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Comparison of Bladder Filling vs. Non-Filling in Cesarean Hysterectomy for Placenta Percreta

Primary Purpose

Placenta Accreta

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Filled-bladder
non filled-bladder
Sponsored by
Hatem AbuHashim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Accreta

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant women in their third trimester (35-37 W).
  • Placenta previa accreta spectrum identified by the Ultrasound (low lying anterior or major degree anterior).
  • With at least one prior cesarean section.
  • Elective cesarean hysterectomy.
  • Evidence of gross placental invasion at the time of surgery (FIGO grade 3a.

Exclusion Criteria:

  • Patients undergoing conservative treatment.
  • Emergency cesarean hysterectomy.
  • No evidence of gross placental invasion at the time of surgery.
  • Posterior placenta.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Filled-bladder

    non filled-bladder

    Arm Description

    Bladder filling with 300ml diluted methylene blue.

    Outcomes

    Primary Outcome Measures

    Rate of urinary bladder injury
    Unintentional bladder injury during elective cesarean hysterectomy

    Secondary Outcome Measures

    Full Information

    First Posted
    December 21, 2019
    Last Updated
    December 23, 2019
    Sponsor
    Hatem AbuHashim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04210479
    Brief Title
    Comparison of Bladder Filling vs. Non-Filling in Cesarean Hysterectomy for Placenta Percreta
    Official Title
    Bladder Filling in Cesarean Hysterectomy for Placenta Percreta: A Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 15, 2020 (Anticipated)
    Primary Completion Date
    March 31, 2021 (Anticipated)
    Study Completion Date
    June 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hatem AbuHashim

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates. including less blood loss, fewer transfusion requirements and, intraoperative urinary tract injury as well as improve fetal outcome. Ultrasound evaluation is the recommended first-line modality for diagnosing PAS. Ultrasound features suggestive of PAS include loss of the normal retroplacental clear zone, attenuation of the uterine-bladder interface, reduced retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder. A systematic review reported that the antenatal diagnosis of PAS significantly lowered the rate of urinary tract injury (from 63% to 39%) during cesarean hysterectomies in these cases. Unlike other elective cesarean hysterectomies, cesarean hysterectomy with a placenta previa increta/percreta, is more difficult. There is a greater need to both keep a margin from the vascular cervical-placental mass and simultaneously protect the urinary bladder. Case series reported that bladder filling helps the surgeon to more clearly identify the planes of dissection and secure the engorged aberrant vessels, thereby reduces bladder injury. Accordingly, a prospective randomized study in pregnant patients with placenta previa increta/percreta undergoing elective cesarean hysterectomy will be conducted to address this important issue.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Placenta Accreta

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Filled-bladder
    Arm Type
    Experimental
    Arm Description
    Bladder filling with 300ml diluted methylene blue.
    Arm Title
    non filled-bladder
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Filled-bladder
    Intervention Description
    Urinary bladder filling with 300 ml diluted methylene blue
    Intervention Type
    Procedure
    Intervention Name(s)
    non filled-bladder
    Intervention Description
    Pull up the empty (non-filled) urinary bladder using Allis forceps
    Primary Outcome Measure Information:
    Title
    Rate of urinary bladder injury
    Description
    Unintentional bladder injury during elective cesarean hysterectomy
    Time Frame
    Intra-operative (i.e. during surgery).

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pregnant women in their third trimester (35-37 W). Placenta previa accreta spectrum identified by the Ultrasound (low lying anterior or major degree anterior). With at least one prior cesarean section. Elective cesarean hysterectomy. Evidence of gross placental invasion at the time of surgery (FIGO grade 3a. Exclusion Criteria: Patients undergoing conservative treatment. Emergency cesarean hysterectomy. No evidence of gross placental invasion at the time of surgery. Posterior placenta.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hatem Abu Hashim, MD.FRCOG.PhD
    Phone
    +20502300002
    Email
    hatem_ah@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hatem Abu Hashim, MD. FRCOG. PhD
    Organizational Affiliation
    Faculty of Medicine, Mansoura University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mostafa Aboelenin, MBBCh
    Organizational Affiliation
    Samnoud General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23445140
    Citation
    Matsubara S. Caesarean hysterectomy for placenta praevia accreta: filling the bladder technique to identify an appropriate bladder separation site. J Obstet Gynaecol. 2013 Feb;33(2):163-4. doi: 10.3109/01443615.2012.740525. No abstract available.
    Results Reference
    result

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    Comparison of Bladder Filling vs. Non-Filling in Cesarean Hysterectomy for Placenta Percreta

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