Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management
NCT ID: NCT06562712
Last Updated: 2025-06-26
Study Results
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2024-08-20
2024-12-01
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional management
Patients will be subjected to conventional management for placenta accreta spectrum.
Conventional management
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.
Bilateral internal iliac artery balloon occlusion
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.
Bilateral internal iliac artery balloon occlusion
Patients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum.
Eligibility Criteria
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Inclusion Criteria
* Women with placenta accreta spectrum based on ultrasound (US) and/or magnetic resonance imaging (MRI) findings.
Exclusion Criteria
* 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.
18 Years
40 Years
FEMALE
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Mohamed Ibrahim Adel Eleissawy
Lecturer of Vascular and Endovascular Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.
Locations
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Tanta University
Tanta, El-Gharbia, Egypt
Countries
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Other Identifiers
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36264PR753/7/24
Identifier Type: -
Identifier Source: org_study_id
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