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

NCT04003428 | Withdrawn DMC

• 2 other identifiers: 69HCL17_03352017-A01376-47
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Placenta Accreta

Keywords

High Intensity Focused Ultrasound (HIFU); Placenta accreta; Feasibility; Safety

Outcome Measures

Primary Outcomes (1)

• Success of HIFU per-caesarean shots

  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.

  Up to 30 days after procedure

Secondary Outcomes (6)

• Ultrasound characteristics of placental lesions produced over time

  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

• Spontaneous uterine vacuity

  Up to 6 months after procedure

• Spontaneous uterine vacuity delay

  Up to 6 months after procedure

Study Arms (1)

Per-caesarean HIFU shots

EXPERIMENTAL

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.

Device: High Intensity Focused Ultrasound

Interventions

High Intensity Focused Ultrasound DEVICE

HIFU shots will be performed on the placental tissue to produce necrotic lesions of approximately 30% of the total volume. A latency time of 2 minutes between each shot will be observed to avoid the accumulative heat effect, and to ensure optimal positioning of the treatment probe. The maximum duration of the operating time for HIFU shooting shall not exceed 60 minutes.

Per-caesarean HIFU shots

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: July 1, 2019
• Study Start: November 1, 2021
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11