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 Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Placenta Accreta Spectrum; Bladder Injury; Cesarean Hysterectomy; Urinary Tract Injury; Abnormal Placentation
• Intervention / Treatment: Procedure: The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11562
      • Faculty of Medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group, Methylene Blue Group, (Filled bladder Group)	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.
No Intervention: Control Group, Standard Care Group, (Not filled bladder Group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: Usama Ahmed Elsaeed Salem, MD

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2023
• Primary Completion (Actual): August 5, 2024
• Study Completion (Actual): August 25, 2024

Study Registration Dates

• First Submitted: August 4, 2025
• First Submitted That Met QC Criteria: August 18, 2025
• First Posted (Actual): August 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Bladder Injury; Methylene Blue; Surgical Complications; Placenta Accreta Spectrum; Cesarean Hysterectomy; Bladder Filling; Ureteric Injury
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Placenta Accreta; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: MD-316-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 12 months after publication of study results for a year.
• IPD Sharing Access Criteria: Data will be shared upon reasonable request by contacting the corresponding author. Researchers must sign a data use agreement to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No