Is Application of Uterine Fundus Pressure With a Sandbag Effective in Reduction of Cesarean Bleeding? A Prospective Case Control Stud
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 482
- 试验地点
- 1
- 主要终点
- Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.
研究概览
简要总结
Uterine compression methods reduce the amount of postpartum bleeding. In our study, we investigated the effect of fundal pressure, which will be created by a sandbag placed on the abdomen, on reducing post-cesarean bleeding. Material and Methods: A total of 482 patients who delivered by cesarean section (CS) in the Obstetrics Clinic of Fırat University Faculty of Medicine between January 2021 and December 2021 were included in this prospective, randomized, single-center study.
详细描述
A total of 482 patients who gave birth by CS in the Obstetrics Clinic of Fırat University Faculty of Medicine between 1 January 2021 and 31 December 2021 were included in the study. Approval was obtained from the Ethics Committee of Fırat University for this prospective randomized single-center study (Ethics committee date = 15.10.2020; decision no = 2020/14-02). The 482 patients who had CS were divided into two groups, control group (n = 246), weighted group (n = 236) was randomized. Each patient was followed up in our obstetrics clinic until discharge from the hospital after surgery and the data were analyzed. The same techniques were used in all surgical procedures in order not to create differences in terms of surgical techniques and operation times that may affect intraoperative bleeding. However, to minimize inter-operator variations, surgical procedures were performed by operators with sufficient surgical experience.
The standard sandbag used in our clinic was 20 × 20 × 3 cm3 in dimensions and 3 kg in weight. Sandbags of the same standard were used for all patients. After the patient was taken to the patient's bed, the uterine fundus was palpated, and then the sandbag was placed on the abdomen, just above the fundus, in such a way as to apply pressure to the fundus. The sandbag was kept on the abdomen for approximately 6 hours. During this period, the patient was followed up frequently and care was taken not to change the position of the sandbag. Sandbags were removed just before our patients were mobilized (approximately 6 hours). The sandbag was placed on the same spot in each patient by the obstetric assistants in our author team. In addition, preoperative and postoperative follow-ups and data acquisition and storage were performed by the same team 2.1 Study Design
It is a prospective, randomized, controlled single-center study.
2.2 Inclusion Criteria
All cases with CS who had a live pregnancy after 24 weeks of gestation were included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The 482 patients who had CS were divided into two groups, control group (n = 246), weighted group (n = 236) was randomized.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All cases with CS who had a live pregnancy after 24 weeks of gestation were included in the study.
排除标准
- •Invasion anomaly,
- •Diagnosed with preeclampsia,
- •Placenta previa cases,
- •Hypertensive pregnant women receiving antihypertensive therapy,
- •Diabetic pregnant women,
- •Multiple pregnancies,
- •Major hepatic, cardiac, renal, respiratory disorders
- •Deep vein thrombosis during pregnancy,
- •Receiving anticoagulant therapy
- •Patients who developed atony and uterine rupture in the operating room,
- •Suspected placental invasion
- •Uterine balloon tamponade
- •Arterial embolization
- •Uterine and hypogastric artery ligation,
- •Uterine compression sutures
- •Intraoperative blood loss was estimated to be over 1000 mL during CS and who received intraoperative blood transfusion
结局指标
主要结局
Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.
时间窗: 24 hours
Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.
次要结局
未报告次要终点
研究者
Mustafa YILMAZ
Firat University
Firat University