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

NCT ID: NCT06562712

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2024-12-01

Brief Summary

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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

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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

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Internal Iliac Artery Balloon Occlusion Placenta Accreta Spectrum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional management

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

Group Type ACTIVE_COMPARATOR

Conventional management

Intervention Type PROCEDURE

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

Bilateral internal iliac artery balloon occlusion

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

Group Type EXPERIMENTAL

Bilateral internal iliac artery balloon occlusion

Intervention Type PROCEDURE

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

Interventions

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Conventional management

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

Intervention Type PROCEDURE

Bilateral internal iliac artery balloon occlusion

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ibrahim Adel Eleissawy

Lecturer of Vascular and Endovascular Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264PR753/7/24

Identifier Type: -

Identifier Source: org_study_id

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