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

Tanta University

Status: Completed

Conditions: Internal Iliac Artery; Placenta Accreta Spectrum; Balloon Occlusion

Treatments: Procedure: Bilateral internal iliac artery balloon occlusion; Procedure: Conventional management

Study type: Interventional

Funder types: Other

Identifiers

NCT06562712

36264PR753/7/24

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18 to 40 years.
• Women with placenta accreta spectrum based on ultrasound (US) and/or magnetic resonance imaging (MRI) findings.

Exclusion criteria

• Women with a bleeding disorder.
• History of known allergy to contrast media.
• Women with Impaired renal function.
• Emergency cesarean section.
• Women had severe attack of bleeding before the operation affecting patient's general condition.
• Women had previous four or more cesarean scars.
• If ultrasound (US) and magnetic resonance imaging (MRI) suspect the presence of placenta accrete preoperative, then intraoperative the placenta is found to have normal adhesion to the uterine wall, this case will be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Conventional management

Active Comparator group

Description:

Patients will be subjected to conventional management for placenta accreta spectrum.

Treatment:

Procedure: Conventional management

Bilateral internal iliac artery balloon occlusion

Experimental group

Description:

Patients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum.

Treatment:

Procedure: Bilateral internal iliac artery balloon occlusion