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
About this trial
This is an interventional prevention trial for Placenta Accreta
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.
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
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
Learn more about this trial
Comparison of Bladder Filling vs. Non-Filling in Cesarean Hysterectomy for Placenta Percreta
We'll reach out to this number within 24 hrs