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

Usama Ahmed Elsaeed Salem, MD

Status: Completed

Conditions: Urinary Tract Injury; Bladder Injury; Cesarean Hysterectomy; Placenta Accreta Spectrum; Abnormal Placentation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07129135

MD-316-2021

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

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

Experimental group

Treatment:

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 group