Clinical trial NCT06562712: Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management
Official title: Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Internal Iliac Artery
Balloon Occlusion
Placenta Accreta Spectrum
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Amount of intraoperative blood loss
timeFrame: Intraoperatively
Secondary outcomes:
measure: Operation time
timeFrame: From the start till the end of surgery
measure: Number of blood products units transfused
timeFrame: 24 hours postoperatively
measure: Hospitalization length
timeFrame: 28 days postoperatively
measure: Incidence of hysterectomy
timeFrame: 24 hours postoperatively
measure: Intensive Care Unit (ICU) admission rate
timeFrame: 24 hours postoperatively
measure: Intraoperative complications
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: