Blue dye may shield bladder in dangerous placenta surgeries
NCT ID NCT07129135
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether filling the bladder with a blue dye before surgery helps surgeons avoid accidentally injuring the bladder or ureters during a cesarean hysterectomy for placenta accreta. Sixty women were randomly assigned to receive the dye or standard care. The goal was to see if the dye reduces urinary tract injuries and improves recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- methylene blue dye
- What this could lead to
- If it works, this simple procedure could reduce bladder and ureter injuries during high-risk cesarean hysterectomy.
- What could go wrong
- This is a small, completed study with only 60 participants, so results may not apply to all patients. The dye may cause allergic reactions or not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
60 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Aug 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Faculty of Medicine, Cairo University
Cairo, Cairo Governorate, 11562, Egypt
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Other studies related to the condition(s) this trial covers.
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