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NCT Number: NCT07129135

Effect of Methylene Blue Bladder Instillation on Urinary Tract Injuries During Cesarean Hysterectomy for Placenta Accreta Spectrum

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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Key information

Conditions

Placenta Accreta Spectrum Abnormal Placentation Bladder Injury Cesarean Hysterectomy Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Accreta Placenta Diseases Pregnancy Complications Urinary Tract Injury Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Preoperative Hemoglobin recorded in g/dl

    Time frame: within 24 hours before surgery

    Venous sample obtained within 24 hours before surgery;Analyzed using the hospital's hematology analyzer; results recorded in g/dL.

  2. Total number of Units of Packed Red Blood Cells (PRBC) Transfused

    Time frame: from surgery start to 24 hours postoperatively

    Total units from surgery start to 24 hours postoperatively, following a standardized transfusion protocol based on predefined hemoglobin thresholds, hemodynamic status, and coagulation parameters.

  3. Total number of Units of Fresh Frozen Plasma (FFP) Transfused

    Time frame: from surgery start to 24 hours postoperatively

    Total units from surgery start to 24 hours postoperatively, given for abnormal coagulation (PT/aPTT >1.5× normal), suspected coagulopathy, or massive transfusion activation.

  4. Total Operative time (minutes)

    Time frame: Measured in minutes from skin incision to closure.

  5. Postoperative Hemoglobin recorded in g/dl

    Time frame: within 24 hours after surgery completion

    Venous sample obtained within 24 hours after surgery completion; earlier if major bleeding or hemodynamic instability occurred. Same analyzer used for consistency.

  6. Number and percentage of patients admitted to ICU postoperatively.

    Time frame: Postoperatively during hospital stay up to 14 days postoperative.

  7. Number of participants with postoperative complications

    Time frame: From time of surgery until hospital discharge (up to 14 days).

    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

  8. Post operative hospital stay : Number of days from surgery to discharge .

    Time frame: Number of days from surgery to discharge (up to 14 days).

    Number of days of hospital stay from surgery to discharge (up to 14 days).

Sponsors and collaborators

Lead sponsor

Usama Ahmed Elsaeed Salem, MD

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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