Cystoinflation to Prevent Bladder Injury in Cases of Placenta Accreta Spectrum

NCT07050082 | Completed DMC

• 1 other identifier: Cystoinflation in PAS cases
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Injury; Accreta, Placenta

Outcome Measures

Primary Outcomes (1)

• Incidence of bladder injury in two groups

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

  18 months

Study Arms (2)

Bladder filling

EXPERIMENTAL

42 case of PAS , bladder dissection done after filling bladder with 200 cc saline

Procedure: Bladder dissection after filling with 200 cc saline solution

Non bladder filling

ACTIVE COMPARATOR

42 case of PAS , bladder dissection done with empty bladder

Other: Bladder dissection with empty bladder

Interventions

Bladder dissection after filling with 200 cc saline solution PROCEDURE

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

Also known as: Bladder filling, Cystoinflation, Bladder dissection

Bladder filling

Bladder dissection with empty bladder OTHER

After entering peritoneal cavity, bladder dissection done with empty bladder

Also known as: Classic bladder dissection

Non bladder filling

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• medical disorders
• History of bladder injury or previous bladder surgery

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: June 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: September 10, 2025

Record last verified: 2023-06

Locations

EG (1)