Feasibility of HIFU for Management of Placenta Accreta (HIFU-ACCRETA)

Not Applicable

Withdrawn

• Conditions: Placenta Accreta
• Interventions: Device: High Intensity Focused Ultrasound

• Registration Number: NCT04003428
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-07-01
• Study Start: 2021-11-01
• Primary Completion: 2023-09-04
• Study Completion: 2023-09-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Per-caesarean HIFU shots	High Intensity Focused Ultrasound	Adjuvant treatment with High Intensity Focused Ultrasound (HIFU) performed the day of the scheduled childbirth, after confirmation of placenta accreta, and after fetal extraction by caesarian section.

Primary Outcome Measures

Name	Time	Method
Success of HIFU per-caesarean shots	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.

Secondary Outcome Measures

Name	Time	Method
Spontaneous uterine vacuity delay	Up to 6 months after procedure	measured in daytime. This is an estimate. After surgery on the uterus (e.g. hysterectomy, hysteroscopy, aspiration-curetage endo-uterin) it is considered that spontaneous uterine emptiness is not obtained.
Ultrasound characteristics of placental lesions produced over time	Up to 6 months after procedure
Spontaneous uterine vacuity	Up to 6 months after procedure	evaluated by endovaginal ultrasound examination. This examination will be supplemented by a liquid contrast ultrasound in accordance with standard clinical practices to identify the possible presence of synechia
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