: a Clinical Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Placenta Accreta
Keywords: High Intensity Focused Ultrasound (HIFU)
Placenta accreta
Feasibility
Safety
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Success of HIFU per-caesarean shots
timeFrame: Up to 30 days after procedure
Secondary outcomes:
measure: Ultrasound characteristics of placental lesions produced over time
timeFrame: Up to 6 months after procedure
measure: MRI characteristics of placental lesions produced over time
timeFrame: Up to 6 months after procedure
measure: Characteristics of lesions produced by macroscopic and microscopic pathological examination of the placenta (only in case of hysterectomy)
timeFrame: Up to 6 months after procedure
measure: Spontaneous uterine vacuity
timeFrame: Up to 6 months after procedure
measure: Spontaneous uterine vacuity delay
timeFrame: Up to 6 months after procedure
measure: Occurrence of a complication (hemorrhage, infection or other)
timeFrame: Up to 6 months after procedure
Other outcomes:
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