Placenta AccretaNCT06957184
A Comparison Between Bladder Dissection Before and After Uterine Incision During Cesarean Section for Placenta Accreta Spectrum: A Randomized Controlled Study
A study testing bladder dissection in placenta accreta spectrum in people with Placenta Accreta, run by Ain Shams University.
Trial summary
The worldwide incidence of placenta accreta spectrum is increasing, following the trend of rising caesarean delivery. It is an heterogeneous condition associated with a high maternal morbidity and mortality rate (Jauniaux et al., 2018). 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
- What is being tested?
- bladder dissection in placenta accreta spectrum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women with BMI at or under 35kg/m2
- Women with history of at least previous two caesarean section
- Gestational age more than 32 weeks with viable fetus.
- Women with any degree of placenta previa.
- Women with placenta falling in the PAS.
- Willing and able to provide informed consent.
Who cannot join
- o History of urinary bladder injury.
- History of urinary or renal disorders
- Women with coagulation disorders or on anticoagulation therapy.
- Patients who are hemodynamically unstable before skin incision
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hatem Elsayed, lecturer contact
About this study
The worldwide incidence of placenta accreta spectrum is increasing, following the trend of rising caesarean delivery. It is an heterogeneous condition associated with a high maternal morbidity and mortality rate (Jauniaux et al., 2018).
caesarean hysterectomy is considered the gold standard for the treatment of placenta accreta. Also this radical approach is associated with high rates of severe maternal morbidity as hemorrhage and insult to surrounding organs during surgery (Hoffman et al., 2010).
Read more
Surgeons should be able to dissect the bladder safely and confidently through minimally invasive techniques, to avoid surgical injury, it is important to use anatomic landmarks, minimize the use of cauterization (Farhat and Casale, 2018).
All centers are encouraged to develop guidelines to manage the potential urologic complications of these cases tailored to their resources (Taneja and Shah, 2017).
This study aims to evaluate the timing of bladder dissection in caesarean section in patient with placenta accreta spectrum.
Read the detailed description
Objective:
Try to provide preliminary data to judge between two different approaches during caesarean section for morbidly adherent placenta, that's are bladder dissection before and after uterine incision as regard operative time, blood loss, and incidence of urological injuries.
Research Question:
- Does bladder dissection after uterine incision in caesarean sections with PAS avoids bladder injuries compared to bladder dissection before uterine incision and does it affects operative time and blood loss.
Research hypothesis:
- Null Hypothesis (H₀): There is no significant difference in performing bladder dissection prior nor after uterine incision in caesarean sections with PAS
- Alternative Hypothesis (H₁):. bladder dissection before uterine incision in caesarean sections with PAS has superior outcomes compared to bladder dissection after uterine incision.
- Conditions
- Placenta Accreta
- Being tested
- bladder dissection in placenta accreta spectrum
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bladder dissection in placenta accreta spectrumProcedure or surgery
All caesarean sections will be performed by a surgeon who has experience in performing caesarean hysterectomy in both groups.
- Scrubbing the abdomen as usual.
- Subumblical midline skin incision versus Pfannenstiel incision will be chosen according to site of the placenta and previous surgeries.
- In group A careful bladder dissection will be done before uterine incision with ensuring hemostasis, uterine incision will be done above the placenta, after delivering the baby awaiting for placental separation if not proceeding for caesarean hysterectomy.
- In group B uterine incision will be done above the placenta and after delivering the baby awaiting for placental separation if not proceeding to caesarean hysterectomy and dissecting bladder just before clamping uterine artery.
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | 40 patients will have bladder dissection at the start of caesarean section for patient with morbidly adherent placenta Receives: Procedure: bladder dissection in placenta accreta spectrum |
| group b | Active comparator | 40 patients will have bladder dissection after closing uterine incision and just before clamping uterine artery in case of caesarean hysterectomy Receives: Procedure: bladder dissection in placenta accreta spectrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
o Blood loss
assessed by number of soaked towels and suction reservoir)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- khaled saed, professor, Study director, direcror
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957184
- Sponsor's protocol ID
- bladder disection in PAS
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eller AG, Porter TF, Soisson P, Silver RM. Optimal management strategies for placenta accreta. BJOG. 2009 Apr;116(5):648-54. doi: 10.1111/j.1471-0528.2008.02037.x. Epub 2009 Feb 4.
PubMed 19191778Hoffman MS, Karlnoski RA, Mangar D, Whiteman VE, Zweibel BR, Lockhart JL, Camporesi EM. Morbidity associated with nonemergent hysterectomy for placenta accreta. Am J Obstet Gynecol. 2010 Jun;202(6):628.e1-5. doi: 10.1016/j.ajog.2010.03.021.
PubMed 20510963Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.
PubMed 28599899Marshall NE, Fu R, Guise JM. Impact of multiple cesarean deliveries on maternal morbidity: a systematic review. Am J Obstet Gynecol. 2011 Sep;205(3):262.e1-8. doi: 10.1016/j.ajog.2011.06.035. Epub 2011 Jun 15.
PubMed 22071057
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Bladder Dissection Before and After Uterine Incision During Cesarean Section for Placenta Accreta Spectrum: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06957184
- Acronym / sponsor ID
- bladder disection in PAS
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 4 May 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.
The worldwide incidence of placenta accreta spectrum is increasing, following the trend of rising caesarean delivery. It is an heterogeneous condition associated with a high maternal morbidity and mortality rate (Jauniaux et al., 2018).
caesarean hysterectomy is considered the gold standard for the treatment of placenta accreta. Also this radical approach is associated with high rates of severe maternal morbidity as hemorrhage and insult to surrounding organs during surgery (Hoffman et al., 2010).
Surgeons should be able to dissect the bladder safely and confidently through minimally invasive techniques, to avoid surgical injury, it is important to use anatomic landmarks, minimize the use of cauterization (Farhat and Casale, 2018).
All centers are encouraged to develop guidelines to manage the potential urologic complications of these cases tailored to their resources (Taneja and Shah, 2017).
This study aims to evaluate the timing of bladder dissection in caesarean section in patient with placenta accreta spectrum.
Detailed description
Objective:
Try to provide preliminary data to judge between two different approaches during caesarean section for morbidly adherent placenta, that's are bladder dissection before and after uterine incision as regard operative time, blood loss, and incidence of urological injuries.
Research Question:
- Does bladder dissection after uterine incision in caesarean sections with PAS avoids bladder injuries compared to bladder dissection before uterine incision and does it affects operative time and blood loss.
Research hypothesis:
- Null Hypothesis (H₀): There is no significant difference in performing bladder dissection prior nor after uterine incision in caesarean sections with PAS
- Alternative Hypothesis (H₁):. bladder dissection before uterine incision in caesarean sections with PAS has superior outcomes compared to bladder dissection after uterine incision.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: bladder dissection in placenta accreta spectrum40 patients will have bladder dissection at the start of caesarean section for patient with morbidly adherent placenta |
| group b | Active comparator | Procedure: bladder dissection in placenta accreta spectrum40 patients will have bladder dissection after closing uterine incision and just before clamping uterine artery in case of caesarean hysterectomy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women with BMI at or under 35kg/m2
- Women with history of at least previous two caesarean section
- Gestational age more than 32 weeks with viable fetus.
- Women with any degree of placenta previa.
- Women with placenta falling in the PAS.
Key exclusion criteria (4 listed)
- o History of urinary bladder injury.
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 |
|---|---|---|
| bladder dissection in placenta accreta spectrumAll caesarean sections will be performed by a surgeon who has experience in performing caesarean hysterectomy in both groups. * Scrubbing the abdomen as usual. * Subumblical midline skin incision versus Pfannenstiel incision will be chosen according to site of the placenta and previous surgeries. * In group A careful bladder dissection will be done before uterine incision with ensuring hemostasis, uterine incision will be done above the placenta, after delivering the baby awaiting for placental separation if not proceeding for caesarean hysterectomy. * In group B uterine incision will be done above the placenta and after delivering the baby awaiting for placental separation if not proceeding to caesarean hysterectomy and dissecting bladder just before clamping uterine artery. | Procedure or surgery | group A, group b |
Primary outcome
o Blood loss
Time frame: 1 year
assessed by number of soaked towels and suction reservoir)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 19191778Eller AG, Porter TF, Soisson P, Silver RM. Optimal management strategies for placenta accreta. BJOG. 2009 Apr;116(5):648-54. doi: 10.1111/j.1471-0528.2008.02037.x. Epub 2009 Feb 4.
- Background: PubMed 20510963Hoffman MS, Karlnoski RA, Mangar D, Whiteman VE, Zweibel BR, Lockhart JL, Camporesi EM. Morbidity associated with nonemergent hysterectomy for placenta accreta. Am J Obstet Gynecol. 2010 Jun;202(6):628.e1-5. doi: 10.1016/j.ajog.2010.03.021.
- Background: PubMed 28599899Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.
- Background: PubMed 22071057Marshall NE, Fu R, Guise JM. Impact of multiple cesarean deliveries on maternal morbidity: a systematic review. Am J Obstet Gynecol. 2011 Sep;205(3):262.e1-8. doi: 10.1016/j.ajog.2011.06.035. Epub 2011 Jun 15.
- pubmedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hatem Elsayed, lecturer contact
khaled saed, professor study director
direcror
Questions about this trial
What is this clinical trial studying?
A study testing bladder dissection in placenta accreta spectrum in people with Placenta Accreta, run by Ain Shams University.
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 4 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: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact salma M hussain, assistan lecturer (00201145895970, salmaa_mohd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
o Blood loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06957184, which also lists 4 linked publications.
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 4 May 2025.