Placenta Accreta SpectrumNCT05752513
Early vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion
A study testing Late bladder dissection and early bladder dissection in people with Placenta Accreta Spectrum and Cesarean Hysterectomy, run by Cairo University at 1 site in Egypt.
Trial summary
Thirty-six singleton pregnant women with PAS and bladder invasion; total anterior or anterolateral invasion, who were scheduled for cesarean hysterectomy were randomly assigned into two equal groups Group 1: included 18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta with or without… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta Spectrum, Cesarean Hysterectomy
- What is being tested?
- Late bladder dissection and early bladder dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Feb 2023to 1 May 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: reproductive age.
- Pregnant with singleton living fetus.
- Previous one or more cesarean sections.
- Gestational age: > 34 weeks.
- Elective or non-emergency cesarean sections.
- Preoperative hemoglobin more than 9.5 gm/dl.
Who cannot join
- Women with history of any medical disorder with pregnancy eg. gestational diabetes, hypertension, or anemia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Ahmed Rashwan, 01002592250, ahmedrashwan1981@gmail.com
About this study
Official title: Early vs Late Bladder Dissection During Cesarean Hysterectomy in Patients With Placenta Accreta Spectrum With Bladder Invasion
Thirty-six singleton pregnant women with PAS and bladder invasion; total anterior or anterolateral invasion, who were scheduled for cesarean hysterectomy were randomly assigned into two equal groups
- Group 1: included 18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta with or without ligation of anterior division of internal iliac artery before cesarean section.
- Group 2: included 18 pregnant women scheduled for bladder last cesarean hysterectomy with or without ligation of anterior division of internal iliac artery.
- Conditions
- Placenta Accreta Spectrum, Cesarean Hysterectomy
- Being tested
- Late bladder dissection, early bladder dissection
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Late bladder dissectionProcedure or surgery
The bladder dissection is reserved as the last step of the cesarean hysterectomy with excellent dissection of the ureteric course till the ureteric tunnel to reduce the incidence of inadvertent ureteric clamping during uterine vessel ligating and transection
early bladder dissectionProcedure or surgery
The bladder dissection is early as in classic cesarean hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | 18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta Receives: Procedure: early bladder dissection |
| Group 2 | Experimental | 18 pregnant women scheduled for bladder last cesarean hysterectomy Receives: Procedure: Late bladder dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood loss
Measured: during cesarean hysterectomy
Secondary outcomes (4)
Operative time
Measured: during cesarean hysterectomy
bladder injury
Measured: during cesarean hysterectomy
ureteric injury
Measured: during cesarean hysterectomy
Need for massive blood transfusion
Measured: during cesarean hysterectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start23 Feb 2023
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalla Mousa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752513
- Sponsor's protocol ID
- MS-345-2022
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early vs Late Bladder Dissection During Cesarean Hysterectomy in Patients With Placenta Accreta Spectrum With Bladder Invasion
- ClinicalTrials.gov ID
- NCT05752513
- Acronym / sponsor ID
- MS-345-2022
- Conditions
- Placenta Accreta Spectrum, Cesarean Hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 2 Mar 2023 (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.
Thirty-six singleton pregnant women with PAS and bladder invasion; total anterior or anterolateral invasion, who were scheduled for cesarean hysterectomy were randomly assigned into two equal groups
- Group 1: included 18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta with or without ligation of anterior division of internal iliac artery before cesarean section.
- Group 2: included 18 pregnant women scheduled for bladder last cesarean hysterectomy with or without ligation of anterior division of internal iliac artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Procedure: early bladder dissection18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta |
| Group 2 | Experimental | Procedure: Late bladder dissection18 pregnant women scheduled for bladder last cesarean hysterectomy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: reproductive age.
- Pregnant with singleton living fetus.
- Previous one or more cesarean sections.
- Gestational age: > 34 weeks.
- Elective or non-emergency cesarean sections.
Key exclusion criteria (1 listed)
- Women with history of any medical disorder with pregnancy eg. gestational diabetes, hypertension, or anemia.
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 |
|---|---|---|
| Late bladder dissectionThe bladder dissection is reserved as the last step of the cesarean hysterectomy with excellent dissection of the ureteric course till the ureteric tunnel to reduce the incidence of inadvertent ureteric clamping during uterine vessel ligating and transection | Procedure or surgery | Group 2 |
| early bladder dissectionThe bladder dissection is early as in classic cesarean hysterectomy | Procedure or surgery | Group 1 |
Primary outcome
Amount of blood loss
Time frame: during cesarean hysterectomy
4 secondary outcomes
Operative time
Time frame: during cesarean hysterectomy
bladder injury
Time frame: during cesarean hysterectomy
ureteric injury
Time frame: during cesarean hysterectomy
Need for massive blood transfusion
Time frame: during cesarean hysterectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Late bladder dissection and early bladder dissection in people with Placenta Accreta Spectrum and Cesarean Hysterectomy, run by Cairo University 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdalla Mousa, Lecturer (01277664430, Dr_abdallamousa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of blood loss (time frame: during cesarean hysterectomy). 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 2 Mar 2023.