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

Ain Shams University

Status: Not yet enrolling

Conditions: Placenta Accreta

Treatments: Procedure: bladder dissection in placenta accreta spectrum

Study type: Interventional

Funder types: Other

Identifiers

NCT06957184

bladder disection in PAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

group A

Active Comparator group

Description:

40 patients will have bladder dissection at the start of caesarean section for patient with morbidly adherent placenta

Treatment:

Procedure: bladder dissection in placenta accreta spectrum

group b

Active Comparator group

Description:

40 patients will have bladder dissection after closing uterine incision and just before clamping uterine artery in case of caesarean hysterectomy

Treatment:

Procedure: bladder dissection in placenta accreta spectrum