Trials / Completed
CompletedNCT07129135
Effect of Methylene Blue Bladder Instillation on Urinary Tract Injuries During Cesarean Hysterectomy for Placenta Accreta Spectrum
The Effect of Methylene Blue Bladder Instillation Versus No Intervention on Urinary Tract Injuries During Cesarean Hysterectomy for Placenta Accreta Spectrum: A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Usama Ahmed Elsaeed Salem, MD · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
This randomized controlled trial 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.
Conditions
- Placenta Accreta Spectrum
- Abnormal Placentation
- Cesarean Hysterectomy
- Urinary Tract Injury
- Bladder Injury
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-01-22
- Primary completion
- 2025-01-05
- Completion
- 2025-01-25
- First posted
- 2025-08-19
- Last updated
- 2025-08-22
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT07129135. Inclusion in this directory is not an endorsement.