A Comparison Between Bladder Dissection Before and After Uterine Incision During Cesarean Section for Placenta Accreta Spectrum: A Randomized Controlled Study

April 26, 2025 updated by: Ain Shams University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hatem Elsayed, lecturer
  • Phone Number: 00201009525878

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
40 patients will have bladder dissection at the start of caesarean section for patient with morbidly adherent placenta
Procedure: bladder dissection in placenta accreta spectrum

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.
Active Comparator: group b
40 patients will have bladder dissection after closing uterine incision and just before clamping uterine artery in case of caesarean hysterectomy
Procedure: bladder dissection in placenta accreta spectrum

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
o Blood loss
Time Frame: 1 year
assessed by number of soaked towels and suction reservoir)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: khaled saed, professor, direcror

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

April 26, 2025

First Submitted That Met QC Criteria

April 26, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 26, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bladder disection in PAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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