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

NCT07129135 | Completed DMC

• 1 other identifier: MD-316-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Placenta Accreta Spectrum; Cesarean Hysterectomy; Methylene Blue; Bladder Filling; Bladder Injury; Ureteric Injury; Surgical Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Preoperative Hemoglobin recorded in g/dl

  within 24 hours before surgery

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

  from surgery start to 24 hours postoperatively

• Total number of Units of Fresh Frozen Plasma (FFP) Transfused

  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

  within 24 hours after surgery completion

Study Arms (2)

Intervention Group, Methylene Blue Group, (Filled bladder Group)

EXPERIMENTAL

Procedure: The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter

Control Group, Standard Care Group, (Not filled bladder Group)

NO INTERVENTION

Interventions

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.

Intervention Group, Methylene Blue Group, (Filled bladder Group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Usama Ahmed Elsaeed Salem, MD: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, 11562, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Cairo University.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 19, 2025
• Study Start: January 22, 2023
• Primary Completion: January 5, 2025
• Study Completion: January 25, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after publication of study results for a year.
• 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.

Locations

EG (1)