Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery (SPARTACUS) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraoperative quantified blood loss
研究概览
简要总结
Background: An optimal international standard for PAS surgery is not yet available, and the establishment of a suitable surgical method is an important focus of in PAS management.
Objective: To assess the efficacy and safety of tourniquet uses for conservative approach in the management of placenta accerta spectrum.
Patients and Methods: 40 pregnant women who underwent conservative management of placenta accrete at Kasr El-Aini hospital (Obstetrics and gynecology department - Faculty of medicine - Cairo university) were included and were divided according to the use of tourniquet into 2 equal groups: Study group (tourniquet group): consists of 20 women for whom tourniquet was used in the lower part of the uterus during surgical treatment of placenta accreta spectrum.Control group (no tourniquet group): consists of 20 women for whom no tourniquet was used.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant females with previous CS deliveries (at least 1).
- •Patients with ultrasound criteria of placenta accerta spectrum.
- •Patients desiring fertility (uterine conservation).
- •Patients with gestational age that completed 34 weeks (or more) confirmed by the 1st day of the LMP or 1st trimester ultrasound scan.
排除标准
- •Maternal age above 40 years.
- •Chronic medical disorders (e.g., cardiac, renal, DM and hepatic diseases).
- •Patients presented with severe antepartum hemorrhage (unstable vital signs).
- •Patients requested radical management (caesarean hysterectomy).
研究组 & 干预措施
conservation without the use of a tourniquet
surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, without the use of a tourniquet
干预措施: Conventional conservative surgery (Procedure)
conservation with the use of a tourniquet
surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, with the use of a uterovesical tourniquet before fetal extraction
干预措施: Uterovesical tourniquet before uterine devascularization steps (Procedure)
结局指标
主要结局
Intraoperative quantified blood loss
时间窗: during operation
Quantified blood loss estimate with the tourniquet
次要结局
- amount of blood and blood product transfusion(during operation and 48 hours post operative)
研究者
Abdalla Mousa
Lecturer of obgyn Cairo university
Cairo University