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临床试验/NCT03741075
NCT03741075Unknown不适用

Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Hemorrhagic Cesarean Delivery for Complete 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 100 人开始时间: 2018年12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
100
试验地点
1
主要终点
Number of Participants with postpartum hemorrhage

研究概览

简要总结

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.

Various conservative measures have been developed to avoid hysterectomy and preserve fertility in patients with PP. Bilateral Uterine artery ligation (BUAL) is one of the reported surgical procedures carried out in these cases as it is easy and quick. It can be used alone or with adjunctive measures with a fair success rate. The aim is to reduce the blood supply to the uterus and to prevent postpartum hemorrhage.

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.

详细描述

Study inclusion criteria will be women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures Eligible participants were allocated to one of two groups. Group (I): patients managed by bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures. Group (II): patients received 1 gm TA (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) topically applied to the placental bed plus BUA when not respond to uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures.

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

The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which was used

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

BUAL plus placebo

Active Comparator

bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus 200 ml saline topical application to placental bed

干预措施: BUA (Procedure)

BUAL plus placebo

Active Comparator

bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus 200 ml saline topical application to placental bed

干预措施: placebo (Drug)

BUAL plus topical tranexamic acid

Experimental

bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus topical application of 20ml saline contains 2 gm tranexamic acid

干预措施: BUA (Procedure)

BUAL plus topical tranexamic acid

Experimental

bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus topical application of 20ml saline contains 2 gm tranexamic acid

干预措施: topical tranexamic acid (Drug)

结局指标

主要结局

Number of Participants with postpartum hemorrhage

时间窗: 6 hours post operative

number pf participants with blood loss \> 1000ml

次要结局

  • The number of participant needed for blood transfusion(24 hours post operative)
  • The number of participant needed of extra surgical maneuvers(24 hours post operative)
  • intraoperative blood loss(during the operation)

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

Principal Investigator

Aswan University Hospital

研究点 (1)

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