Placenta Accreta SpectrumNCT07129135
Effect of Methylene Blue Bladder Instillation on Urinary Tract Injuries During Cesarean Hysterectomy for Placenta Accreta Spectrum
A study testing The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter in people with Placenta Accreta Spectrum and Abnormal Placentation, run by Usama Ahmed Elsaeed Salem, MD at 1 site in Egypt.
Trial summary
This prospective cohort study 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Accreta Spectrum, Abnormal Placentation, Cesarean Hysterectomy
- What is being tested?
- The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2023to 25 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to 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.
- Singleton pregnancy.
- BMI <35 kg/m²
- Suitable for standardized General anaesthesia
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Cairo University
Cairo, Cairo Governorate, 11562
About this study
Official title: The Effect of Methylene Blue Bladder Instillation Versus No Intervention on Urinary Tract Injuries During Cesarean Hysterectomy for Placenta Accreta Spectrum: A Prospective Cohort Study
This prospective cohort study 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
- Being tested
- The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter
- Keywords
- Placenta Accreta Spectrum, Cesarean Hysterectomy, Methylene Blue, Bladder Filling, Bladder Injury, Ureteric Injury, Surgical Complications
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheterProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group, Methylene Blue Group, (Filled bladder Group) | Experimental | Not described Receives: 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (Day 0) to 24 hours post operatively.
Secondary outcomes (8)
Preoperative Hemoglobin recorded in g/dl
Venous sample obtained within 24 hours before surgery;Analyzed using the hospital's hematology analyzer; results recorded in g/dL.
Measured: within 24 hours before surgery
Total number of Units of Packed Red Blood Cells (PRBC) Transfused
Total units from surgery start to 24 hours postoperatively, following a standardized transfusion protocol based on predefined hemoglobin thresholds, hemodynamic status, and coagulation parameters.
Measured: from surgery start to 24 hours postoperatively
Total number of Units of Fresh Frozen Plasma (FFP) Transfused
Total units from surgery start to 24 hours postoperatively, given for abnormal coagulation (PT/aPTT >1.5× normal), suspected coagulopathy, or massive transfusion activation.
Measured: from surgery start to 24 hours postoperatively
Total Operative time (minutes)
Measured: Measured in minutes from skin incision to closure.
Postoperative Hemoglobin recorded in g/dl
Venous sample obtained within 24 hours after surgery completion; earlier if major bleeding or hemodynamic instability occurred. Same analyzer used for consistency.
Measured: within 24 hours after surgery completion
Number and percentage of patients admitted to ICU postoperatively.
Measured: Postoperatively during hospital stay up to 14 days postoperative.
Number of participants with postoperative complications
Postoperative complications were recorded for each participant from the time of surgery until hospital discharge. Complications included pelvic hematoma and whether or not need relaparotomy , urinoma , thromboembolic events, ileus, and any other clinically significant adverse events documented in the patient's chart
Measured: From time of surgery until hospital discharge (up to 14 days).
Post operative hospital stay : Number of days from surgery to discharge .
Number of days of hospital stay from surgery to discharge (up to 14 days).
Measured: Number of days from surgery to discharge (up to 14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start22 Jan 2023
- Primary completion5 Aug 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta SpectrumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Usama Ahmed Elsaeed Salem, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Usama Ahmed Elsaeed Salem, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129135
- Sponsor's protocol ID
- MD-316-2021
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Methylene Blue Bladder Instillation Versus No Intervention on Urinary Tract Injuries During Cesarean Hysterectomy for Placenta Accreta Spectrum: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07129135
- Acronym / sponsor ID
- MD-316-2021
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Usama Ahmed Elsaeed Salem, MDUniversity, hospital or other
- Study start
- 22 Jan 2023 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective cohort study 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- Previous bladder surgery or known urologic abnormalities.
- Bleeding tendency disorder
- Renal failure .
- Allergy to methylene blue dye.
- Emergency hysterectomy without time for protocol preparation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheterThe 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. | Procedure or surgery | Intervention Group, Methylene Blue Group, (Filled bladder Group) |
Primary outcome
Number and percentage of patients with intraoperative urinary tract injuries (bladder, ureters).
Time frame: Intraoperative (Day 0) to 24 hours post operatively.
Number and percentage of patients with bladder or ureteric injury confirmed intraoperatively by direct visualization or intraoperative dye testing.
8 secondary outcomes
Preoperative Hemoglobin recorded in g/dl
Time frame: within 24 hours before surgery
Total number of Units of Packed Red Blood Cells (PRBC) Transfused
Time frame: from surgery start to 24 hours postoperatively
Total number of Units of Fresh Frozen Plasma (FFP) Transfused
Time frame: from surgery start to 24 hours postoperatively
Total Operative time (minutes)
Time frame: Measured in minutes from skin incision to closure.
Postoperative Hemoglobin recorded in g/dl
Time frame: within 24 hours after surgery completion
Number and percentage of patients admitted to ICU postoperatively.
Time frame: Postoperatively during hospital stay up to 14 days postoperative.
Number of participants with postoperative complications
Time frame: From time of surgery until hospital discharge (up to 14 days).
Post operative hospital stay : Number of days from surgery to discharge .
Time frame: Number of days from surgery to discharge (up to 14 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter in people with Placenta Accreta Spectrum and Abnormal Placentation, run by Usama Ahmed Elsaeed Salem, MD at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of patients with intraoperative urinary tract injuries (bladder, ureters). (time frame: Intraoperative (Day 0) to 24 hours post operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.