NCT06562712

Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management

Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.

Detailed description

Placenta accreta spectrum (PAS) is abnormal placental adhesion beyond superficial myometrium, which includes placenta accreta, placenta increta, and placenta percreta. However, there is a desire to preserve the uterus and fertility, so alternatives to hysterectomy are needed. Presently, attempts to avoid hysterectomy include reducing intraoperative hemorrhage such as uterine compression sutures, intrauterine balloon tamponade, pelvic artery ligation, and spiral suturing of the lower uterine segment. Intrauterine balloon tamponade may increase CS scar dehiscence, uterine rupture, and infection. Combined with compression sutures, it may induce uterine necrosis. Placement of balloons in the bilateral internal iliac arteries before caesarean section can reduce uterine artery pressure and intraoperative blood loss during balloon inflation, thus temporarily blocking the main blood supply of the uterus, helping to expose the visual field, shortening the operation time during surgery, and leading to opportunities for timely adjustments to the operative plan during surgery.

Conditions

• Internal Iliac Artery
• Balloon Occlusion
• Placenta Accreta Spectrum

Interventions

Type	Name	Description
PROCEDURE	Conventional management	Patients will be subjected to conventional management for placenta accreta spectrum.
PROCEDURE	Bilateral internal iliac artery balloon occlusion	Patients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum.

Timeline

• Start date: 2024-08-20
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-08-20
• Last updated: 2025-06-26

Locations

1 site across 1 country: Egypt