Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Amount of intraoperative blood loss
研究概览
简要总结
This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 40 years.
- •Women with placenta accreta spectrum based on ultrasound (US) and/or magnetic resonance imaging (MRI) findings.
排除标准
- •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.
结局指标
主要结局
Amount of intraoperative blood loss
时间窗: Intraoperatively
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.
次要结局
- Number of blood products units transfused(24 hours postoperatively)
- Incidence of hysterectomy(24 hours postoperatively)
- Hospitalization length(28 days postoperatively)
- Operation time(From the start till the end of surgery)
- Intraoperative complications(Intraoperatively)
- Intensive Care Unit (ICU) admission rate(24 hours postoperatively)
研究者
Mohamed Ibrahim Adel Eleissawy
Lecturer of Vascular and Endovascular Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University