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临床试验/NCT04518163
NCT04518163Unknown不适用

Bakri Balloon Tamponade Plus Intravenous Tranexamic Acid During Cesarean Delivery for Placenta Previa: a Randomized Double-blind Controlled Trial

Aswan University Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年9月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Active Comparator

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

Active Comparator

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

发起方
Aswan University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

hany farouk

A Professor

Aswan University Hospital

研究点 (1)

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