Bakri Balloon Tamponade Plus Intravenous Tranexamic Acid During Cesarean Delivery for Placenta Previa: a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- mean Blood loss after placental separation
研究概览
简要总结
Objective to investigate the effect of adjunctive intravenous tranexamic acid (TA) on blood loss during cesarean section (CS) in patients with placenta previa undergone Bakri balloon tamponade
详细描述
Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate.
Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind randomized controlled trial
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
- •women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
排除标准
- •patients with the high possibility of morbid adherent placenta
- •those presented with severe antepartum hemorrhage
- •Patients with cardiac, hepatic, renal, or thromboembolic disease;
- •hypersensitivity or contraindications of use of tranexamic acid
- •patient refuses to consent
研究组 & 干预措施
study group
Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus 1gm tranexamic acid by intravenous infusion
干预措施: Tranexamic Acid (Drug)
study group
Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus 1gm tranexamic acid by intravenous infusion
干预措施: Bakri Balloon (Device)
control group
Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus saline by intravenous infusion
干预措施: placebo to TA (Drug)
control group
Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus saline by intravenous infusion
干预措施: Bakri Balloon (Device)
结局指标
主要结局
mean Blood loss after placental separation
时间窗: 30 minutes
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
次要结局
- Number of Participants with postpartum hemorrhage(12 hours)
- The number of participant needed of extra surgical maneuvers(30minutes)
研究者
hany farouk
A Professor
Aswan University Hospital
