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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-06-15

Brief Summary

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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.

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Detailed Description

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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

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Placenta Accreta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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group A

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

Group Type ACTIVE_COMPARATOR

bladder dissection in placenta accreta spectrum

Intervention Type PROCEDURE

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.

group b

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

Group Type ACTIVE_COMPARATOR

bladder dissection in placenta accreta spectrum

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes