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

Placenta Accreta Clinical Trial

— HIFU-ACCRETA  

Official title:

Perioperative Evaluation of High Intensity Focalized Ultrasound for Adjuvant Management of Placenta Accreta: a Clinical Feasibility Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04003428
• Other study ID #: 69HCL17_0335
• Secondary ID: 2017-A01376-47
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: September 4, 2023

Study information

• Verified date: November 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 4, 2023
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

Device:
• High Intensity Focused Ultrasound
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ultrasound characteristics of placental lesions produced over time		Up to 6 months after procedure
Secondary	MRI characteristics of placental lesions produced over time		Up to 6 months after procedure
Secondary	Characteristics of lesions produced by macroscopic and microscopic pathological examination of the placenta (only in case of hysterectomy)		Up to 6 months after procedure
Secondary	Spontaneous uterine vacuity	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	Up to 6 months after procedure
Secondary	Spontaneous uterine vacuity delay	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.	Up to 6 months after procedure
Secondary	Occurrence of a complication (hemorrhage, infection or other)		Up to 6 months after procedure