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

Not Applicable

Recruiting

• Conditions: Internal Iliac Artery; Balloon Occlusion; Placenta Accreta Spectrum
• Interventions: Procedure: Conventional management; Procedure: Bilateral internal iliac artery balloon occlusion

• Registration Number: NCT06562712
• Lead Sponsor: Tanta University

Brief 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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-17
• Study Start: 2024-08-20
• Study First Posted: 2024-08-20
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Amount of intraoperative blood loss	Intraoperatively	The amount of intraoperative blood loss will be calculated with reference to the contents of the suction apparatus and to weight of the surgical pads and the hemoglobin concentration difference, immediate preoperative (the morning of cesarean delivery) and postoperative (immediately after cesarean delivery) hemoglobin levels.

Secondary Outcome Measures

Name	Time	Method
Number of blood products units transfused	24 hours postoperatively	Number of blood products units transfused will be recorded.
Hospitalization length	28 days postoperatively	Hospitalization length will be recorded from admission till discharge from hospital.
Operation time	From the start till the end of surgery	Operation time will be recorded from start till end of surgery.
Incidence of hysterectomy	24 hours postoperatively	Incidence of hysterectomy will be recorded.
Intraoperative complications	Intraoperatively	Intraoperative complications such as bladder injury, ureteric ligature, and uterine atony will be recorded.
Intensive Care Unit (ICU) admission rate	24 hours postoperatively	Intensive Care Unit (ICU) admission rate will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt