The Effect of Methylene Blue Bladder Instillation Versus No Intervention on Urinary Tract Injuries During Cesarean Hysterectomy for Placenta Accreta Spectrum: A Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Number and percentage of patients with intraoperative urinary tract injuries (bladder, ureters).
Study Overview
Brief Summary
This prospective cohort study aims to evaluate whether preoperative bladder filling with methylene blue dye can reduce the incidence of urinary tract injuries during cesarean hysterectomy in patients diagnosed with placenta accreta spectrum. A total of 60 patients will be randomly assigned to either an intervention group receiving methylene blue bladder instillation or a control group receiving standard surgical care. The primary outcome is the rate of intraoperative urinary tract injuries. Secondary outcomes include total operative time, , and pre and post operative hemoglobin level , number of units of packed RBCs transfused, number of units of fresh frozen plasma transfused, number of participants admitted to ICU postoperatively,number of participants with postoperative complications, duration of hospital stay of participants.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-45 years
- •Pregnant women diagnosed antenatally with placenta accreta spectrum (PAS).
- •Pregnant women with history of previous one or more caesarian deliveries .
- •Planned cesarean hysterectomy at ≥33 weeks of gestation.
- •Singleton pregnancy.
- •BMI <35 kg/m²
- •Suitable for standardized General anaesthesia
Exclusion Criteria
- •Previous bladder surgery or known urologic abnormalities.
- •Bleeding tendency disorder
- •Renal failure .
- •Allergy to methylene blue dye.
- •Emergency hysterectomy without time for protocol preparation.
- •Conservative uterine- preservation management.
- •Refusal or inability to provide informed written consent
Arms & Interventions
Control Group, Standard Care Group, (Not filled bladder Group)
Intervention Group, Methylene Blue Group, (Filled bladder Group)
Intervention: The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter (Procedure)
Outcomes
Primary Outcomes
Number and percentage of patients with intraoperative urinary tract injuries (bladder, ureters).
Time Frame: Intraoperative (Day 0) to 24 hours post operatively.
Number and percentage of patients with bladder or ureteric injury confirmed intraoperatively by direct visualization or intraoperative dye testing.
Secondary Outcomes
- Preoperative Hemoglobin recorded in g/dl(within 24 hours before surgery)
- Total number of Units of Packed Red Blood Cells (PRBC) Transfused(from surgery start to 24 hours postoperatively)
- Total number of Units of Fresh Frozen Plasma (FFP) Transfused(from surgery start to 24 hours postoperatively)
- Total Operative time (minutes)(Measured in minutes from skin incision to closure.)
- Postoperative Hemoglobin recorded in g/dl(within 24 hours after surgery completion)
- Number and percentage of patients admitted to ICU postoperatively.(Postoperatively during hospital stay up to 14 days postoperative.)
- Number of participants with postoperative complications(From time of surgery until hospital discharge (up to 14 days).)
- Post operative hospital stay : Number of days from surgery to discharge .(Number of days from surgery to discharge (up to 14 days).)
Investigators
Usama Ahmed Elsaeed Salem, MD
MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Cairo University.
Cairo University