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

NCT ID: NCT07129135

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-22
• Study Completion Date: 2025-01-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Usama Ahmed Elsaeed Salem, MD

OTHER

Sponsor Role: lead

Responsible Party

Usama Ahmed Elsaeed Salem, MD

MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Cairo University.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

MD-316-2021

Identifier Type: -

Identifier Source: org_study_id