An interventional study of The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter in Placenta Accreta Spectrum, Abnormal Placentation and Cesarean Hysterectomy, sponsored by Usama Ahmed Elsaeed Salem, MD. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Usama Ahmed Elsaeed Salem, MD · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Procedure: The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter
The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter before uterine incision or bladder dissection to help determine the borders better and enable dissection of the lower uterine segment without excessive bleeding or unintended Bladder kept distended during dissection.
Number and percentage of patients with intraoperative urinary tract injuries (bladder, ureters).
Number and percentage of patients with bladder or ureteric injury confirmed intraoperatively by direct visualization or intraoperative dye testing.
Time frame: Intraoperative (Day 0) to 24 hours post operatively.
Preoperative Hemoglobin recorded in g/dl
Venous sample obtained within 24 hours before surgery;Analyzed using the hospital's hematology analyzer; results recorded in g/dL.
Time frame: within 24 hours before surgery
Total number of Units of Packed Red Blood Cells (PRBC) Transfused
Total units from surgery start to 24 hours postoperatively, following a standardized transfusion protocol based on predefined hemoglobin thresholds, hemodynamic status, and coagulation parameters.
Time frame: from surgery start to 24 hours postoperatively
Total number of Units of Fresh Frozen Plasma (FFP) Transfused
Total units from surgery start to 24 hours postoperatively, given for abnormal coagulation (PT/aPTT \>1.5× normal), suspected coagulopathy, or massive transfusion activation.
Time frame: from surgery start to 24 hours postoperatively
Total Operative time (minutes)
Time frame: Measured in minutes from skin incision to closure.
Postoperative Hemoglobin recorded in g/dl
Venous sample obtained within 24 hours after surgery completion; earlier if major bleeding or hemodynamic instability occurred. Same analyzer used for consistency.
Time frame: within 24 hours after surgery completion
Number and percentage of patients admitted to ICU postoperatively.
Time frame: Postoperatively during hospital stay up to 14 days postoperative.
Number of participants with postoperative complications
Postoperative complications were recorded for each participant from the time of surgery until hospital discharge. Complications included pelvic hematoma and whether or not need relaparotomy , urinoma , thromboembolic events, ileus, and any other clinically significant adverse events documented in the patient's chart
Time frame: 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 of hospital stay from surgery to discharge (up to 14 days).
Time frame: Number of days from surgery to discharge (up to 14 days).
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
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Usama Ahmed Elsaeed Salem, MD