Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003428
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Placenta Accreta Device: High Intensity Focused Ultrasound Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Evaluation of High Intensity Focalized Ultrasound for Adjuvant Management of Placenta Accreta: a Clinical Feasibility Study
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Per-caesarean HIFU shots
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
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.




Primary Outcome Measures :
  1. Success of HIFU per-caesarean shots [ Time Frame: 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 :
  1. Ultrasound characteristics of placental lesions produced over time [ Time Frame: Up to 6 months after procedure ]
  2. MRI characteristics of placental lesions produced over time [ Time Frame: Up to 6 months after procedure ]
  3. Characteristics of lesions produced by macroscopic and microscopic pathological examination of the placenta (only in case of hysterectomy) [ Time Frame: Up to 6 months after procedure ]
  4. Spontaneous uterine vacuity [ Time Frame: 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

  5. Spontaneous uterine vacuity delay [ Time Frame: 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.

  6. Occurrence of a complication (hemorrhage, infection or other) [ Time Frame: Up to 6 months after procedure ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003428


Contacts
Layout table for location contacts
Contact: Cyril HUISSOUD +33 4 72 07 29 09 cyril.huissoud@chu-lyon.fr

Locations
Layout table for location information
France
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, France, 69004
Contact: Cyril HUISSOUD    +33 4 72 07 29 09    cyril.huissoud@chu-lyon.fr   
Principal Investigator: Cyril HUISSOUD         
Sponsors and Collaborators
Hospices Civils de Lyon
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04003428    
Other Study ID Numbers: 69HCL17_0335
2017-A01376-47 ( Other Identifier: ANSM )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
High Intensity Focused Ultrasound (HIFU)
Placenta accreta
Feasibility
Safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases