Early vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2023
CompletedStudy Start
First participant enrolled
February 23, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedMarch 2, 2023
February 1, 2023
2 months
February 22, 2023
February 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of blood loss
during cesarean hysterectomy
Secondary Outcomes (4)
Operative time
during cesarean hysterectomy
bladder injury
during cesarean hysterectomy
ureteric injury
during cesarean hysterectomy
Need for massive blood transfusion
during cesarean hysterectomy
Study Arms (2)
Group 1
PLACEBO COMPARATOR18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta
Group 2
EXPERIMENTAL18 pregnant women scheduled for bladder last cesarean hysterectomy
Interventions
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
The bladder dissection is early as in classic cesarean hysterectomy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women with history of any medical disorder with pregnancy eg. gestational diabetes, hypertension, or anemia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
February 22, 2023
First Posted
March 2, 2023
Study Start
February 23, 2023
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
March 2, 2023
Record last verified: 2023-02