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

What Was Tested

In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).

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.

It had two arms (groups): Intervention Group, Methylene Blue Group, (Filled bladder Group) (experimental) and Control Group, Standard Care Group, (Not filled bladder Group) (no intervention).

The registry classes the interventions as procedure.

Who Took Part

60 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. BMI \<35 kg/m².

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: previous bladder surgery or known urologic abnormalities; bleeding tendency disorder; renal failure .

How the Study Was Run

It was run as a non-randomized, parallel-group and double-blind study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2023-01-22 with completion listed for 2024-08-05.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Number and percentage of patients with intraoperative urinary tract injuries (bladder, ureters) (time frame: Intraoperative (Day 0) to 24 hours post operatively).

It also tracked 8 secondary outcomes, for example Preoperative Hemoglobin recorded in g/dl, Total number of Units of Packed Red Blood Cells (PRBC) Transfused, Total number of Units of Fresh Frozen Plasma (FFP) Transfused, Total Operative time (minutes), Postoperative Hemoglobin recorded in g/dl and Number and percentage of patients admitted to ICU postoperatively.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Methylene blue (non-peptide stack partner) in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.