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NCT Number: NCT06957184

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

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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Key information

Conditions

Placenta Accreta Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bladder dissection in placenta accreta spectrum

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.

Primary outcomes

o Blood loss

Time frame: 1 year

assessed by number of soaked towels and suction reservoir)

Study contacts

Contact information is provided by the study sponsor or research team.

Hatem Elsayed, lecturer

CONTACT

00201009525878

salma M hussain, assistan lecturer

CONTACT

[email protected]

00201145895970

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 4, 2025
Registry last updated: May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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