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

NCT06562712 | Completed

• 1 other identifier: 36264PR753/7/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Internal Iliac Artery; Balloon Occlusion; Placenta Accreta Spectrum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Operation time

  From the start till the end of surgery

• Number of blood products units transfused

  24 hours postoperatively

• Hospitalization length

  28 days postoperatively

• Incidence of hysterectomy

  24 hours postoperatively

• Intensive Care Unit (ICU) admission rate

  24 hours postoperatively

Study Arms (2)

Conventional management

ACTIVE COMPARATOR

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

Procedure: Conventional management

Bilateral internal iliac artery balloon occlusion

EXPERIMENTAL

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

Procedure: Bilateral internal iliac artery balloon occlusion

Interventions

Conventional management PROCEDURE

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

Conventional management

Bilateral internal iliac artery balloon occlusion PROCEDURE

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

Bilateral internal iliac artery balloon occlusion

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women with placenta accreta spectrum
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, 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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Vascular and Endovascular Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 20, 2024
• Study Start: August 20, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)