Completed

NCT Number: NCT07050082

Cystoinflation to Prevent Bladder Injury in Cases of Placenta Accreta Spectrum

Placenta accreta spectrum (PAS) disorders are associated with a high risk of bladder injury .leading to increased morbidity. Cystoinflation, involving controlled retrograde bladder filling, has been proposed as a technique to improve intraoperative visualization and reduce bladder injuries.

Objective To evaluate the efficacy and safety of cystoinflation in preventing bladder injuries in cases of PAS.

Methods This randomized controlled trial included 84 women diagnosed with PAS, allocated equally into cystoinflation and control groups. The cystoinflation group underwent bladder filling with 200 mL saline to facilitate dissection, while the control group did not. Primary outcome measures included the incidence of bladder injury, operative time. Data were analyzed using appropriate statistical tests with significance set at p<0.05.

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Key information

Conditions

Bladder Injury Accreta, Placenta Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Accreta Placenta Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine Cairo university

Cairo, Egypt

About this study

The global incidence of placenta accreta spectrum (PAS) disorders are rising in parallel with the increasing rates of cesarean delivery, posing significant challenges in obstetric practice due to its association with severe maternal morbidity and mortality . PAS encompasses a spectrum of abnormal placental adherence, which can lead to life-threatening hemorrhage during delivery.

In response to the limitations of traditional terminology (placenta accreta, increta, percreta), the International Federation of Gynecology and Obstetrics introduced a standardized classification under the umbrella of PAS disorders, aiming to improve diagnostic clarity and clinical management.

Surgical management recognized as the standard of care for invasive placentation .However, this procedure carries a substantial risk, with severe maternal morbidity rates reaching 40-50%, primarily due to hemorrhage and injury to adjacent organs. In extreme cases, maternal mortality may reach up to 7% .The complexity of the surgery is heightened by the high risk of adjacent organ injury, with an adjusted odds ratio of 8.2 for damage to nearby structures .

Among these complications, urinary tract injury is notably prevalent. Risk factors include the depth and lateral extension of placental invasion, the extent of intraoperative blood loss, and the number of prior cesarean sections . Urinary tract trauma occurs in approximately 29% of PAS-related surgeries, with bladder lacerations accounting for 76%, ureteral injuries for 17%, and genitourinary fistulas for 5% . Although injuries to the bowel, pelvic vasculature, and nerves are less common, they remain clinically significant .

Bladder injury, in particular, has profound implications, contributing to prolonged operative time, urinary tract infections, voiding dysfunction, and extended catheterization, all of which adversely affect a patient's physical and psychological well-being .While routine preoperative bladder catheterization aids in visualizing the surgical field, it often fails to prevent bladder injury in cases with dense adhesions.

This study aims to assess the efficacy and safety of bladder filling with 200 cc saline during bladder dissection in women diagnosed with PAS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Gestational age 34 weeks or more
BMI 18.5-29.9
Placcenta accreta diagnosed by ultrasound
Previous caesarian section
General anaesthetia

Exclusion criteria

medical disorders
History of bladder injury or previous bladder surgery

Treatment and study plan

Bladder dissection after filling with 200 cc saline solution

Procedure

Bladder filling after entering peritoneal cavity, then bladder dissection done to avoid bladder injury

Other names: Bladder filling, Cystoinflation, Bladder dissection

Bladder dissection with empty bladder

Other

After entering peritoneal cavity, bladder dissection done with empty bladder

Other names: Classic bladder dissection

Primary outcomes

Incidence of bladder injury in two groups

Time frame: 18 months

Comparing incidence of bladder injury in cases of PAS with and without bladder filling

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Cystoinflation to Prevent Bladder Injury in Cases of Placenta Accreta Spectrum , a Randomized Controlled Trial

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Jul 3, 2025
Registry last updated: Sep 10, 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.

Completed