Back to resultsEarly vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion
Primary Purpose
Placenta Accreta Spectrum, Cesarean Hysterectomy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Late bladder dissection
early bladder dissection
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta Spectrum
Eligibility Criteria
Inclusion Criteria: Age: reproductive age. Pregnant with singleton living fetus. Previous one or more cesarean sections. Gestational age: > 34 weeks. Elective or non-emergency cesarean sections. Preoperative hemoglobin more than 9.5 gm/dl. Exclusion Criteria: Women with history of any medical disorder with pregnancy eg. gestational diabetes, hypertension, or anemia.
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Group 1
Group 2
Arm Description
18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta
18 pregnant women scheduled for bladder last cesarean hysterectomy
Outcomes
Primary Outcome Measures
Amount of blood loss
Secondary Outcome Measures
Operative time
bladder injury
ureteric injury
Need for massive blood transfusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05752513
Brief Title
Early vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion
Official Title
Early vs Late Bladder Dissection During Cesarean Hysterectomy in Patients With Placenta Accreta Spectrum With Bladder Invasion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
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
Thirty-six singleton pregnant women with PAS and bladder invasion; total anterior or anterolateral invasion, who were scheduled for cesarean hysterectomy were randomly assigned into two equal groups
Group 1: included 18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta with or without ligation of anterior division of internal iliac artery before cesarean section.
Group 2: included 18 pregnant women scheduled for bladder last cesarean hysterectomy with or without ligation of anterior division of internal iliac artery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta Spectrum, Cesarean Hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta
Arm Title
Group 2
Arm Type
Experimental
Arm Description
18 pregnant women scheduled for bladder last cesarean hysterectomy
Intervention Type
Procedure
Intervention Name(s)
Late bladder dissection
Intervention Description
The bladder dissection is reserved as the last step of the cesarean hysterectomy with excellent dissection of the ureteric course till the ureteric tunnel to reduce the incidence of inadvertent ureteric clamping during uterine vessel ligating and transection
Intervention Type
Procedure
Intervention Name(s)
early bladder dissection
Intervention Description
The bladder dissection is early as in classic cesarean hysterectomy
Primary Outcome Measure Information:
Title
Amount of blood loss
Time Frame
during cesarean hysterectomy
Secondary Outcome Measure Information:
Title
Operative time
Time Frame
during cesarean hysterectomy
Title
bladder injury
Time Frame
during cesarean hysterectomy
Title
ureteric injury
Time Frame
during cesarean hysterectomy
Title
Need for massive blood transfusion
Time Frame
during cesarean hysterectomy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: reproductive age.
Pregnant with singleton living fetus.
Previous one or more cesarean sections.
Gestational age: > 34 weeks.
Elective or non-emergency cesarean sections.
Preoperative hemoglobin more than 9.5 gm/dl.
Exclusion Criteria:
Women with history of any medical disorder with pregnancy eg. gestational diabetes, hypertension, or anemia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdalla Mousa, Lecturer
Phone
01277664430
Email
Dr_abdallamousa@hotmail.com
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Rashwan
Phone
01002592250
Email
ahmedrashwan1981@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Early vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion
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