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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group, Methylene Blue Group, (Filled bladder Group) | Experimental |
| |
| Control Group, Standard Care Group, (Not filled bladder Group) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative (Day 0) to 24 hours post operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 24 hours before surgery |
| Total number of Units of Packed Red Blood Cells (PRBC) Transfused |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Cairo University | Cairo | Cairo Governorate | 11562 | Egypt |
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12 months after publication of study results for a year.
Data will be shared upon reasonable request by contacting the corresponding author. Researchers must sign a data use agreement to access the data.
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Total units from surgery start to 24 hours postoperatively, following a standardized transfusion protocol based on predefined hemoglobin thresholds, hemodynamic status, and coagulation parameters. |
| 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. | 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 | Venous sample obtained within 24 hours after surgery completion; earlier if major bleeding or hemodynamic instability occurred. Same analyzer used for consistency. | 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 | 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 | 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). | Number of days from surgery to discharge (up to 14 days). |
| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010922 | Placenta Diseases |
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