Effect of Methylene Blue Bladder Instillation on Urinary Tract Injuries During Cesarean Hysterect… (NCT07129135) | Clinical Trial Compass
CompletedNot Applicable
Effect of Methylene Blue Bladder Instillation on Urinary Tract Injuries During Cesarean Hysterectomy for Placenta Accreta Spectrum
Egypt60 participantsStarted 2023-01-22
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and percentage of patients with intraoperative urinary tract injuries (bladder, ureters).
Timeframe: Intraoperative (Day 0) to 24 hours post operatively.