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

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

Study Overview

• Status: Completed
• Conditions: Placenta Accreta Spectrum; Internal Iliac Artery; Balloon Occlusion
• Intervention / Treatment: Procedure: Conventional management; Procedure: Bilateral internal iliac artery balloon occlusion

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional management; Patients will be subjected to conventional management for placenta accreta spectrum.	Procedure: Conventional management; Patients will be subjected to conventional management for placenta accreta spectrum.
Experimental: Bilateral internal iliac artery balloon occlusion; Patients will be subjected to bilateral internal iliac artery balloon occlusion 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of intraoperative blood loss	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.	Intraoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 17, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: 36264PR753/7/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No