Glove-loaded Foley's Catheter Tamponade to Reducing Blood Loss During Cesarean Delivery for Complete Placenta Previa: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- intraoperative blood loss
研究概览
简要总结
Objective: To investigate the effect of A glove-loaded Foley's catheter tamponade versus stepwise uterine devascularization on blood loss during cesarean section (CS) in patients with complete placenta previa.
详细描述
Postpartum hemorrhage (PPH) due to placenta previa is usually from the placental bed at the lower uterine segment and it occurs after the placenta separation.
Despite placenta previa can be diagnosed by obstetrician before delivery nowadays, still a leading etiology of maternal mortality and morbidity.
Placenta previa is an obstetric condition that is closely linked with massive obstetric hemorrhage. Is not only associated with increased chance of requiring massive transfusion (> 3 units of packed red blood cells) but also a is now the leading etiology of the cesarean hysterectomies. The incidence has progressively risen worldwide, mainly due to the increasing rates of cesarean section.
Uterine tamponade can be considered as a line of treatment before performing surgical procedures in PPH resulting from the placental site bleeding. It can save the life, avoid laparotomy and preserve fertility.
Nowadays, the use of intrauterine balloons has been developed and become effective for the control of placental site bleeding not responding to medical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The participants were blinded to the procedure performed.
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 pregnant women with a single-term fetus scheduled for elective CD for complete placenta previa
排除标准
- •• Patients with the cardiac, hepatic, renal, or thromboembolic disease;
- •patients with the high possibility of morbid adherent placenta;
- •known coagulopathy, and
- •those presented with severe antepartum hemorrhage were excluded.
结局指标
主要结局
intraoperative blood loss
时间窗: during the operation
blood loss during operation
次要结局
- need for blood transfusion(intraoperative and post operative 4 hours blood loss estimation)
- cesarean hysterectomy(intraoperative)
- postoperative blood loss(4 hours post operative)
研究者
hany farouk
lecturer
Aswan University Hospital